New drug combination effective for patients with advanced ovarian cancer

"Novel approaches for relapsed ovarian cancer are desperately needed as limited effective combinations currently exist to treat our patients. The results of this study demonstrated a drug combination that may be an effective treatment for this type of ovarian cancer," said Alessandro Santin, MD, Professor of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine and Disease Aligned Research Team Leader for the Gynecological Cancers Program at Yale Cancer Center and Smilow Cancer Hospital and senior author of the study.

Ovarian cancer is the most lethal gynecologic malignancy. According to the American Cancer Society, nearly 20,000 women will be diagnosed with ovarian cancer in the United States every year, and more than 12,000 women will die from the disease. IXA is a microtubule-stabilizing agent that may be beneficial in patients treated with platinum/paclitaxel. Bevacizumab (BEV) is an antibody that keeps new blood vessels from forming and has shown clinical activity in ovarian cancer.

In this phase II study, researchers randomly assigned 78 patients to receive IXA+BEV or IXA alone. The primary endpoint was progression-free survival (PFS), Overall survival (OS), safety, and response rates served as secondary endpoints. Researchers also examined whether the presence of the protein TUBB3 within the tumor could predict clinical response to these drugs. Among 76 evaluable patients who received IXA+BEV compared to IXA, the response rate was 33% versus 8%, with clinical benefit durable at 6 months in 37% and 3%. The addition of BEV significantly improved both PFS (5.5 months vs 2.2 months) and OS (10 months vs 6 months). Both regimens were well-tolerated.

"We expect our findings to have major implications in the field of gynecologic oncology since they add a new, effective treatment for these extremely challenging tumors for which there are otherwise few options," said first author Dana M. Roque, MD, Associate Professor of the Division of Gynecologic Oncology at the University of Maryland School of Medicine and member of the Marlene & Stewart Greenebaum Comprehensive Cancer Center.

Other Yale authors of the study include: Gloria Huang, MD, Gulden Menderes, MD, and Elena Ratner, MD, Natalia Buza, MD, Stefania Bellone, PhD, Vaagn Andikyan, MD, Mitchell Clark, MD, Masoud Azodi, MD, Peter E. Schwartz, MD, Pei Hui, MD, PhD,Joan R. Tymon-Rosario, Justin Harold, MD, Dennis Mauricio, Burak Zeybek, and Gary Altwerger, MD.

Funding for the study was provided by RPharm-US, grants from the National Institutes of Health, the National Cancer Institute, the Deborah Bunn Alley Ovarian Cancer Research Foundation, the Discovery to Cure Foundation, the Stand Up to Cancer Foundation (SU2C), the Guido Berlucchi Foundation, and the Domenic Cicchetti Foundation.