title: Full-dose cisplatin and oral vinorelbine concomitant with radiotherapy in unresectable stage III non-small cell lung cancer: a multi-center phase II study.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicities of combination of cisplatin and oral vinorelbine given at full doses concomitantly with radiotherapy for non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Untreated patients with locally advanced inoperable stage IIIA/IIIB NSCLC were eligible for study inclusion. Treatment consisted of four cycles of oral vinorelbine at 60 mg/m(2) on days 1 and 8, and cisplatin at 80 mg/m(2) on day 1 every three weeks plus radiotherapy 66 Gy starting on day 1 of cycle 2 in fractions of 2 Gy/day over 6.5 weeks.
  
  
  RESULTS
  Forty-eight patients were enrolled. Their characteristics included: median age 61 years; female gender 10%; stage IIIA 46% and IIIB 54%; squamous carcinoma 63%, performance status PS0 42%; PS1 58%. Selected grade 3/4 toxicities were as follows: neutropenia 33%, concomitant febrile neutropenia 14.6%, anemia 12.5%, thrombocytopenia 16.6%, and esophagitis 12.5%. Two treatment-related deaths were reported, both during cycle 1. Radiotherapy was administered to 87.5% of patients; 7.1% of them received less than 60 Gy and 23.8% had delays due to adverse events. The objective response rate was 77.3%, with two complete responses and 32 partial responses. With a median follow-up of 19 months, the median progression-free survival was 12 months, and the 1-year overall survival rate was 72.3%. Median overall survival was 27.8 months, although the 95% confidence interval has not yet been achieved.
  
  
  CONCLUSIONS
  Full doses of cisplatin and oral vinorelbine can be administered with concomitant radiotherapy, with good efficacy and an acceptable safety profile for patients with stage IIIA/IIIB NSCLC.
authors.affiliation: Department of Medical Oncology, La Fe University Hospital, Bulevar Sur s/n. 46026, Valencia, Spain. juan_osc@gva.es.
authors.forename: Oscar
authors.initials: O
authors.lastname: Juan
authors.forename: Alfredo
authors.initials: A
authors.lastname: Sánchez-Hernández
authors.forename: Sergio
authors.initials: S
authors.lastname: Vázquez
authors.forename: Joaquín
authors.initials: J
authors.lastname: Casal
authors.forename: José Luis
authors.initials: JL
authors.lastname: Firvida
authors.forename: Francisco
authors.initials: F
authors.lastname: Aparisi
authors.forename: José
authors.initials: J
authors.lastname: Muñoz
authors.forename: José
authors.initials: J
authors.lastname: García-Sánchez
authors.forename: Regina
authors.initials: R
authors.lastname: Gironés
authors.forename: Martín
authors.initials: M
authors.lastname: Lázaro
authors.forename: Vicente
authors.initials: V
authors.lastname: Giner
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012074:Remission Induction; D012307:Risk Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine
keywords: Oral vinorelbine; cisplatin phase II study; concomitant radiotherapy; locally advanced; lung cancer