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Medline ® Abstract for Reference 24

of 'Systemic treatment for unresectable malignant pleural mesothelioma'

Phase II trial of pemetrexed and gemcitabine in chemotherapy-naive malignant pleural mesothelioma.
Jänne PA, Simon GR, Langer CJ, Taub RN, Dowlati A, Fidias P, Monberg M, Obasaju C, Kindler H
J Clin Oncol. 2008;26(9):1465.
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/m(2) on days 1 and 8, with pemetrexed 500 mg/m(2) on day 8, and cohort 2 received gemcitabine 1,250 mg/m(2) on days 1 and 8, with pemetrexed 500 mg/m(2) on day 1. Cycles were repeated every 21 days; all patients were supplemented with folic acid and vitamin B(12) 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.
Dana Farber Cancer Institute, Lowe Center for Thoracic Oncology, 44 Binney St, Dana D820A, Boston, MA 02115, USA. pjanne@partners.org