5-Fluorouracil and folinic acid with or without CPT-11 in advanced colorectal cancer patients: A multicenter randomised phase II study of the Southern Italy Oncology Group

E. Maiello, V. Gebbia, F. Giuliani, G. Paoletti, N. Gebbia, S. Cigolari, S. Fortunato, T. Pedicini, N. Borsellino, M. Lopez, G. Colucci

Research output: Contribution to journalArticle

Abstract

Purpose: The combination regimen CPT-plus bolus and infusion 5-fluorouracil (5-FU) with high-dose leucovorin (hybrid regimen LV5FU2) has been tested for activity and toxicity against advanced colorectal carcinoma in a randomised, multicenter phase II trial. Patients and methods: A total of 102 chemotherapy-naive patients were randomised in a 1:2 fashion to receive: leucovorin 100 mg/m2 administered as a two-hour infusion before 5-FU 400 mg/m2 as an intravenous bolus, and FU 600 mg/m2 as a 22-hour infusion immediately after 5-FU bolus injection repeated on days 1 and 2 (LV5FU2 regimen, arm A, 34 patients) or CPT-at 180 mg/m2 (150 mg/m2 for patients of age ≥ 70 and <75 years) only on day 1 immediately before LV5FU2 therapy (LV5FU2 + CPT-regimen, arm B 68 patients). Both treatments were repeated every two weeks. The presence of a calibration arm assured consistency and more realistic evaluation of results achieved with the LV5FU2 + CTP-11 regimen. Results: Thirty-three and sixty-four patients were evaluable in arm A and B, respectively. The overall response rate was 18% in arm A (95% CI: 7%-34%) and 40% in arm B (95% CI: 28%-52%). Median time to progression, median duration of response and survival were similar in both groups. Responders (CR + PR) survived statistically longer than non-responders only in arm B (20 vs. 10 months, P = 0.0016). All patients were evaluable for toxicity which was mild in both groups; gastrointestinal disturbances were the most common. There were no treatment-related deaths. Grade 3-4 toxicity was uncommon in both arms. Conclusions: The addition of CPT-to the hybrid LV5FU2 regimen provided a significant overall response rate (40%) with relatively mild toxicity. The overall response rate was 18% in patients treated with LV5FU2 alone in the calibration arm. Thus, considering other encouraging data from the literature, the CPT-11 + FU-LV combination therapy can be regarded as a new, very effective treatment option for first-line treatment of advanced colorectal cancer patients.

Original languageEnglish
Pages (from-to)1045-1051
Number of pages7
JournalAnnals of Oncology
Volume11
Issue number8
DOIs
Publication statusPublished - 2000

Keywords

  • Colorectal cancer
  • Combination therapy
  • Fluorouracil
  • Folinic acid
  • Irinotecan

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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