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Preliminary analysis of a randomized clinical trial of adjuvant postoperative RT vs. postoperative RT plus 5‐FU and levamisole in patients with TNM stage II‐III resectable rectal cancer
Author(s) -
Cafiero F.,
Gipponi M.,
Peressini A.,
Bertoglio S.,
Lionetto R.
Publication year - 2000
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/1096-9098(200010)75:2<80::aid-jso2>3.0.co;2-o
Subject(s) - medicine , levamisole , regimen , surgery , bolus (digestion) , toxicity , stage (stratigraphy) , chemotherapy , radiation therapy , colorectal cancer , clinical endpoint , adjuvant , randomized controlled trial , gastroenterology , cancer , paleontology , biology
Objectives Two‐hundred eighteen patients with TNM stage II‐III resectable rectal cancer, enrolled into a randomized clinical trial, were assessed for efficacy and toxicity of adjuvant postoperative radiation therapy (RT) vs. those of combined RT and chemotherapy (CT), with 5‐fluorouracil (5‐FU) plus levamisole. End points were overall survival, disease‐free survival, the rate of loco‐regional recurrence, and treatment‐related toxicity. Methods Patients in arm I underwent RT (50 Gy) in daily fractions of 2 Gy, 5 days/week for 5 weeks. Patients in arm II began with 5‐FU (450 mg/m 2 /day intravenous bolus, days 1–5) plus levamisole (150 mg/day orally, days 1–3); postoperative RT was delivered during week 2 at the same dosage and schedule as in arm I. The other five cycles of CT (5‐FU every 28 days and levamisole every 15 days for the length of 5‐FU administration) continued after the end of RT if clinical and hemato‐biochemical parameters were normal. Results RT was completed or modified in 170 (90%) of 189 evaluable patients undergoing RT (both treatment groups). Only 44 (59%) of 75 evaluable patients of arm II completed or had an adjustment of the CT schedule; the remaining 31 patients (41%) had to stop or never started the CT regimen. Patients undergoing combined RT and CT had more severe toxicity (enteritis, P = 0.03). There was one CT‐related death (gastrointestinal bleeding) in this subset. No significant difference was observed in outcome of patients in the two study groups, nor for pattern of recurrence (heterogeneity χ 2 = 4.82; d.f. = 2; P = 0.08). Conclusions These preliminary findings suggest a similar efficacy, coupled with less morbidity, of postoperative RT alone compared with a combined regimen of postoperative RT and CT in patients undergoing radical surgery for stage II‐III rectal cancer. J. Surg. Oncol. 2000;75:80–88. © 2000 Wiley‐Liss, Inc.