Cisplatin and gemcitabine treatment for malignant mesothelioma: A phase IIstudy

Purpose: We performed a phase II study of combined cisplatin 100 mg/m(2), g iven intravenously on day 1, and gemcitabine 1,000 mg/m(2), given intraveno usly on days 1, 8, and 15 of a 28-day cycle for six cycles among patients w ith advanced measurable pleural mesothelioma. Patients and Methods: Pleural tumor was measured at three levels on compute d tomographic scans at study entry and before the second, fourth, and sixth cycles and every 2 months thereafter to disease progression. Of the 21 pat ients treated, 19 were male; the median age was 62 years (range, 46 to 74 y ears); 62% had epithelial tumors; and 18 were classified as tumor-node-meta stasis system stage III or IV. Ninety-four cycles were given (median, six; mean, 4.5 per patient), with a mean relative dose intensity of cisplatin 96 .7% and gemcitabine 82.5%. Results: Best objective responses achieved were as follows: complete respon se, no patients; partial response, 10 patients (complete response + partial response, 47.6% [95% confidence interval, 26.2% to 69.0%]); no change, nin e patients; and progressive disease, two patients, Median response duration was 25 weeks, progression-free survival was 25 weeks, and overall survival was 41 weeks. Nine of the 10 responders (90%) and three of nine patients w ith no change had significant symptom improvement. Serial measurements of v ital capacity were performed on three of the responders; all showed a signi ficant increase during the time of remission. toxicity was mainly gastroent erologic and hematologic. Grade 3 nausea and vomiting occurred in 33% of pa tients, grade 3 leukopenia in 38%, grade 3 thrombocytopenia in 14%, and gra de 4 thrombocytopenia in 19%, Conclusion: Combined cisplatin and gemcitabine is an active combination in malignant mesothelioma and produces symptomatic benefit in responding patie nts. J Clin Oncol 17:25-30. (C) 1999 by American Society of Clinical Oncology.