A phase II study of irinotecan, fluoroxuridine and leucovorin (IFLUX) as a first-line chemotherapy in advanced colorectal cancer

Abstract

3599 Background: Irinotecan combined with bolus or infusion 5-Fluorouracil (5-FU) regiment has demonstrated efficacy in advanced colorectal cancer (ACRC). In our current study we have replaced 5-FU with Fluoroxuridine (FUdR) and we are reporting our Results: A phase II study was conducted to assess the efficacy and tolerability of substituting FUdR infusion for 5-FU in combination with irinotecan in patients with ACRC. Methods: Patients with measurable colorectal adenocarcinoma received intravenous (IV) irinotecan 110 mg/m2 days 1, 8, 15, and 22, followed by FUdR 120mg/Kg and Leucovorin 500mg/ m2 as a 24 hour infusion on days 1, 8, 15, and 22, followed by 2 weeks of rest. 38 patients were enrolled on this study; all were evaluable for toxicity and antitumor activity. There were 22 males and 16 females, the average age was 58 years with range 28–81 years, and median Karnofsky performance status was 90. Twenty-one of 38 patients who received adjuvant chemotherapy and upon relapse were placed on our therapy. A total of 766 cycles of treatment were given, the average number of cycles completed per patient was 5. Results: Five patients (13%) achieved complete response (CR), 10 patients (26%) achieved partial response (PR), 17 patients (45%) attained stable disease (SD), and 6 patients (16%) progressed. The median time to progression was 11.5 months (347.5 days) with 95% confidence interval (206, 389) days. The time to progression has ranged 1.8–34 months. The median survival of the patients in this trial was 36.6 months (1,098 days) with 95% confidence interval (694, NA) days. The upper limit has not been reached since 21 patients are still alive (55%). The most common grade 3/4 toxicity were diarrhea, neutropenia and anemia. Conclusions: The combination of irinotecan, FUdR and leucovorin (IFLUX) has promising antitumor activity with a median survival greater than 36 months and was well tolerated in patients with advanced colorectal cancer. No significant financial relationships to disclose.