title: A phase II trial of pemetrexed and gemcitabine as first line therapy for poor performance status and/or elderly patients with stage IIIB/IV non-small cell lung cancer.
abstract: Pemetrexed and gemcitabine are both active agents for the treatment of locally advanced or metastatic NSCLC. We tested a novel biweekly combination of pemetrexed and gemcitabine for tolerability and efficacy in 45 elderly and/or poor performance status patients (44% female, mean age of 72.4 years) with measurable stage IIIB/IV NSCLC. Patients received biweekly cycles of pemetrexed 500 mg/m(2) IV over 10 min followed by gemcitabine 1500 mg/m(2) IV with vitamin B12 1000 microg IM, and folic acid 1mg po daily beginning 7 days before and continuing throughout treatment (median of 4 cycles). Ten patients experienced grade 3/4 neutropenia, two had grade 3 febrile neutropenia, and two had grade 3 anemia. Patients with ECOG PS 2 appeared poorly suited for the regimen, with 61.5% completing < or = 2 cycles. The overall response rate was 17.8%, the clinical benefit rate (CR+PR+SD >24 weeks) was 26.7%, and the median progression free survival was 3.5 months. However, ECOG 0-1 patients had longer PFS and tended to have a better response rate than ECOG 2 patients.
authors.affiliation: Accelerated Community Oncology Research Network, Memphis, TN 38138, United States. jblakely@westclinic.com
authors.forename: L Johnetta
authors.initials: LJ
authors.lastname: Blakely
authors.forename: Lee
authors.initials: L
authors.lastname: Schwartzberg
authors.forename: Mark
authors.initials: M
authors.lastname: Keaton
authors.forename: Fred
authors.initials: F
authors.lastname: Schnell
authors.forename: David
authors.initials: D
authors.lastname: Henry
authors.forename: Amanda
authors.initials: A
authors.lastname: Epperson
authors.forename: Mark S
authors.initials: MS
authors.lastname: Walker
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003710:Demography; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000627:therapeutic use*; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D000068437:Pemetrexed; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D000093542:Gemcitabine