ベバシズマブは卵巣がん患者の無増悪生存期間を延長させる（Abstract#: LBA1）

標準的な化学療法にベバシズマブを追加することにより進行卵巣がん患者の生存率が改善する

Adding bevacizumab to standard chemotherapy improves survival in women with advanced ovarian cancer

第46回ASCOのプレナリーセッションで取り上げられたphase IIIの婦人科がんグループ臨床試験の結果、初回化学療法にベバシズマブを追加し、さらにベバシズマブを維持療法として投与することにより、進行性の上皮性卵巣がん、原発性腹膜がん、または輸卵管がんの進行を有意に遅延させることができることが示された。この国際スタディには新たにstage IIIまたはIVの卵巣がん、原発性腹膜がん、または輸卵管がんと診断され手術でがんを可能な限り多く切除された女性1,873人を対象とした。患者らは、標準的化学療法（パクリタキセルとカルボプラチン）にプラセボを追加しプラセボで維持；標準的化学療法にベバシズマブを追加しプラセボで維持；標準的化学療法にベバシズマブを追加しベバシズマブで維持の3群のいずれかに無作為に割り付けられた。標準的化学療法とベバシズマブを投与され最長10ヵ月間にわたりベバシズマブで維持された女性は標準的化学療法のみを受けた患者群と比較し、無増悪生存期間が長く（それぞれの中央値は14.1ヵ月と10.3ヵ月）、その差は統計学的に有意であった。化学療法とベバシズマブを投与されプラセボで維持された患者の無増悪生存期間中央値は11.2ヵ月であり、標準治療単独群との差は統計学的に有意ではなかった。

A Phase III Gynecologic Oncology Group (GOG) clinical trial featured in a plenary session at the 46th Annual Meeting of the American Society of Clinical Oncology finds that adding bevacizumab (Avastin) to initial chemotherapy treatment - and then giving bevacizumab as maintenance therapy - significantly slows disease progression in women with advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.

"This is the first time a Phase III trial has demonstrated that an anti-angiogenic agent improved progression-free survival in women with this very hard-to-treat disease," said lead researcher Robert A. Burger, M.D., director of the Women's Cancer Center at Fox Chase Cancer Center in Philadelphia, and GOG Lead Investigator. "Based on the results of this GOG trial, bevacizumab is an acceptable initial treatment option for patients with advanced ovarian, primary peritoneal and fallopian tube cancers."

Bevacizumab, which blocks the development of tumor growth-promoting blood vessels, is approved for several metastatic cancers, including those of the colon, breast, kidney, brain and lung. Previous small clinical trials showed promising activity in patients with recurrent ovarian and peritoneal cancer.

This international study included 1,873 women with newly diagnosed stage III or IV ovarian, primary peritoneal or fallopian tube cancer who had undergone surgery to remove as much of the cancer as possible. Patients were randomly assigned to one of three groups: standard chemotherapy (paclitaxel plus carboplatin) and placebo plus placebo maintenance; standard chemotherapy with bevacizumab plus placebo maintenance; or standard chemotherapy with bevacizumab, followed by bevacizumab maintenance. Maintenance therapy is defined as longer-term treatment given after standard chemotherapy, with the goal of extending cancer progression-free survival.

The researchers found that women who received standard chemotherapy plus bevacizumab followed by up to 10 months of bevacizumab maintenance had a longer period of progression free survival (median of 14.1 months) compared with those who received standard chemotherapy alone (median of 10.3 months), a difference that was statistically significant. Those who received chemotherapy and bevacizumab followed by placebo maintenance had a median progression-free survival of 11.2 months, a difference that was not statistically significant compared with those who received standard chemotherapy alone.

Although patients experienced bevacizumab-associated side effects (primarily hypertension and low white blood cell counts), the types and frequency appeared to be similar to what has been reported previously.