Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer.

作者: C G Moertel , T R Fleming , J S Macdonald , D G Haller , J A Laurie

DOI: 10.1200/JCO.1995.13.12.2936

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摘要: PURPOSETo determine the effectiveness of fluorouracil plus levamisole administered postoperatively to patients with resected stage II (Dukes' B2) colon cancer.PATIENTS AND METHODSThis randomized controlled clinical trial (INT-0035) was performed by National Cancer Institute-sponsored cancer trials cooperative groups. Patients were assigned observation only or (450 mg/m2 intravenously [IV] daily for 5 days and, beginning at 28 days, weekly 48 weeks) (50 mg orally three times 3 repeated every 2 weeks 1 year). recurrence, survival, and treatment side effects assessed.RESULTSThree hundred eighteen eligible analyzed a median follow-up time 7 years. Fluorouracil reduced recurrence rate 31%, although this trend not statistically significant (P = .10). A total 87 died: 43 on 44 levamisole. Disparity between o...

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