Cetuximab is typically administered on a weekly schedule for patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC). This study explores cetuximab administered every 2 weeks (q2w). In this multicenter randomized prospective phase II study, eligible patients (≤2 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease; ECOG performance status ≤2) were randomized to receive cetuximab q2w at 500 mg/m2 (Group A) or 750 mg/m2 (Group B). The primary end point was response rate (RECIST 1.0). Sixty-one patients were enrolled: 35 in Group A and 26 in Group B, which was closed early for lack of efficacy. Confirmed partial response rates were 11% for Group A (4/35) and 8% for Group B (2/26) according to intention to treat analysis. Partial responses occurred only among patients whose primary tumors were in the oral cavity or larynx. Median progression-free survival (PFS) and median overall survival (OS) were similar for both groups (PFS, 2.2 and 2.0 months; OS, 7.0 and 9.4 months; Groups A and B, respectively). The most common cetuximab-related adverse events (all grades) among treated subjects included rash, fatigue, and hypomagnesemia. Cetuximab, 500 mg/m2, q2w achieves similar efficacy as conventional dosing for patients with recurrent or metastatic HNSCC. Escalating the dose to 750 mg/m2 q2w offers no obvious therapeutic advantage.
Matthew G. Fury, Eric Sherman, Donna Lisa, Neeraj Agarwal, Kenneth Algazy, Bruce Brockstein, Corey Langer, Dean Lim, Ranee Mehra, Sandeep K. Rajan, Susan Korte, Brynna Lipson, Furhan Yunus, Tawee Tanvetyanon, Stephanie Smith-Marrone, Kenneth Ng, Han Xiao, Sofia Haque and David G. Pfister
David S. Ettinger, Debra K. Armstrong, Sally Barbour, Michael J. Berger, Philip J. Bierman, Bob Bradbury, Georgianna Ellis, Steve Kirkegaard, Dwight D. Kloth, Mark G. Kris, Dean Lim, Michael Anne Markiewicz, Lida Nabati, Carli Nesheiwat, Hope S. Rugo, Steven M. Sorscher, Lisa Stucky-Marshal, Barbara Todaro and Susan Urba
David S. Ettinger, Debra K. Armstrong, Sally Barbour, Michael J. Berger, Philip J. Bierman, Bob Bradbury, Georgianna Ellis, Steve Kirkegaard, Dwight D. Kloth, Mark G. Kris, Dean Lim, Laura Boehnke Michaud, Lida Nabati, Kim Noonan, Hope S. Rugo, Darby Siler, Steven M. Sorscher, Sundae Stelts, Lisa Stucky-Marshall, Barbara Todaro and Susan G. Urba
Michael J. Berger, David S. Ettinger, Jonathan Aston, Sally Barbour, Jason Bergsbaken, Philip J. Bierman, Debra Brandt, Dawn E. Dolan, Georgiana Ellis, Eun Jeong Kim, Steve Kirkegaard, Dwight D. Kloth, Ruth Lagman, Dean Lim, Charles Loprinzi, Cynthia X. Ma, Victoria Maurer, Laura Boehnke Michaud, Lisle M. Nabell, Kim Noonan, Eric Roeland, Hope S. Rugo, Lee S. Schwartzberg, Bridget Scullion, John Timoney, Barbara Todaro, Susan G. Urba, Dorothy A. Shead and Miranda Hughes
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Antiemesis address all aspects of management for chemotherapy-induced nausea and vomiting. These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Antiemesis, specifically those regarding carboplatin, granisetron, and olanzapine.