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- Title
A Randomized Phase II Trial of Pemetrexed plus Irinotecan (ALIRI) versus Leucovorin-Modulated 5-FU plus Irinotecan (FOLFIRI) in First-Line Treatment of Locally Advanced or Metastatic Colorectal Cancer.
- Authors
Underhill, Craig; Goldstein, David; Gorbounova, Vera A.; Biakhov, Mikhail Y.; Bazin, Igor S.; Granov, Dmitry A.; Hossain, Anwar M.; Blatter, Johannes; Kaiser, Christopher; Ma, Doreen
- Abstract
Background: This multicenter, randomized trial compared overall response rate between pemetrexed plus irinotecan (ALIRI) and leucovorin-modulated 5-fluorouracil plus irinotecan (FOLFIRI) in patients with advanced colorectal cancer. Secondary objectives included overall and progression-free survival, duration of response, toxicities, and biomarkers. Patients and Methods: ALIRI patients received pemetrexed 500 mg/m2 and irinotecan 350 mg/m2 with vitamin supplementation on day 1 of each 21-day cycle. FOLFIRI patients received irinotecan 180 mg/m2 on days 1, 15, 29; on days 1, 2, 15, 16, 29, 30, patients received leucovorin 200 mg/m2, bolus 5-fluorouracil 400 mg/m2, and 5-fluorouracil 600 mg/m2 as 22-hour infusion. Results: Of 132 patients randomly assigned, 130 patients (64 = ALIRI, 66 = FOLFIRI) received ≥1 dose of treatment. Response rates (ALIRI = 20.0%, FOLFIRI = 33.3%) were not significantly different between arms (p = 0.095). Progression-free survival was 5.7 months for ALIRI and 7.7 months for FOLFIRI (p < 0.001). Neutropenia, fatigue, diarrhea, nausea, and vomiting were the major toxicities. There were 5 drug-related deaths (ALIRI = 4, FOLFIRI = 1). Biomarker analysis failed to reveal that any of the 18 preselected genes were clearly associated with tumor response. Conclusions: Neither efficacy nor safety improved on the ALIRI arm compared to the FOLFIRI arm. Progression-free survival on FOLFIRI was significantly longer compared to ALIRI. Potential biomarkers capable of predicting response to either regimen in advanced or metastatic colorectal carcinoma need further characterization. Copyright © 2008 S. Karger AG, Basel
- Subjects
COLON cancer; FOLINIC acid; CANCER treatment; BIOMARKERS; ANTINEOPLASTIC agents
- Publication
Oncology, 2007, Vol 73, Issue 1/2, p9
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000120626