Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study

Purpose. The Gynecologic Oncology Group (COG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGER antibody cetuximab. in persistent or recurrent carcinoma of the cervix. Patients and methods. Eligible patients had cervical cancer, measurable disease, and COG performance status <= 2.Treatment consisted of cetuximab 400 mg/m(2) initial dose followed by 250 mg/m(2) weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PES) at 6 months and response. The study used a 2-stage group sequential design. Results. Thirty-eight patients were entered with 3 exclusions. leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n =25. 71.4%) or 2 (n = 10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n = 5), Cl (n =4). anemia (n = 2). constitutional (n= 3), infection (n= 2), vascular (n = 2), pain (n = 2). and pulmonary, neurological, vomiting and metabolic (n = 1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% Cl, 5.8% to 30%) survived without progression for at least 6 months. The median PES and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology. Conclusion. Cetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology. (C) 2011 Elsevier Inc. All rights reserved.