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Phase II Trial of Pemetrexed and Gemcitabine in Chemotherapy-Naïve Malignant Pleural Mesothelioma

Pasi A. Jänne, George R. Simon, Corey J. Langer, Robert N. Taub, Afshin Dowlati, Panos Fidias, Matthew Monberg, Coleman Obasaju, Hedy Kindler

From the Lowe Center for Thoracic Oncology, Dana Farber Cancer Institute; Department of Medicine, Brigham and Women's Hospital; Massachusetts General Hospital, Boston, MA; H. Lee Moffitt Cancer Center, Tampa, FL; Fox Chase Cancer Center, Philadelphia, PA; Columbia University, New York, NY; University of Colorado Health Sciences Center, Denver, CO; Eli Lilly & Co, Indianapolis, IN; and the University of Chicago Medical Center, Chicago, IL

Corresponding author: Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute, Lowe Center for Thoracic Oncology, 44 Binney St, Dana D820A, Boston, MA 02115; e-mail: pjanne{at}partners.org

Purpose Pemetrexed and gemcitabine have single-agent activity in malignant pleural mesothelioma (MPM). The combination of pemetrexed/gemcitabine has not previously been studied in MPM to our knowledge.

Patients and Methods Patients with histologic or cytologic diagnosis of MPM were included. Cohort 1 received gemcitabine 1,250 mg/m² on days 1 and 8, with pemetrexed 500 mg/m² on day 8, and cohort 2 received gemcitabine 1,250 mg/m² on days 1 and 8, with pemetrexed 500 mg/m² on day 1. Cycles were repeated every 21 days; all patients were supplemented with folic acid and vitamin B₁₂ and received dexamethasone.

Results One hundred eight patients (cohort 1, n = 56; cohort 2, n = 52) with pleural mesothelioma were enrolled. Among assessable patients, response rate was 26.0% in cohort 1 and 17.1% in cohort 2. Median time to disease progression was 4.34 months for cohort 1 and 7.43 months for cohort 2. Median survival was 8.08 months for cohort 1 (1-year survival = 31.14%) and 10.12 months for cohort 2 (1-year survival = 45.80%). In cohorts 1 and 2, incidence of grade 4 neutropenia was 25.0% and 29.4%, grade 4 thrombocytopenia was 14.3% and 3.9%, grade 3 or 4 anemia was 5.4% and 5.9%, and grade 3 or 4 fatigue was 23.2% and 15.7%, respectively.

Conclusion The combination of pemetrexed and gemcitabine resulted in moderate clinical activity in MPM. However, the median survival times are similar to those with single-agent pemetrexed and inferior to outcomes observed with cisplatin in combination with an antifolate.

Sponsored by Eli Lilly & Co.

Part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA; and the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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