Bakhshandeh A, Bruns I, Traynor A, Robins H I, Eberhardt K, Demedts A, Kaukel E, Koschel G, Gatzemeier U, Kohlmann Th, Dalhoff K, Ehlers E M, Gruber Y, Zumschlinge R, Hegewisch-Becker S, Peters S O, Wiedemann G J
Medical University of Lübeck, Ratzeburger Allee 160, 23538, Luebeck, Germany.
Lung Cancer. 2003 Mar;39(3):339-45. doi: 10.1016/s0169-5002(02)00536-6.
We performed a phase II study combining 41.8 degrees C whole body hyperthermia with ICE chemotherapy, i.e. ifosfamide (5 g/m(2)), carboplatin (300 mg/m(2)) and etoposide (150 mg/m(2) on days 2 and 3), administered every 4 weeks, for patients with malignant pleural mesothelioma. Of 27 chemonäive, non-metastatic patients enrolled, 25 patients were evaluable for response. Overall response rate was 20% (five partial remissions; 95% CI 8.9-39.1%). Median survival time from the start of treatment for all patients was 76.6 weeks (95% CI 65.4-87.8 weeks). Progression free survival for all patients measured 29.6 weeks (95% CI 24.4-34.7 weeks). One year overall survival was 68% and 2 year overall survival was 20%. Major treatment toxicities included grade 3/4 neutropenia and thrombocytopenia in 74 and 33% of treatment cycles, respectively. One patient died due to sepsis. These promising results are consistent with continued clinical investigation; a phase III clinical trial with whole body hyperthermia as the independent variable has been initiated.
我们开展了一项II期研究，将41.8摄氏度的全身热疗与ICE化疗联合应用于恶性胸膜间皮瘤患者，即每4周给予异环磷酰胺（5 g/m²）、卡铂（300 mg/m²）和依托泊苷（第2天和第3天为150 mg/m²）。在纳入的27例未经化疗、无转移的患者中，25例患者可评估疗效。总缓解率为20%（5例部分缓解；95%置信区间8.9 - 39.1%）。所有患者从治疗开始的中位生存时间为76.6周（95%置信区间65.4 - 87.8周）。所有患者的无进展生存期为29.6周（95%置信区间24.4 - 34.7周）。1年总生存率为68%，2年总生存率为20%。主要治疗毒性包括3/4级中性粒细胞减少和血小板减少，分别出现在74%和33%的治疗周期中。1例患者死于败血症。这些有前景的结果与持续的临床研究一致；一项以全身热疗为自变量的III期临床试验已经启动。
