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Cancer Consult
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F a l l 2 011
Nonsurgical
Lung Cancer
Treatments
Ranked as one of America’s Top 10 Cancer Programs by U.S.News & World Report.
cancer consult
fall 2011
Nonsurgical Lung Cancer Treatments
Lung cancer has the highest mortality rate in the United States
Nonsurgical
Lung Cancer
Treatments….2
Research Allows
Early Detection of
Tumors…5
Deciphering
TET2 Protein’s
Fundamental
Function….6
Cleveland Clinic
Researcher Leads
First Head-toHead Phase III
Study of Targeted
Kidney Cancer
Treatments….8
Watchful Waiting vs.
Active Surveillance:
A More Obvious
Answer?…9
Intraoperative
Radiation
Therapy Shows
Promise……10
Case Study:
Cleveland Clinic
Surgeon Performs
First Robotic
Partial Removal of
Transplanted Kidney
Tumor…12
Outcomes Reporting
Helps Advance
Transparency in
Healthcare….14
Selected
Publications…..15
in both men and women, claiming more lives than other common
cancers —breast, colon and prostate — combined.
While its incidence has gone down in men and
stabilized in women, long-term survival rates
remain low because lung cancer is usually diagnosed at a stage when the cancer has spread to
the lymph nodes or to other organs and structures
outside the chest. Even in patients with lung
cancer involving the lymph nodes and who may
be potentially curable, many are not considered
appropriate candidates for surgery, either because
their cancer is too bulky in the chest or they have
medical conditions such as COPD or heart disease, which make surgery unsafe. Unfortunately,
comorbidities and cancer often go hand in hand
and are common in the lung cancer population,
which make even early lung cancers (most often
managed by surgeons) sometimes very challenging because of the risks to patients.
The good news is that there have been major
advances in nonsurgical treatments that are benefiting the medically unfit patient with early stage
cancer. One important innovation is stereotactic
body radiation therapy (SBRT), which delivers
very high doses of radiation precisely targeted to
the tumor in the lung only, while sparing normal
tissues. Since the lung is a resilient organ that
can compensate for small losses of tissue when a
tumor is eradicated, it is well-suited to this aggressive form of radiotherapy. “SBRT is very effective
at local control of early cancers and has been
safely delivered,” says Gregory Videtic, MD, radiation oncologist and Section Head for Thoracic
Malignancies. Dr. Videtic is the principal investigator for a recently completed randomized Phase II
trial comparing SBRT treatment schedule which
was sponsored by RTOG, the national collaborative
research group that studies radiotherapy.
SBRT is very effective at
local control of early cancers
and remarkably safe.
At Cleveland Clinic, SBRT is a primary treatment
for medically inoperable patients with non-small
cell lung cancer (NSCLC) that hasn’t spread to
other organs. Since the majority of SBRT patients
treated have a lung disability such as COPD, it has
been reassuring to find that less than 5 percent of
such patients will experience clinically significant
changes in their breathing after therapy. SBRT
requires far fewer treatments than conventional
radiation — between one and five sessions over
one week depending on the tumor’s size and location in the lung. “The advantage over conventional
radiotherapy isn’t just the low number of treatments but also the higher radiation doses which
change the cancer’s biology,” says Dr. Videtic.
Cleveland Clinic is one of a select number of medical institutions that offers SBRT. “Patients with
early-stage cancer who are medically inoperable
should consider SBRT at Cleveland Clinic,” says
Nathan Pennell, MD, PhD, a medical oncologist
specializing in thoracic cancers with a focus on
lung cancer.
In Japan, where SBRT was pioneered, anecdotal
evidence suggests that SBRT may be as effective
as surgery at curing cancer, based on results for a
small number of patients who have now been followed for more than 10 years; these were patients
who could have had surgery but refused. Formal
Cancer Answer Line 866.223.8100
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,
Dear Colleagues and Friends:
I am pleased to send you the latest issue of
Cleveland Clinic Cancer Consult. On behalf
of the physicians, researchers and other
healthcare professionals at the Taussig Cancer
Institute, I welcome your interest in the
exciting work being done here.
In this issue, we review nonsurgical solutions
Above: Representative image taken from the SBRT
planning system, depicting dose shaped around the
target. The image is seen in three dimensions.
for disease, new applications for genetic
testing, exciting results from kidney cancer
drug trials and several other initiatives of our
internationally recognized staff. I am proud
to share these examples of our strengths in
clinical excellence, innovation and patientcentered care. We are inspired by our patients
to challenge the status quo, developing new
ways to treat cancer today with an ultimate
goal of eradicating it in the future.
In addition to providing care to more than
28,000 patients annually on our main
Left image: Previously treated
Right image: One year later,
campus, we offer treatment at 13 other
patient who was treated in
showing disappearance of the
locations in Northeast Ohio. Every member of
2004 with SBRT for a new left
tumor after treatment.
our team is committed to giving our patients
upper lobe tumor.
the best opportunity to beat their disease.
I hope you find this issue of Cancer Consult
valuable and inspiring. I encourage you
research studies in the United States for potentially
operable patients are planned for the near future.
Moving from the concept of a physical target
(tumor) for which SBRT is well-designed,
lung cancer has been revolutionized by an
understanding of the molecular makeup of
cancer cells. This has led to the development of
molecularly based “targeted” therapies, which act
on the cellular mechanisms that lead to cancer
growth. Identifying abnormal pathways and
genetic mutations has led to the development of
a number of innovative treatments, including,
for example, drugs like bevacizumab (Avastin®)
aimed at blocking blood vessel growth in tumors.
Such drugs can often be used with conventional
chemotherapy to treat lung cancer.
2 | 3 | clevelandclinic.org/cancer
to explore our care further by reviewing
our Outcomes books, produced annually
and available at www.clevelandclinic.org/
outcomesonline.
Please feel free to email me at bolwelb@
ccf.org with suggestions and questions. The
Cleveland Clinic cancer team looks forward
to collaborating with you in the care of your
patients.
Sincerely,
Brian J. Bolwell, MD
Chairman
Taussig Cancer Institute
cancer consult
fall 2011
Nonsurgical Treatments (continued)
To learn more about
this research or
to refer a patient,
call Dr. Pennell at
216.445.9282
or Dr. Videtic at
216.444.9797.
In another setting, currently all patients with
adenocarcinoma, the most common type of
NSCLC, are routinely tested for a genetic mutation
in the epidermal growth factor receptor (EGFR),
which is a normal part of the cell. This testing is
conducted to determine if the patients might be
candidates for the drug erlotinib (Tarceva®), which
in appropriate patients may be more effective than
conventional chemotherapy in extending lifespan.
In the past, doctors had to rely on patient characteristics rather than a test to estimate the chance
that the mutation would be present; for example, it
is found mainly in people who are light smokers or
who’ve never smoked.
Treatment for another genetic mutation,
echinoderm microtubule associated protein like
4-anaplastic lymphoma kinase (EML4-ALK), is
currently being investigated in a Phase III trial at
Cleveland Clinic. A newly developed ALK inhibitor,
crizotinib, has shown impressive results and may
receive early FDA approval. Together, EGFR and
EML4-ALK are found in about 60 percent of people
with lung cancer who’ve never smoked.
Cleveland Clinic is participating in a comprehensive study to identify the entire spectrum of
genomic changes in human cancer — The Cancer
Genome Atlas — conducting the research on lung,
bladder and brain cancers. “It will provide a road
map of how we can treat lung cancer by identifying
more mutations and pathways,” says Dr. Pennell.
New advances haven’t replaced standard chemotherapy and radiation, which continue to be used
in the vast majority of patients, both as adjuncts to
surgery and as primary treatments for nonsurgical
patients, not the least of which is for palliative
care.
Ultimately, the greatest hope for improving lung
cancer prognosis is early detection. The National
Lung Screening Trial has compared screening
with chest X-rays with a new type of CT scan, spiral
CT, in 50,000 people at high risk for lung cancer.
Preliminary results indicate that people screened
with spiral CT have a 20 percent lower risk of dying
from lung cancer. Research is also under way to
develop a lung cancer blood test. “It’s an incredibly
exciting time to be working with lung cancer. If we
can identify people at Stage 1, we could potentially
cure them,” says Dr. Pennell.
Cancer Answer Line 866.223.8100
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Research Allows Early
Detection of Tumors
Researchers discover
genetic predisposition for
breast, kidney cancers.
To learn more about this
research, call Dr. Eng at
216.444.3440
Researchers at Cleveland Clinic’s Genomic
Medicine Institute have revealed multiple genetic
discoveries that may permit easier diagnosis
and disease management for Cowden syndrome
patients who are predisposed to breast and kidney
cancer.
The research, which could allow for earlier
discovery of cancerous tumors, was published
in the Dec. 22, 2010, issue of the Journal of the
American Medical Association.
Charis Eng, MD, PhD, Chair of the Genomic
Medicine Institute at Cleveland Clinic, led the
research. It revealed KILLIN as a novel predisposition gene for Cowden syndrome (CS) and
Cowden-like syndrome (CLS) features in individuals without germline PTEN mutations, which also
plays a role in cancer risk.
According to Dr. Eng, “CLS is at least 10 times
more common than CS, but the genetic alteration
responsible for CLS and its cancers has eluded
the scientific community for more than a decade.
From our research, we now know that KILLIN
accounts for almost half of CLS, making diagnosis
much more accurate.”
Mutations in the PTEN gene are the foundation of
Cowden syndrome. PTEN is a tumor suppressor
gene, helping to direct the growth and division of
cells. Inherited mutations in the PTEN gene have
been found in approximately 80 percent of Cowden
syndrome patients. These mutations prevent
the PTEN protein from effectively regulating
cell survival and division, which can lead to the
formation of tumors.
4 | 5 | clevelandclinic.org/cancer
However, not all CS and CLS patients carry
mutated PTEN. In fact, in CLS, less than 10 percent
of patients have PTEN mutations, yet they develop
cancers just like CS. In those patients without the
PTEN mutation, 42 percent of Cowden syndrome
patients and 33 percent of Cowden-like syndrome
patients have low levels of KILLIN tumor suppressor gene.
“We know that 80 percent of Cowden patients carry
the PTEN mutation, and half of the remaining 20
percent carry the inactive KILLIN gene,” Dr. Eng
says. “What that means is that altogether PTEN
and KILLIN should account for 90 percent of all
cases of classic Cowden syndrome — a huge step
forward in diagnosing an often overlooked disease.
More important, KILLIN and PTEN should account
for almost half of CLS individuals.”
This study shows that CS/CLS individuals with
KILLIN-promoter methylation, which switches the
KILLIN gene off, have a threefold greater risk of
breast cancer, and a twofold greater risk of kidney
cancer, compared to those with mutant PTEN.
Having the ability to identify these individuals
will allow for more proactive management of their
health, such as more careful screening and shared
best practices among physicians who treat them.
Findings from this study indicate that individuals
with classic Cowden syndrome should be offered
PTEN testing first; those found not to have PTEN
mutations should then be screened for the inactivated KILLIN gene and offered genetic counseling.
Those patients who carry neither the PTEN mutation nor the inactive KILLIN gene should be offered
additional/alternative genetic testing and importantly, encouraged to participate in research.
cancer consult
fall 2011
Deciphering
TET2 Protein’s
Fundamental
Function
Researchers at Cleveland Clinic’s Taussig Cancer Institute have shown that measurement of
5-hydroxymethylcytosine (5-hmC) levels in myeloid malignancies may prove valuable as a diagnostic
and prognostic tool and in tailoring therapies and assessing responses to anticancer drugs.
To learn more about
this research, call
Dr. Maciejewski at
216.445.5962.
For appointments, call
216.444.6833.
The team’s discovery of TET2 (Ten-Eleven
Translocation 2) gene mutations and their function in methylcytosine hydroxylation is an entirely
new line of scientific study into the function and
pattern of hydroxymethylation and its likely alteration of epigenetic regulation. This work led to a
publication in Nature (Ko et al. Impaired hydroxylation of 5-methylcytosine in myeloid cancers
with mutant TET2. Nature 2010;468(7325);839843.) and was presented asAbstract No. 1 at the
plenary session of the 2010 American Society of
Hematology annual meeting.
Clinical Trials
Directory Now Online
Cleveland Clinic Taussig Cancer Institute offers an
online tool for physicians, patients and caregivers to
search for open clinical trials. The web-based clinical
trials database lists all the trials being managed by
oncologists in the Taussig Cancer Institute that are
accepting patients. At any given time, several hundred
cancer clinical trials are under way on the main campus
and at some Cleveland Clinic regional facilities.
To search the database, visit
clevelandclinic.org /cancerclinicaltrials
The collaborative study — led by investigators
here and in the United Kingdom and at Harvard
Medical School, the Dana-Farber Cancer Institute
in Boston and the National Institutes of Health
— assessed the frequency of TET2 mutations in
more than 100 patient samples of the various
myeloid malignancies, including myelodysplastic
syndromes (MDSs), myeloproliferative neoplasms
(MPNs), and both primary and secondary acute
myeloid leukemias (AMLs and sAMLs, respectively). Results from the research showed that in
general TET2 converts 5-methlycytosine (5-mC) to
5-hmC, which predicts that the bone marrow cells
of patients with mutated TET2 would have lower
levels of 5-hmC incorporated into their DNA.
“The function of this gene was a mystery until work
from our laboratory, in collaboration with colleagues from Harvard Medical School, showed that
TET2 is a dioxygenase domain-containing enzyme
utilizing a-ketoglutarate to hydroxylate methylcytosine in genomic DNA. We have demonstrated
that mutations in human TET2 encountered in
leukemia impair this important function, and as a
result the content of hydroxymethylcytosine in the
genome of cancer cells affected by these mutations
is decreased,” says senior study author Jaroslaw
P. Maciejewski, MD, PhD, FACP, Chairman of the
Department of Translational Hematology and
Oncology Research at the Taussig Cancer Institute.
The level of 5-hmC in DNA was identified
through the development of an immunoblot
Cancer Answer Line 866.223.8100
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“Our study has led to the realization that
there are not only four or five building
blocks of DNA, but six, with one of them
being hydroxymethylcytosine.”
Jaroslaw P. Maciejewski, MD, PhD, FACP
assay to detect 5-hmC in genomic DNA,
followed by a more sensitive test that indirectly
measured 5-hmC through the accumulation of
5-methylenesulfonate (CMS) after treating DNA
with bisulfite. The results support the finding that
the TET2 gene alters methylated cytosines in the
DNA by showing that TET2 gene alters methylated
cytosines in the DNA, the experimental results
demonstrate TET2 mutation led to lower levels of
5-hmC in both the bone marrow cells of patients
with various myeloid malignances, as well as in
genetically engineered mouse cells. Additionally,
experimentally decreased TET2 levels result in
lower hydroxymethylcytosine levels and perturbed
maturation of stem cells. These results suggest
that 5-hmC levels might constitute a functionally
more significant classification of myeloid cancers
than TET2 mutational status alone.
“Our study has led to the realization that there are
not only four or five building blocks of DNA, but
six, with one of them being hydroxymethylcytosine.
Hydroxylation of methylcytosine as a fundamental
biological process and its impairment in leukemia
constitutes a totally new scientific lead and a novel
line of cancer research,” says Dr. Maciejewski.
“TET2 is one of the first of the mutated genes
found to be involved in epigenetic regulation and
thereby establishes a link between epigenetic and
genomic instability. A decrease in methylcytosine
hydroxylation is a ubiquitous phenomenon that
needs to be explored should the pathogenesis
of certain malignant conditions be clarified.
This study has instigated an entirely new line of
investigations, which brings an incredible level of
innovation and contributes to acceleration of the
progress in this field.”
6 | 7 | clevelandclinic.org/cancer
Cancer Consult provides information from Cleveland
Clinic Taussig Cancer Institute specialists about
innovative research and diagnostic and management
techniques.
Please direct correspondence to
Taussig Cancer Institute/R35
Cleveland Clinic
9500 Euclid Avenue
Cleveland, OH 44195
Cleveland Clinic Taussig Cancer Institute annually
serves more than 28,000 cancer patients. More than
250 cancer specialists are committed to researching
and applying the latest, most effective techniques for
diagnosis and treatment to achieve long-term survival
and improved quality of life for all cancer patients.
Taussig Cancer Institute is part of Cleveland Clinic,
an independent, not-for-profit, multispecialty
academic medical center.
Cancer Consult Medical Editor
Brian Rini, MD
Solid Tumor Oncology
Cancer Consult Editorial Board
Brian J. Bolwell, MD, Chairman,
Taussig Cancer Institute
Robert Dreicer, MD, Chairman,
Solid Tumor Oncology
Timothy Spiro, MD, Chairman,
Regional Oncology
John Suh, MD, Chairman,
Radiation Oncology
Gene Barnett, MD, Director, Ella Burkhardt Brain
Tumor and Neuro-Oncology Center
Eric Klein, MD, Chairman, Urologic Oncology,
Glickman Urological & Kidney Institute
Managing Editor
Kimberley Sirk
Designer
Amy Buskey-Wood
Photography
Russell Lee, Yu Kwan Lee, Steve Travarca, Don
Gerda, Toni Greaves
Marketing
Matthew Chaney
Cancer Consult is written for physicians and should
be relied upon for medical education purposes only.
It does not provide a complete overview of the topics
covered and should not replace the independent
judgment of a physician about the appropriateness or
risks of a procedure for a given patient.
© 2011 The Cleveland Clinic Foundation
10-CNR-008
cancer consult
fall 2011
Cleveland Clinic Researcher Leads
First Head-to-Head Phase III Study of
Targeted Kidney Cancer Treatments
Results show axitinib is
more effective than sorafenib.
To learn more about this
research, call Dr. Rini at
216.444.9567
At the 47th Annual American Society of Clinical
Oncology (ASCO) meeting, researchers at
Cleveland Clinic’s Taussig Cancer Institute
reported that cancer progression in patients with
previously treated advanced renal cell carcinoma
was delayed by an average of two months when
treated with axitinib versus sorafenib.
reduction for axitinib vs. sorafenib. Complete or
partial response to treatment more than doubled
in patients treated with axitinib compared to
sorafenib (19 percent vs. 9 percent). Axitinib also
proved to be generally well-tolerated among study
participants, with a lower rate of discontinuation
due to adverse events (3.9 percent vs. 8.2 percent).
In a global, randomized, Phase III trial of axitinib
vs. sorafenib as second-line therapy for mRCC,
axitinib was superior to sorafenib in the primary
endpoint of median progression-free survival
(PFS). Axitinib was also superior when considering
patient-reported quality of life measures.
Importantly, this was the first trial to compare targeted therapies against each other in kidney cancer patients. All prior Phase III studies of targeted
drugs compared their effectiveness against either
placebo or cytokines. Given that axitinib is biochemically more potent against the VEGF receptor,
this trial suggests that biochemical potency translates into clinical efficacy in this setting.
This Phase III trial, also called AXIS 1032, was
an international study involving 723 patients
with clear-cell advanced kidney cancer who
had disease progression on one prior standard
regimen (cytokines, sunitinib, bevacizumab
or temsirolimus). The study population was
reflective of a general kidney cancer population.
Patients were randomized to receive axitinib 5 mg
twice daily or sorafenib 400 mg twice daily. The
Functional Assessment of Therapy-Kidney Cancer
Symptom Index [FKSI-15] patient questionnaires
and its disease-related symptoms subscale [FKSIDRS] were administered at several points during
the study.
The results showed a median PFS of 6.7 months
with axitinib compared to 4.7 months for
sorafenib, with benefit maintained in all patient
subgroups. The composite time to deterioration endpoint (which included deterioration in
quality-of-lifescores) showed a 25 percent risk
“Before this study, we had limited proven options
for previously treated patients. Now, we can better
understand how to build an effective sequence of
treatments for patients with relapsed or refractory
kidney cancer,” says Cleveland Clinic oncologist
Brian Rini, MD, the principal investigator on the
AXIS 1032 international trial.
A Phase III trial front-line therapies is under way,
axitinib vs. sorafenib with results expected in the
next one to two years. “We expect axitinib to be
much more active as a first-line therapy since it has
shown such good results as a second-line therapy,”
Dr. Rini says. There are many remaining questions about the optimal use of targeted therapy in
advanced kidney cancer, but these Phase III results
are an important step forward.
Cancer Answer Line 866.223.8100
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Watchful Waiting vs. Active Surveillance:
A More Obvious Answer?
In a new study designed to use the study of the human genome to eliminate unnecessary
cancer treatments, Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute
and his colleagues analyzed prostate tissue samples to determine a way to gauge the
likelihood of cancer recurrence.
To learn more about this
research or to refer a
patient, call Dr. Klein at
216.444.5591
The team studied tissue sampled from more than
440 prostate tumors that had been removed from
men treated at Cleveland Clinic from 1987 to
2004. In those surgically removed specimens, the
researchers discovered a set of nearly 300 genes
that accurately predicts whether cancer will recur
after surgery.
Those genes, says Dr. Klein, provided a wealth of
information beyond standard measures, such as
Gleason scores or PSA levels.
“The biggest challenge in treating newly diagnosed
prostate cancer,” Dr. Klein says, “is deciding what
to do for men with low-grade tumors found on
biopsy. Many, if not most, of these tumors do not
behave aggressively and can be safely watched. At
present we do not have good ways of distinguishing between tumors that need treatment and those
that don’t.”
“Currently, 90 percent of men diagnosed with
low-risk cancer select the most radical options of
radiation therapy or removal of the prostate,” he
says.
Each year, more than 200,000 patients are diagnosed with prostate cancer.
“The biggest challenge in treating newly diagnosed
prostate cancer is deciding what to do for men with
low-grade tumors found on biopsy.”
Eric Klein, MD
8 | 9 | clevelandclinic.org/cancer
“If physicians had better tools for more accurately
determining whether tumors need treatment,” Dr.
Klein says, “many men could avoid unnecessary
treatment that has negative side effects.”
As Dr. Klein reported at the recent ASCO conference, the research team used a quantitative
RT-PCR analysis of the RNA from tumor specimens
to discover 295 genes that are strongly associated
with cancer recurrence after radical prostatectomy.
The team is currently validating these results on
prostate biopsy specimens. If the results are replicated, a test to help men choose surveillance rather
than immediate treatment could be developed.
Dr. Klein presented an additional study utilizing a separate analysis of RNA from those same
specimens on the aggressiveness of prostate
cancer after RP. That review found no association
of expression of TMPRSS2-ERG fusions or ERG
expression on the recurrent cancer. Both papers
can be viewed at the ASCO proceedings website at
asco.org.
cancer consult
fall 2011
Intraoperative Radiation Therapy Shows Promise
Intraoperative radiation therapy (IORT) is a technique used to deliver a high dose of
radiation to tumor sites exposed during surgery. Since the radiation is delivered directly to
the tumor site, IORT spares normal surrounding tissue and may have fewer side effects
than standard external beam radiation therapy (EBRT).
To learn more about this
research or to refer a
patient, call Dr. John
Suh at 216.444.5574.
As IORT technology has evolved and become more
flexible and convenient, its use has expanded in
recent years. IORT typically requires resection of
the tumor prior to radiation. Intraoperative radiation therapy is used to treat select types of retroperitoneal, intra-abdominal, breast, pancreatic, rectal,
gynecologic and brain cancers and is typically
indicated for patients with tumors in close proximity to vital healthy tissues. In some cases, IORT may
also make radiation therapy available to patients
who live far from major medical centers and can’t
undergo weeks of conventional EBRT.
At Cleveland Clinic, IORT is most commonly used
to treat patients with retroperitoneal sarcomas.
Retroperitoneal sarcomas are frequently located
close to vital organs, such as the kidney, small
bowel and liver. As such, these patients are good
candidates for IORT since standard EBRT doses
can, in some circumstances, locally damage these
nearby healthy tissues. During IORT treatment, the
vital surrounding organs are moved away from the
radiation field or shielded and thereby protected
from radiation exposure.
Intraoperative radiation therapy may also offer an
advantage when combined with surgical resection
of locally advanced malignancies that are invading tissue where the surgeon is unlikely to get a
wide margin of resection, such as in patients with
locally advanced colon cancer or rectal cancer
invading the presacral space. IORT also offers
advantages to patients with cancers that have
recurred within a previously radiated field, as it
allows for precise retreatment of tumors even if the
surrounding normal tissues have already received
maximum radiation doses.
Patients with tumors that may benefit from IORT
are identified by surgeons during the preoperative evaluation. Patients should discuss the risks
and benefits of IORT treatment in detail with the
surgeon and radiation oncologist prior to surgery.
Planning ahead is critical, as IORT may require the
availability of specialized equipment or surgical
suites. Patients and radiation oncologists should
also discuss other forms of radiation therapy that
may be beneficial. Finally, including patient caregivers in the consultation with the surgeon and
radiation oncologist is helpful. The final decision
to use IORT may be made during surgery, and the
surgeon and radiation oncologist will inform and
discuss this with waiting caregivers.
Several factors, including each patient’s circumstance and the technology and expertise available,
impact the use and method of IORT employed by
the surgeon and radiation oncologist. In some
cases, the surgeon is able to remove the tumor
with clean margins and IORT is not needed. For
some patients, the tumor is surgically removed
and IORT is used to treat the surface of the surgical
cavity during the surgical procedure. Two IORT
devices — IntraBeam and Mobetron — deliver
radiation nearly instantly during surgery and are
used for single fraction treatments. The IntraBeam
emits low-energy, high-dose X-rays up to 50 kV,
which penetrate only a few centimeters of tissue.
Since the treatment device is mobile and does not
require additional shielding, it can be used in a
range of operating rooms; however, its maximal
field size is 5 cm, limiting its use to a small spherical radiation volume. The Mobetron, which will be
introduced at Cleveland Clinic this year, is housed
in a shielded OR. With an energy range of 4 MeV
Cancer Answer Line 866.223.8100
cleveland clinic | Taussig cancer institute | cancer consult
Above: A HAM applicator.
Inset: Images show device implanted in a
patient after removal of a retroperitoneal
sarcoma to allow for radiation of the areas
at highest risk for recurrence while avoiding
radiation to senistive normal tissues.
to 12 MeV and a field size of 3 cm to 10 cm, the
Mobetron can be used to treat the spherical radiation volume of most tumors.
Another option for delivery of IORT involves the
use of an intraoperative IORT applicator, such
as the HAM applicator. The HAM applicator is
a 22-cm-long applicator that is placed in the
patient’s surgical cavity at the time of surgery. It
be tailored to many shapes and sizes to provide
customizable 3D radiation coverage of an operative
bed. The applicator delivers high-intensity energy
radiation and must be used in a well-shielded OR.
If no shielded OR is available, the patient can be
transported after surgery to the radiation oncology
department for treatment planning and radiation
delivery. The HAM applicator is used in cases that
require a larger applicator and greater flexibility
of coverage, such as patients with cancers in the
abdominal wall, retroperitoneum or lower pelvis.
The applicator can be used for single or multiple
fraction treatments and is removed at a later date.
10 | 11 | clevelandclinic.org/cancer
Research on treatment outcomes using modern
IORT is limited but growing. Because IORT allows
for a higher radiation dose due to normal tissue
shielding, it is often correlated with better control
rates. Immediate treatment with radiation after
surgery may also prevent the repopulation of
tumor cells. Targeted intraoperative radiotherapy
(TARGIT-A) is a multicenter clinical trial comparing single-dose IORT using IntraBeam with
a standard three-to-six-week course of EBRT in
women with early-stage breast cancer.
Cleveland Clinic has been collecting IORT patient
data, particularly for patients with colorectal
cancer and retroperitoneal sarcomas. As more
data becomes available, IORT has the potential to
become a more commonly used modality for providing radiation therapy, saving time and money
for both patients and healthcare providers.
cancer consult
fall 2011
Case Study:
Cleveland Clinic Surgeon Performs
First Robotic Partial Removal of
Transplanted Kidney Tumor
Jihad Kaouk, MD, Director of the Center for Robotic and
Laparoscopic Surgery at the Glickman Urological & Kidney
Institute, performed the first robotic partial nephrectomy on
a patient with a 7 cm tumor in her transplanted kidney.
History: A routine ultrasound on a 35-year-old woman
revealed a large mass on the transplanted kidney she had
received from her father 24 years ago. Patient presented to
Cleveland Clinic after consults with two other centers. Both
centers had offered total nephrectomy with lifelong dialysis.
Cleveland Clinic consult: Additional testing was done to
determine the proximity of the kidney tumor to the renal
vessels. Examination of the CT scan led to a decision to
remove only the cancerous part of the kidney. Dr. Kaouk’s
experience in more than 2,000 laparoscopic and robotic
urologic surgeries was critical in such a decision. Surgery: A robotic partial nephrectomy was performed
successfully. The modified robotic approach allowed for more
controlled surgery to minimize bleeding and the removal of the
tumor alone with reasonable warm ischemia time. Patient was
kept in the hospital two extra days for observation due to the
complexity of the procedure. One week postop the patient was
doing fine and had no pain. Surgical margins were negative,
and serum creatinine returned to baseline two weeks after
surgery.
Outcome: Removing only the cancerous part of the kidney
spared the patient from losing the transplanted kidney
and undergoing long-term dialysis treatment.
For more information, contact
Dr. Kaouk at 216.444.2976.
Cancer Answer Line 866.223.8100
cleveland clinic | Taussig cancer institute | cancer consult
Shrinking Tumors
to Allow for Partial
Nephrectomy
Therapy targeting the vascular endothelial
growth factor (VEGF) pathway has revolutionized the management of advanced renal
cell carcinoma (RCC), in part due to robust
effects in shrinking RCC tumors. Cleveland
Clinic recently completed a Phase II trial
of neoadjuvant sunitinib, a VEGF-receptor
(VEGF-R) inhibitor in patients with primary
RCC tumors not amenable to resection.
Neoadjuvant sunitinib led to downsizing/
downstaging of primary tumors and permitted resection in more than 40 percent of
initially unresectable primary RCC tumors.
The most clinically relevant effect was in
patients with an anatomic or functionally
solitary kidney in which partial nephrectomy
was not technically possible due to tumor
anatomy, and radical nephrectomy was not
desirable because of the need for subsequent dialysis.
Based on these preliminary data, Cleveland
Clinic has designed a prospective Phase II
trial of a similar VEGF-R inhibitor, pazopanib, as neoadjuvant therapy in localized
RCC patients to enable partial nephrectomy. Patients with a primary RCC tumor
in whom a partial nephrectomy is desired,
but not currently possible due to anatomic
considerations, will receive pazopanib in
an attempt to downsize tumors and enable
partial nephrectomy. Thirty patients with
histologically proven clear-cell RCC who
meet strict eligibility criteria will be enrolled
on a prospective Phase II trial, giving 90
percent power to identify a conversion to
partial nephrectomy rate of 40 percent.
Pazopanib 800 mg daily will be given for
two eight-week cycles, with amenability to
partial nephrectomy assessed by CT scans at
the end of week eight and week 16.
12 | 13 | clevelandclinic.org/cancer
cancer consult
fall 2011
Outcomes Reporting
Helps Advance Transparency in Healthcare
Public reporting of outcomes data has been making headlines recently as more and more cancer
centers announce the debut of their first editions. The Taussig Cancer Institute is one of 16
institutes at Cleveland Clinic that has reported its outcomes for physicians and patients since
2008 as part of the organization’s commitment to transparency.
“Cleveland Clinic firmly believes that our patients and peers deserve transparency — how many
cases we see, how our patients fare with their treatments, and how these numbers compare to
national averages,” says Brian J. Bolwell, MD, Chairman of Taussig Cancer Institute. “In 2008,
when we started publishing our annual outcomes booklets, other organizations were surprised that
we were willing to take this on. Now, we’re proud to see many others joining in.”
A member of Cleveland Clinic’s Board of Governors, Dr. Bolwell says the organization strives to
make data easily accessible to patients as part of a belief that consistent dialogue with patients
results in fully informed patients.
“Informed patients are empowered patients who can take a more proactive approach to their own
healthcare,” he says.
The vast data collection involved in releasing outcomes books every year allows the organization to
uncover strengths that are then cultivated, and also weaknesses that warrant increased attention.
Among cancer centers, Dr. Bolwell says the pressure to publish outcomes is continuing to grow. As
consumers become more savvy, they are asking important questions about the quality of care that
is being delivered by their treatment teams.
Taussig Cancer Institute’s outcomes book includes data from patients receiving initial cancer
treatment at Cleveland Clinic’s main campus as well as its regional oncology practices. All told, the
most recent outcomes book comprises data for more than 120,000 patients.
“We maintain an extensive tumor registry, which is the source for much of the data we publish,”
Dr. Bolwell says. Besides data on overall survival by disease, the report provides results on
patients receiving certain treatments, such as radiation therapy. For example, it provides five- and
10-year survival rates for prostate cancer when using external beam radiotherapy, low-dose-rate
brachytherapy or radical prostatectomy.
Dr. Bolwell cautions that current outcomes reporting methods are not without limitations. Taussig
Cancer Institute compares statistics with the National Cancer Institute’s Surveillance, Epidemiology
and End Results (SEER) data. He says SEER is good for demographics but less valuable for
advanced profiling of diseases, such as molecular typing. Ensuring “apples-to-apples” comparisons
that will truly benefit patients and physicians requires that all cancer centers report their outcomes
in relation to the same national dataset, adds Dr. Bolwell.
Even with its current limitations, outcomes reporting is certain to become more important as
healthcare reimbursement moves toward a “pay for performance” model.
“We support the transformation to a system that ultimately compensates providers according to
the results they achieve rather than the amount of service they deliver,” says Dr. Bolwell. “Once
a link has been made between compensation and results, provider accountability will grow.
Ultimately, it’s the patients who will benefit.”
Taussig Cancer Institute’s Outcomes booklets are available at clevelandclinic.org/outcomesonline.
Each provides a dashboard scorecard on specific metrics for each institute, and those scorecards are reviewed
quarterly with the goal of continuous improvement.
Cancer Answer Line 866.223.8100
cleveland clinic | Taussig cancer institute | Publications
Selected Publications
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14 | 15 | clevelandclinic.org/cancer
Burdick MJ, Stephans KL. Gastrointestinal (non-esophageal)
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cancer consult
fall 2011
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cleveland clinic | Taussig cancer institute | Publications
prostate cancer: results from a phase 2 trial. Cancer
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Gilligan T. To better manage cancer symptoms. Cleve Clin J
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Gladson CL, Liu WM, Berens ME. Molecular regulators of
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Gromova P, Rubin BP, Thys A, Erneux C, Vanderwinden JM.
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Hercbergs AH, Lin HY, Davis FB, Davis PJ, Leith JT. Radiosensitization and production of DNA double-strand breaks in
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16 | 17 | clevelandclinic.org/cancer
cancer consult
fall 2011
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