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/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.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021, USA. JNCCN@nccn.org
authors.forename: Matthew G
authors.initials: MG
authors.lastname: Fury
authors.forename: Eric
authors.initials: E
authors.lastname: Sherman
authors.forename: Donna
authors.initials: D
authors.lastname: Lisa
authors.forename: Neeraj
authors.initials: N
authors.lastname: Agarwal
authors.forename: Kenneth
authors.initials: K
authors.lastname: Algazy
authors.forename: Bruce
authors.initials: B
authors.lastname: Brockstein
authors.forename: Corey
authors.initials: C
authors.lastname: Langer
authors.forename: Dean
authors.initials: D
authors.lastname: Lim
authors.forename: Ranee
authors.initials: R
authors.lastname: Mehra
authors.forename: Sandeep K
authors.initials: SK
authors.lastname: Rajan
authors.forename: Susan
authors.initials: S
authors.lastname: Korte
authors.forename: Brynna
authors.initials: B
authors.lastname: Lipson
authors.forename: Furhan
authors.initials: F
authors.lastname: Yunus
authors.forename: Tawee
authors.initials: T
authors.lastname: Tanvetyanon
authors.forename: Stephanie
authors.initials: S
authors.lastname: Smith-Marrone
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ng
authors.forename: Han
authors.initials: H
authors.lastname: Xiao
authors.forename: Sofia
authors.initials: S
authors.lastname: Haque
authors.forename: David G
authors.initials: DG
authors.lastname: Pfister
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000068818:Cetuximab; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab