title: A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study).
abstract: BACKGROUND
  There is no consensus on the optimal treatment for patients with advanced non-small cell lung cancer and stable disease after cisplatin-based chemotherapy. The objective of the trial was to evaluate a switch to a different dual-agent chemotherapy.
  
  
  METHODS
  Patients with stage IV non-small cell lung cancer and stable disease after two cycles of cisplatin (P) and gemcitabine (G) (P day1 (d(1)): 75 mg/m(2), G: 1250 mg/m(2) d(1) and d(8) every 3 weeks) were randomized to receive either two further cycles of PG (arm A) or paclitaxel (100 mg/m(2) d(1), d(8), d(15)) plus gemcitabine (1250 mg/m(2) d(1) and d(8), every 4 weeks) (arm B).
  
  
  RESULTS
  Two-hundred-twenty-eight patients were enrolled between October 2003 and August 2006. After two cycles of PG, 98 patients (43%) had stable disease; 87 were randomized: 45 to arm A and 42 to arm B. The objective response rates were 15.6% (6.5-29.4) and 21.4% (10.3-36.8) in arms A and B. Overall survival after randomization was 9.6 months (7.0-13.8) in arm A and 9.3 months (7.4-13.3) in arm B. Adverse events were similar in the two arms for hematological and non hematological toxicities.
  
  
  CONCLUSIONS
  Sequential first-line chemotherapy in these patients is feasible with no difference in response rates. These results do not warrant a phase III trial.
authors.affiliation: Service de Pathologie Respiratoire, CHU, Limoges, France. alain.vergnenegre@unilim.fr
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenègre
authors.forename: Julie
authors.initials: J
authors.lastname: Tillon
authors.forename: Romain
authors.initials: R
authors.lastname: Corre
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlési
authors.forename: Henri
authors.initials: H
authors.lastname: Berard
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Vernejoux
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Caer
authors.forename: Pierre
authors.initials: P
authors.lastname: Fournel
authors.forename: Benoit
authors.initials: B
authors.lastname: Marin
authors.forename: Christos
authors.initials: C
authors.lastname: Chouaïd
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011336:Probability; D011379:Prognosis; D011788:Quality of Life; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine