Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: Initial results of intergroup 0114

J. E. Tepper*, M. J. O'Connell, G. R. Petroni, D. Hollis, E. Cooke, A. B. Benson, B. Cummings, L. L. Gunderson, J. S. Macdonald, J. A. Martenson

*Corresponding author for this work

Research output: Contribution to journalArticle

241 Citations (Scopus)

Abstract

Purpose: The combination of radiation therapy with fluorouracil (5-FU)- based chemotherapy is generally accepted as appropriate postoperative therapy for patients with adenocarcinomas of the rectum that extend through the bowel wall or with lymph nodes positive for tumor. We attempted to determine whether the efficacy of this postoperative therapy could be improved by the addition of leucovorin and/or levamisole. Methods: A total of 1,696 patients were randomized and eligible for treatment with one of four treatment schemes. All patients received two cycles of bolus 5-FU-based systemic chemotherapy followed by pelvic radiation therapy with chemotherapy and two more cycles of the same systemic chemotherapy. Chemotherapy was either 5-FU alone, 5-FU with leucovorin, 5-FU with levamisole, or 5-FU with leucovorin and levamisole. Results: With a median follow-up duration of 48 months, there is no statistically significant advantage to any of the treatment regimens compared with bolus 5-FU alone. There is evidence of increased gastrointestinal toxicity with the three-drug combination compared with bolus 5-FU alone. Statistical analysis suggests it is very unlikely that either levamisole-containing combination will be shown to be of value with further follow-up evaluation. Conclusion: There is no evidence at present for a beneficial effect of levamisole in the adjuvant treatment of rectal cancer. Definitive evaluation of the effect of the addition of leucovorin to 5-FU and pelvic radiation will require further follow-up evaluation.

Original languageEnglish (US)
Pages (from-to)2030-2039
Number of pages10
JournalJournal of Clinical Oncology
Volume15
Issue number5
DOIs
StatePublished - Jan 1 1997

Fingerprint

Rectal Neoplasms
Fluorouracil
Radiotherapy
Drug Therapy
Levamisole
Leucovorin
Therapeutics
Drug Combinations
Rectum
Adenocarcinoma
Lymph Nodes
Radiation

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Tepper, J. E. ; O'Connell, M. J. ; Petroni, G. R. ; Hollis, D. ; Cooke, E. ; Benson, A. B. ; Cummings, B. ; Gunderson, L. L. ; Macdonald, J. S. ; Martenson, J. A. / Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer : Initial results of intergroup 0114. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 5. pp. 2030-2039.
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title = "Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: Initial results of intergroup 0114",
abstract = "Purpose: The combination of radiation therapy with fluorouracil (5-FU)- based chemotherapy is generally accepted as appropriate postoperative therapy for patients with adenocarcinomas of the rectum that extend through the bowel wall or with lymph nodes positive for tumor. We attempted to determine whether the efficacy of this postoperative therapy could be improved by the addition of leucovorin and/or levamisole. Methods: A total of 1,696 patients were randomized and eligible for treatment with one of four treatment schemes. All patients received two cycles of bolus 5-FU-based systemic chemotherapy followed by pelvic radiation therapy with chemotherapy and two more cycles of the same systemic chemotherapy. Chemotherapy was either 5-FU alone, 5-FU with leucovorin, 5-FU with levamisole, or 5-FU with leucovorin and levamisole. Results: With a median follow-up duration of 48 months, there is no statistically significant advantage to any of the treatment regimens compared with bolus 5-FU alone. There is evidence of increased gastrointestinal toxicity with the three-drug combination compared with bolus 5-FU alone. Statistical analysis suggests it is very unlikely that either levamisole-containing combination will be shown to be of value with further follow-up evaluation. Conclusion: There is no evidence at present for a beneficial effect of levamisole in the adjuvant treatment of rectal cancer. Definitive evaluation of the effect of the addition of leucovorin to 5-FU and pelvic radiation will require further follow-up evaluation.",
author = "Tepper, {J. E.} and O'Connell, {M. J.} and Petroni, {G. R.} and D. Hollis and E. Cooke and Benson, {A. B.} and B. Cummings and Gunderson, {L. L.} and Macdonald, {J. S.} and Martenson, {J. A.}",
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Tepper, JE, O'Connell, MJ, Petroni, GR, Hollis, D, Cooke, E, Benson, AB, Cummings, B, Gunderson, LL, Macdonald, JS & Martenson, JA 1997, 'Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: Initial results of intergroup 0114', Journal of Clinical Oncology, vol. 15, no. 5, pp. 2030-2039. https://doi.org/10.1200/JCO.1997.15.5.2030

Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer : Initial results of intergroup 0114. / Tepper, J. E.; O'Connell, M. J.; Petroni, G. R.; Hollis, D.; Cooke, E.; Benson, A. B.; Cummings, B.; Gunderson, L. L.; Macdonald, J. S.; Martenson, J. A.

In: Journal of Clinical Oncology, Vol. 15, No. 5, 01.01.1997, p. 2030-2039.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer

T2 - Initial results of intergroup 0114

AU - Tepper, J. E.

AU - O'Connell, M. J.

AU - Petroni, G. R.

AU - Hollis, D.

AU - Cooke, E.

AU - Benson, A. B.

AU - Cummings, B.

AU - Gunderson, L. L.

AU - Macdonald, J. S.

AU - Martenson, J. A.

PY - 1997/1/1

Y1 - 1997/1/1

N2 - Purpose: The combination of radiation therapy with fluorouracil (5-FU)- based chemotherapy is generally accepted as appropriate postoperative therapy for patients with adenocarcinomas of the rectum that extend through the bowel wall or with lymph nodes positive for tumor. We attempted to determine whether the efficacy of this postoperative therapy could be improved by the addition of leucovorin and/or levamisole. Methods: A total of 1,696 patients were randomized and eligible for treatment with one of four treatment schemes. All patients received two cycles of bolus 5-FU-based systemic chemotherapy followed by pelvic radiation therapy with chemotherapy and two more cycles of the same systemic chemotherapy. Chemotherapy was either 5-FU alone, 5-FU with leucovorin, 5-FU with levamisole, or 5-FU with leucovorin and levamisole. Results: With a median follow-up duration of 48 months, there is no statistically significant advantage to any of the treatment regimens compared with bolus 5-FU alone. There is evidence of increased gastrointestinal toxicity with the three-drug combination compared with bolus 5-FU alone. Statistical analysis suggests it is very unlikely that either levamisole-containing combination will be shown to be of value with further follow-up evaluation. Conclusion: There is no evidence at present for a beneficial effect of levamisole in the adjuvant treatment of rectal cancer. Definitive evaluation of the effect of the addition of leucovorin to 5-FU and pelvic radiation will require further follow-up evaluation.

AB - Purpose: The combination of radiation therapy with fluorouracil (5-FU)- based chemotherapy is generally accepted as appropriate postoperative therapy for patients with adenocarcinomas of the rectum that extend through the bowel wall or with lymph nodes positive for tumor. We attempted to determine whether the efficacy of this postoperative therapy could be improved by the addition of leucovorin and/or levamisole. Methods: A total of 1,696 patients were randomized and eligible for treatment with one of four treatment schemes. All patients received two cycles of bolus 5-FU-based systemic chemotherapy followed by pelvic radiation therapy with chemotherapy and two more cycles of the same systemic chemotherapy. Chemotherapy was either 5-FU alone, 5-FU with leucovorin, 5-FU with levamisole, or 5-FU with leucovorin and levamisole. Results: With a median follow-up duration of 48 months, there is no statistically significant advantage to any of the treatment regimens compared with bolus 5-FU alone. There is evidence of increased gastrointestinal toxicity with the three-drug combination compared with bolus 5-FU alone. Statistical analysis suggests it is very unlikely that either levamisole-containing combination will be shown to be of value with further follow-up evaluation. Conclusion: There is no evidence at present for a beneficial effect of levamisole in the adjuvant treatment of rectal cancer. Definitive evaluation of the effect of the addition of leucovorin to 5-FU and pelvic radiation will require further follow-up evaluation.

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