BACKGROUND:Triplet chemotherapy has demonstrated manageable toxicities and a favorable response rate. The addition of cetuximab to chemotherapy can increase treatment efficacy. We evaluated the efficacy and safety of cetuximab plus 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), the ERBIRINOX regimen, as first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: In a phase II study, treatment consisted of weekly cetuximab plus biweekly. Treatment was continued for a maximum of 12 cycles and tumor response was evaluated every four cycles. The primary efficacy criterion was the complete response (CR) rate. RESULTS:From April 2006 to April 2008, 42 patients were enrolled. The median age was 60 years (range, 32-76 years). The median duration of treatment was 5.2 months (range, 0.7-8.5 months), and a median of nine cycles was given per patient (range, 1-12 cycles). Five patients (11.9%) showed a CR, with a median duration of 23.1 months (95% confidence interval [CI], 10.8-39.7 months). The objective response rate was 80.9% (95% CI, 65.9%-91.4%). The median overall and progression-free survival times were 24.7 months (95% CI, 22.6 months to not reached) and 9.5 months (95% CI, 7.6-10.4 months), respectively. The most frequent grade 3-4 adverse events were diarrhea (52%), neutropenia (38%), and asthenia (32%). CONCLUSION: The ERBIRINOX regimen appears to be effective and feasible in first-line treatment of mCRC patients. These promising results led us to initiate a multicenter, randomized, phase II trial ([Research Partnership for Digestive Oncology] PRODIGE 14) in patients with potentially resectable mCRC.
RCT Entities:
BACKGROUND: Triplet chemotherapy has demonstrated manageable toxicities and a favorable response rate. The addition of cetuximab to chemotherapy can increase treatment efficacy. We evaluated the efficacy and safety of cetuximab plus 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), the ERBIRINOX regimen, as first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: In a phase II study, treatment consisted of weekly cetuximab plus biweekly. Treatment was continued for a maximum of 12 cycles and tumor response was evaluated every four cycles. The primary efficacy criterion was the complete response (CR) rate. RESULTS: From April 2006 to April 2008, 42 patients were enrolled. The median age was 60 years (range, 32-76 years). The median duration of treatment was 5.2 months (range, 0.7-8.5 months), and a median of nine cycles was given per patient (range, 1-12 cycles). Five patients (11.9%) showed a CR, with a median duration of 23.1 months (95% confidence interval [CI], 10.8-39.7 months). The objective response rate was 80.9% (95% CI, 65.9%-91.4%). The median overall and progression-free survival times were 24.7 months (95% CI, 22.6 months to not reached) and 9.5 months (95% CI, 7.6-10.4 months), respectively. The most frequent grade 3-4 adverse events were diarrhea (52%), neutropenia (38%), and asthenia (32%). CONCLUSION: The ERBIRINOX regimen appears to be effective and feasible in first-line treatment of mCRC patients. These promising results led us to initiate a multicenter, randomized, phase II trial ([Research Partnership for Digestive Oncology] PRODIGE 14) in patients with potentially resectable mCRC.
Authors: W De Roock; H Piessevaux; J De Schutter; M Janssens; G De Hertogh; N Personeni; B Biesmans; J-L Van Laethem; M Peeters; Y Humblet; E Van Cutsem; S Tejpar Journal: Ann Oncol Date: 2007-11-12 Impact factor: 32.976
Authors: Gunnar Folprecht; Thomas Gruenberger; Wolf O Bechstein; Hans-Rudolf Raab; Florian Lordick; Jörg T Hartmann; Hauke Lang; Andrea Frilling; Jan Stoehlmacher; Jürgen Weitz; Ralf Konopke; Christian Stroszczynski; Torsten Liersch; Detlev Ockert; Thomas Herrmann; Eray Goekkurt; Fabio Parisi; Claus-Henning Köhne Journal: Lancet Oncol Date: 2009-11-26 Impact factor: 41.316
Authors: M Ychou; F Viret; A Kramar; F Desseigne; E Mitry; R Guimbaud; J R Delpero; M Rivoire; F Quénet; G Portier; B Nordlinger Journal: Cancer Chemother Pharmacol Date: 2007-09-28 Impact factor: 3.333
Authors: Eric Van Cutsem; Claus-Henning Köhne; Erika Hitre; Jerzy Zaluski; Chung-Rong Chang Chien; Anatoly Makhson; Geert D'Haens; Tamás Pintér; Robert Lim; György Bodoky; Jae Kyung Roh; Gunnar Folprecht; Paul Ruff; Christopher Stroh; Sabine Tejpar; Michael Schlichting; Johannes Nippgen; Philippe Rougier Journal: N Engl J Med Date: 2009-04-02 Impact factor: 91.245
Authors: Margaret E Macy; Tracey Duncan; James Whitlock; Stephen P Hunger; Jessica Boklan; Aru Narendren; Cynthia Herzog; Robert J Arceci; Rochelle Bagatell; Tanya Trippett; Uwe Christians; Katherine Rolla; S Percy Ivy; Lia Gore Journal: Pediatr Blood Cancer Date: 2012-09-28 Impact factor: 3.167