• J. Clin. Oncol. · Dec 2014

    Randomized Controlled Trial Comparative Study

    Randomized phase III trial to test accelerated versus standard fractionation in combination with concurrent cisplatin for head and neck carcinomas in the Radiation Therapy Oncology Group 0129 trial: long-term report of efficacy and toxicity.

    • Phuc Felix Nguyen-Tan, Qiang Zhang, K Kian Ang, Randal S Weber, David I Rosenthal, Denis Soulieres, Harold Kim, Craig Silverman, Adam Raben, Thomas J Galloway, André Fortin, Elizabeth Gore, William H Westra, Christine H Chung, Richard C Jordan, Maura L Gillison, Marcie List, and Quynh-Thu Le.
    • Phuc Felix Nguyen-Tan and Denis Soulieres, Centre Hospitalier de l'Université de Montréal Hôpital Notre-Dame, Montreal; André Fortin, Centre Hospitalier Universitaire Hôtel-Dieu de Québec, Quebec City, Quebec, Canada; Qiang Zhang, NRG Oncology Statistics and Data Management Center; Thomas J. Galloway, Fox Chase Cancer Center, Philadelphia, PA; K. Kian Ang, Randal S. Weber, and David I. Rosenthal, University of Texas MD Anderson Cancer Center, Houston, TX; Harold Kim, Wayne State University, Detroit, MI; Craig Silverman, James Graham Brown Cancer Center, Louisville, KY; Adam Raben, Christiana Care Community Clinical Oncology Program, Newark, DE; Elizabeth Gore, Medical College of Wisconsin, Milwaukee, WI; William H. Westra and Christine H. Chung, Johns Hopkins University, Baltimore, MD; Richard C. Jordan, University of California at San Francisco, San Francisco; Quynh-Thu Le, Stanford University, Stanford, CA; Maura L. Gillison, Ohio State University Comprehensive Cancer Center, Columbus, OH; and Marcy List, University of Chicago Medicine Comprehensive Cancer Research Center, Chicago, IL. felix.nguyen.chum@ssss.gouv.qc.ca.
    • J. Clin. Oncol. 2014 Dec 1; 32 (34): 3858-66.

    PurposeWe tested the efficacy and toxicity of cisplatin plus accelerated fractionation with a concomitant boost (AFX-C) versus standard fractionation (SFX) in locally advanced head and neck carcinoma (LA-HNC).Patients And MethodsPatients had stage III to IV carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Radiation therapy schedules were 70 Gy in 35 fractions over 7 weeks (SFX) or 72 Gy in 42 fractions over 6 weeks (AFX-C). Cisplatin doses were 100 mg/m(2) once every 3 weeks for two (AFX-C) or three (SFX) cycles. Toxicities were scored by using National Cancer Institute Common Toxicity Criteria 2.0 and the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria. Overall survival (OS) and progression-free survival (PFS) rates were estimated by using the Kaplan-Meier method and were compared by using the one-sided log-rank test. Locoregional failure (LRF) and distant metastasis (DM) rates were estimated by using the cumulative incidence method and Gray's test.ResultsIn all, 721 of 743 patients were analyzable (361, SFX; 360, AFX-C). At a median follow-up of 7.9 years (range, 0.3 to 10.1 years) for 355 surviving patients, no differences were observed in OS (hazard ratio [HR], 0.96; 95% CI, 0.79 to 1.18; P = .37; 8-year survival, 48% v 48%), PFS (HR, 1.02; 95% CI, 0.84 to 1.24; P = .52; 8-year estimate, 42% v 41%), LRF (HR, 1.08; 95% CI, 0.84 to 1.38; P = .78; 8-year estimate, 37% v 39%), or DM (HR, 0.83; 95% CI, 0.56 to 1.24; P = .16; 8-year estimate, 15% v 13%). For oropharyngeal cancer, p16-positive patients had better OS than p16-negative patients (HR, 0.30; 95% CI, 0.21 to 0.42; P < .001; 8-year survival, 70.9% v 30.2%). There were no statistically significant differences in the grade 3 to 5 acute or late toxicities between the two arms and p-16 status.ConclusionWhen combined with cisplatin, AFX-C neither improved outcome nor increased late toxicity in patients with LA-HNC. Long-term high survival rates in p16-positive patients with oropharyngeal cancer support the ongoing efforts to explore deintensification.© 2014 by American Society of Clinical Oncology.

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