Malignant Pleural Mesothelioma: Results of a phase II Trial of Combined Chemotherapy.
S. Kasseyet, C. BOUTIN, pH. ASTOUL, C. FRENAY
1 Hopital la Conception - 13005 Marseilles France
We conducted a prospective phase II trial of a combined four drugs chemotherapy PMFE for patients with unresectable mesothelioma: Cisplatin 60 mg\m2 dat 1, 5 Fluorouracil 60 mg day 1 -> 4, Elvorin 100 mg\m2 days 1 ->, C Mitomycin 10 mg day 3, Etoposide 100 mg\m2 IV days 1 -> 3 or oral Etoposide 50 mg\day 1 -> 21; one cycle every 28 days. Tumour response was evaluated by chest CT Scan 15 days after the fourth cycle.
55 patients were enrolled and 50 were eligible for response evaluation. Characteristics of the patients were: male\female ration 4,5/; mean age 60, 14+9,96; asbestose exposure 72%; majority of advanced diseases (Stage IIA 88%) and epithelial type (74%). A total of 236 cycles were administered. The treatment was relatively well tolerated and major toxicity was hematologic: anemia 30%; neutropenia 24%; there were 2 probable mitomycin-induced pneumonitis; other toxicities > grade 2 included nausea and asthenia. No treatment-related death occured. The objective response rate was 34% (17/50 partial response, no CR) with a mean response duration of 11,74 months.
The overall median survival time was 16 months (95% confidence interval 9,89 - 21,51). There was a significant survival difference comparing the group of partial responders versus the group of stabilised and progressive patients (p 0,0417). With a 34% objective response rate, PMFE is an interesting regimen that deserves further consideration, e.g. in combined multimodal therapy.