The prognosis of
malignant pleural mesothelioma is poor, with a median survival time from diagnosis of 7 to 17 months. At present there is no standardized treatment of this
neoplasia. Between July 1995 and January 1999, 22 patients with
malignant pleural mesothelioma were enrolled in our study. The characteristics of patients were: 16 men and 6 women; median age 61 years (range, 49-77 years); stage (according to Butchart): 8 patients stage I, 10 stage II, 2 stage III, and 2 stage IV; cytologic diagnosis in 5 cases and histologic diagnosis in 17 cases. The treatment consisted of
mitoxantrone 10 mg/m2 intravenous (IV) or intrapleural (IPL),
methotrexate 35 mg/m2 IV, and
mitomycin 7 mg/m2 IV on day 1 and repeated every 3 weeks, with
mitomycin in alternate cycles (
MMM regimen). One complete response (4.5%) (42 months of duration) and 6 partial responses (27.3%) (5, 5, 7, 9, 14, and 19 months of duration) were achieved; the overall response rate (ORR) was 31.8% (95% CI, 12.4-51.3%); 7 patients were stable under this treatment (31.8%). According to the pathologic type, ORR for the only epithelial type was 39.9% (95% CI, 15.2-64.8%). Median time to progression was 6 months (range, 1-22). The overall median survival time was 13.5 months (range, 1-50); the median survival time of responders significantly differed from that of nonresponders (18.0 versus 8.5 months; p = 0.017). This treatment produced a considerable clinical benefit, with improvement of
dyspnea (68.4%) and
pain (33.3%); 15 of 19 patients (78.9%) with
pleural effusion at the time of diagnosis showed an important reduction in pleural fluid during
chemotherapy. Hematologic toxicity was the main side effect; World Health Organization grade III to IV of
neutropenia,
anemia, and
thrombocytopenia were observed in 81.8%, 13.6%, and 22.7% of patients, respectively. From the data presented here, this regimen can be considered active in the treatment of
malignant pleural mesothelioma.