進行子宮頸がんに対する初めての有効な生物学的治療（Abstract # 3）

化学療法にベバシズマブを併用することにより転移性または再発性子宮頸がんの女性の生存期間が改善する

Adding bevacizumab to chemotherapy improves survival for women with metastatic or relapsed cervical cancer

第49回American Society of Clinical Oncology年次集会で発表された第III相無作為化スタディの結果、標準的な化学療法にベバシズマブを併用することにより転移性または再発性子宮頸がんの女性の生存期間が改善したことが報告された。これらの患者集団において生物学的製剤が生存期間を有意に延長したのはこれが初めてである。今回の4群の臨床試験において、再発性転移性子宮頸がんの女性452人が従来通りの化学療法のみまたは化学療法にベバシズマブを併用する治療群に無作為に割り付けられた。検証された2つの化学療法レジメンは、シスプラチンとパクリタキセルの併用およびトポテカンとパクリタキセルの併用であった。これらの2つのレジメンを比較し、これらの患者群における標準的な化学療法であるシスプラチンよりもトポテカンがより有益であるかどうかを調べた。その結果、これら2つの化学療法群で生存期間に有意差はなかった。全体的に見て、ベバシズマブと化学療法を併用された患者の生存期間中央値は17.0か月であったのに対し化学療法のみを施行された患者では13.3か月であった。腫瘍縮小率はベバシズマブ投与群で高く（48%対36%）、奏効は長く持続した。さらに、ベバシズマブに関連した生存期間に関する有益性はQOL低下の代償として得られるものではなかった。

A randomized phase III study presented at the 49th Annual Meeting of the American Society of Clinical Oncology reports that adding bevacizumab to standard chemotherapy improved survival for women with metastatic or relapsed cervical cancer. This is the first time a biologic drug has significantly prolonged survival in this setting. The study was performed by the Gynecologic Oncology Group.

Chemotherapy regimens are largely ineffective against advanced cervical cancer. Worldwide, cervical cancer takes 250,000 women's lives every year. This is the first study showing that a targeted drug that blocks blood vessel formation in the tumor can prolong survival for women with gynecologic cancers.

"Women with advanced cervical cancer don't have many options. We finally have a drug that helps women live longer," said lead study author Krishnansu Sujata Tewari, M.D., a professor of obstetrics and gynecology at the University of California Irvine in Orange, California. "This is also possibly a first step toward turning cervical cancer into a chronic disease, helping women live longer and allowing time for additional treatments that could further slow the cancer's progression and improve survival."

In this four-armed clinical trial, 452 women with recurrent of metastatic cervical cancer were randomly assigned to treatment with a chemotherapy regimen alone or a chemotherapy regimen plus bevacizumab. The two chemotherapy regimens tested were cisplatin plus paclitaxel and topotecan plus paclitaxel. Those two regimens were compared to determine if topotecan would be more beneficial than cisplatin, a standard chemotherapy option in this setting. There were no significant differences in survival between the two chemotherapy arms.

Overall, the median survival for patients who received bevacizumab plus chemotherapy was 17.0 months vs. 13.3 months for those who received only chemotherapy. Tumor shrinkage rates were higher in patients who received the bevacizumab (48 percent vs. 36 percent) and responses lasted longer. Analysis of quality of life data was also reported at the ASCO Annual Meeting. Generally, the results indicate that survival benefit associated with bevacizumab did not come at the cost of diminished quality of life.

"Treatment options for women with recurrent or advanced disease have been insufficient for far too long. This study clearly shows how our nation's investment in clinical cancer research pays off, offering the first ever treatment to extend the lives of women with aggressive cervical cancer," said Carol Aghajanian, M.D., ASCO spokesperson and gynecologic cancers expert.

Bevacizumab is currently approved by the FDA for use in several advanced cancers, but has not to date received approval in any gynecologic cancer.

This research was supported by the National Cancer Institute.