Preoperative radiochemotherapy in rectal cancer: long-term results of a phase II trial.

PURPOSE: To assess toxicity and long-term results of preoperative chemoradiotherapy in rectal cancer. METHODS AND MATERIALS: Between 1989 and 1997, as a phase II study, 66 patients with T3 M0, rectal cancer received preoperatively a 45 Gy dose pelvic radiotherapy (XRT) combined with two 5-day chemotherapy courses (CT) of 5-Fluorouracil (5-FU) and Leucovorin (LV) delivered the first and fifth week of XRT. For each CT course, LV:20 mg/m2/d1-d5,. While the 5-FU dose was variable from 450 to 350 mg/m2/d first course and 370 to 350 mg/m2/d second course. Surgery was planned 3 weeks later. RESULTS: XRT-CT was stopped in 1 patient due to progressive disease. CT was stopped in 1 patient due to toxicity. Grades 2 and 3 diarrhea were observed in 8 and 3 patients, respectively. One patient died from acute diarrhea due to deviation from recommendations; 60 patients went to surgery. Among the 58 patients operated on for cure, 5 had an R1-resection. After a 4.5-year median follow-up, the 5-year pelvic disease-free survival was 92% for the whole group and 96% in the R0-resection group. CONCLUSION: Preoperative combined XRT-5-FU-LV is feasible if optimal XRT and patients are carefully managed. The recommended 5-FU daily dose is 350 mg/m2 for both CT courses. This approach is currently tested in a large EORTC phase III trial.

[Prognostic factors in operable epidermoid esophageal cancers]. / Facteurs pronostiques des cancers épidermoïdes de l'oesophage opérables.

OBJECTIVE: The aims of the study were to determine the prognostic factors on overall survival in patients with resectable squamous cell esophageal carcinoma. POPULATION: Two hundred and ninety three patients with stage I and II tumor were included in a phase III clinical trial that compared surgery alone to preoperative chemoirradiation. Eighteen parameters issued from clinical, biological radiological and pathological characteristics were included in univariate and multivariate analysis. RESULTS: The overall survival was influenced by: quality of surgical resection tumor response, nodal involvement on the CT-scan, tumor length and tumor location. Three groups of patients could be identified on two simple clinical preoperative variables. The first group: patients without dysphagia with or without nodal involvement on the CT-scan. The second group: patients with dysphagia and without nodal involvement on the CT-scan. The third group: patients with dysphagia and with nodal involvement with CT-scan. The 5 years survival rates were 34% for the first group, 23% for the second group and 0% for the third group. CONCLUSION: The identification of prognostic factors is valuable for the stratification of patients in future therapeutic studies.