Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer

  • Authors:
    • N. Tsavaris
    • K. Gennatas
    • C. Kosmas
    • H. M. Skopelitis
    • P. Gouveris
    • A. Dimitrakopoulos
    • M. Zacharakis
    • G. Kouraklis
    • J. Vasiliou
    • E. Felekouras
    • D. Voros
    • G. Zografos
    • M. Balafouta
    • M. Paraskevaidis
    • M. Safioleas
    • K. Fotiadis
    • G. Papastratis
    • G. Karatzas
    • E. Papalambros
  • View Affiliations

  • Published online on: October 1, 2004     https://doi.org/10.3892/or.12.4.927
  • Pages: 927-932
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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.

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October 2004
Volume 12 Issue 4

Print ISSN: 1021-335X
Online ISSN:1791-2431

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Spandidos Publications style
Tsavaris N, Gennatas K, Kosmas C, Skopelitis HM, Gouveris P, Dimitrakopoulos A, Zacharakis M, Kouraklis G, Vasiliou J, Felekouras E, Felekouras E, et al: Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer. Oncol Rep 12: 927-932, 2004.
APA
Tsavaris, N., Gennatas, K., Kosmas, C., Skopelitis, H.M., Gouveris, P., Dimitrakopoulos, A. ... Papalambros, E. (2004). Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer. Oncology Reports, 12, 927-932. https://doi.org/10.3892/or.12.4.927
MLA
Tsavaris, N., Gennatas, K., Kosmas, C., Skopelitis, H. M., Gouveris, P., Dimitrakopoulos, A., Zacharakis, M., Kouraklis, G., Vasiliou, J., Felekouras, E., Voros, D., Zografos, G., Balafouta, M., Paraskevaidis, M., Safioleas, M., Fotiadis, K., Papastratis, G., Karatzas, G., Papalambros, E."Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer". Oncology Reports 12.4 (2004): 927-932.
Chicago
Tsavaris, N., Gennatas, K., Kosmas, C., Skopelitis, H. M., Gouveris, P., Dimitrakopoulos, A., Zacharakis, M., Kouraklis, G., Vasiliou, J., Felekouras, E., Voros, D., Zografos, G., Balafouta, M., Paraskevaidis, M., Safioleas, M., Fotiadis, K., Papastratis, G., Karatzas, G., Papalambros, E."Leucovorin and fluorouracil vs levamisole and fluorouracil as adjuvant chemotherapy in rectal cancer". Oncology Reports 12, no. 4 (2004): 927-932. https://doi.org/10.3892/or.12.4.927