@article{3096689,
    title = "Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer",
    author = "Tsavaris, N. and Gennatas, K. and Kosmas, C. and Skopelitis, H.M. and Gouveris, P. and Dimitrakopoulos, A. and Zacharakis, M. and Kouraklis, G. and Vasiliou, J. and Felekouras, E. and Voros, D. and Zografos, G. and Balafouta, M. and Paraskevaidis, M. and Safioleas, M. and Fotiadis, K. and Papastratis, G. and Karatzas, G. and Papalambros, E.",
    journal = "ONCOLOGY REPORTS",
    year = "2004",
    volume = "12",
    number = "4",
    pages = "927-932",
    publisher = "Spandidos Publications",
    issn = "1021-335X",
    doi = "10.3892/or.12.4.927",
    keywords = "antineoplastic agent;  fluorouracil;  folinic acid;  levamisole, adjuvant chemotherapy;  adult;  aged;  article;  cancer staging;  clinical trial;  comparative study;  controlled clinical trial;  controlled study;  female;  human;  male;  middle aged;  multicenter study;  pathology;  randomized controlled trial;  rectum tumor;  survival rate;  treatment outcome;  tumor recurrence, Adult;  Aged;  Antineoplastic Combined Chemotherapy Protocols;  Chemotherapy, Adjuvant;  Female;  Fluorouracil;  Humans;  Leucovorin;  Levamisole;  Male;  Middle Aged;  Neoplasm Recurrence, Local;  Neoplasm Staging;  Rectal Neoplasms;  Survival Rate;  Treatment Outcome",
    abstract = "The aim of this study was to evaluate the effectiveness of 6-month therapy with leucovorin (LV) + 5-fluorouracil (5-FU) vs 12 months of therapy with levamisole (LVZ) + 5-FU, as adjuvant chemotherapy in patients with completely resected Dukes' stage B2 or C rectal cancer. One hundred and fifty patients with surgically resected rectal carcinoma, were enrolled in the present study; Dukes' stage B2 (n=70) or C (n=80), were randomly assigned to chemotherapy with 5-FU + LV x 6 months or 5-FU + LVZ x 12 months. Patient characteristics were equally balanced between the examined groups. Adjuvant CT consisted of LV 20 mg/m2 intravenously (i.v.) plus 5-FU 450 mg/m2 i.v., on days 1-5 every 4 weeks for 6 cycles or 5-FU 450 mg/m2 i.v. every week plus LVZ 50 mg t.i.d x 3 days for 1 year. All patients received radiotherapy with a three-field technique to a total dose of 45 Gy, over 5 weeks. After a median follow-up of 7.4 years there were no significant differences between the two treatment groups with respect to the recurrence rates (P=0.821). Moreover, there was no difference in disease-free survival for patients stage Dukes' B2 (log-rank P=0.73); median for LV group 90 (8-131) months, and for LVZ group 86.5 (3-129) months. No difference was noted in disease-free survival for patients stage Dukes' C (log-rank P=0.73); median for LV group 60 (17-128) months, and for LVZ group 64 (2-123) months. There was no difference in overall survival for patients stage Dukes' B2 (log-rank P=0.75); median for LV group 90 (22-131) months, and for LVZ group 86 (10-129) months. For stage Dukes' C (log-rank P=0.73); median for LV group 67 (17-128) months, and for LVZ group 64 (5-123) months. Toxicities were as follows in the 5-FU + LVZ vs 5-FU + LV group; myelosuppression (leucopenia grade 3, 12% vs 4%, P<0.04), diarrhea (grade 0, 60% vs 76%, P<0.02), and liver toxicity (increase of transaminases >3-fold, 12 patients vs 2, P<0.03), were more frequent in LVZ group. None of the patients stopped chemotherapy because of the toxicity, and there were no toxicity-related deaths. In conclusion, adjuvant chemotherapy in RC with LV + 5-FU for 6 months is equally effective and less toxic than LVZ + 5-FU for 12 months."
}