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Clinical Trial
. 2011 Sep;122(3):495-500.
doi: 10.1016/j.ygyno.2011.05.040.

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

Alessandro D Santin  1 , Michael W Sill, D Scott McMeekin, Mario M Leitao Jr, Jubilee Brown, Gregory P Sutton, Linda Van Le, Patricia Griffin, Cecelia H Boardman
Affiliations
Clinical Trial

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

Alessandro D Santin et al. Gynecol Oncol. 2011 Sep.

Abstract

Purpose: The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix.

Patients and methods: Eligible patients had cervical cancer, measurable disease, and GOG 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 (PFS) 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), GI (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% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS 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.

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Figures

Figure 1
Figure 1
Kaplan-Meier estimates of PFS and OS for the entire study population.
Figure 2
Figure 2
Kaplan-Meier estimates of PFS and OS for the study population of patients harboring squamous versus non-squamous cervical cancer.
See this image and copyright information in PMC

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