A finalized phase II report of pemetrexed (P) plus gemcitabine (G) as front-line chemotherapy for patients with peritoneal mesothelioma (PM)

2050 Background: P in combination with cisplatin is approved for the treatment of malignant pleural mesothelioma. In an expanded access program, P ± cisplatin was shown to have activity in PM. P plus G are synergistic in preclinical models, but the activity of this combination in PM is unknown. The primary objective of this study was to determine time to disease progression in pts with PM receiving P plus G. Methods: Twenty pts were accrued. Treatment consisted of G 1250 mg/m2/30 minutes on D 1 and 8, and P 500mg/m2 /10 minutes on D 8, immediately before G. Treatment was repeated every 21 days for a total of 6 cycles or until progressive disease. All received folic acid, vitamin B12 and steroid prophylaxis. Results: Median age was 67.5 years (range: 46–79). Histology was epithelial:other = 14:6, M:F = 15:5, and ECOG PS 0:1:2 = 9:6:4. A total of 93 cycles (median 6) were administered. Patient-specific Grade 3/4 hematologic toxicity included neutropenia (60.0%), febrile neutopenia (10%; including one toxic ...