血管新生阻害薬は卵巣がんの無病生存期間を延長する（Abstract # LBA5503）

進行卵巣がんを有する女性におけるパゾパニブを用いた維持療法は再発を遅延させる

Maintenance therapy with pazopanib delays relapse in women with advanced ovarian cancer

進行卵巣がん女性を対象とした第III相臨床試験の結果、初回の化学療法が奏効した後の経口分子標的薬パゾパニブによる治療はプラセボと比較し無病生存期間を平均5.6か月延長させたことが示された。パゾパニブは経口薬で、血管新生に関わるいくつかの標的を遮断する。今回のスタディにおいてstage III/IVの卵巣がん、卵管がん、および原発性腹膜がん患者をパゾパニブまたはプラセボを毎日24か月間内服する群に無作為に割り付けた。全ての患者はすでに手術を受け、5サイクル以上の化学療法が奏効し疾患の増悪が予防されていた。患者は平均24か月間追跡された。パゾパニブ群とプラセボ群における無増悪生存期間中央値は、それぞれ17.9か月および12.3か月であった。初回の手術および化学療法による治療が奏効したにもかかわらず、進行卵巣がん患者の70%が再発を経験し、半数は1年以内である。再発した際に、患者は強力な治療を受けなくてはならない。現時点で患者の再発リスクを予測する検査はなく、したがって今回のような維持療法が多くの患者において行われるであろう。このスタディ結果は第49回American Society of Clinical Oncology年次集会で発表された。

A phase III clinical trial in women with advanced ovarian cancer finds that treatment with the oral targeted drug pazopanib following initial successful chemotherapy extends disease-free survival by an average of 5.6 months, compared to placebo. The study was presented at the American Society of Clinical Oncology's 2013 annual meeting.

Advanced ovarian cancer is an aggressive disease with a cure rate of only 20-25 percent. Despite successful initial treatment with surgery and chemotherapy, about 70 percent of patients with advanced ovarian cancer experience a relapse, half in the first year. Upon relapse, patients have to resume aggressive treatments. At this time, there is no test available to predict a patient's risk for relapse, so a maintenance therapy such as this one would be used for most patients.

"Our findings show that we finally have a drug that can maintain control over ovarian cancer growth achieved through initial treatments," said lead author Andreas du Bois, M.D., a professor of gynecologic oncology at Kliniken Essen Mitte in Essen, Germany. "If pazopanib is approved for ovarian cancer, many patients will experience longer disease-free and chemotherapy-free periods. During this time, the patient keeps control over the disease instead of the disease having control over patient's life."

Pazopanib is an oral drug that blocks several targets involved in angiogenesis. In the study, 940 patients with stage III/IV ovarian, fallopian tube, and primary peritoneal cancer were randomly assigned to receive pazopanib or placebo daily for 24 months. All patients had prior surgery and five or more rounds of chemotherapy that successfully prevented the disease from worsening. Patients were followed for 24 months, on average. The median progression-free survival time in the pazopanib and placebo group was 17.9 and 12.3 months, respectively.

"Relapses remain all too common for women with advanced ovarian cancer. This large trial shows us that targeting multiple molecular cancer drivers can have a substantial impact on this cancer's ability to grow, giving our patients significantly longer time before relapse. This study offers a real-world example of how the precision medicine era of cancer research is paying off in areas where no alternate approved drugs exist," said Carol Aghajanian, M.D., ASCO spokesperson and gynecologic cancers expert.

Ovarian cancer is the fifth leading cause of cancer death among women in developed countries. An immediate goal for this research is to combine pazopanib with other targeted drugs and personalize therapy according to patient and tumor characteristics.

This research was supported by GlaxoSmithKline.