Acute diarrhea during adjuvant therapy for rectal cancer: A detailed analysis from a randomized intergroup trial

Robert C. Miller, Daniel J. Sargent, James A. Martenson, John S. Macdonald, Daniel Haller, Robert J. Mayer, Leonard L. Gunderson, Tyvin A. Rich, Stephen S. Cha, Michael J. O'Connell

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Purpose: During adjuvant radiotherapy (RT) for rectal cancer, patients receiving 5-fluorouracil (5-FU) by protracted venous infusion have a higher risk of diarrhea than have patients receiving bolus 5-FU. Toxicity from a previously reported randomized clinical trial was analyzed to quantify the difference in this risk. Additionally, the persistence of diarrhea after RT was analyzed. Methods and Materials: A total of 656 patients were eligible. Patients with T3-4 N0-2 M0 or T1-2 N1-2 M0 resected, high-risk rectal cancer were randomly allocated to receive 5-FU by either protracted venous infusion or bolus during RT (50.4-54.0 Gy). Two cycles of bolus 5-FU were given before and after RT. One-half of the first 445 patients were also randomly allocated to receive lomustine in conjunction with the bolus 5-FU. The incidence and severity of diarrhea in relation to patient and treatment characteristics were evaluated. Results: The rate of diarrhea was significantly greater in patients receiving 5-FU by protracted venous infusion than in patients receiving bolus 5-FU; the difference was most pronounced for Grade 3 (severe) diarrhea (21% versus 13%, p = 0.007). The incidence and magnitude of diarrhea before and after RT were similar. Patients treated with an anterior resection had a higher rate of severe or life-threatening diarrhea than did patients treated with an abdominoperineal resection (31% vs. 12%, p < 0.001). Conclusions: During pelvic RT, patients who receive 5-FU by protracted venous infusion rather than by bolus have a higher risk of severe or life-threatening diarrhea during RT. This risk does not appear to persist during chemotherapy after completion of pelvic RT.

Original languageEnglish (US)
Pages (from-to)409-413
Number of pages5
JournalInternational Journal of Radiation Oncology Biology Physics
Volume54
Issue number2
DOIs
StatePublished - Oct 1 2002

Keywords

  • 5-Fluorouracil
  • Adjuvant chemotherapy
  • Diarrhea
  • Intravenous infusion
  • Radiotherapy

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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    Miller, R. C., Sargent, D. J., Martenson, J. A., Macdonald, J. S., Haller, D., Mayer, R. J., Gunderson, L. L., Rich, T. A., Cha, S. S., & O'Connell, M. J. (2002). Acute diarrhea during adjuvant therapy for rectal cancer: A detailed analysis from a randomized intergroup trial. International Journal of Radiation Oncology Biology Physics, 54(2), 409-413. https://doi.org/10.1016/S0360-3016(02)02924-3