A randomized phase II study of cetuximab every 2 weeks at either 500 or 750 mg/m2 for patients with recurrent or metastatic head and neck squamous cell cancer

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, David G. Pfister

Research output: Contribution to journalArticle

Abstract

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/m 2, 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.

Original languageEnglish (US)
Pages (from-to)1391-1398
Number of pages8
JournalJNCCN Journal of the National Comprehensive Cancer Network
Volume10
Issue number11
DOIs
StatePublished - Nov 1 2012

ASJC Scopus subject areas

  • Oncology

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    Fury, M. G., Sherman, E., Lisa, D., Agarwal, N., Algazy, K., Brockstein, B., Langer, C., Lim, D., Mehra, R., Rajan, S. K., Korte, S., Lipson, B., Yunus, F., Tanvetyanon, T., Smith-Marrone, S., Ng, K., Xiao, H., Haque, S., & Pfister, D. G. (2012). A randomized phase II study of cetuximab every 2 weeks at either 500 or 750 mg/m2 for patients with recurrent or metastatic head and neck squamous cell cancer. JNCCN Journal of the National Comprehensive Cancer Network, 10(11), 1391-1398. https://doi.org/10.6004/jnccn.2012.0144