Phase II trial of pemetrexed and gemcitabine in chemotherapy-naive malignant pleural mesothelioma

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.

1: J Clin Oncol. 2008 Mar 20;26(9):1465-71, Jänne PA, Simon GR, Langer CJ, Taub RN, Dowlati A, Fidias P, Monberg M, Obasaju C, Kindler H.

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

PMID: 18349397 [PubMed – in process]

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