Annual Meeting Proceedings Part 1 - American Society of Clinical ...

TPS1612 General Poster Session (Board #10F), Sat, 1:15 PM-5:15 PM
The MIRACLE trial: A randomized, controlled trial comparing green tea
extract versus placebo for the prevention of metachronous colon adenomas
in a screening population. Presenting Author: Thomas Ettrich, Department
of Internal Medicine I, Martin-Luther-University Halle-Wittenberg, Halle,
Germany
Background: Prevention of colorectal cancer is a major health care issue.
After polypectomy there is an increased risk of polyp recurrence and various
means of chemoprevention have been tried to prevent this. NSAIDs have
been shown to be effective but confer side effects such as gastrointestinal
bleeding. Nutraceuticals such as polyphenols from tea plants have demonstrated
remarkable therapeutic and preventive effects in molecular, epidemiological
and some clinical trials. However, their value in preventing
colorectal polyps has not been demonstrated in a large, randomized trial.
The beneficial safety profile of decaffeinated green tea extract and
accumulating evidence of its cancer preventive potential justify and
require, in our view, a validation of this compound for the nutriprevention of
colorectal adenoma. Good accessibility and low costs might render this
neutraceutical a top candidate for wider use as nutritional supplement in
colon cancer prevention. Methods: Randomized, double blinded, placebocontrolled,
multicenter trial. After a one month run-in period with verum,
2534 patients (age: 50-80 years) who have undergone polypectomy within
the last 6 months will be randomized to receive either decaffeinated green
tea extract (containing 150 mg epigallocatechin gallate (EGCG) two times
daily) or placebo over a period of three years. 2028 patients are expected to
complete the whole study course. Primary outcome: Incidence of metachronous
colorectal adenomas (tubulovillous, tubular, villous, serrated lesions)
at the 3 year follow-up colonoscopy Secondary outcomes: Occurrences,
number, localization, size and histological subtypes of adenomas, frequency
of colorectal carcinoma. In addition, genetic and biochemical
biomarkers in blood samples and genetic alterations (e.g. K-ras, B-raf,
specific microRNAs) in tissue samples of adenomas will be analyzed
(biobanking subprojects). Additionally, nutrikinetics and nutrigenetics of
EGCG and other catechins will be assessed in healthy volunteers. Patient
recruitment has started in November 2011. We expect the last patient out
in fall 2017. (Trial identifier: NCT01360320)
TPS1614 General Poster Session (Board #11B), Sat, 1:15 PM-5:15 PM
Trial of exercise in ovarian cancer survivors. Presenting Author: Melinda
Irwin, Yale University, New Haven, CT
Background: Physical activity (PA) has been associated with improved QOL
and survival in breast and colorectal cancer survivors, yet no study has
examined the effect of exercise on ovarian cancer outcomes. The purpose of
our NCI-funded trial is to examine, in 230 women diagnosed with Stage I-IV
ovarian cancer, the impact of exercise vs. attention control on: QOL, body
composition, and serum markers associated with ovarian cancer. This
abstract presents preliminary recruitment and adherence results. Methods:
Women are being recruited via Connecticut Tumor Registry and Yale Cancer
Center into the Women’s Activity and Lifestyle Study in Connecticut
(WALC). We are also recruiting patients nationally via self-referral and
collaboration with medical oncologists at DFCI and Summa Akron City
Hospital. Women are randomly assigned to exercise (n � 115) or attention
control (n � 115). Both groups receive weekly telephone calls for six
months from a certified health educator to discuss ovarian cancer health
topics. In addition, the exercise group receives PA counseling to participate
in 150 min/wk of aerobic exercise (primarily brisk walking) for six months.
Results: Study recruitment began in March, 2010 and will be ongoing
through December, 2013. As of December 31, 2011, we have identified
556 potentially eligible women. Of these, 145 are recently diagnosed and
are awaiting screening, 115 were unable to be contacted, and 296 have
completed the telephone screening. Of the 270, 46% were ineligible (e.g.,
already exercising, physical limitations); 30% were not interested, 24% (n
� 66) have been randomized, and 9% (n � 24) are undergoing baseline
visits. On average, women are 62 years old, diagnosed 1.8 years in the past,
with primarily stage III disease. Thirty-three patients have completed the
trial, with high adherence among women randomized to exercise (average
141 min/wk of exercise reported and 75% of exercisers participating in at
least 150 min/wk of exercise). Conclusions: Women are interested in and
able to participate in exercise after an ovarian cancer diagnosis. Our trial
could suggest a unique and important role for exercise in ovarian cancer
care given that physical and functional aspects of QOL are often the most
compromised in ovarian cancer patients.
Cancer Prevention/Epidemiology
TPS1613 General Poster Session (Board #11A), Sat, 1:15 PM-5:15 PM
Mitigation of iatrogenic risk in young women Hodgkin’s survivors, acceptability
of a structured information process. Presenting Author: François
Eisinger, Institut Paoli Calmettes, Marseille, France
Background: Long term follow up of cancer survivors uncovers iatrogenic
risk. Higher risk for second cancers should be mainly observed for cancer
with a high rate of therapeutic efficacy, using aggressive therapeutic and for
cancers occurring in young people. Hodgkin lymphoma fits all these
criteria. Consistent data about higher risk for breast cancer in these women
had been published. However, risk management is not yet often carried out.
Methods: We plan to carry out a national program aiming both at offering
counselling and screening protocol and to assess key parameters allowing
to better estimate risk, and offering acceptable and effective risk management
option. Our National program will start in January 2013. We are now
in a pilot phase in a single medical institution in which we offered women
previously affected with an Hodgkin lymphoma to have access to risk
analysis and information and if they agree to a specific breast cancer
screening program. We present some of our psychosocial questionnaire
analysis based on 27 women (aged 19-50 years old) fulfilled at the end of
the information consultation and one month latter. Results: There was few
or no negative assessment: no one stated that they express regrets to have
been informed, nor they better ignore some delivered information, no one
feel that risk management description is unsatisfying and no one will advice
an other women against that kind of consultation. Only 4 out 27 i.e. 15%
stated that there was in delivered information a source for anxiety. However
positive assessment was only fairly high and not stable after one month.
Information process to inform women survivors from Hodgkin lymphoma of
their higher risk of being affected with a breast cancer and the current
recommendation for earlier breast cancer screening reach a high level of
satisfaction at the initial stage of the process. However it could decrease
with time and thus, need to be monitored.
At the end of
the consult
113s
One month
later
No induced anxiety 11/27 (41%) 8/27 (30%)
No regrets 17/27 (63%) 13/27 (48%)
Nothing better to ignore 18/27 (67%) 13/27 (48%)
Risk management clear and fine 17/27 (63%) 11/27 (41%)
Advise other women to undergone such consult 16/27 (59%) 12/27 (44%)
TPS1615 General Poster Session (Board #11C), Sat, 1:15 PM-5:15 PM
Statin polyp prevention trial in patients with resected colon cancer: NSABP
protocol P-5. Presenting Author: Bruce M. Boman, National Surgical
Adjuvant Breast and Bowel Project and Helen F. Graham Cancer Center,
Newark, DE
Background: HMG-CoA reductase inhibitors (statins) are effective lipidlowering
agents that are used for treating hyperlipidemia. Results from cell
culture, animal experiments, and epidemiologic studies indicate that
statins may be active chemopreventive agents against colorectal cancer
(CRC). However, the clinical studies come largely from retrospective,
observational studies originally designed to investigate lipid-lowering or
cardiovascular endpoints rather than tumor endpoints. Methods: NSABP
P-5 is a randomized, prospective placebo-controlled, double-blind study of
rosuvastatin (10 mg per day x 5 years) or placebo for the prevention of
adenomatous polyps of the colon or rectum, metachronous colorectal
carcinoma, and colon cancer recurrence. Additional secondary endpoints
include the size, number and features of the colorectal adenomas as well as
health-related quality of life and self-reported symptoms. Selected Eligibility:
(1) Patients who have undergone complete resection of AJCC Stage I or
II colon cancer within 1 year before randomization. (2) Colonoscopy within
180 days before randomization. Selected Ineligibility: (1) Hyperlipidemia,
(2) Familial Adenomatous Polyposis, (3) Lynch Syndrome. Sample Size:
1,740 patients will be entered, and as of January 23, 2012, 163 (9.37%)
have been randomized. The study is open at NSABP and CTSU sites in
North America. Funded by NCI PHS grants U10-CA-37377 and U10-CA-
6974, with additional funding from AstraZeneca Pharmaceuticals, LP.
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