The efficacy of preoperative 5‐fluorouracil, high‐dose leucovorin, and sequential radiation therapy for unresectable rectal cancer Journal Article


Authors: Minsky, B. D.; Cohen, A. M.; Kemeny, N.; Enker, W. E.; Kelsen, D. P.; Saltz, L.; Frankel, J.
Article Title: The efficacy of preoperative 5‐fluorouracil, high‐dose leucovorin, and sequential radiation therapy for unresectable rectal cancer
Abstract: Background. The encouraging results seen in patients who received postoperative combined modality therapy in the adjuvant setting have prompted increased interest in preoperative combined modality therapy for patients with unresectable rectal cancer. The authors report the local control and survival of a previously reported Phase I dose escalation trial of combined preoperative 5‐fluorouracil (5‐FU), high‐dose leucovorin (LV), and sequential radiation therapy followed by postoperative LV–5‐FU for the treatment of patients with unresectable rectal cancer. Methods. Twenty patients (13, primary and 7, recurrent disease) received LV–5‐FU for one cycle. Radiation therapy (5040 cGy) began on day 8. A second cycle of LV–5‐FU was given concurrently with week 4 of radiation. Six patients received intraoperative brachytherapy. Postoperatively, the patients received LV–5‐FU. The pathologic complete response rate was 20%, and 89% underwent a complete resection with negative margins. Results. The crude local failure rate was 26%, and the 3‐year actuarial local failure rate was 29% (95% confidence interval [CI],±8.94%). The crude abdominal and distant failure rates were 40% and 30%, respectively. The 3‐year actuarial disease‐free survival was 64% (95% CI,±6.75%), and the overall survival was 69% (95% CI,±7.65%). Conclusions. These preliminary data revealed encouraging local control and survival rates. Preoperative combined modality therapy is an attractive approach in patients with unresectable rectal cancer. Copyright © 1993 American Cancer Society
Keywords: adult; cancer survival; clinical article; aged; fluorouracil; drug efficacy; adjuvant therapy; cancer adjuvant therapy; cancer radiotherapy; combined modality therapy; prospective studies; neoplasm recurrence, local; radiotherapy dosage; drug administration schedule; postoperative complication; postoperative complications; cancer regression; folinic acid; brachytherapy; radiation therapy; preoperative treatment; cancer control; rectal neoplasms; rectum cancer; leucovorin; intravenous drug administration; rectal cancer; premedication; middle age; sigmoid neoplasms; human; male; female; priority journal; article
Journal Title: Cancer
Volume: 71
Issue: 11
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 1993-06-01
Start Page: 3486
End Page: 3492
Language: English
DOI: 10.1002/1097-0142(19930601)71:11<3486::Aid-cncr2820711105>3.0.Co;2-c
PUBMED: 8490898
PROVIDER: scopus
DOI/URL:
Notes: Source: Scopus
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MSK Authors
  1. Leonard B Saltz
    790 Saltz
  2. Bruce Minsky
    306 Minsky
  3. Alfred M Cohen
    244 Cohen
  4. David P Kelsen
    537 Kelsen
  5. Nancy Kemeny
    543 Kemeny
  6. Joanne F Kelvin
    91 Kelvin
  7. Warren E. Enker
    70 Enker