Gemcitabine and epirubicin in patients with malignant pleural mesothelioma (MPM): A North Central Cancer Treatment Group phase II study.

7264 Background: MPM is a relentlessly progressive disease. Optimal chemotherapy for MPM is unknown, but there is preclinical evidence of cytotoxic synergy between gemcitabine (G) and epirubicin (E) that provides a rationale for studying this combination in MPM.,Pts received 3-week cycles (for a max of 6 cycles) of GEMZAR 750 mg/m IV infusion (over 30 minutes) on d1, d8 and EPIRUB 70 mg/m (IV push into free flowing IV of NS) on d1. Planned accrual was 41 pts, where 8 of 41 with a confirmed tumor response was evidence of promising activity.,45 eligible pts (35 M, 39/6 ECOG PS of 0-1/2) were enrolled in 20 months (mos) from 08/02-04/04. Median age was 67 years (range 38-85). 20% of pts had prior chemo; 69% had epitheliod histology; and 64% had IMIG stage 4 disease. 45 of 46 pts were evaluable for response and adverse events (AEs). Pts received a median of 4 cycles (range 1-6). 4 confirmed responses were observed (4 PR/0 CR), for a confirmed response rate of 9% (95% CI: 4%-30%). 34 pts have progressed and 33 have died, with a median follow-up of 5.2 mos (range 1.8-7.5). Median time to progression was 4.4 mos (95% CI: 2.7-5.6), and the median survival was 5.7 mos (95% CI: 4.7-8.6). 27 patients (60%) experienced at least one grade 4+ AE, with 4 pts having a grade 5 AE. Gr. 5 AEs included: pneumonitis (possibly related to Rx), hypoxia (possibly related to Rx), ischemia/infarction (not related to Rx), and cardiovascular (not related to Rx). Common Gr. 3-4 AEs included (pts): neutropenia (32), leukopenia (24), dyspnea (13), fatigue (10), and thrombocytopenia (9).,Gemcitabine and epirubicin as given in this trial had limited activity and did not meet our predefined criteria for success. Supported by NCCTG Grant CA25224. No significant financial relationships to disclose.