title: A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer.
abstract: BACKGROUND
  Concomitant platinum-based chemotherapy and radiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced stage III non-small cell lung cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of fractionated oral vinorelbine with cisplatin as induction CT followed by CT-RT.
  
  
  METHODS
  Patients with stage III NSCLC received 2 induction cycles of intravenous vinorelbine 25 mg/m2 and cisplatin 80 mg/m2 on day 1 and oral vinorelbine 60 mg/m2 on day 8. Responding patients received 2 more cycles of cisplatin 80 mg/m2 on day 1 and oral vinorelbine 20 mg on days 1, 3 and 5 concomitantly with radiotherapy 2 Gy daily, 5 days/week for a total of 66 Gy.
  
  
  RESULTS
  Seventy patients, median age 61 years, were enrolled. Overall response rate (ORR) was 50.0%; Disease Control Rate was 81.42%. Median PFS was 14.58 months [95% CI, 10.97-18.75]. Median OS was 17.08 months [95% CI, 13.57-29.57]. One-year and 2-year survival rates were 68.6% [95% CI, 57.7-79.4] and 37%. One patient had a grade 3 pulmonary radiation injury and 26.5% had graded 1/2 esophagitis.
  
  
  CONCLUSIONS
  In non-operable IIIA-IIIB NSCLC, the combination oral vinorelbine (fractionated fixed dose) plus cisplatin, during concomitant CT-RT, could offer a well-tolerated option, with comparable activity to I.V. vinorelbine-based chemoradiotherapy regimens.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01839032.
authors.forename: Delphine
authors.initials: D
authors.lastname: Lerouge
authors.forename: Alain
authors.initials: A
authors.lastname: Rivière
authors.forename: Eric
authors.initials: E
authors.lastname: Dansin
authors.forename: Christos
authors.initials: C
authors.lastname: Chouaid
authors.forename: Cécile
authors.initials: C
authors.lastname: Dujon
authors.forename: Roland
authors.initials: R
authors.lastname: Schott
authors.forename: Armelle
authors.initials: A
authors.lastname: Lavole
authors.forename: Vincent
authors.initials: V
authors.lastname: Le Pennec
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Fabre
authors.forename: Jacky
authors.initials: J
authors.lastname: Crequit
authors.forename: Francis
authors.initials: F
authors.lastname: Martin
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Dehette
authors.forename: Pierre
authors.initials: P
authors.lastname: Fournel
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Precheur-Agulhon
authors.forename: Eric
authors.initials: E
authors.lastname: Lartigau
authors.affiliation: Deparment of Pneumology and Thoracic Oncology, Centre Hospitalier Universitaire de Caen, France. zalcman-g@chu-caen.fr.
authors.forename: Gérard
authors.initials: G
authors.lastname: Zalcman
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D009367:Neoplasm Staging; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine