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Adjuvant intraperitoneal 5-fluorouracil and intravenous leucovorin after colorectal cancer surgery: a randomized phase II placebo-controlled study

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Abstract

Fifty patients were randomized to receive adjuvant intraperitoneal 5-fluorouracil (5-FU, 500 mg/m2/day) and intravenous leucovorin (60 mg/m2/day) and 51 to receive placebo after curative surgery for colorectal cancer. Treatment started on the day after surgery and continued for 6 days. One case of stomatitis, one of leucopenia and one case of abnormal liver function tests were the only chemotherapy-related toxic effects. From the second day of treatment, pain during intraperitoneal infusions occurred more frequently in the 5-FU group, although statistical significance was only attained on day 2 (P<0.05). The groups did not differ substantially regarding any other adverse effects, the incidence of surgical complications, second laparotomies, time from surgery to discharge, or premature treatment terminations. The postoperative course after intraperitoneal 5-FU and intravenous leucovorin was thus not more complicated than that in patients treated with placebo. The tolerance was acceptable and chemotherapy-related toxicity was rare. Thus important prerequisites exist for more widespread use of the present regimen in order to evaluate its impact on survival.

Résumé

Cent un patients ont été randomisés après traitement chirurgical curatif d'un cancer colorectal; 50 patients ont reçu un traitement adjuvant intrapéritional de 5-FU (500 mg/m2/jour) et intraveineux de Leucovorine (60 mg/m2/jour) et 51 patients ont reçu un placebo. Le traitement a été instauré le 1er jour postopératoire et poursuivi durant 6 jours. Les seuls troubles consécutifs à la chimiothérapie observés ont été: 1 cas de stomatite, 1 cas de leucopénie et 1 cas de perturbation des tests hépatiques. A partir du 2ème jour de traitement, des douleurs intraperitionales surviennent plus fréquemment après l'infusion de 5FU bien que la différence ne soit statistiquement significative que pour le 2ème jour (P<0,05). Les groupes ne différent pas de manière significative quant à d'autres effets secondaires: incidence de complications chirurgicales, taux de relaparotomies, durée des séjours hospitaliers, interruption prématurée du traitement. Les suites postopératoires après injection intrapéritionale de 5FU et intraveineuse de Leucovorine ne sont pas plus compliquées qu'après l'administration d'un placebo. La tolérance est acceptable et la toxicité due à la chimiothérapie est rare. Ainsi, les bases sont établies pour un emploi plus extensif de cette combinaison chimiothérapique dans le but d'établir l'impact sur le taux de survie.

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Authors and Affiliations

  1. Department of Surgery, Akademiska Sjukhuset, Uppsala, Sweden

    W. Graf & L. Påhlman

  2. Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden

    J. -E. Westlin & B. Glimelius

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  1. W. Graf
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  2. J. -E. Westlin
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  3. L. Påhlman
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  4. B. Glimelius
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Graf, W., Westlin, J.E., Påhlman, L. et al. Adjuvant intraperitoneal 5-fluorouracil and intravenous leucovorin after colorectal cancer surgery: a randomized phase II placebo-controlled study. Int J Colorect Dis 9, 35–39 (1994). https://doi.org/10.1007/BF00304298

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  • DOI: https://doi.org/10.1007/BF00304298

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