Upfront Modified FOLFOXIRI Plus Panitumumab for <i>RAS/BRAF</i> Wild-Type Metastatic Colorectal Cancer: Final Results of the Phase III TRIPLETE Study
Abstract
We report 5-year results of the phase III randomized TRIPLETE study. Eligible patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC) received first-line modified fluorouracil, leucovorin, oxaliplatin (mFOLFOX)/panitumumab (control group, n = 217) versus modified fluorouracil, leucovorin, oxaliplatin, irinotecan (mFOLFOXIRI)/panitumumab (experimental group, n = 218). We present overall survival (OS) and updated outcomes in the intention-to-treat population. The median follow-up was 60.2 months (IQR, 49.3-70.0). The median OS was 41.1 and 33.3 months for experimental and control groups, respectively (hazard ratio [HR], 0.79 [95% CI, 0.63 to 0.99]; P = .049). OS outcomes favored the experimental group regardless of clinical features. No differences in objective response rate (primary end point; 75%/78%, odds ratio, 0.84 [95% CI, 0.54 to 1.31]; P = .442), early tumor shrinkage rate ( P = .954), depth of response ( P = .573), no residual tumor resection rate ( P = .329), and progression-free survival (HR, 0.95 [95% CI, 0.78 to 1.16]; P = .606) were confirmed. Among patients alive at the time of disease progression, the median postprogression survival was 24.6 and 17.7 months for experimental and control groups, respectively (HR, 0.79 [95% CI, 0.62 to 1.01]; P = .062). Similar proportions of patients in both groups received subsequent lines of therapy (control/experimental: second line 73%/71%, third line 51%/49%, fourth line 31%/32%), as well as nonpalliative locoregional treatments (control/experimental: 16%/16%). Upfront mFOLFOXIRI/panitumumab significantly improves OS compared with mFOLFOX/panitumumab in patients with RAS/BRAF wild-type mCRC.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (27)
Veronica Conca
Veronica Conca, MD, PhD, Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, Department of Translational Research and New Technology in Medicine and Surgery, University of Pisa, Pisa, Italy; Daniele Rossini, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; and Chiara Cremolini, MD, PhD, Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, Department of Translational Research and New Technology in Medicine and Surgery, University of Pisa, Pisa, Italy
Daniele Rossini
Carlotta Antoniotti
Sara Lonardi
Filippo Pietrantonio
Roberto Moretto
Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Lorenzo Antonuzzo
Azienda Ospedaliero Universitaria Careggi, Florence, Italy
Giovanni Randon
Daniele Lavacchi
Carmelo Pozzo
Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
Federica Marmorino
Francesca Bergamo
Emiliano Tamburini
Oncology Department and Palliative Care, Cardinale Panico Tricase City Hospital, Tricase, Italy
Alessandro Passardi
Medical Oncology, IRST-IRCCS "Dino Amadori", Meldola, Italy
Roberta Fazio
Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, NA, Italy
Sabina Murgioni
Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy
Beatrice Borelli
Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Angela Buonadonna
Department of Medical Oncology San Vito site, CRO Aviano-IRCCS, Aviano, Italy
Marco Maria Germani
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
Vincenzo Formica
Medical Oncology Unit, Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy
Martina Carullo
Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana and Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
Roberto Bordonaro
Giuseppe Aprile
Alberto Zaniboni
Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy
Gianluca Masi
Luca Boni
Department of Medical Oncology, U.O.C. Clinica di Oncologia Medica, IRCCS Azienda Ospedaliera Metropolitana, Genova, Italy
Chiara Cremolini