Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: A gynecologic oncology group study Journal Article

Authors: Aghajanian, C.; Sill, M. W.; Darcy, K. M.; Greer, B.; McMeekin, D. S.; Rose, P. G.; Rotmensch, J.; Barnes, M. N.; Hanjani, P.; Leslie, K. K.
Article Title: Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: A gynecologic oncology group study
Abstract: Purpose: Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor-A (VEGF-A), has clinical activity in multiple tumor types. We conducted a phase II trial to assess the activity and tolerability of single-agent bevacizumab in recurrent or persistent endometrial cancer (EMC). Patients and Methods: Eligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and Gynecologic Oncology Group performance status of ≤ 2. Treatment consisted of bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression or prohibitive toxicity. VEGF-A was assessed by immunohistochemistry in archival tumor and by enzyme-linked immunosorbent assay in pretreatment plasma. Primary end points were progression-free survival (PFS) at 6 months and overall response rate. Results: Fifty-six patients were enrolled. Fifty-two patients were eligible and evaluable. Median age was 62 years, and prior treatment consisted of one or two regimens in 33 (63.5%) and 19 (36.5%) patients, respectively. Twenty-nine patients (55.8%) received prior radiation. Adverse events were consistent with those expected with bevacizumab treatment. No GI perforations or fistulae were seen. Seven patients (13.5%) experienced clinical responses (one complete response and six partial responses; median response duration, 6.0 months), and 21 patients (40.4%) survived progression free for at least 6 months. Median PFS and overall survival times were 4.2 and 10.5 months, respectively. Suggested associations were observed between high VEGF-A and adjusted hazard of death or tumor response when evaluated in tumor/plasma or plasma, respectively. Conclusion: Bevacizumab is well tolerated and active based on PFS at 6 months in recurrent or persistent EMC and warrants further investigation. © 2011 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 29
Issue: 16
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2011-06-01
Start Page: 2259
End Page: 2265
Language: English
DOI: 10.1200/jco.2010.32.6397
PROVIDER: scopus
PMCID: PMC3107744
PUBMED: 21537039
Notes: --- - "Export Date: 23 June 2011" - "CODEN: JCOND" - "Source: Scopus"
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