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‘Dealer’s Choice’ Rectal Cancer Trial Proposed

‘Dealer’s Choice’ Rectal Cancer Trial Proposed

CHICAGO—A "dealer’s choice" rectal cancer trial in which
treatment would be chosen by the physician and patient together has been
proposed by the National Cancer Institute (NCI) Gastrointestinal Intestinal
Intergroup. The Intergroup now includes research groups from the American
College of Surgeons Oncology Group, Cancer and Leukemia Group B, the Eastern
Cooperative Oncology Group, the North Central Cancer Treatment Group, the NCI
Canada, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the
Radiation Therapy Oncology Group, and the Southwest Oncology Group.

Al B. Benson III, MD, professor of medicine and director of the Clinical
Investigations Program at Northwestern University’s Robert H. Lurie
Comprehensive Cancer Center in Chicago, Illinois, discussed the proposed study.
"This group has now come together with the goal to work as a united front
for the first time, to design large trials for rectal cancer," Dr. Benson
said.

The first Intergroup trial supported the use of continuous infusion
5-fluorouracil (5-FU) in rectal cancer. The second Intergroup trial (INT-0114)
is raising significant concern because of deaths occurring beyond 5 years after
treatment, especially in poor-risk patients. There were no significant
differences in outcome by treatment arm among the nearly 1,700 patients on this
study, with median follow-up of 7.4 years.

Area of Great Concern

One additional area of great concern is that for N0 patients, outcome was
strongly dependent on the total number of nodes examined by the pathologist.
Dr. Benson said this suggested that many patients who are classified as N0 are
really N1. Patients thought to be node-negative who had fewer than 14 nodes
examined had significantly worse survival than node-negative patients who had
14 or more nodes examined. This difference did not affect node-positive
patients.

"Although this could be due to the surgeon not dissecting nodes
adequately, it is more likely a sign of inadequate detection by the
pathologist. The point has been raised by Intergroup pathologists that we need
to start integrating much more careful attention to pathology and surgical
issues in our clinical trial designs. We also need to start reimbursing
pathologists and surgeons who are participating in these trials. Presently,
most grants go to support medical oncology and the research offices," Dr.
Benson said.

Dr. Benson said that one of the great disappointments in rectal research in
the United States has been lack of success in conducting trials to compare
preoperative vs postoperative therapy. Incomplete and preliminary data from the
NSABP-R03 study suggests that preoperative therapy permits sphincter-saving
surgery for more patients, although it does cause more toxicity.

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