A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study Journal Article


Authors: Chan, J. K.; Deng, W.; Higgins, R. V.; Tewari, K. S.; Bonebrake, A. J.; Hicks, M.; Gaillard, S.; Ramirez, P. T.; Chafe, W.; Monk, B. J.; Aghajanian, C.
Article Title: A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study
Abstract: Background Brivanib is an oral, tyrosine kinase inhibitor against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR). We studied its efficacy and tolerability in persistent or recurrent cervical cancer patients. Methods Eligible patients had at least one prior cytotoxic regimen for recurrence and with measurable disease. Brivanib 800 mg was administered orally every day (1 cycle = 28 days) until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) > 6 months and objective tumor response. Results Of 28 eligible and evaluable women enrolled, 11 (39%) had primary surgery and 25 (89%) had prior radiation. Eighteen (64%) received one prior cytotoxic treatment and 10 (36%) had 2 prior regimens. Twelve (43%) had > 2 cycles of brivanib with 4 (14%) receiving > 10 cycles (range: 1–20). Seven (25%) patients had PFS > 6 months (90% CI: 7.3%–33.9%). Two (7%) (90% CI: 1.3%–20.8%) patients had partial tumor response with duration of 8 and 22 months and 12 (43%) had stable disease. The median PFS was 3.2 months (90% CI: 2.1–4.4). The median overall survival was 7.9 months (90% CI: 6.1–11.7). More common grade 3 adverse events were hypertension, anemia, hyponatremia, hyperglycemia, elevated liver enzymes, nausea, headache, and colon hemorrhage. Grade 4 adverse events included sepsis and hypertension. Conclusions Based on early results of this phase II trial, brivanib was well tolerated and demonstrated sufficient activity after first stage but trial was stopped due to lack of drug availability. © 2017
Keywords: brivanib; recurrent cervical carcinoma
Journal Title: Gynecologic Oncology
Volume: 146
Issue: 3
ISSN: 0090-8258
Publisher: Elsevier Inc.  
Date Published: 2017-09-01
Start Page: 554
End Page: 559
Language: English
DOI: 10.1016/j.ygyno.2017.05.033
PROVIDER: scopus
PUBMED: 28728751
PMCID: PMC5728988
DOI/URL:
Notes: Article -- Export Date: 1 September 2017 -- Source: Scopus
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