Originally published as JCO Early Release 10.1200/JCO.2008.18.9043 on January 12 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Monk, B. J. Articles by Roman, L. D. Search for Related Content PubMed PubMed Citation Articles by Monk, B. J. Articles by Roman, L. D. Social Bookmarking                            What's this?

Phase II Trial of Bevacizumab in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

From the University of California Irvine, Chao Family Comprehensive Cancer Center, Orange; Women's and Children's Hospital, University of Southern California, Los Angeles, CA; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute; Department of Biostatistics, University at Buffalo, Buffalo, NY; University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA; and University of Iowa, Iowa City, IA.

Corresponding author: Bradley J. Monk, MD, University of California, Irvine Medical Center, Bldg 56, Room 262, 101 The City Dr, Orange, CA 92868; e-mail: bjmonk{at}uci.edu.

Purpose Vascular endothelial growth factor is a key promoter of tumor progression in cervical carcinoma. The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of bevacizumab, a recombinant humanized anti–vascular endothelial growth factor monoclonal antibody.

Patients and Methods Eligible patients had recurrent cervical cancer, measurable disease, and GOG performance status 2. Treatment consisted of bevacizumab 15 mg/kg intravenously every 21 days until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and toxicity.

Results Forty-six patients were enrolled (median age, 46 years); 38 patients (82.6%) received prior radiation as well as either one (n = 34, 73.9%) or two (n = 12, 26.1%) prior cytotoxic regimens for recurrent disease. Grade 3 or 4 adverse events at least possibly related to bevacizumab included hypertension (n = 7), thrombo-embolism (n = 5), GI (n = 4), anemia (n = 2), other cardiovascular (n = 2), vaginal bleeding (n = 1), neutropenia (n = 1), and fistula (n = 1). One grade 5 infection was observed. Eleven patients (23.9%; two-sided 90% CI, 14% to 37%) survived progression free for at least 6 months, and five patients (10.9%; two-sided 90% CI, 4% to 22%) had partial responses. The median response duration was 6.21 months (range, 2.83 to 8.28 months). The median PFS and overall survival times were 3.40 months (95% CI, 2.53 to 4.53 months) and 7.29 months (95% CI, 6.11 to 10.41 months), respectively. This compared favorably with historical phase II GOG trials in this setting.

Conclusion Bevacizumab seems to be well tolerated and active in the second- and third-line treatment of patients with recurrent cervical cancer and merits phase III investigation.

Supported by Grant No. CA 27469 to the Gynecologic Oncology Group Administrative Office and Grant No. CA 37517 to the Gynecologic Oncology Group Statistical and Data Center from the National Cancer Institute (NCI) and Grant No. CA 87558 (K-23 grant; B.J.M.) from the National Institutes of Health. The clinical trial upon which this article is based was sponsored by the Cancer Therapy Evaluation Program of the NCI, under the Collaborative Research and Development Agreement for bevacizumab between NCI and Genentech Inc.

Presented in part at the 39th Annual Meeting of the Society of Gynecologic Oncologists, March 9-12, 2008, Tampa, FL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. Zangari, L. M. Fink, F. Elice, F. Zhan, D. M. Adcock, and G. J. Tricot Thrombotic Events in Patients With Cancer Receiving Antiangiogenesis Agents J. Clin. Oncol., October 10, 2009; 27(29): 4865 - 4873. [Abstract] [Full Text] [PDF]

				B. J. Monk, M. W. Sill, D. S. McMeekin, D. E. Cohn, L. M. Ramondetta, C. H. Boardman, J. Benda, and D. Cella Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study J. Clin. Oncol., October 1, 2009; 27(28): 4649 - 4655. [Abstract] [Full Text] [PDF]