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Maintenance pazopanib extends DFS in women with advanced ovarian cancer
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CHICAGO — Maintenance therapy with pazopanib extended DFS by 5.6 months in women with stage III/IV ovarian cancer who responded to initial chemotherapy, according to results of a phase 3 trial presented at the ASCO Annual Meeting.
About 70% of patients with advanced ovarian cancer experience disease relapse. However, there is currently no test to predict the risk for relapse, so maintenance therapy is needed, according to researchers.
Pazopanib is an orally administered multi-targeted tyrosine kinase inhibitor that is approved to treat renal cancer and soft tissue sarcoma.
“Preclinical data have shown efficacy in ovarian cancer, and this is why we designed this trial,” Andreas du Bois, MD, professor of gynecologic oncology at Kliniken Essen Mitte in Essen, Germany, said during a press conference.
The analysis included 940 patients with stage III/IV ovarian, fallopian tube and primary peritoneal cancer. All patients previously received five or more cycles of chemotherapy and underwent surgery for ovarian cancer.
Researchers randomly assigned patients to once-daily 800 mg pazopanib (Votrient, GlaxoSmithKline) or placebo daily for 2 years.
Median follow-up was 24 months.
Median PFS was 17.9 months in patients assigned to pazopanib compared with 12.3 months for those assigned to placebo (HR=0.766; 95% CI, 0.64-0.91).
Adverse events — which included diarrhea, fatigue, headache, hypertension, nausea and neutropenia — were more frequent in the pazopanib arm (26% vs. 11%).
“Pazopanib maintenance therapy significantly extends time without recurrence, and thus increases PFS and delays need for further chemotherapy,” du Bois said. “It prolongs the time for the patient to have control over the disease instead of the disease having control over the patient.”
OS data are immature, but they currently show no trend in favor of either regimen, du Bois said. Researchers need 551 events for a meaningful analysis, and follow-up is ongoing.
For more information:
du Bois A. Abstract #LBA5503. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The researchers report research funding and honoraria from, as well as consulting or advisory roles with, GlaxoSmithKline, PharmaMar and Roche.
Perspective
Back to TopGregory A. Masters, MD, FACP
This is how we build bridges to conquer cancer — from a basic science lab in Boston to a cancer clinic in Germany, and from a large research conference in Chicago to a patient in Delaware. Our job as oncologists is not only to deliver chemotherapy. We are educating our patients, other doctors and the public. We are working with the government and designing clinical trials to try to help build the knowledge that we gain from these meetings and research studies so that we can become better doctors and be better able to help patients understand their disease, their options and the side effects.
Perspective
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Carol Aghajanian, MD
Pazopanib is FDA-approved in kidney cancer and sarcoma, so I think there is a broad experience with what the side effect profile is. Dr. du Bois reported nothing new in terms of adverse events. The evidence continues to mount in targeting angiogenesis. All trials looking at these drugs have been positive. As we move forward, we need further study and clarification on how to use these drugs. We have good news in ovarian cancer in that patients are living longer with the disease. They all have been treated with multiple therapies, and it is very clear to those of us who are treating ovarian cancer patients that they are living longer. The challenge in clinical trials has been what treatment along the course of the disease is leading to that survival benefit, and how to measure this and correlate this with clinical benefit so that we can continue to meet that challenge.
Perspective
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Nefertiti C. duPont, MD, MPH
The role of maintenance therapy in advanced ovarian cancer is intriguing, but to date no improvement in OS has been reported. The data presented by du Bois and colleagues show a prolonged PFS in the pazopanib arm when compared with placebo, but the OS data are not mature. The oncology community should await the final results of this trial before maintenance therapy with pazopanib is fully embraced.
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