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

John K. Chan, Wei Deng, Robert V. Higgins, Krishnansu S. Tewari, Albert J. Bonebrake, Michael Hicks, Stephanie Gaillard, Pedro T. Ramirez, Weldon Chafe, Bradley J. Monk, Carol Aghajanian

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)554-559
Number of pages6
JournalGynecologic oncology
Volume146
Issue number3
DOIs
StatePublished - Sep 2017

Keywords

  • Brivanib
  • Recurrent cervical carcinoma

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study'. Together they form a unique fingerprint.

Cite this