A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum

作者：David M. Hyams, Eleftherios P. Mamounas, Nicholas James Petrelli, Howard E. Rockette, Judy Jones, Sam H. Wieand, Melvin Deutsch, Lawrence D. Wickerham, Bernard Fisher, Norman Wolmark · 发表于：Diseases of the Colon & Rectum · 年份：1997 · DOI：10.1007/bf02054976 · 被引用次数：363 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Breast Cancer Treatment Studies

PURPOSE: National Surgical Adjuvant Breast and Bowel Project Protocol R-03 was designed to determine the worth of preoperative chemotherapy and radiation therapy in the management of operable rectal cancer. METHODS: Thus far, 116 patients of an eventual 900 with primary operable rectal cancer have been randomized to receive multimodality therapy to begin preoperatively (59 patients) or identical therapy beginning after curative surgery (57). All patients received seven cycles of 5-fluorouracil (FU)/leucovorin (LV) chemotherapy. Cycles 1 and 4 through 7 used a high-dose weekly FU regimen. In Cycles 2 and 3, FU and low-dose LV chemotherapy was given during the first and fifth week of radiation therapy (5,040 cGy). The preoperative arm (Group 1) received the first three cycles of chemotherapy and all radiation therapy before surgery. The postoperative arm (Group 2) received all radiation and chemotherapy after surgery. Primary study end points included disease-free survival and survival. Secondary end points included local recurrence, primary tumor response to combination therapy, tumor downstaging, and sphincter preservation. RESULTS: Overall treatment-related toxicity was similar in both groups. Although seven preoperative patients had events after randomization that precluded surgery, eight events occurred during an equivalent follow-up period in the postoperative group. No patient was deemed inoperable because of progressive local disease. Sphincter-saving surgery was intend...