Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 7192. Link
A. J. Wozniak, P. Janne, C. P. Belani, M. L. Keohan, H. Ross, J. Polikoff, D. Mintzer, C. Obasaju; Wayne State University, Detroit, MI; Dana Farber Cancer Institute, Boston, MA; University of Pittsburgh Cancer Institute, Pittsburgh, PA; Columbia-Presbyterian Medical Center, New York, NY; Oregon Health Sciences University, Portland, OR; Kaiser Hospital San Diego, San Diego, CA; Pennsylvania Hospital, Philadelphia, PA; Lilly Oncology, Indianapolis, IN
Background: The high efficacy rates of pemetrexed in combination with cisplatin in the treatment of MPM demonstrated in a Phase 3 trial has led to a strong demand for patient access to pemetrexed prior to regulatory approval. The Eli Lilly and Company EAP was opened to provide pemetrexed to all prospective patients. This non-randomized, open-label study was designed to gather additional efficacy and safety data of pemetrexed alone or in combination with cisplatin.
Methods: Treatment in chemonaive patients consisted of pemetrexed 500mg/m2 in combination with cisplatin 75mg/m2. It was administered once every 21 days for a maximum of 6 cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis.
Results: To date, 476 patients (400 M/74 F) have been treated in the program. Median age was 70.0 (range = 23.0 to 86.0). Response data available from 295 patients show 10 (3.4%) with CR, 42 (14.2%) with PR, 129 (43.7%) with SD and 114 (38.6%) with PD. SAEs irrespective of causality reported by number of events were; neutropenia (7), neutropenic fever (4), anemia (12) and thrombocytopenia (7), nausea (44), vomiting (41), diarrhea (21), renal impairment (21), atrial fibrillation (13), asthenia (13), cellulites (9), constipation (8), dysphagia (4), rash (4), neuropathy (2) and mucositis (2).
Conclusions: The clinical benefit rate of 61.7% supports that this doublet is effective in the treatment of MPM. The modest number of SAE events reported suggests a favorable toxicity profile.