ゲムシタビン単剤について

摘要

目的．進行非小細胞肺癌に対する化学療法におけるゲムシタビン単剤療法の位置づけを明らかにする．研究方法．進行非小細胞肺癌に対するゲムシタビン単剤療法に関する文献をレビューする．結果．ゲムシタビン単剤の第Ⅱ相試験では，奏効率20％，生存期間中央値40過と他の新規抗癌剤と同様の成績が得られている．Best Supportive Careとの無作為化比較試験では有意な延命効果が認められなかったが，旧抗癌剤とシスプラチンの併用療法との比較では腫瘍縮小効果·延命効果に有意差なく，毒性面ではゲムシタビン単剤の方が優れていた．カルボプラチンとの併用療法と単剤との比較では前者が腫瘍縮小効果·延命効果ともに有意に優れていた．結論．ゲムシタビン単剤療法は，PS良好な進行非小細胞肺癌患者に対する第一選択とはならないが，高齢者·PS不良例など毒性軽減を重視する必要のある場合における治療の選択肢のひとつとなる．Objective. To clarify the role of gemcitabine as a single agent in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Study Design. The results of the trials evaluating gemcitabine monotherapy for advanced NSCLC were reviewed. Results. Phase Ⅱstudies of gemcitabine have shown consistent activity against NSCLC. The response rate was 20%, and the median survival was 40 weeks, which were similar to those obtained with other newer chemotherapeutic agents. Although the survival advantage of gemcitabine was not significant in a randomized trial comparing gemcitabine to best supportive care, gemcitabine as a single agent is as effective and less toxic than older cisplatin- based combinations. A recent randomized trial has compared gemcitabine as a single agent with a two-drug combination of gemcitabine and carboplatin. In this trial, the combination produced a significantly higher response rate and a superior survival compared with gemcitabine alone. Conclusion. Gemcitabine mono-therapy is not the standard chemotherapy for advanced NSCLC patients with good performance status (PS). However it can be one of the treatment choices for elderly or poor PS patients, for whom the safety of chemotherapy is particularly important.