Download National Medical Policy

National Medical Policy
Subject:
Prophylactic Mastectomy
Policy Number:
NMP21
Effective Date*:
September 2003
Updated:
May 2016
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
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Prophylactic Mastectomy May 16
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Current Policy Statement
Please refer to the HN NMP on Genetic Testing for BRCA1 and BRCA2
Health Net, Inc. considers prophylactic mastectomy medically necessary for patients
with a high risk of hereditary breast cancer when they meet the following criteria.
These criteria are based on a position statement on Prophylactic Mastectomy
developed by the Society of Surgical Oncology.
Health Net, Inc. considers reduction mammoplasty, as an alternative to prophylactic
mastectomy for women at high risk of developing breast cancer for the primary
purpose of reducing cancer risk, not medically necessary due to lack of evidence from
peer reviewed randomized control trials comparing the efficacy of reduction
mammoplasty to other recommended options for the prevention of breast cancer in
these individuals.
Bilateral Prophylactic Mastectomy
Bilateral prophylactic mastectomy is medically necessary in patients with no cancer
diagnosis in any of the following clinical scenerios that portend a high risk of cancer:
1. Atypical hyperplasia of lobular or ductal origin confirmed on biopsy by a
qualified pathologist. This diagnosis takes on added significance if atypical
hyperplasia is present in multiple sites in a breast and/or if it is bilateral; or
2. Family history of breast and /or ovarian cancer in a first-degree relative,
(especially a mother or sister) who is premenopausal and has had bilateral
breast cancer (family cancer syndrome), with no demonstrative mutation or a
genetic mutation conferring a high risk of breast cancer *; or
3. Dense, fibronodular breasts that are mammographically or clinically difficult to
evaluate in a patient with either (or both) of the above clinical presentations.
The combination of atypical hyperplasia with a family history of breast cancer
implies significant risk (8-l0x) in excess of that of index populations; or
4. Family history of multiple family members with bilateral and/or premenopausal and/or male breast cancer may be associated with a familial
breast cancer syndrome. Genetic counseling should be strongly considered,
although prophylactic surgery is appropriate in women with a family history
consistent with genetic predisposition and no demonstrative genetic mutation*;
or
5. Prior thoracic radiation therapy <30 y of age.
*Note - Per NCCN (Version 2.2016) on Guidelines for Breast Cancer Risk
Reduction; Genetic/Familial High-Risk Assessment: Breast and Ovarian, “The
option of risk-reduction mastectomy (RRM) is warranted based on gene and/or risk
level (i.e., BRCA1, BRCA2, CDH1, PTEN, TP53 and PALB2). There is insufficient
evidence for RRM for ATM, CHEK2, and STK11 genetic mutations, however,
intervention may be warranted based on family history or other clinical factors.

The value of risk reducing mastectomy in women with deleterious mutations in
other genes associated with a 2-fold or greater risk of breast cancer (based on
Prophylactic Mastectomy May 16
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large epidemiologic studies) in the absence of a compelling family history of breast
cancer is unknown. (NCCN v1.2016, Breast Cancer Risk Reduction)
Unilateral Prophylactic Mastectomy
Unilateral prophylactic mastectomy is medically necessary in patients with a diagnosis
of cancer in the ipsilateral breast in any of the following clinical scenerios that portend
a high risk of cancer:
1. Diffuse microcalcifications in the remaining breast, especially when ductal
carcinoma in situ has been diagnosed in the ipsilateral breast. In this individual,
there is a 30-40% probability that these microcalcifications will harbor carcinoma;
or
2. Lobular carcinoma in situ (LCIS) in the remaining breast. This diagnosis is a
marker of risk for the development of invasive cancer and carries special
significance when the previously treated breast had either invasive or in situ
lobular disease. The tissue diagnosis has a bilateral incidence approaching 80% in
many instances; or
3. Development of either invasive lobular or ductal carcinoma in a patient who
elected surveillance for lobular carcinoma in situ. This patient is at significant risk
(8-10x) for the development of cancer in the intact breast; or
4. The large, breast and/or ptotic, dense, or disproportionately-sized breast that is
difficult to evaluate mammographically and clinically. This presentation has added
significance when any of the qualifiers listed below are present:






Atypical hyperplasia
Multicentric primary tumor
Family history of breast or ovarian cancer in a first-degree relative (mother,
sister, etc.)
Young age (<40 years)
Presence of a BRCA1 or BRCA2 breast cancer susceptibility gene mutation
Multiple breast biopsies resulting in difficulty performing or interpreting
diagnostic breast exams; or
5. Previous cancer in one breast as recommended by the American Cancer Society
(9/18/2006), for women at high risk of breast cancer.
Individuals with known mutations in BRCA1 and BRCA2. or who potentially meet
criteria for an inherited syndrome, should also be offered counseling about the risks,
benefits, and limitations of other management options including intensive surveillance
and chemoprevention. Ideally, the patient should be informed of the breast cancer risk
reduction that can be achieved with tamoxifen alone (~50%). Patients undergoing
prophylactic mastectomy for suspected hereditary disease should also consider
ovarian screening or prophylactic removal, as well as colon screening. Prophylactic
mastectomy in men is medically necessary for those men who have been diagnosed
with breast cancer.
Prophylactic Mastectomy May 16
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Definitions
LCIS
PM
BPM
CPM
BCT
UM
TM
MRI
CBC
DFS
RRM
Lobular carcinoma in situ
Prophylactic mastectomy
Bilateral prophylactic mastectomy
Contralateral prophylactic mastectomy
Breast conservation therapy
Unilateral mastectomy
Therapeutic mastectomy
Magnetic resonance imaging
Contralateral breast cancer
Disease-free survival
Risk reduction mastecomy
Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in this
policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical
necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures have been replaced by ICD-10 code sets.
ICD-9 Codes
V16.3
V16.9
V50.41
V84.01
174
174.0
174.1
174.2
174.3
174.4
174.5
174.6
174.8
174.9
175
175.0
175.9
Family history of malignant neoplasm-breast
Unspecified malignant neoplasm
Prophylactic organ removal, breast
Genetic susceptibility to malignant neoplasm of breast
Malignant neoplasm of female breast
Nipple and areola
Central portion
Upper-inner quadrant
Lower-inner quadrant
Upper-outer quadrant
Lower-outer quadrant
Axillary tail
Other specified sites of female breast
Breast (female) unspecified
Malignant neoplasm of male breast
Nipple and areola
Other and unspecified sites of male breast
ICD-10 Codes
C50.011C50.929
Z15.01
Z40.01
Z80.3
Z80.9
Malignant neoplasm of breast
Genetic susceptibility to malignant neoplasm of breast
Encounter for prophylactic removal of breast
Family history of malignant neoplasm of breast
Family history of malignant neoplasm, unspecified
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CPT Codes
19301
19302
19303
19304
19305
19306
19307
81214
81215
81216
81217
Mastectomy, partial;(eg, lumpectomy, tylectomy, quadrantectomy,
segmentectomy);
Mastectomy, partial; with axillary lymphadenectomy
Mastectomy, simple, complete
Mastectomy, subcutaneous
Mastectomy, radical, including pectoral muscles, axillary lymph nodes
Mastectomy, radical, including pectoral muscles, axillary and internal
mammary lymph nodes (Urban type operation)
Mastectomy, modified radical, including axillary lymph nodes, with or
without pectoralis minor muscle, but excluding pectoralis major muscle
BRCA 1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer)
gene analysis; full sequence analysis and common duplication/deletion
variants (i.e., exon 13 del 3.835kb, exon 13 dup6kb, exon14-20
del26kb, exon 22del 510bp, exon8-9 del 7.1kb)
BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer)
gene analysis; known familial variant
BRCA 2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; full sequence analysis
BRCA 2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; known familial variant
HCPCS Codes
N/A
Scientific Rationale – Update May 2016
Per the NCCN Guidelines, (Version 2.2016) on Genetic / Familial High Risk
Assessment: Breast or Ovarian, it notes the following:
Breast and Ovarian Management Based on Genetic Tests Results
Recommended
Discuss Option of Recommendation/Consider
Breast MRI
Risk Reducing
Risk-Reducing SalpingoMastectomy
oopherectomy (RRSO)
(RRM)
Intervention
ATM, BRCA1,
BRCA1, BRCA2,
BRCA1, BRCA2, Lynch
warranted based
BRCA2, CDH1,
CDH1, PTEN,
Syndrome, BRIP1,
on gene &/risk
CHEK2, PALB2,
TP53, PALB2
RAD51C, RAD51D
level
PTEN, STK11,
TP53
Insufficient
BRIP1
ATM, CHEK2,
PALB1
evidence for
STK11
intervention
Per the same NCCN Guidelines as noted above, it also states:

“The panel specifically focuses on assessment of known high-penetrance
mutations (i.e., BRCA 1/2, TP53, PTEN) and recommendations for genetic testing,
counseling and management strategies in individuals with these mutations. There
are additional gene mutations that the NCCN panel feels warrant additional
screening beyond what is recommended in the general population (i.e., those
without the specific gene mutation). These include mutations for CDH1, CHEK2,
PALB2, STK11, BRIP1, RAD51C, and RAD51D”.
Prophylactic Mastectomy May 16
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


“A retrospective analysis of 337 patients who met NCCN criteria for BRCA 1 /2
mutation testing and had multigene testing showed that showed that 25 patients
(7.4%) had non-BRCA mutations. The most common of these mutations were
PALB (23%), CHEK2 (15%), and ATM (15%)”.
Another breast cancer susceptibility gene that has been identified is CHEK2. Walsh
et al. (2006) completed a study of breast cancer patients in the U.S. with a strong
family history of breast or ovarian cancer but who tested negative for a BRCA 1 /2
mutation, 5% had CHEK2 mutations. Deleterious CHEK2 mutations have been
reported to occur with a higher frequency in Northern and Eastern European
countries compared with North America. The cumulative lifetime risk for breast
cancer in women with CHEK2 mutations and familial breast cancer has been
estimated to range from approximately 28% to 37%, and is higher in women with
this gene mutation.
Kurian et al. (2014) completed a study of 198 women who were referred for BRCA
1 / 2 testing and underwent multi-gene testing which showed 16 deleterious
mutations out of 141 women who tested negative for BRCA 1 / 2 (11.4%, 95%
Cl=7.0-17.7). The discovery of these mutations led to recommendations for
further screening. Therefore, findings from multigene testing may have the
potential to alter clinical management.
The NCCN Guidelines, (Version 2.2016) on Genetic / Familial High Risk Assessment:
Breast or Ovarian, has a section on the overview of multi-gene testing which notes:
1. The recent introduction of multi-gene testing for hereditary forms of cancer has
rapidly altered the clinical approach to testing at-risk patients and their families.
Based on next-generation sequencing technology, these tests simultaneously
analyze a set of genes that are associated with a specific family cancer phenotype
or multiple phenotypes.
2. Patients who have a personal or family history suggestive of a single inherited
cancer syndrome are most appropriately managed by genetic testing for that
specific syndrome. When more than one gene can explain an inherited cancer
syndrome, then multi-gene testing may be more efficient and/or cost-effective.
3. There is a role for multi-gene testing in individuals who have tested negative
(indeterminate) for a single syndrome, but whose personal or family history
remains strongly suggestive of an inherited susceptibility.
4. As commercially available tests differ in the specific genes analyzed (as well as
classification of variants and many other factors), choosing the specific laboratory
and test panel is important.
5. Multi-gene testing can include “intermediate’” penetrant (moderate-risk) genes.
For many of these genes, there are limited data on the degree of cancer risk and
there are no clear guidelines on risk management for carriers of mutations. Not all
genes included on available multi-gene tests are necessarily clinically actionable.
6. As is the case with high-risk genes, it is possible that the risks associated with
moderate risk genes may not be entirely due to that gene alone, but may be
influenced by gene/gene or gene/environment interactions. In addition, certain
mutations in a gene may pose higher or lower risk than other mutations in that
same gene. Therefore. It may be difficult to use a known mutation alone to assign
risk for relatives.
7. In many cases the information from testing for moderate penetrance genes does
not change risk management compared to that based on family history alone.
8. Mutations in many breast cancer susceptibility genes involved in DNA repair may
be associated with the rare autosomal recessive condition, Fanconi anemia.
9. It is for these and other reasons that multi-gene testing is ideally offered in the
context of professional genetic expertise for pre-and post-test counseling.
Prophylactic Mastectomy May 16
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Wang et al. (2015) Certain predisposition factors such as BRCA1/2 and CHEK2
mutations cause familial breast cancers that occur early. In China, breast cancers are
diagnosed at relatively younger age, and higher percentage of patients are diagnosed
before 40 years, than that in Caucasians. However, the prevalence for BRCA1/2
mutations and reported. CHEK2 germline mutations is much lower or absent in
Chinese population, arguing for the need to study other novel risk alleles among
Chinese breast cancer patients. In this study, we searched for CHEK2 mutations in
young, high-risk breast cancer patients in China and detected a missense variant
Y390C (1169A>G) in 12 of 150 patients (8.0%) and 2 in 250 healthy controls (0.8%,
P=0.0002). Four of the Y390C carriers have family history of breast and/or
ovarian cancer. In patients without family history, Y390C carriers tend to
develop breast cancer early, before 35 years of age. The codon change at Y390, a
highly conserved residue located in CHEK2's kinase domain, appeared to significantly
impair CHEK2 activity. Functional analysis suggested that the CHEK2 Y390C mutation
is deleterious as judged by the mutant protein's inability to inactivate CDC25A or to
activate p53 after DNA damage. Cells expressing the CHEK2 Y390C variant showed
impaired p21 and Puma expression after DNA damage, and the deregulated cell cycle
checkpoint and apoptotic response may help conserve mutations and therefore
contribute to tumorigeneisis. Taken together, our results not only identified a novel
CHEK2 allele that is associated with cancer families and confers increased breast
cancer risk, but also showed that this allele significantly impairs CHEK2 function
during DNA damage response. Our results provide further insight on how the function
of such an important cancer gene may be impaired by existing mutations to facilitate
tumorigenesis. It also offers a new subject for breast cancer monitoring, prevention
and management.
Easton et al. (2015) completed an article in the New England Journal of Medicine that
reported that the magnitude of relative risk of breast cancer associated with CHEK2
truncating mutations is likely to be moderate and unlikely to be high. On the basis of
two large case-control analyses, the authors calculated an estimated relative risk of
breast cancer associated with CHEK2 mutations of 3.0 (90% confidence interval [CI],
2.6 to 3.5), and an absolute risk of 29% by age 80 years.
Kuusisto et al. (2011) completed a study in which 82 well-characterized, high-risk
hereditary breast and/or ovarian cancer (HBOC) BRCA1/2-founder mutation-negative
Finnish individuals, were screened for germline alterations in seven breast cancer
susceptibility genes, BRCA1, BRCA2, CHEK2, PALB2, BRIP1, RAD50, and CDH1.
BRCA1/2 were analyzed by multiplex ligation-dependent probe amplification (MLPA)
and direct sequencing. CHEK2 was analyzed by the high resolution melt (HRM)
method and PALB2, RAD50, BRIP1 and CDH1 were analyzed by direct sequencing.
Carrier frequencies between 82 (HBOC) BRCA1/2-founder mutation-negative Finnish
individuals and 384 healthy Finnish population controls were compared by using
Fisher's exact test. Three previously reported breast cancer-associated variants,
BRCA1 c.5095C > T, CHEK2 c.470T > C, and CHEK2 c.1100delC, were observed in
eleven (13.4%) individuals. Ten of these individuals (12.2%) had CHEK2 variants,
c.470T > C and/or c.1100delC. Fourteen novel sequence alterations and nine
individuals with more than one non-synonymous variant were identified. One of the
novel variants, BRCA2 c.72A > T (Leu24Phe) was predicted to be likely pathogenic in
silico. No large genomic rearrangements were detected in BRCA1/2 by multiplex
ligation-dependent probe amplification (MLPA). In this study, mutations in previously
known breast cancer susceptibility genes can explain 13.4% of the analyzed high-risk
BRCA1/2-negative HBOC individuals. CHEK2 mutations, c.470T > C and c.1100delC,
Prophylactic Mastectomy May 16
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make a considerable contribution (12.2%) to these high-risk individuals but further
segregation analysis is needed to evaluate the clinical significance of these mutations
before applying them in clinical use. Additionally, we identified novel variants that
warrant additional studies. Our current genetic testing protocol for 28 Finnish
BRCA1/2-founder mutations and protein truncation test (PTT) of the largest exons is
sensitive enough for clinical use as a primary screening tool.
Scientific Rationale – Update October 2015
Per the NCCN Guidelines, (Version 2.2015) on Breast Cancer Risk Reduction, under
(BRISK)-6 Footnotes, the following modifications are noted:
“Risk-reduction mastectomy should generally be considered only in women with a
genetic mutation conferring a high risk for breast cancer (see NCCN Guidelines for
Genetic/Familial High-Risk assessment; Breast and Ovarian- Table on GENE-2),
compelling family history, or possible with LCIS or prior thoracic radiation therapy<30
years of age. The value of risk-reducing mastectomy in women with deleterious
mutations in other genes associated with a 2-fold or greater risk for breast cancer
(based on large epidemiologic studies) in the absence of a compelling family history
of breast cancer is unknown.”
Breast and Ovarian Management Based on Genetic Testing Results
Discuss Option of Risk Reduction
Mastectomy
Intervention Warranted based on gene
BRCA1
and/or risk level
BRCA2
CDH1
PTEN
TP53
Insufficient evidence for intervention*
ATM
BARD1
CHEK2
PALB2
STK11
*Intervention may still be warranted based on family history or other clinical factors
**NCCN Guidelines Genetic/Familial High-Risk Assessment: Breast and Ovarian
(2.2015)
King et al (2015) reviewed 29-year longitudinal experience with LCIS to evaluate
factors associated with breast cancer risk. Patients participating in surveillance after
an LCIS diagnosis were observed in a prospectively maintained database.
Comparisons were made among women choosing surveillance, with or without
chemoprevention, and those undergoing bilateral prophylactic mastectomies between
1980 and 2009. One thousand sixty patients with LCIS without concurrent breast
cancer were identified. Median age at LCIS diagnosis was 50 years (range, 27 to 83
years). Fifty-six patients (5%) underwent bilateral prophylactic mastectomy; 1,004
chose surveillance with (n = 173) or without (n = 831) chemoprevention. At a median
follow-up of 81 months (range, 6 to 368 months), 150 patients developed 168 breast
cancers (63% ipsilateral, 25% contralateral, 12% bilateral), with no dominant
histology (ductal carcinoma in situ, 35%; infiltrating ductal carcinoma, 29%;
infiltrating lobular carcinoma, 27%; other, 9%). Breast cancer incidence was
significantly reduced in women taking chemoprevention (10-year cumulative risk: 7%
Prophylactic Mastectomy May 16
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with chemoprevention; 21% with no chemoprevention; P < .001). In multivariable
analysis, chemoprevention was the only clinical factor associated with breast cancer
risk (hazard ratio, 0.27; 95% CI, 0.15 to 0.50). In a subgroup nested case-control
analysis, volume of disease, which was defined as the ratio of slides with LCIS to total
number of slides reviewed, was also associated with breast cancer development (P =
.008). The authors concluded they observed a 2% annual incidence of breast cancer
among women with LCIS. Common clinical factors used for risk prediction, including
age and family history, were not associated with breast cancer risk. The lower breast
cancer incidence in women opting for chemoprevention highlights the potential for risk
reduction in this population.
DeFelice et al (2015) sought to clarify the role of bilateral risk-reducing mastectomy
(BRRM) in reducing breast cancer risk in women carriers of BRCA1 and BRCA2
mutations. The Pubmed, MEDLINE and Scopus databases were searched to retrieve
articles written in the English language. Two investigators independently extracted the
characteristics and results of the selected studies. Only prospective trials with
available absolute numbers of breast cancer and death events were included. Pooled
hazard ratio (HR) with 95 % confidence interval (CI) was calculated using fixed or
random effects model. Meta-analysis of four prospective studies, including 2635
patients, demonstrated a significant risk reduction of breast cancer incidence in BRCA1
and BRCA2 mutation carriers receiving BRRM (HR 0.07; 95 % CI 0.01-0.44; p =
0.004). Among patients without previous risk-reducing salpingo-oophorectomy, a
significant benefit was similarly recorded (HR 0.06; 95 % CI 0.01-0.41; p = 0.005).
The reviewers concluded performing BRRM may lead to highly significant risk
reduction of breast cancer in BRCA1 and BRCA2 mutation carriers. These data allow
clinicians to discuss more in-depth with patients all the available options in order to
design better management strategies.
Scientific Rationale – Update October 2014
Per the NCCN Guidelines, Version 1.2014 on Breast Cancer Risk Reduction, under
(BRISK)-6 Footnotes, the following modifications are noted:

Risk reduction mastectomy should generally be considered only in women with a
genetic mutation conferring a high risk for breast cancer (BRCA1/2, PTEN, TP53,
CDH1, STK11), compelling family history, or possibly with LCIS or prior thoracic
radiation therapy at <30 Yrs of age.

The value of risk reducing mastectomy in women with deleterious mutations in
other genes associated with a 2-fold or greater risk for breast cancer (based on
large epidemiologic studies) in the absense of a compelling family history of
breast cancer is unknown.

Axillary node assessment has limited indication at the time of risk reduction
procedure surgery.
Scientific Rationale – Update October 2013
Peled et al (2013) reported total skin-sparing mastectomy (TSSM) with preservation of
the nipple-areolar complex skin has become increasingly accepted as an oncologically
safe procedure. Oncologic outcomes after TSSM in BRCA mutation carriers have not
been well-studied. The authors identified 53 BRCA-positive patients who underwent
bilateral TSSM for prophylactic (26 patients) or therapeutic indications (27 patients)
from 2001 to 2011. Cases were age-matched (for prophylactic cases) or age- and
Prophylactic Mastectomy May 16
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stage-matched (for therapeutic cases) with non-BRCA-positive patients. Outcomes
included tumor involvement of resected nipple tissue, the development of new breast
cancers in patients who underwent risk-reducing TSSM, and local-regional recurrence
in patients who underwent therapeutic TSSM. Outcomes from 212 TSSM procedures
in 53 cases and 53 controls were analyzed. In patients undergoing TSSM for
prophylactic indications, in situ cancer was found in one (1.9 %) nipple specimen in
BRCA-positive patients versus two specimens (3.8 %) in the non-BRCA-positive cohort
(p = 1). At a mean follow-up of 51 months, no new cancers developed in either
cohort. In patients undergoing TSSM for therapeutic indications, in situ or invasive
cancer was found in zero of the nipple specimens in BRCA-positive patients versus two
specimens (3.7 %) in the non-BRCA-positive cohort (p = 0.49). At a mean follow-up
of 37 months, there were no local-regional recurrences in the BRCA-positive cohort
and 1 (3.7 %) in the non-BRCA-positive cohort. Investigators concluded TSSM is an
oncologically safe procedure in BRCA-positive patients. In patients undergoing TSSM
as a risk-reducing strategy, 4-year follow-up demonstrates no increased risk of
developing new breast cancers; longer-term follow-up is ongoing.
Singh et al (2013) reported that despite substantial survival benefits of risk-reducing
mastectomy (RRM) and risk-reducing bilateral salpingo-oophorectomy (RRBSO)
among BRCA mutation carriers, only a minority elect to undergo these procedures.
This study investigated factors that might influence decision making regarding
prophylactic surgeries among women with BRCA mutations. Unaffected BRCA mutation
carriers who were counseled at a single center and either underwent prophylactic
surgery or participated in a high-risk surveillance program at our institution from 1998
through 2010 were included in the study. Medical records were reviewed and data
collected included age, family history, parity, mutation type, history of breast biopsy
or cosmetic surgery, and uptake of prophylactic surgeries. Among 136 unaffected
women with BRCA mutations, uptake of RRM was 42% and uptake of RRBSO was
52%. Family history of first- and second-degree relatives being deceased from breast
cancer was predictive of uptake of RRM and of RRBSO (odds ratio [OR], 11.0; P =
.005; and OR, 15.8; P = .023, respectively), and history of a mother lost to pelvic
cancer was predictive of uptake of RRBSO (OR, 7.9; P = .001). Parity also predicted
both RRM and RRBSO uptake (OR, 4.2; P = .001; and OR, 5.4; P = .003,
respectively). Age at the time of genetic testing and history of breast biopsy or
cosmetic surgery were not predictive of RRM uptake. The authors concluded
perceptions of cancer risk are heavily influenced by particular features of an
individual's family history and may be motivators in preventive surgery more than
actual cancer risk estimations themselves. Awareness of subtle factors beyond the
statistical risk for cancers is relevant when counseling at-risk women.
Dražan et al (2012) sought to verify if prophylactic mastectomy with immediate breast
reconstruction can prevent breast cancer in BRCA positive patients. There were 100
BRCA positive women in which prophylactic mastectomy with immediate
reconstruction, 75 dieps, 25 with implants, performed in period 2000-2011. Group A
was composed of healthy, non-affected 41 patients, group B of 59 patients in
remission after breast cancer treatment. These groups were compared to group C that
consisted of 219 healthy carriers of BRCA1/2, non-operated, from registry of genetic
department of a single center from 2000-2011. Follow-up for oncology status was
done in September 2011 for all 3 groups. Average follow-up of 21 months revealed
that in group A there was no breast cancer, in group B 4 patients died and 2 had
treatment for metastases. In group C, there were 16 new cases of breast cancer.
Authors concluded bilateral prophylactic mastectomy with immediate reconstruction
can be an effective way in breast cancer prevention in healthy carriers of BRCA1/2
Prophylactic Mastectomy May 16
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mutation. In BRCA positive patients treated for breast cancer, the effect of
prophylactic mastectomy is unclear. Their survival is more influenced by their previous
disease than by a new tumor in the breast.
This et al (2012) described the various modalities of breast and ovarian cancer risk
management, patient choices and their outcome in a single-center cohort of 158
unaffected women carrying a BRCA1 or BRCA2 germline mutation. Between 1998 and
2009, 158 unaffected women carrying a BRCA1 or BRCA2 gene mutation were
prospectively followed. The following variables were studied: general and
gynecological characteristics, data concerning any prophylactic procedures, and data
concerning the outcome of these patients. Median age at inclusion was 37 years and
median follow-up was 54 months. Among the 156 women who received systematic
information about prophylactic mastectomy, 5.3 % decided to undergo surgery within
36 months after disclosure of genetic results. Prophylactic salpingo-oophorectomy was
performed in 68 women. Among women in whom follow-up started between the ages
of 40 and 50 years, prophylactic salpingo-oophorectomy was performed, within 24
months after start of follow-up, in 83.7 and 52 % of women with BRCA1 and BRCA2
mutations, respectively. Twenty four women developed breast cancer. Ovarian cancer
was detected during prophylactic salpingo-oophorectomy in two women (2.9 %). In
this cohort of French women carrying BRCA1/2 mutations, prophylactic mastectomy
was a rarely used option. However, good compliance with prophylactic salpingooophorectomy was observed. The authors reported this study confirms the high breast
cancer risk in these women.
Scientific Rationale – October 2012
According to the NCCN, the lifetime risk of breast cancer in BRCA 1/2 mutation
carriers has been estimated to be 56%-84%. Per the NCCN guidelines on breast
cancer risk reduction:
“Risk reduction mastectomy should generally be considered only in women with
BRAC 1/2 or other strongly predisposing gene mutations, compelling family history
or possibly women with lobular carcinoma in situ (LCIS) or prior thoracic radiation
therapy <30 y of age (e.g., to treat Hodgkins Disease). Evaluation should include
consultation with surgery and reconstructive surgery. Psychological consultation
may also be considered. Discussion regarding the risk of breast or ovarian cancer
and the option of risk reduction bilateral ovarian salpingo-oophorectomy.”
Dražan et al (2012) sought to verify if prophylactic mastectomy with immediate breast
reconstruction can prevent breast cancer in BRCA positive patients. There were 100
BRCA positive women in which prophylactic mastectomy with immediate
reconstruction, 75 dieps, 25 with implants, performed in period 2000-2011. Group A
was composed of healthy, non-affected 41 patients, group B of 59 patients in
remission after breast cancer treatment. These groups were compared to group C that
consisted of 219 healthy carriers of BRCA1/2, non-operated, from registry of genetic
department of the Masaryk Memorial Cancer in Brno, from 2000-2011. Average
follow-up of 21 months revealed that in group A there was no breast cancer, in group
B 4 patients died and 2 had treatment for metastases. In group C, there were 16 new
cases of breast cancer. Investigators concluded bilateral prophylactic mastectomy
with immediate reconstruction can be an effective way in breast cancer prevention in
healthy carriers of BRCA1/2 mutation. In BRCA positive patients treated for breast
cancer, the effect of prophylactic mastectomy is unclear. Their survival is more
influenced by their previous disease than by a new tumor in the breast.
Prophylactic Mastectomy May 16
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Scientific Rationale – Update February 2011
Lostumbo et al (2010) performed a Cochrane data base review to determine whether
prophylactic mastectomy (PM) reduces death rates from any cause in women who
have never had breast cancer and in women who have a history of breast cancer in
one breast, and also examined the effect of prophylactic mastectomy on other
endpoints, including breast cancer incidence, breast cancer mortality, disease-free
survival, physical morbidity, and psychosocial outcomes. The study included women
at risk for breast cancer in at least one breast. Interventions included all types of
mastectomy performed for the purpose of preventing breast cancer. At least two
authors independently abstracted data. Data were summarized descriptively;
quantitative meta-analysis was not feasible due to heterogeneity of study designs and
insufficient reporting. Data were analyzed separately for bilateral prophylactic
mastectomy (BPM) and contralateral prophylactic mastectomy (CPM). All 39 included
studies were observational studies with some methodological limitations; randomized
trials were absent. The studies presented data on 7,384 women with a wide range of
risk factors for breast cancer who underwent PM. BPM studies on the incidence of
breast cancer and/or disease-specific mortality reported reductions after BPM
particularly for those with BRCA1/2 mutations. For CPM, studies consistently reported
reductions in incidence of contralateral breast cancer but were inconsistent about
improvements in disease-specific survival. Only one study attempted to control for
multiple differences between intervention groups and this study showed no overall
survival advantage for CPM at 15 years. Another study showed significantly improved
survival following CPM but after adjusting for bilateral prophylactic oophorectomy, the
CPM effect on all-cause mortality was no longer significant. Sixteen studies assessed
psychosocial measures; most reported high levels of satisfaction with the decision to
have PM but more variable satisfaction with cosmetic results. Worry over breast
cancer was significantly reduced after BPM when compared both to baseline worry
levels and to the groups who opted for surveillance rather than BPM. Case series
reporting on adverse events from PM with or without reconstruction reported rates of
unanticipated re-operations from 4% in those without reconstruction to 49% in
patients with reconstruction. The reviewers concluded while published observational
studies demonstrated that BPM was effective in reducing both the incidence of, and
death from, breast cancer, more rigorous prospective studies (ideally randomized
trials) are needed. BPM should be considered only among those at very high risk of
disease. There is insufficient evidence that CPM improves survival and studies that
control for multiple confounding variables are needed.
Stucky et al (2010) investigated factors associated with CPM. A breast cancer
database collected from 2000 through 2008 was retrospectively reviewed. Treatment
groups analyzed included breast conservation therapy (BCT), unilateral mastectomy
(UM) with or without reconstruction (± R), and CPM ± R. Variables were compared
using ANOVA F-tests and chi-square tests. Multivariate analysis was performed using
logistic regression. A total of 1,391 patients underwent surgery for invasive breast
cancer: 69% BCT, 21% UM, and 10% bilateral mastectomy. Of those undergoing
bilateral mastectomy, 30% had bilateral cancer and were excluded from analysis. The
rate of CPM increased significantly from 0 to 20%, whereas the rate of UM remained
relatively stable. Factors associated with CPM included younger age, significant family
history, genetic testing, positive BRCA gene mutation, and preoperative magnetic
resonance imaging (MRI). Tumor characteristics associated with CPM included positive
axillary lymph node metastases and triple-negative disease (ER-/PR-/HER2 normal).
Breast reconstruction was more common among women who underwent CPM. On
multivariate regression comparing BCT with CPM, younger age, larger tumors,
multifocal disease, and MRI significantly predicted CPM. Comparing UM with CPM, only
Prophylactic Mastectomy May 16
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age and genetic testing significantly predicted CPM. The reviewers concluded the rate
of bilateral mastectomy for unilateral breast cancer is increasing. This is particularly
true for younger patients with strong family history. The availability of breast
reconstruction may play a role and the effects of stage and multifocal disease needs
further exploration.
Boughey et al (2010) investigated whether CPM in addition to therapeutic mastectomy
(TM) is associated with a survival advantage in high-risk women with breast cancer. A
total of 385 women with stage I or II breast cancer and a family history of breast
cancer who underwent TM and CPM between 1971 and 1993 were evaluated and
compared to 385 patients matched on age at diagnosis, tumor stage, nodal status,
and year of diagnosis who underwent TM-only. Contralateral breast cancer (CBC)
events and survival outcomes were compared. At a median follow-up of 17.3 years, 2
CBCs (0.5%) developed in the CPM cohort and 31 (8.1%) in the TM-only cohort,
representing a 95% decreased risk of CBC. One hundred twenty-eight women in the
CPM group and 162 women in the TM-only group have died, resulting in 10-year
overall survival estimates of 83 and 74%, respectively. This difference in overall
survival persisted in multivariate analysis. Disease-free survival (DFS) was better in
the CPM cohort than the TM-only group and remained significant in multivariate
analysis. In this retrospective cohort study, the authors concluded CPM was associated
with decreased CBC event and improved overall survival and disease free survival.
Scientific Rationale – June 2009
It has been suggested that breast reduction surgery may be an alternative
preventative option to prophylactic mastectomy for women at high risk of developing
breast cancer.
For women who have a genetic mutation that predisposes them to breast and ovarian
cancer, the currently accepted options include prophylactic surgery, intensified
surveillance, and chemoprevention. There is no clear "best" choice among these
alternatives and the choice usually depends on patient preference.
Prophylactic bilateral mastectomy has been demonstrated to reduce breast cancer
incidence in women with a high inherited susceptibility to breast cancer. In both
retrospective and prospective studies, prophylactic mastectomy decreases the
incidence of breast cancer by 90 percent or more in women at high risk. A prospective
study (Rebbeck et al 2004) of 105 healthy BRCA1/2 carriers who underwent
prophylactic mastectomy demonstrated two cases of breast cancer after an average of
6.4 years of follow-up, compared with 184 cases of breast cancer among 378
mutation carriers matched for specific gene, center, and age who did not undergo the
procedure. The two cases of breast cancer in women undergoing prophylactic surgery
occurred after subcutaneous rather than total mastectomy. Among mutation carriers
undergoing bilateral mastectomy, the risk of subsequent breast cancer was reduced
by 95 percent in women who had undergone prior or concurrent bilateral
oophorectomy and by 90 percent in those with intact ovaries. Total (or simple)
mastectomy is recommended for prophylaxis because subcutaneous mastectomy
leaves behind more glandular tissue that remains at risk for future cancers.
Tarone et al (2004) reported that that several epidemiological follow-up studies have
indicated that there may be a substantial reduction in breast cancer risk among
women who have undergone breast reduction surgery. The authors note that although
such observational studies cannot demonstrate definitively that reduction
mammaplasty reduces the risk of breast cancer, the evidence from these studies is
Prophylactic Mastectomy May 16
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sufficiently strong to warrant the evaluation of breast reduction surgery as an option
for primary prevention in clinical studies of women at increased risk of breast cancer.
The authors suggest that the availability of a more acceptable surgical option for
primary prevention of breast cancer could increase the number of women willing to
choose risk reduction surgery and thus may result in an overall reduction in breast
cancer mortality among high-risk women.
Brinton et al (2001) investigated whether the reduction in breast cancer risk was
related directly to the amount of breast tissue removed. Medical record retrieval was
attempted for 161 breast cancer patients in a Swedish cohort of 31,910 women who
had had breast reduction surgery and for 483 women who had not developed breast
cancer. Information on amount of breast tissue removed was abstracted along with
other factors that influence breast cancer risk. Odds ratios of developing breast cancer
were calculated based on amount of breast tissue removed. The amount of tissue
removed was a significant predictor of risk, as subjects in the highest quartile of tissue
removal had a significantly lower risk than those in the lowest quartile. Considering
the total amount of tissue removed (both breasts), subjects with > 1600 versus < 800
grams removed had an odds ratio (OR) of 0.24. This relation persisted after
adjustment for other breast cancer risk factors and was apparent within every
subgroup examined.
Fryzek et al (2006) extended the above study yielding an average of nearly 16 years
of follow-up. Standardized incidence ratios (SIRs) and 95% confidence intervals (CIs)
were calculated comparing women who underwent breast reduction surgery with
women in the general Swedish population. Breast cancer was observed in 443 women
versus 624 expected for a statistically significant reduced SIR of 0.71 (95% CI=0.650.78). Analyses by age at surgery, time since surgery or calendar year of surgery
revealed similar reductions in risk. The investigators concluded the study offers
further evidence that women undergoing breast reduction surgery have reduced
breast cancer risk. They recommend direct testing of this reduction in risk through
clinical trials should be considered.
According to the American Society of Breast Surgeons, the National Comprehensive
Cancer Network (NCCN), National Cancer Institute, American College of Obstetricians
and Gynecologists and the American Cancer Society, risk reduction interventions for
those at high risk include bilateral total mastectomy, bilateral salpingo-oophorectomy
and/or chemoprevention. None of these societies make any recommendations for
breast reduction surgery as a risk reducer for breast cancer in the average or high-risk
individuals.
At this time, there is a lack of evidence from peer reviewed randomized control trials
comparing the efficacy of reduction mammoplasty to other recommended options for
the prevention of breast cancer in high risk individuals.
Scientific Rationale – June 2007
In September 2005, the U.S. Preventive Services Task Force (USPSTF) published
recommendations for genetic counseling and BRCA mutation testing for women with
family history patterns associated with an increased risk for mutations in BRCA1 or
BRCA2 genes because of an increased risk for developing breast or ovarian cancer.
The USPSTF does not endorse routine genetic testing in the general female population.
The USPSTF recommended that high risk women seek genetic counseling to allow for
informed decision making about testing and to determine if further prophylactic
Prophylactic Mastectomy May 16
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treatment is advised. There is insufficient evidence to determine the benefits of
chemoprevention or intensive screening in improving health outcomes in these women
if they test positive for BRCA1 or BRCA2 mutations. However, there is fair evidence
that prophylactic surgery for these women significantly decreases breast and ovarian
cancer incidence.
In addition, the USPSTF has recommended genetic testing for the BRCA gene for
women who are not of Ashkenazi (Eastern European) Jewish heritage and possess any
of the following criteria:
1. Two first-degree relatives with breast cancer, one of whom was diagnosed
when they were younger than 50; or
2. Three or more first or second degree relatives diagnosed with breast cancer at
any age; or
3. A first degree relative diagnosed with cancer in both breasts; or
4. Two or more first or second degree relatives diagnosed at any age; or
5. A male relative with breast cancer.
Women of Ashkenazi (Eastern European) Jewish heritage should be referred for
genetic evaluation if they have either of the following criteria:
1. A first degree relative with breast or ovarian cancer at any age or
2. Two second degree relatives on the same side of the family with breast or
ovarian cancer at any age.
(2006) The American Cancer Society Board of Directors has stated that "only very
strong clinical and/or pathologic indications warrant doing this type of preventive
operation (prophylactic mastectomy)." Nonetheless, after careful consideration, this
might be the right choice for some women.
Per the National Cancer Institute, the estimated new cases and deaths from breast
cancer in the United States in 2007 are 178,480 (female) and 2,030 (male). The
estimated deaths in 2007 are 40,460 (female) and 450 (male).
In March 2007, the Society of Surgical Oncology, developed a position statement in
favor of prophylactic mastecomy. This relates to patients without a cancer diagnosis
but are high risk with any of the following factors:


BRCA mutations or any other susceptibility genes; (eg. A known mutation of
BRCA 1 or BRCA 2 genes or other stongly predisposing breast cancer
susceptibility genes) or
Strong family history with no demonstrative mutation; (eg. A family history of
breast cancer in multiple first-degree relatives and/or multiple successive
generations of family members with breast and/or ovarian cancer (family
cancer syndrome). Additionally a family history of multiple family members
with bilateral and/or pre-menopausal and/or male breast cancer may be
associated with a familial breast cancer syndrome. Genetic counseling should
be strongly considered, although prophylactic surgery is appropriate in women
Prophylactic Mastectomy May 16
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
with a family history consistent with genetic predisposition and no demonstrive
genetic mutation) or
Histologic risk factors. (eg. Atypical ductal or lobular hyperplasia or lobular
carcinoma insitu confirmed on biopsy. These changes are especially significant
if present with a strong family history of breast cancer.)
It is important for women with a BRCA 1 or BRCA 2 mutation to recognize that they
have a high risk of developing ovarian cancer, as well as breast cancer. They should
be given the option of prophylactic oopherectomy to be done once child bearing is
complete. (See Health Net’s National Medical Policy on Prophylactic Oopherectomy). In
addition, women who have the BRCA1 mutation and who have their ovaries surgically
removed after child bearing is complete, appear to have a reduced risk of breast
cancer.
Per the peer-reviewed medical literature, prophylactic mastectomy is indicated as an
effective treatment in reducing the occurrence of breast cancer for individuals in highrisk categories. It is important that affected individuals receive counseling regarding
all available options, in addition to the risks and benefits of this procedure. It is also
imperative that the patient understand that the surgery will not eliminate the risk of
developing cancer. However, for patients who carry the BRCA mutation, prophylactic
mastectomy can minimize the additional risk conferred by genetics.
Scientific Rationale - Initial
For women at high risk for hereditary breast cancer, there are three general
approaches to the development of intervention/prevention strategies: intensified
surveillance, chemoprevention, and prophylactic mastectomy.
Intensified Surveillance
An alternative to prophylactic mastectomy includes a regular annual schedule of
clinical breast exams (CBE) starting at age 25-35, annual mammography starting at
age 25-35, and self breast exams (SBE) starting at age 18-21. Intensified screening
may identify disease at a favorable stage, but it does not prevent cancer.
Chemoprevention - Tamoxifen and Other SERMs
Tamoxifen is known as a selective estrogen-receptor modulator (SERM) and is FDA
approved for women at high risk of developing breast cancer, and reducing the risk for
recurring cancer. It has also been shown to improve survival rates in women who
have estrogen-receptor positive breast cancer. Research has shown that tamoxifen
can reduce the chances of developing breast cancer by 49% in high-risk women, and
is particularly protective in women over 60. Tamoxifen is the most widely used
chemoprevention agent for the prevention of breast cancer, although there are other
antiestrogens currently being tested.
Investigative Agents
 Raloxifene is another SERM that is also proving to be protective against breast
cancer and has a lower risk than tamoxifen of causing uterine cancer. In 2001, a
major on-going study on raloxifene reported a reduced risk for breast cancer of
72% over a four-year period and an 84% reduced risk for hormone receptivepositive breast cancer. More research is warranted.
 Aromatase inhibitors are proving to be effective treatments for hormone-receptor
positive breast cancer. Like tamoxifen, they are also being investigated for
protection in high-risk women.
Prophylactic Mastectomy May 16
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

COX-2 inhibitors, which include celecoxib (Celebrex), rofecoxib (Vioxx), and
valdecoxib (Bextra), are newer anti-inflammatory agents normally used for pain
relief. They also have anti-cancer properties, and, in fact, celecoxib has been
approved for preventing an inherited form of colon cancer. Researchers hope
these agents may also help reduce the risk for breast cancer, although there is
currently no firm evidence that these agents can do so.
Retinoids. Analogues of vitamin A called retinoids are being studied for protection
against breast cancer. One retinoid, fenretinide, appears to offer some protection
against a second breast cancer in previously diagnosed, premenopausal women
(but not in postmenopausal women, who in fact may do worse).
Prophylactic mastectomy
According to the American Cancer Society (2003), recent studies have shown that
about 10% of breast cancer cases are hereditary as a result of genetic changes
(mutations). The most common genetic changes are those of the BRCA1 and BRCA2
genes. Normally, these genes help to prevent cancer by making proteins that keep
cells from growing abnormally. However, if a genetic mutation is inherited from either
parent, the risk for developing breast cancer increases in relation to the general
population.
The availability of genetic markers such as BRCA1 and BRCA2 can help to quantify the
cancer risks for some individuals suspected as having a dominantly inherited
susceptibility to breast and/or ovarian cancer. The results of these tests are used for
estimation of risk for the disease. It is important to note however that, in women,
breast cancer risk is based on the combination of many heterogeneous risk factors
including family history, menstrual history, pregnancy as well as the presence or
absence of a BRCA1 or BRCA2 mutation. Also, although both men and women can
inherit and pass on defective BRCA genes, genetic screening for breast cancer in men
with no symptoms is not recommended.
Alterations in BRCA1 and BRCA2 explain a majority, but not all, of the inherited forms
of breast and ovarian cancers. According to lifetime risk estimates for women in the
general population, about 12% (1 in 8 women) will develop breast cancer, compared
with an estimated 50 to 85% of women with mutations in the BRCA1 or BRCA2 genes.
Women with these inherited mutations also have an increased risk for developing
ovarian cancer. Lifetime risk estimates for women in the general population predict
that 1.5% (1 in 70 women) will develop ovarian cancer, compared with an estimated
40-60% of women with mutations in BRCA1 and 10-15% of women with mutations in
BRCA2.
Breast cancer risk is higher among women whose close blood relatives have this
disease. Blood relatives can be from either the mother’s or father's side of the family.
Having one first-degree relative (mother, sister, or daughter) with breast cancer
approximately doubles a woman's risk, and having two first-degree relatives increases
her risk 5-fold. Although the exact risk is not known, women with a family history of
breast cancer in male family members also have an increased risk of breast cancer.
Though extremely rare, male breast cancer does occur. Males who have had breast
cancer, particularly those with a family history of the disease (in either male or female
relatives), may want to consider prophylactic treatment of the ipsilateral breast.
With respect to breast cancer, it is important to note that BRCA1 and BRCA2 gene
mutations are only associated with hereditary forms of the disease-and only about 5
Prophylactic Mastectomy May 16
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percent of all breast cancers are inherited. The remaining 95 percent are nonhereditary or of unknown cause.
Breast cancer is common enough that random, non-inherited breast tumors may
appear in more than one member of a single family. However, that does not
necessarily mean family members have inherited an abnormal gene which predisposes
them to breast cancer, especially if the disease occurs late in life. Families in which
breast cancer is inherited typically demonstrate the following characteristics:







Breast cancer in two or more close relatives, such as a mother and sister;
Early onset of breast cancer in family members, often before age 50;
History of breast cancer in more than one generation;
Cancer in both breasts in other family members;
Frequent occurrence of ovarian cancer;
Ashkenazi (Eastern and Central European) Jewish ancestry, with a family history
of breast and/or ovarian cancer;
Male breast cancer
Prophylactic mastectomy is the surgical removal of one or both breasts to try to
prevent or reduce the risk of breast cancer. Prophylactic mastectomy can be
performed either as a subcutaneous or a total simple mastectomy. Subcutaneous
mastectomy removes the majority of glandular breast tissue while sparing the skin,
lymphatic drainage system, and nipple-areolar complex. Simple total mastectomy
removes the vast majority of the glandular breast tissue extended to include a layer of
pectoralis major fascia and the lower-level axilla along with the axillary nodes, and is
the procedure of choice.
Prophylactic mastectomy is often considered by women who have a strong family
history of breast cancer, especially among close relatives who develop the disease
before age 50. Although having a preventive mastectomy can reduce the risk, no one
can be certain that this procedure will protect a woman from breast cancer. Because it
is impossible to remove all breast tissue, breast cancer can still develop in the small
amount of remaining tissue. However, according to a study supported by the Agency
for Health Care Policy and Research (NRSA Training Grant HS00020), for young
women with BRCA gene mutations, prophylactic mastectomy may substantially
improve life expectancy.
Still, the decision is not easy. Having the genes does not mean that cancer will always
occur, meaning that mastectomy might not be necessary in all such women.
Nevertheless, in one 2000 study, 70% of women were satisfied with their decision to
have prophylactic breast removal. Women should discuss all options with their
physician, including oophorectomy and close monitoring.
Review History
August 2003 – September 2003
August 2005
March 2007
June 2007
Prophylactic Mastectomy May 16
Medical Advisory Council Review
Medical Advisory Council Review
Coding Updates
Update. Unilateral prophylactic mastectomy added
as medically necessary, per recommendation of
A.C.S., for patients with a high risk of hereditary
breast cancer who have had previous cancer in one
breast. Additional guidelines from the Society of
18
June 2009
February 2011
November 2011
October 2012
October 2013
October 2014
October 2015
May 2016
Surgical Oncology, have been added under bilateral
prophylactic mastectomy, #2&4.
Added reduction mammoplasty for the primary
purpose of reducing breast cancer risk as
investigational and therefore not medically
necessary.
Update – no revisions
Update – no revisions
Added “Prior thoracic radiation therapy <30 y of
age” as a medically necessary indication for
prophylactic mastectomy based on NCCN
recommendations.
Update – no revisions. Code Updates
Update – Added genetic mutation conferring a high
risk of breast cancer (i.e., PTEN, TP53, CDH1,
STK11), per NCCN V1.2014, on Breast Cancer Risk
Reduction. Codes reviewed.
Update – Under section on Bilateral Prophylactic
Mastectomy, revised criteria #2, removing specific
genetic mutations (BRCA 1 or BRCA2, PTEN, TP53,
CDH1, STK11) and adding note “The option of riskreduction mastectomy is warranted based on gene
and/or risk level (i.e., BRCA1, BRCA2, CDH1, PTEN
and TP53). There is insufficient evidence for
intervention for the ATM, BARD1, CHEK2, PALB2
and STK11 genetic mutation, however, intervention
may be warranted based on family history or other
clinical factors” as per recommendations from NCCN
on Breast cancer risk reduction (2.2015).
Code updates.
Per NCCN (V2.2016) on Genetic Familial High Risk
Assessment: Breast or Ovarian: genetic mutation,
added PALB2 as an option for risk reduction
mastectomy, based on gene &/risk level. Codes
updated.
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
5.
National Cancer Institute. Breast Cancer. Available at:
http://www.cancer.gov/cancertopics/types/breast
National Guideline Clearinghouse. Genetic risk assessment and BRCA mutation
testing for breast and ovarian cancer susceptibility: recommendation statement.
Ann Intern Med 2005 Sep 6;143(5):355-61.
National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in
Oncology: Breast Cancer Risk Reduction. V.1.2007. Updated v.1 2008. Updated
V.1. 2009. Updated V.1. 2010. Updated V.1.2011. Updated V.I. 2012 . Updated
version V.1.2013. Updated Version 1. 2014. Update 2.2015. Updated Version
1.2016.
The American Society of Breast Surgeons. BRCA Genetic Testing for Patients
With and Without Breast Cancer. Available at:
http://www.breastsurgeons.org/statements/brca.php
American College of Obstetricians and Gynecologists. ACOG Practice Bulletin. No.
103. April 2009. Reaffirmed 2013. Hereditary Breast and Ovarian Cancer
Syndrome.
Prophylactic Mastectomy May 16
19
6.
Society of Surgical Oncology (SSO) Position Statement on Prophylactic
Mastectomy. March 2007. Updated 2010-2014. Available at:
http://www.surgonc.org/resources/consensus-statements/position-statement-onprophylactic-mastectomy
7. National Cancer Institute. Preventive Mastectomy. July 2006. Available at:
http://www.cancer.gov/cancertopics/factsheet/Therapy/preventive-mastectomy
8. Hayes. Medical Technology Directory. Risk-Reducing (Prophylactic) Mastectomy.
December 9, 2013. Update Dec 2014. Updated November 16, 2015.
9. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in
Oncology: Genetic/Familial High Risk Assessment: Breast and Ovarian. Version
1.2014. Update 2.2015. Updated Version 2.2016.
10. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in
Oncology. Breast Cancer. Version 3.2014. Updated Version 1.2016.
11. Hayes. GTE Report. CHEK2-Related Susceptibility to Breast Cancer. April 26,
2013. Updated April 3, 2015.
References – Update May 2016
1.
2.
3.
4.
5.
6.
7.
Easton DF, Pharoah PD, Antoniou AC, et al. Gene-panel sequencing and the
prediction of breast-cancer risk. The New England journal of medicine. 2015 Jun
4;372(23):2243-57. PMID: 26014596.
Kriege M, Hollestelle A, Jager A, et al. Survival and contralateral breast cancer in
CHEK2 1100delC breast cancer patients: impact of adjuvant chemotherapy. Br J
Cancer. 2014 Aug 26;111(5):1004-13. doi: 10.1038/bjc.2014.306. Epub 2014
Jun 10.
Kurian AW, Hare EE, Mills MA, et al. Clinical evaluation of a multiple-gene
sequencing panel for hereditary cancer risk assessment. J Clin Oncol. 2014 Jul
1;32(19):2001-9. doi: 10.1200/JCO.2013.53.6607. Epub 2014 Apr 14.
Kuusisto KM1, Bebel A, Vihinen M, et al. Screening for BRCA1, BRCA2, CHEK2,
PALB2, BRIP1, RAD50, and CDH1 mutations in high-risk Finnish BRCA1/2-founder
mutation-negative breast and/or ovarian cancer individuals. Breast Cancer Res.
2011 Feb 28;13(1):R20. doi: 10.1186/bcr2832.
Pfeifer W, Sokolenko AP, Potapova ON, et al. Breast cancer sensitivity to
neoadjuvant therapy in BRCA1 and CHEK2 mutation carriers and non-carriers.
Breast Cancer Res Treat. 2014 Dec;148(3):675-83. doi: 10.1007/s10549-0143206-1. Epub 2014 Nov 21.
Walsh T, Casadei S, Coats KH, et al. Spectrum of mutations in BRCA1, BRCA2,
CHEK2, and TP53 in families at high risk of breast cancer. JAMA. 2006;295
(12):1379-1388.
Wang N, Ding H, Liu C, et al. A novel recurrent CHEK2 Y390C mutation identified
in high-risk Chinese breast cancer patients impairs its activity and is associated
with increased breast cancer risk. Oncogene. 2015 Jan 26. doi:
10.1038/onc.2014.443. [Epub ahead of print].
References – Update October 2015
1.
2.
3.
Ashfaq A, McGhan LJ, Pockaj BA, et al. Impact of breast reconstruction on the
decision to undergo contralateral prophylactic mastectomy. Ann Surg Oncol. 2014
Sep;21(9):2934-40
Basu NN, Ingham S, Hodson J, et al. Risk of contralateral breast cancer in BRCA1
and BRCA2 mutation carriers: a 30-year semi-prospective analysis. Fam Cancer.
2015 Aug 4.
Chai X, Friebel TM, Singer CF, et al. Use of risk-reducing surgeries in a
prospective cohort of 1,499 BRCA1 and BRCA2 mutation carriers. Breast Cancer
Res Treat. 2014 Nov;148(2):397-406.
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20
4.
5.
6.
7.
8.
Davies KR, Cantor SB, Brewster AM. Better contralateral breast cancer risk
estimation and alternative options to contralateral prophylactic mastectomy. Int J
Womens Health. 2015 Feb 4;7:181-7.
De Felice F, Marchetti C, Musella A, et al. Bilateral Risk-Reduction Mastectomy in
BRCA1 and BRCA2 Mutation Carriers: A Meta-analysis. Ann Surg Oncol. 2015
Sep;22(9):2876-80.
Fayanju OM, Stoll CR, Fowler S, et al. . Contralateral prophylactic mastectomy
after unilateral breast cancer: a systematic review and meta-analysis. Ann Surg.
2014 Dec;260(6):1000-10.
King TA, Pilewskie M, Muhsen S, et al. Lobular Carcinoma in Situ: A 29-Year
Longitudinal Experience Evaluating Clinicopathologic Features and Breast Cancer
Risk. J Clin Oncol. 2015 Sep 14.
Sismondi P, D'Alonzo M, Pecchio S, et al. Chemoprevention or mastectomy for
high risk women. Maturitas. 2015 Jul 26.
References – Update October 2014
1.
2.
3.
4.
Chagpar AB. Contralateral prophylactic mastectomy. June 30, 2014.
McLaughlin S. Breast Conservation Therapy and Mastectomy. Surgical Clinics of
North America. Volume 93, Issue 2. April 2013.
Niederhuber: Abeloff's Clinical Oncology, 5th ed. 2013 Saunders, An Imprint of
Elsevier. Management of Patients at High Risk for Breast Cancer
Rosenberg SM, Tracy MS, Meyer ME, et al. Perceptions, knowledge, and
satisfaction with contralateral prophylactic mastectomy among young women with
breast cancer: a cross-sectional survey. Ann Intern Med 2013; 159:373.
References – Update October 2013
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5.
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7.
Dražan L, Veselý J, Hýža P, et al. Surgical prevention of breast carcinoma in
patients with hereditary risk. Klin Onkol. 2012;25 Suppl:S78-83.
Koslow S, Pharmer LA, Scott AM, et al. Long-term patient-reported satisfaction
after contralateral prophylactic mastectomy and implant reconstruction. Ann Surg
Oncol. 2013 Oct;20(11):3422-9.
Noguès C, Mouret-Fourme E. Prophylactic surgery in common hereditary cancer
syndromes. Bull Acad Natl Med. 2012 Oct;196(7):1237-45.
Peled AW, Irwin CS, Hwang ES, et al. Total Skin-Sparing Mastectomy in BRCA
Mutation Carriers. Ann Surg Oncol. 2013 Aug 28.
Singh K, Lester J, Karlan B, et al. Impact of family history on choosing riskreducing surgery among BRCA mutation carriers. Am J Obstet Gynecol. 2013
Apr;208(4):329.e1-6.
Spurná Z, Dražan L, Foretová L, Dvorská L. The effect of prophylactic
mastectomy with recontruction on quality of life in BRCA positive women. Klin
Onkol. 2012;25 Suppl:S74-7.
This P, de la Rochefordière A, Savignoni A, et al. Breast and ovarian cancer risk
management in a French cohort of 158 women carrying a BRCA1 or BRCA2
germline mutation: patient choices and outcome. Fam Cancer. 2012
Sep;11(3):473-82.
References – Update October 2012
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Barry PN, Johnson RR, Harkenrider MM, et al. Contralateral Prophylactic
Mastectomy: Clinical and Pathological Features From a Prospective Database. Am
J Med Sci. 2012 Mar 5.
Dražan L, Veselý J, Hýža P, et al. Surgical prevention of breast carcinoma in
patients with hereditary risk. Klin Onkol. 2012;25 Suppl:S78-83.
Unukovych D, Sandelin K, Liljegren A, et al. Contralateral prophylactic
mastectomy in breast cancer patients with a family history: A prospective 2-years
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Cancer. 2012 Jun 11.
References – Update November 2011
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2.
King TA, Sakr R, Patil S, et al. Clinical management factors contribute to the
decision for contralateral prophylactic mastectomy. J Clin Oncol. 2011 Jun
1;29(16):2158-64
Rueth NM, McMahon M, Arrington AK, et al. Preoperative risk assessment among
women undergoing bilateral prophylactic mastectomy for cancer risk reduction.
Ann Surg Oncol. 2011 Sep;18(9):2515-20
References – Update February 2011
1.
Boughey JC, Hoskin TL, Degnim AC, et al. Contralateral prophylactic mastectomy
is associated with a survival advantage in high-risk women with a personal history
of breast cancer. Ann Surg Oncol. 2010 Oct;17(10):2702-9.
2. Hoover DJ, Paragi PR, Santoro E, et al. Prophylactic mastectomy in high risk
patients: a practice-based review of the indications. Do we follow guidelines?
Breast Dis. 2010 Jan 1;31(1):19-27.
3. Jones NB, Wilson J, Kotur L, et al. Contralateral prophylactic mastectomy for
unilateral breast cancer: an increasing trend at a single institution.
4. Ann Surg Oncol. 2009 Oct;16(10):2691-6.
5. Lostumbo L, Carbine NE, Wallace J. Prophylactic mastectomy for the prevention
of breast cancer. Cochrane Database Syst Rev. 2010 Nov 10;11:CD002748
6. Salhab M, Bismohun S, Mokbel K. Risk-reducing strategies for women carrying
BRCA1/2 mutations with a focus on prophylactic surgery. BMC Womens Health.
2010 Oct 20;10:28.
7. Stucky CC, Gray RJ, Wasif N, et al. Increase in contralateral prophylactic
mastectomy: echoes of a bygone era? Surgical trends for unilateral breast cancer.
Ann Surg Oncol. 2010 Oct;17(Suppl 3):330-7.
8. Stuckey A, Dizon D, Scalia Wilbur J, et al. Clinical characteristics and choices
regarding risk-reducing surgery in BRCA mutation carriers. Gynecol Obstet
Invest. 2010;69(4):270-3.
9. Yi M, Hunt KK, Arun BK, et al. Factors affecting the decision of breast cancer
patients to undergo contralateral prophylactic mastectomy. Cancer Prev Res
(Phila). 2010 Aug;3(8):1026-34.
10. Yao K, Stewart AK, Winchester DJ, Winchester DP. Trends in contralateral
prophylactic mastectomy for unilateral cancer: a report from the National Cancer
Data Base, 1998-2007. Ann Surg Oncol. 2010 Oct;17(10):2554-62.
References – Update June 2009
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Rebbeck, TR, Friebel, T, Lynch, HT, et al. Bilateral Prophylactic Mastectomy
Reduces Breast Cancer Risk in BRCA1 and BRCA2 Mutation Carriers: The PROSE
Study Group. J Clin Oncol 2004; 22:1055.
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2.
3.
4.
5.
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17.
Rebbeck TR, Kauff ND, Domchek SM. Meta-analysis of risk reduction estimates
associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2
mutation carriers. J Natl Cancer Inst. 2009 Jan 21; 101(2): 80-7.
Litton JK, Westin SN, Ready K et al. Perception of screening and risk reduction
surgeries in patients tested for a BRCA deleterious mutation. Cancer. 2009 Apr
15; 115(8): 1598-604
Metcalfe KA, Birenbaum-Carmeli D, Lubinski J, et al. International variation in
rates of uptake of preventive options in BRCA1 and BRCA2 mutation carriers. Int
J Cancer. 2008 May 1; 122(9): 2017-22.
Scheufler O, Fritschen U. Prophylactic mastectomy in women at high risk for
breast cancer: indications and options. Handchir Mikrochir Plast Chir. 2008 Aug;
40(4): 239-47
Nguyen JT, Wheatley MJ, Schnur PL et al. Reduction mammaplasty: a review of
managed care medical policy coverage criteria. Plast Reconstr Surg. 2008 Apr;
121(4): 1092-100.
Heemskerk-Gerritsen BA, Brekelmans CT, Menke-Pluymers MB et al. Prophylactic
mastectomy in BRCA1/2 mutation carriers and women at risk of hereditary breast
cancer: long-term experiences at the Rotterdam Family Cancer Clinic. Ann Surg
Oncol. 2007 Dec; 14(12): 3335-44.
Uyei A, Peterson SK, Erlichman J et al. Association between clinical characteristics
and risk-reduction interventions in women who underwent BRCA1 and BRCA2
testing: a single-institution study. Cancer. 2006 Dec 15; 107(12): 2745-51.
Fryzek JP, Ye W, Nyrén O, et al. A nationwide epidemiologic study of breast
cancer incidence following breast reduction surgery in a large cohort of Swedish
women. Breast Cancer Res Treat. 2006 May; 97(2): 131-4
Calderon-Margalit R, Paltiel O. Prevention of breast cancer in women who carry
BRCA1 or BRCA2 mutations: a critical review of the literature. Int J Cancer. 2004
Nov 10; 112(3): 357-64
Tarone RE, Lipworth L, Young VL, McLaughlin JK. Breast reduction surgery and
breast cancer risk: does reduction mammaplasty have a role in primary
prevention strategies for women at high risk of breast cancer? Plast Reconstr
Surg. 2004 Jun; 113(7): 2104-10
Kneser U, Jaeger K, Bach AD et al. Breast-reduction surgery--a long-term survey
of indications and outcomes. MMW Fortschr Med. 2004 Oct 14; 146(42): 36-8, 40
Lostumbo L, Carbine N, Wallace J, Ezzo J. 4: Prophylactic mastectomy for the
prevention of breast cancer. Cochrane Database Syst Rev. 2004 Oct
18;(4):CD002748.
Brinton LA, Persson I, Boice JD Jr, et al. Breast cancer risk in relation to amount
of tissue removed during breast reduction operations in Sweden. Cancer. 2001
Feb 1; 91(3): 478-83.
Brown MH, Weinberg M, Chong N, et al. A cohort study of breast cancer risk in
breast reduction patients. Plast Reconstr Surg. 1999 May; 103(6): 1674-81.
Hartmann LC, Schaid DJ, Woods JE, et al. Efficacy of bilateral prophylactic
mastectomy in women with a family history of breast cancer. N Engl J Med. 1999
Jan 14; 340(2): 77-84.
Tang CL, Brown MH, Levine R, et al. A follow-up study of 105 women with breast
cancer following reduction mammaplasty. Plast Reconstr Surg. 1999 May;
103(6): 1687-90.
References – Update June 2007
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2.
American Cancer Society (ACS). Cancer Facts and Figures 2007.
The National Surgical Adjuvant Breast and Bowel Project (NSABP). 2007.
Available at: http://www.nsabp.pitt.edu/
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3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Society of Surgical Oncology. Position statement on prophylactic mastectomy.
March 2007.
U.S. Preventive Services Task Force (USPSTF). Genetic Risk Assessment and
BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility. Summary of
Recommendations. September 2005. Updated December 2013. Available at:
http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm
Walsh T, Casadei S, Coats KH, et al. Spectrum of mutations in BRCA1, BRCA2,
CHEK2, and TP53 in families at high risk of breast cancer. JAMA. 2006; 295(12):
1379-1388.
Chen J, Pee D, Ayyagari R, et al. Projecting absolute invasive breast cancer risk
in white women with a model that includes mammographic density. J Natl Cancer
Inst 98 (17): 1215-26, 2006.
McGuire V, John EM, Felberg A, et al. No increased risk of breast cancer
associated with alcohol consumption among carriers of BRCA1 and BRCA2
mutations ages <50 years. Cancer Epidemiol Biomarkers Prev 15 (8): 1565-7,
2006.
Andrieu N, Easton DF, Chang-Claude J, et al.: Effect of chest X-rays on the risk of
breast cancer among BRCA1/2 mutation carriers in the international BRCA1/2
carrier cohort study: a report from the EMBRACE, GENEPSO, GEO-HEBON, and
IBCCS Collaborators' Group. J Clin Oncol 24 (21): 3361-6, 2006.
Narod SA, Lubinski J, Ghadirian P, et al.: Screening mammography and risk of
breast cancer in BRCA1 and BRCA2 mutation carriers: a case-control study.
Lancet Oncol 7 (5): 402-6, 2006.
American Cancer Society. Can Breast Cancer Be Prevented. Revised 9/18/2006.
Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2006. CA Cancer J Clin.
2006;56:106-130.
Vogel VG, Costantion JP, Wickerham DL, et al. Effects of tamoxifen vs raloxifene
on the risk of developing invasive breast cancer and other disease outcomes: the
NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006;
295:2727-2741.
Cuzick J, Forbes JF, Howell A. Re: Tamoxifen for the prevention of breast cancer:
current status of the National Surgical Adjuvant Breast and Bowel Project P-1
study. J Natl Cancer Inst. 2006; 98:643.
Land SR, Wickerham DL, Costantino JP, et al. Patient-reported symptoms and
quality of life during treatment with tamoxifen or raloxifene for breast cancer
prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.
JAMA. 2006; 295:2742-2751.
Abramson N, Costantino JP, Garber JE, et al. Effect of Factor V Leiden and
prothrombin G20210-->A mutations on thromboembolic risk in the National
Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl
Cancer Inst. 2006; 98:904-910.
Rosenberg L, Palmer JR, Wise LA, Adams-Campbell LL. A prospective study of
female hormone use and breast cancer among black women. Arch Intern Med.
2006; 166:760-765.
Chen WY, Manson JE, Hankinson SE, et al. Unopposed estrogen therapy and the
risk of invasive breast cancer. Arch Intern Med. 2006;166:1027-1032.
Terry MB, Zhang FF, Kabat G, et al. Lifetime alcohol intake and breast cancer
risk. Ann Epidemiol. 2006;16:230-240.
Tehard B, Friedenreich CM, Oppert JM, et al. Effect of physical activity on women
at increased risk of breast cancer: results from the E3N cohort study. Cancer
Epidemiol Biomarkers Prev. 2006;15:57-64.
Prentice RL, Caan B, Chlebowski RT, et al. Low-fat dietary pattern and risk of
invasive breast cancer: the Women's Health Initiative Randomized Controlled
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Dietary Modification Trial. JAMA. 2006;295:629-642.
21. Eliassen AH, Colkditz GA, Rosner B, et al. Adult weight change and risk of
postmenopausal breast cancer. JAMA. 2006;296:193-201.
22. McGahan L, Kakuma R, Ho C, et al. BRCA1 and BRCA2 predictive genetic testing
for breast and ovarian cancers: A systematic review of clinical evidence.
Technology Report No. 66. Ottawa, ON: Canadian Coordinating Office for Health
Technology Assessment (CCOHTA); March 31, 2006.
23. Tranchemontagne J, Boothroyd L, Blancquaert I. Contribution of BRCA1/2
mutation testing to risk assessment for susceptibility to breast and ovarian
cancer. Summary Report. Montreal, QC. March 2006.
References - Initial
1. Adem C, Reynolds C, Soderberg CL, et al. Pathologic characteristics of breast
parenchyma in patients with hereditary breast carcinoma, including BRCA1 and
BRCA2 mutation carriers. Cancer. 2003 Jan 1; 97(1): 1-11.
2. Ali-Fehmi R, Carolin K, Wallis T, Visscher DW. Clinicopathologic analysis of breast
lesions associated with multiple papillomas. Hum Pathol. 2003 Mar;34(3):234-9.
3. Bodian CA, Perzin KH, Lattes R, et al. Prognostic significance of benign proliferative
breast disease. Cancer. 1993 Jun 15;71(12):3896-907.
4. Botkin JR, Smith KR, Croyle RT, et al. Genetic testing for a BRCA1 mutation:
Prophylactic surgery and screening behavior in women 2 years post testing. Am J
Med Genet. 2003 Apr 30;118A(3):201-9
5. Carter CL, Corle DK, Micozzi MS, et al. A prospective study of the development of
breast cancer in 16,692 women with benign breast disease. Am J Epidemiol. 1988
Sep;128(3):467-77.
6. Connolly JL, Schnitt SJ. Clinical and histologic aspects of proliferative and nonproliferative benign breast disease. J Cell Biochem Suppl. 1993;17G:45-8.
7. Dupont WD, Page DL. Risk factors for breast cancer in women with proliferative
breast disease. N Engl J Med. 1985 Jan 17;312(3):146-51
8. Dupont WD, Parl FF, Hartmann WH, et al. Breast cancer risk associated with
proliferative breast disease and atypical hyperplasia. Cancer. 1993 Feb
15;71(4):1258-65.
9. Eisen A, Rebbeck TR, Wood WC, et al. Prophylactic Surgery in Women with a
Hereditary Predisposition to Breast and Ovarian Cancer. Journal of Clin Onc.18(9);
(May): 1980-1995
10. Grann VR, Panageas KS, Whang W, et al. Decision analysis of prophylactic
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11. Hartmann LC, Schaid DJ, Woods JE, et al., Efficacy of Bilateral Prophylactic
Mastectomy in Women with a Family History of Breast Cancer. NEJM
1999;340(2):77-84
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mastectomy in BRCA1 and BRCA2 gene mutation carriers. J Natl Cancer Inst. 2001
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13. Meijers-Heijboer H, Brekelmans CT, Menke-Pluymers M, et al. Use of genetic
testing and prophylactic mastectomy and oophorectomy in women with breast or
ovarian cancer from families with a BRCA1 or BRCA2 mutation. J Clin Oncol. 2003
May 1;21(9):1675-81.
14. Meijers-Heijboer H, van Geel B, et al. Breast Cancer after Prophylactic Bilateral
Mastectomy in Women with a BRCA1 or BRCA2 Mutation. NEJM 2001;345(3):159164
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15. Metcalfe KA, Narod SA. Breast cancer risk perception among women who have
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16;94(20):1564-9.
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Mutations. NEJM 1997 May 336(20):1465-1471.
24. Schrag et al., JAMA 2000;283(5):617-624
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National Cancer Institute, 1995:33-6. (NIH publication no. 94-03837.)
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CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery.
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