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 Journal Article
| Authors: | 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. |
| Article Title: | 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 |
| 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. © JNCCN - Journal of the National Comprehensive Cancer Network. |
| Keywords: | adult; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; primary tumor; major clinical study; overall survival; fatigue; cancer recurrence; carcinoma, squamous cell; drug efficacy; side effect; antineoplastic agents; metastasis; neoplasm recurrence, local; nausea; randomized controlled trial; vomiting; cetuximab; drug hypersensitivity; hypomagnesemia; nail disease; antibodies, monoclonal; head and neck neoplasms; multicenter study; muscle weakness; headache; larynx; mouth cavity; desquamation; head and neck squamous cell carcinoma; kaplan-meier estimate; acute generalized exanthematous pustulosis; faintness |
| Journal Title: | Journal of the National Comprehensive Cancer Network |
| Volume: | 10 |
| Issue: | 11 |
| ISSN: | 1540-1405 |
| Publisher: | Harborside Press |
| Date Published: | 2012-11-01 |
| Start Page: | 1391 |
| End Page: | 1398 |
| Language: | English |
| PROVIDER: | scopus |
| PUBMED: | 23138167 |
| PMCID: | PMC5726232 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 2 January 2013" - "Source: Scopus" |
