A Multiinstitutional Feasibility Study of Trimodality Therapy for Resectable Malignant Mesothelioma

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.

[1]  M. Okada,et al.  Current Status of Multi-modality Treatment for Malignant Pleural Mesothelioma in Japan , 2008 .

[2]  Laurence Court,et al.  Fatal pneumonitis associated with intensity-modulated radiation therapy for mesothelioma. , 2006, International journal of radiation oncology, biology, physics.

[3]  K. Rosenzweig,et al.  Induction Chemotherapy, Extrapleural Pneumonectomy, and Postoperative High-Dose Radiotherapy for Locally Advanced Malignant Pleural Mesothelioma: A Phase II Trial , 2006, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[4]  R. Flores Induction chemotherapy, extrapleural pneumonectomy, and radiotherapy in the treatment of malignant pleural mesothelioma: the Memorial Sloan-Kettering experience. , 2005, Lung cancer.

[5]  R. Stahel,et al.  Neoadjuvant chemotherapy followed by extrapleural pneumonectomy in malignant pleural mesothelioma. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  V. Rusch Pemetrexed and cisplatin for malignant pleural mesothelioma: a new standard of care? , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[7]  Claude Denham,et al.  Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[8]  R. V. van Klaveren,et al.  Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma , 2002, British Journal of Cancer.

[9]  K. Rosenzweig,et al.  A phase II trial of surgical resection and adjuvant high-dose hemithoracic radiation for malignant pleural mesothelioma. , 2001, The Journal of thoracic and cardiovascular surgery.

[10]  M. Ghielmini,et al.  The effect of Rituximab on patients with follicular and mantle-cell lymphoma. Swiss Group for Clinical Cancer Research (SAKK). , 2000, Annals of oncology : official journal of the European Society for Medical Oncology.

[11]  A. Musk,et al.  Cisplatin and gemcitabine treatment for malignant mesothelioma: a phase II study. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[12]  W. Richards,et al.  Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. , 1999, The Journal of thoracic and cardiovascular surgery.

[13]  V. Rusch,et al.  The role of extrapleural pneumonectomy in malignant pleural mesothelioma. A Lung Cancer Study Group trial. , 1991, The Journal of thoracic and cardiovascular surgery.

[14]  H. Bloom,et al.  Malignant mesothelioma of the pleura: a study of 52 treated and 64 untreated patients. , 1984, Thorax.

[15]  Ramon Silva Martins,et al.  Malignant pleural mesothelioma. , 2012, Journal of the National Comprehensive Cancer Network : JNCCN.