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/m(2) (Group A) or 750 mg/m(2) (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/m(2) q2w offers no obvious therapeutic advantage.
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Authors | 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 |
Journal | Journal of the National Comprehensive Cancer Network : JNCCN
(J Natl Compr Canc Netw)
Vol. 10
Issue 11
Pg. 1391-8
(Nov 01 2012)
ISSN: 1540-1413 [Electronic] United States |
PMID | 23138167
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
- Cetuximab
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
(administration & dosage, adverse effects)
- Carcinoma, Squamous Cell
(drug therapy, mortality, secondary)
- Cetuximab
- Disease-Free Survival
- Female
- Head and Neck Neoplasms
(drug therapy, mortality, pathology)
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy)
- Treatment Outcome
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