Randomized phase III study of 2 cisplatin‐based chemoradiation regimens in locally advanced head and neck squamous cell carcinoma: Impact of changing disease epidemiology on contemporary trial design. Issue 11 (29th October 2014)

• Record Type: Journal Article
• Authors: Rodriguez, Cristina P.; Adelstein, David J.; Rybicki, Lisa A.; Savvides, Panayiotis; Saxton, Jerrold P.; Koyfman, Shlomo A.; Greskovich, John F.; Yao, Min; Scharpf, Joseph; Lavertu, Pierre; Wood, Benjamin G.; Burkey, Brian B.; Lorenz, Robert R.; Rezaee, Rod P.; Zender, Chad A.; Ives, Denise I.
• Is Part Of: Head & neck. Volume 37:Issue 11(2015:Nov.)
• Page Start: 1583
• Page End: 1589
• Publication Date: 2014-10-29
• Subjects: Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.23794
• Languages: English
• ISSNs: 1043-3074

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="hed23794-sec-0001" sec-type="section"> <title>Background</title> <p>Chemoradiotherapy results in excellent outcomes in locally advanced head and neck squamous cell carcinoma (HNSCC). This trial compared 2 chemoradiotherapy regimens.</p> </sec> <sec id="hed23794-sec-0002" sec-type="section"> <title>Methods</title> <p>Patients with locally advanced HNSCC were treated with radiation (70–74.4 Gy), and randomized to arm A: cisplatin 100 mg/m<sup>2</sup> on radiotherapy (RT) days 1, 22, and 43, or arm B: cisplatin (20 mg/m<sup>2</sup>/day) and 5‐fluorouracil (5‐FU; 1000 mg/m<sup>2</sup>/day) continuous 96‐hour infusions on RT weeks 1 and 4. The primary endpoint was relapse‐free survival (RFS).</p> </sec> <sec id="hed23794-sec-0003" sec-type="section"> <title>Results</title> <p>Between February 2008 and October 2011, 69 patients were enrolled in this study. The study prematurely closed when a scheduled interim analysis showed superior outcomes in both arms and futility of continuation. Eighty‐three percent of patients had oropharyngeal cancer, of these, 86% were human papillomavirus (HPV)/p16+. The 3‐year Kaplan–Meier outcome estimates (median follow‐up, 41 months) for arms A and B were: RFS 87% versus 80% (<italic>p</italic> = .24), overall survival 97% versus 85% (<italic>p</italic> = .013), locoregional control 96% versus 94% (<italic>p</italic> = .52), and distant metastatic control 91% versus 87% (<italic>p</italic> = .9).</p> </sec> <sec id="hed23794-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Multiagent was not superior to single‐agent chemoradiotherapy. Overrepresentation of HPV/p16+ patients resulted in better than expected outcomes. © 2014 Wiley Periodicals, Inc. <italic>Head Neck</italic> 37: 1583–1589, 2015</p> </sec> </abstract>