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The University of Texas M.D. Anderson Cancer Center,
Houston, TX
Breast cancer treatment guidelines in older women.
Giordano SH, et al J Clin Oncol. 2005
• 1,568 patients aged 55+ years, treated at M.D.
Anderson Cancer Center between 1997 and 2002
for stage I to IIIA invasive ductal and lobular breast
cancer.
• Concordance with institutional guidelines was
determined for surgical therapy, radiotherapy,
adjuvant chemotherapy, and adjuvant hormonal
therapy.
• Logistic regression modeling was performed to
determine the independent effect of each variable
on guideline concordance.
• In multivariate analysis, age > 75 years predicted a
deviation from guidelines for definitive surgical
therapy (P < .001), adjuvant chemotherapy (P <
.001), and adjuvant hormonal therapy (P < .001).
Is adjuvant therapy for older patients with node (-)
early breast cancer cost-effective?
Naeim A, Keeler EB. Crit Rev Oncol Hematol. 2005 Jan;53(1):81-9
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Node (-) pts represents >60% of BC cases in older women.
To evaluate if adjuvant treatment is cost-effective in these patients.
DESIGN:
– Decision-analysis modeling using life tables integrated the cost of
treatment in dollars and impact in length and quality of life.
– The primary data sources were meta-analysis from the Early Breast
Cancer Trialists' Collaborative Group and the Red Book Average
Wholesale Price for drugs.
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RESULTS:
– Adjuvant therapy is cost-effective in 65-year-old women with early breast
cancer.
– In a 75-year-old ER (+) patient, hormone therapy, specifically tamoxifen, is
cost-effective, 19,530 dollars/QALY.
– In a 75-year-old ER (-) the use of chemotherapy (AC or CMF) or 85-yearold ER (+) the use of hormone therapy was only marginally cost-effective,
54,000-76,000 dollars/QALY, only if efficacy was assumed to be ageinsensitive (similar to a 65-year-old woman).
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CONCLUSION: Decision-analytic models can help policy makers who
are faced with decisions about whether to support adjuvant therapy in
older breast cancer patients and also outline the important parameters
Chemotherapy for elderly patients with
NSCLC:
a review of the evidence.
Gridelli C, Shepherd FA. Chest. 2005
• Authors' selection of key evidence for the use of cht for
elderly NSCLC pts.
• To date, single-agent cht with vinorelbine, gemcitabine,
docetaxel, and paclitaxel has been a reasonable option.
• Data on non-platinum-based combinations are limited, but
gemcitabine plus vinorelbine failed to show superiority over
either agent alone.
• Retrospective subset analyses from large randomized trials
suggest that the efficacy and tolerability of platinum-based
combination cht are similar in both the elderly and their
younger counterparts.
• Further phase III trials that specifically examine platinumbased combinations in selected elderly NSCLC patients are
therefore warranted.
• The potential impact of new targeted therapies-alone or in
combination with chemotherapy-is being investigated.
Irinotecan in combination with fluorouracil in a 48-hour continuous
infusion as first-line chemotherapy for elderly patients with
metastatic colorectal cancer: a Spanish Cooperative Group for
the Treatment of Digestive Tumors study.
Sastre J, et al. J Clin Oncol. 2005
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85 pts 72+ yrs with mCRC, ECOG PS 0-1, no geriatric syndromes, and
no prior treatment received CPT-11 180 mg/m2 plus FU 3,000 mg/m2
in a 48-hour continuous infusion every 2 weeks.
OR rate 35% (95% CI, 25%-46%), and SD 33% (95% CI, 23%-44%).
Median TTP was 8.0 months (95% CI, 6.0 to 10.0 months)
Median OS was 15.3 months (95% CI, 13.8 to 16.9 months).
Toxicity was moderate. Grade 3 and 4 neutropenia, diarrhea, and
asthenia were observed in 21%, 17%, and 13% of patients,
respectively. Only one case of neutropenic fever occurred.
There were two toxic deaths (1 grade 4 diarrhea and acute kidney
failure, and 1 massive intestinal hemorrhage after the first cycle).
CONCLUSION: Twice a month continuous-infusion CPT-11 combined
with FU is a valid therapeutic alternative for elderly pts in good general
condition.
Capecitabine as first-line treatment for patients older than 70 years with
metastatic colorectal cancer: an oncopaz cooperative group study.
Feliu J, et al. J Clin Oncol. 2005
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51 pts with advanced CRC, 70+ years and ineligible for combination
cht received oral capecitabine 1,250 mg/m(2) twice daily on days 1 to
14 every 3 weeks. Patients with a creatinine clearance of 30 to 50
mL/min received a dose of 950 mg/m(2) twice daily.
A total of 248 cycles of capecitabine were administered (median, 5
cycles; range, 1-8 cycles).
The overall RR was 24% (95% CI, 15% to 41%), including two CR
(4%) and 10 PR (20%).
Disease control (CR + PR + stable disease) was achieved in 67% of
patients.
The median TTP and OS were 7 months (95% CI, 6.4 to 9.5 months)
and 11 months (95% CI, 8.6 to 13.3), respectively.
Treatment-related grade 3 and 4 AE were observed in 6 patients
(12%), (diarrhea, hand-foot syndrome, and thrombocytopenia).
No treatment-related death was reported.
CONCLUSION: Our findings suggest that capecitabine is effective and
well tolerated in elderly patients with advanced CRC who are
considered ineligible for combination chemotherapy.
Systematic review of barriers to the recruitment of older
patients with cancer onto clinical trials.
Townsley CA, et al. J Clin Oncol. 2005
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Only a quarter to one third of potentially eligible older patients are
enrolled onto trials.
Physicians' perceptions, protocol eligibility criteria with restrictions on
comorbid conditions, and functional status to optimize treatment
tolerability are the most important reasons resulting in the exclusion of
older patients.
Other barriers include the lack of social support and the need for extra
time and resources to enroll these patients.
Conversely, older patients do not view their age as an important
reason for refusing trials.
• CONCLUSION:
– Specific clinical trials for older patients should be conducted to
evaluate tumor biology, treatment tolerability, and the effect of
comorbid conditions.
– Protocol designs need to stratify for age and be less restrictive with
respect to exclusions on functional status, comorbidity, and previous
cancers, such that results are generalizable to older patients.
– Physician education and provision of personnel and resources to
accommodate the unique requirements of an older population are
possible solutions to remove the barriers of ageism