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- W2971731593 abstract "e14023 Background: This phase II study evaluates efficacy and tolerance of FOLFIRI +B in first-line MCRC treatment and assesses several genetic polymorphisms as potential markers of treatment activity or toxicity. Methods: Adult patients (pts) with histologically-proven, non-resectable MCRC, ECOG≤2, were included in this two-stage Simon’s design requiring 61 evaluable pts. 14-day cycles consisted of B (5mg/kg), irinotecan (180mg/m²), bolus FU (400mg/m²) and leucovorin (400mg/m²) followed by a 46-hour infusion of FU (2400mg/m²). UGT1A1, thymidylate synthase and VEGFA promoter SNPs were assessed. Primary endpoint was response rate according to RECIST criteria. Results: Sixty-two pts (25 male) from 7 centers were enrolled between Jan07 – Aug09. Median age: 68 years (1 st -3 rd quartile : 60.4-75.4]); ECOG 0-1 (95.2%); primary tumor location was colon (85.4%) or rectum (14.6%). Principal MCRC locations were: liver (54 pts), lung (28 pts) or peritoneum (17 pts). All pts were evaluable for toxicity. 1058 cycles were administered, median of 13 (range 3-62). Grade 3/4 toxicities were: neutropenia 19.4%; no febrile neutropenia; diarrhea 11.3%; nausea-vomiting 1.6%. No hypertension, thrombotic events, proteinuria or gastrointestinal perforation were observed. 59/62 pts were evaluable for efficacy with 28 pts in PR (47.5%; 95%CI 34.3-60.9), 20 with SD (33.9%) and 11 in PD (18.6%). Median response duration: 9.5 months (range 2.7-20); median time to progression: 10.3 months (range 8.8-11.7); median overall survival (OS) 25.7 months (range 20.2-29.7). 11/59 unresectable pts could finally be resected. To date, three VEGFA polymorphisms have been identified and associations with OS tested. The common genotype of rs25648 is associated with better OS (HR: 0.277; 95%CI: 0.12-0.64). Conclusions: FOLFIRI +B has a good safety profile, is active, with a long median OS leading to resect 18.6% of initially unresectable pts. Genetic polymorphism rs25648 has currently been identified as a marker of better OS, and further analyses for potential UGT1A1 and thymidylate synthase markers are underway." @default.
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- W2971731593 date "2012-05-20" @default.
- W2971731593 modified "2023-10-15" @default.
- W2971731593 title "Results of a phase II study assessing efficacy and tolerance of fluorouracil (FU), leucovorin, irinotecan, and bevacizumab (FOLFIRI + B) in first-line metastatic colorectal cancer (MCRC): The Omega Trial (NTC 00467142)." @default.
- W2971731593 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.e14023" @default.
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