Phase I to II Study of Pleurectomy/Decortication and Intraoperative Intracavitary Hyperthermic Cisplatin Lavage for Mesothelioma

摘要: Purpose To evaluate morbidity, mortality, maximum-tolerated dose (MTD), and outcome of intraoperative intracavitary hyperthermic cisplatin lavage in patients undergoing pleurectomy for malignant pleural mesothelioma (MPM). Patients Methods Sixty-one were prospectively registered. Forty-four resectable with MPM underwent pleurectomy, followed by a 1-hour the resection cavity dose-escalated (50, 100, 150, 175, 200, 225, 250 mg/m2) at 42°C then intravenous sodium thiosulfate (16 g/m2 over 6 hours). Survival estimates compared using log-rank test proportional hazards regression. Results Median age was 71 years (range, 50 to 82 years). Twenty-four had epithelial tumors, 20 sarcomatous or mixed histology. Postoperative mortality 11% (five 44 patients). Dose-limiting renal toxicity occurred mg/m2, establishing MTD 225 mg/m2. Other morbidity included atrial fibrillation (14 patients, 32%) deep venou...