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Investigational New Drugs

, Volume 31, Issue 5, pp 1307–1310 | Cite as

A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109

  • Lida A. Mina
  • Menggang Yu
  • Cynthia Johnson
  • Cyndi Burkhardt
  • Kathy D. MillerEmail author
  • Robin Zon
PHASE II STUDIES

Summary

Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.

Keywords

Bevacizumab Sorafenib Metastatic breast cancer 

Notes

Conflict of interest

Lida A Mina, MD.: No Conflict of Interest

Cynthia S Johnson: No Conflict of Interest

Cynthia Burkhardt: No Conflict of Interest

Menggang Yu: No Conflict of Interest

Robin Zon, MD: No Conflict of Interest

Kathy D Miller, MD: Honoraria to disclose: Yes Genentech

Research funding to disclose: Genentech and Trial supported by Bayer

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Copyright information

© The Author(s) 2013

Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

Authors and Affiliations

  • Lida A. Mina
    • 1
  • Menggang Yu
    • 2
  • Cynthia Johnson
    • 2
  • Cyndi Burkhardt
    • 3
  • Kathy D. Miller
    • 1
    Email author
  • Robin Zon
    • 4
  1. 1.Indiana University Melvin and Bren Simon Cancer CenterIndiana Cancer PavilionIndianapolisUSA
  2. 2.Department of BiostatisticsIndiana University School of MedicineIndianapolisUSA
  3. 3.Hoosier Oncology GroupIndianapolisUSA
  4. 4.Northern Indiana Cancer Research ConsortiumSouth BendUSA

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