Trimodality strategy for treating malignant pleural mesothelioma: results of a feasibility study of induction pemetrexed plus cisplatin followed by extrapleural pneumonectomy and postoperative hemithoracic radiation (Japan Mesothelioma Interest Group 0601 Trial).
Trimodality strategy for treating malignant pleural mesothelioma: results of a feasibility study of induction pemetrexed plus cisplatin followed by extrapleural pneumonectomy and postoperative hemithoracic radiation (Japan Mesothelioma Interest Group 0601 Trial).
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DOI：
10.1007/s10147-015-0925-1
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发表时间：
2016-06
影响因子：
3.3
通讯作者：
Nakano T
中科院分区：
文献类型：
--
作者：
Hasegawa S;Okada M;Tanaka F;Yamanaka T;Soejima T;Kamikonya N;Tsujimura T;Fukuoka K;Yokoi K;Nakano T
我们进行了一项前瞻性多机构研究，以确定日本恶性胸膜间皮瘤（MPM）患者的三联疗法（TMT）的可行性，包括诱导化疗，然后进行胸膜外全肺切除术（EPP）和放射治疗。 主要合格标准为组织学确诊的MPM，包括临床亚型T0-3、N 0 -2、M0疾病;既往未接受过疾病治疗;年龄20-75岁;东部肿瘤协作组体能状态0或1;预测术后1秒用力呼气量>1000 ml;书面知情同意书。治疗方法包括培美曲塞（500 mg/m2）联合顺铂（60 mg/m2）诱导化疗3个周期，随后进行EPP和术后半胸放疗（54戈伊）。主要终点为EPP的肉眼完全切除（MCR）率和TMT的治疗相关死亡率。入组了42例合格患者：中位年龄64.5（范围43-74）岁; M：F = 39：3，临床分期I：II：III = 14：13：15;组织学类型上皮样肉瘤样;双相;其他= 28：1：9：4。42例患者中，30例完成EPP和MCR，17例完成TMT。试验符合主要终点，MCR率为71%（30/42），治疗相关死亡率为9.5%（4/42）。42例患者的中位生存时间和2年生存率分别为19.9个月和42.9%。30例完成EPP联合MCR的患者2年无复发生存率为37.0%。这项II期研究符合预定义的主要终点，但其风险/获益比不令人满意。本文的在线版本（doi：10.1007/s10147-015-0925-1）包含补充材料，可供授权用户使用。
We conducted a prospective multi-institutional study to determine the feasibility of trimodality therapy (TMT) comprising induction chemotherapy followed by extrapleural pneumonectomy (EPP) and radiation therapy in Japanese patients with malignant pleural mesothelioma (MPM). Major eligibility criteria were histologically confirmed diagnosis of MPM, including clinical subtypes T0–3, N0–2, M0 disease; no prior treatment for the disease; age 20–75 years; Eastern Cooperative Oncology Group performance status 0 or 1; predicted postoperative forced expiratory volume >1000 ml in 1 s; written informed consent. Treatment methods comprised induction chemotherapy using pemetrexed (500 mg/m2) plus cisplatin (60 mg/m2) for three cycles, followed by EPP and postoperative hemithoracic radiation therapy (54 Gy). Primary endpoints were macroscopic complete resection (MCR) rate for EPP and treatment-related mortality for TMT. Forty-two eligible patients were enrolled: median age 64.5 (range 43–74) years; M:F = 39:3, clinical stage I:II:III = 14:13:15; histological type epithelioid were sarcomatoid; biphasic; others = 28:1:9:4. Of 42 patients, 30 completed EPP with MCR and 17 completed TMT. The trial met the primary endpoints, with an MCR rate of 71 % (30/42) and treatment-related mortality of 9.5 % (4/42). Overall median survival time and 2-year survival rate for 42 registered patients were 19.9 months and 42.9 %, respectively. Two-year relapse-free survival rate of 30 patients who completed EPP with MCR was 37.0 %. This phase II study met the predefined primary endpoints, but its risk/benefit ratio was not satisfactory. The online version of this article (doi:10.1007/s10147-015-0925-1) contains supplementary material, which is available to authorized users.