title: Oral vinorelbine and cisplatin with concurrent radiotherapy after induction chemotherapy with cisplatin and docetaxel for patients with locally advanced non-small cell lung cancer: the GFPC 05-03 study.
abstract: BACKGROUND
  The aim of this multicenter phase II trial was to evaluate the combination of oral vinorelbine and cisplatin with radiotherapy (RT) after cisplatin-docetaxel induction chemotherapy (CT) in patients with locally advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with previously untreated, inoperable, histologically or cytologically confirmed stage IIIA or IIIB NSCLC, with performance status ≤ 1 and weight loss ≤ 10% received two cycles of induction CT with cisplatin (75 mg/m) and docetaxel (75 mg/m) every 3 weeks. Patients with a tumor response or stabilization continued to receive cisplatin (80 mg/m) and oral vinorelbine (40 mg/m) on days 1 and 8 for two cycles, with concomitant thoracic RT (2 Gy/d, 5 d/wk, and total dose 66 Gy).
  
  
  RESULTS
  Fifty-six patients were enrolled. All patients (n = 38) who received CT-RT were assessable for the tumor response. There were no complete responses. In the intent-to-treat analysis, the response rates were 32.1% after induction CT and 41.1% after CT-RT. The median progression-free and overall survival times were 9.2 months (95% confidence interval: 7-14) and 20.8 months (95% confidence interval: 13.7-24.1), respectively. Adverse effects of RT-CT were grades 3 to 4 neutropenia (four patients) and grade 3 esophageal toxicity (one patient). No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  The oral vinorelbine-cisplatin combination with concurrent RT is feasible and has a favorable risk-benefit ratio in stage IIIA/IIIB NSCLC.
authors.affiliation: Institut de Cancérologie et Hématologie, Centre Hospitalier Universitaire Morvan, Brest, France. renaud.descourt@chu-brest.fr
authors.forename: Renaud
authors.initials: R
authors.lastname: Descourt
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenegre
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlesi
authors.forename: Herve
authors.initials: H
authors.lastname: Lena
authors.forename: Pierre
authors.initials: P
authors.lastname: Fournel
authors.forename: Lionel
authors.initials: L
authors.lastname: Falchero
authors.forename: Henri
authors.initials: H
authors.lastname: Berard
authors.forename: Jose
authors.initials: J
authors.lastname: Hureaux
authors.forename: Herve
authors.initials: H
authors.lastname: Le Caer
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Chavaillon
authors.forename: Laurence
authors.initials: L
authors.lastname: Geriniere
authors.forename: Isabelle
authors.initials: I
authors.lastname: Monnet
authors.forename: Stéphane
authors.initials: S
authors.lastname: Chouabe
authors.forename: Gilles
authors.initials: G
authors.lastname: Robinet
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000473:pathology / Q000628:therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D012074:Remission Induction; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine