title: Pemetrexed in small-cell lung cancer: background and review of the ongoing GALES pivotal trial.
abstract: Pemetrexed is a novel, multitargeted antifolate currently under development for the treatment of a number of solid tumors, including small-cell lung cancer. Pemetrexed/platinum combinations appear to compare favorably with other platinum-based doublets in terms of their efficacy and safety profile. The Global Analysis of Pemetrexed in SCLC Extensive Stage (GALES) trial is a direct comparison of pemetrexed and carboplatin with the standard first-line etoposide and carboplatin chemotherapy in extensive-disease small-cell lung cancer. This randomized, multicenter, open-label Phase III study will enroll 1820 patients in 23 countries, with the final analysis planned after 1270 deaths have occurred. An interim analysis will be conducted after 700 patients have been enrolled. The study will also use pharmacogenomic analysis to evaluate biological predictors of response, in particular to pemetrexed.
authors.affiliation: Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK. roberta_ferraldeschi@yahoo.com
authors.forename: Roberta
authors.initials: R
authors.lastname: Ferraldeschi
authors.forename: Nick
authors.initials: N
authors.lastname: Thatcher
authors.forename: Paul
authors.initials: P
authors.lastname: Lorigan
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D005047:Etoposide / Q000008:administration & dosage; D005971:Glutamates / Q000008:administration & dosage*; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008654:Mesothelioma / Q000188:drug therapy; D000068437:Pemetrexed; D016032:Randomized Controlled Trials as Topic
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D005047:Etoposide; D016190:Carboplatin