ISSN:
1569-8041
Keywords:
colorectal cancer
;
combination therapy
;
folinic acid
;
fluorouracil
;
irinotecan
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Purpose:The combination regimen CPT-11 plus bolus and infusion5-fluorouracil (5-FU) with high-dose leucovorin (hybrid regimen LV5FU2) hasbeen tested for activity and toxicity against advanced colorectal carcinomain a randomised, multicenter phase II trial. Patients and methods:A total of 102 chemotherapy-naïvepatients were randomised in a 1 : 2 fashion to receive: leucovorin 100mg/m2 administered as a two-hour infusion before 5-FU 400mg/m2 as an intravenous bolus, and FU 600 mg/m2 as a22-hour infusion immediately after 5-FU bolus injection repeated on days 1 and2 (LV5FU2 regimen, arm A, 34 patients) or CPT-11 at 180 mg/m2 (150mg/m2 for patients of age ≥70 and 〈75 years) only on day 1immediately before LV5FU2 therapy (LV5FU2 + CPT-11 regimen, arm B 68patients). Both treatments were repeated every two weeks. The presence of acalibration arm assured consistency and more realistic evaluation of resultsachieved with the LV5FU2 + CTP-11 regimen. Results:Thirty-three and sixty-four patients were evaluable inarm 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 onlyin arm B (20 vs. 10 months, P = 0.0016). All patients were evaluablefor toxicity which was mild in both groups; gastrointestinal disturbances werethe most common. There were no treatment-related deaths. Grade 3–4toxicity was uncommon in both arms. Conclusions:The addition of CPT-11 to the hybrid LV5FU2 regimenprovided a significant overall response rate (40%) with relatively mildtoxicity. The overall response rate was 18% in patients treated withLV5FU2 alone in the calibration arm. Thus, considering other encouraging datafrom the literature, the CPT-11 + FU–LV combination therapy can beregarded as a new, very effective treatment option for first-line treatmentof advanced colorectal cancer patients.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008342928408
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