Clinical study of LY231514 (pemetrexed) in combination with cisplatin in patients with malignant pleural mesothelioma to determine safety

Abstract

Objective. To examine safety and efficacy of combination therapy with LY231514 (pemetrexed) plus cisplatin in malignant pleural mesothelioma. Methods. Patients aged between 20 and 75 years who were not candidates for surgery, who were given histological diagnoses of malignant pleural mesothelioma, had received no prior systemic chemotherapy, with a performance status (PS) of 0 or 1, and who had normal major organ function were enrolled. On day 1 of a 21-day cycle, patients received intravenous infusion of 500 mg/m2 pemetrexed, followed by intravenous infusion of 75 mg/m2 cisplatin, concomitantly with vitamin preparations. Results. Ten men and two women with a mean age of 63 years (range 50 to 73) were analyzed. The histological subtype was epithelioid in 8 patients, sarcomatoid in 2 patients, and biphasic in 2 patients. Ten patients had stage III/IV disease. Seven patients had a history of asbestos exposure. Hematological toxicities of grade 3 or more included decreased white blood cell count in 1 patient (8.3%) and decreased neutrophil count in 1 patient (8.3%), decreased lymphocyte count in 2 patients (16.7%) and decreased red blood cell count in 2 patients (16.7%), decreased hemoglobin in 4 patients (33.3%), and decreased platelet count in 2 patients (16.7%). Pneumonia was observed in 1 patient (8.3%). Common non-hematological toxicities included gastrointestinal toxicities, such as nausea, vomiting, and anorexia. The response rate was 25.0%. Conclusion. Safety of this combination therapy was confirmed in patients with malignant pleural mesothelioma. © 2009 The Japan Lung Cancer Society.