Gastric Cancer Trials: Implications of the Gastrointestinal Tumor Study Group and the Mount Sinai Medical Center Experience

1989 ◽  
pp. 140-160
Author(s):  
H. W. Bruckner
1992 ◽  
Vol 10 (4) ◽  
pp. 549-557 ◽  

PURPOSE To evaluate the contribution of semustine (MeCCNU) to adjuvant benefit, previously untreated patients with histologically proven adenocarcinoma of the rectum who had undergone curative resection were randomized to treatment with combination radiation therapy and fluorouracil (5-FU) followed by either 12 months of 5-FU and MeCCNU or 6 months of escalating 5-FU. PATIENTS AND METHODS Between March 1981 and November 1985, 210 patients were randomized by Gastrointestinal Tumor Study Group (GITSG) investigators. Subsequent to randomization, 11 (5%) patients (six treated with 5-FU and MeCCNU; five with escalating 5-FU) were found to be ineligible and are excluded from survival analyses. RESULTS About half the patients on each of the two treatment arms experienced at least one episode of severe or worse toxicity, and there was one treatment-related death on each arm. No episodes of leukemia have been reported. Median follow-up time for surviving patients is 5.8 years, and 3-year follow-up is available for all but five surviving patients. Recurrent disease has been reported in 54% (51 of 95) of 5-FU- and MeCCNU-treated patients compared with 43% (45 of 104) of escalating 5-FU-treated patients. Probability of 3-year disease-free survival for the two treatment cohorts is 54% and 68%, respectively. Ninety-one deaths have occurred: 46% (44 of 95) of 5-FU- and MeCCNU-treated patients and 45% (47 of 104) of escalating 5-FU-treated patients. Three-year postsurgery survival probabilities are 66% and 75%. CONCLUSION Substantial differences in survival or recurrence results between the two study arms are unlikely to be observed. We conclude that MeCCNU is not an essential component of effective postoperative combined modality treatment of adjuvant rectal cancer.


1984 ◽  
Vol 2 (7) ◽  
pp. 770-773 ◽  

In an attempt to confirm the previously reported response rates with methyl-CCNU, vincristine, 5-fluorouracil, and streptozotocin (MOF-strep) (34%) in advanced colorectal cancer, the Gastrointestinal Tumor Study Group used the identical treatment schedule in 40 good performance status patients who had received no prior chemotherapy. Four patients (10%) achieved an objective partial tumor response and the median survival for all patients was 7.3 months. The toxicity was evidenced by moderate nausea and vomiting and myelosuppression with one treatment-related death. Based on this trial further evaluation of MOF-strep for advanced colorectal cancer cannot be recommended.


1990 ◽  
Vol 8 (1) ◽  
pp. 185-185 ◽  
Author(s):  
Nicholas Petrelli ◽  
Harold O. Douglass ◽  
Lemuel Herrera ◽  
David Russell ◽  
Donald M. Stablein ◽  
...  

The authorship of the report "The Modulation of Fluorouracil With Leucovorin in Metastatic Colorectal Carcinoma: A Randomized Phase III Trial," published in the October 1989 issue (J Clin Oncol 7:1419–1426, 1989) should have read: "by the Gastrointestinal Tumor Study Group." The following appendix should also have appeared at the end of the report:


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