切除可能悪性胸膜中皮腫に対するペメトレキセドを含む集学的治療に関する妥当性試験

A Multiinstitutional Feasibility Study of Trimodality Therapy for Resectable Malignant Mesothelioma

Tanaka Fumihiro

Hasegawa Seiki

Okada Morihito

Yamanaka Takeharu

Fukuoka Kazuya

Soejima Toshinori

Kamikonya Norihiko

Inai Kouki

Tsujimura Tohru

Nakano Takashi

肺癌

目的.切除可能悪性胸膜中皮腫の手術成績向上のためには集学的治療が必要であるが,その至適治療法は確立していない.術前化学療法,手術および術後放射線治療からなる集学的治療のコンプライアンスと安全性を検証するために前向き臨床試験立案を計画した.研究計画.文部科学省科学技術振興調整費"アスベスト関連疾患への総括的取り組み"の一環として,臨床試験が計画された.結果.多施設共同のfeasibility試験が承認され,現在開始された.適格症例は,シスプラチンとペメトレキセドによる化学療法を3コース行った後に胸膜肺全摘除術と術後の放射線治療により治療される.主要評価項目は完全切除率と治療関連死亡率であり,向こう3年間で40例の適格症例の本臨床試験への参加が期待されている.結論.本臨床試験の完遂により切除可能胸膜中皮腫に対する集学的治療のfeasibilityが確認されれば,引き続いて臨床的有効性を検証する第II相試験へ進む予定である.

Objective. Multimodality therapy is essential to improve surgical outcomes of potentially resectable malignant pleural mesothelioma (MPM), but optimal treatment has not yet been established. To assess compliance and safety of a multimodality therapy consisting of preoperative chemotherapy, surgery and postoperative radiation, a prospective clinical study is planned. Method. We conducted this prospective study as a project of the "Comprehensive approach of asbestos-related diseases" supported by the "Special Coordination Fund for Promoting Science and Technology of the MEXT of Japan". Results. A multi-institutional feasibility study was approved and is now ongoing. Eligible patients will be treated with 3 cycles of chemotherapy using cisplatin and pemetrexed, followed by extrapleural pneumonectomy and postoperative hemithoracic radiation. Primary endpoints are the rate of complete resection and the mortality rate. The expected number of eligible patients participating in the study is 40 during the next 3 years. Conclusion. When this study is completed and the feasibility of multimodality treatment for resectable MPM is confirmed, a phase II study to assess the efficacy may be planned.

悪性胸膜中皮腫

集学的治療

ペメトレキセド

胸膜肺全摘除術

片側全胸郭照射

Malignant pleural mesothelioma

Trimodality therapy

Pemetrexed

Extrapleural pneumonectomy

Hemithoracic radiation

Medical sciences [ 490 ]

jpn

日本肺癌学会

Copyright (c) 2009 日本肺癌学会

[ISSN] 0386-9628

[NCID] AN00203978

[DOI] 10.2482/haigan.49.403

[URI] http://joi.jlc.jst.go.jp/JST.JSTAGE/haigan/49.403 isVersionOf