Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer, an NCCN phase II trial

Mathew Cowan, Wendy M. Swetzig, Valery Adorno-Cruz, Mario J. Pineda, Nikki L. Neubauer, Emily Berry, John R. Lurain, Shohreh Shahabi, Deanna Taiym, Valerie Nelson, Kaitlyn Lucrezia O'Shea, Masha Kocherginsky, Daniela Matei*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Objective: Tivozanib is a potent selective pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor with a long half-life. This study assessed its activity in patients with recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer (OC). Methods: This open-label phase II study used a Simon's two-stage design. Eligible patients had recurrent, platinum-resistant OC and measurable or detectable disease. There was no limit on the number of prior regimens. Treatment consisted of tivozanib 1.5 mg orally once daily for 21 days in a 28-day cycle. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity assessment. Results: Thirty-one patients were enrolled, and 30 were treated. The median age was 59.5 years, and median number of prior regimens was 4 (range 1–9). Twenty-four patients were evaluable for response, and four (16.7%) achieved a partial response (PR; ORR = 16.7%). An additional fourteen (58.3%) patients had stable disease (SD). The clinical benefit rate (PR + SD) was 75.0%, and the median duration of objective response was 5.7 months. For all patients on trial, the median PFS was 4.1 months (95% confidence interval (CI): 1.7–5.8) and OS 8.6 months (95% CI: 5.4–12.5). There were no treatment-related deaths. Serious adverse events occurred in 13.3% of patients and included small intestinal perforation or obstruction and stroke. Grade 3–4 adverse events occurred in 60% of patients, including hypertension (26.7%) and fatigue (10%). Conclusions: Tivozanib is effective in patients with recurrent OC, with moderate toxicity and no treatment-related deaths, supporting its further development.

Original languageEnglish (US)
Pages (from-to)57-63
Number of pages7
JournalGynecologic oncology
Volume163
Issue number1
DOIs
StatePublished - Oct 2021

Funding

This study was approved and funded by the National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) from general research support provided by AVEO. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number P30CA060553 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We appreciate the support from the Clinical Trial Office of the Robert H Lurie Comprehensive Cancer Center . We acknowledge contributions from Drs. Latoya Perry, Alok Pant, Julian Schink, as well as Karen Novak, APN and Nancy Anderson, APN.

Keywords

  • Antiangiogenesis
  • Ovarian cancer
  • Phase II trial
  • Platinum-resistant
  • Tivozanib

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

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