title: Oxaliplatin plus vinorelbine in advanced non-small-cell lung cancer: final results of a multicenter phase II study.
abstract: BACKGROUND
  Oxaliplatin and vinorelbine are both active agents against non-small-cell lung cancer (NSCLC). In a previous phase I trial, we showed that oxaliplatin (130 mg/m2, day 1) and vinorelbine (26 mg/m2/day, days 1 and 8) can be safely combined when given every 21 days. We completed the evaluation of this new platinum-based doublet in advanced NSCLC patients in a multicenter phase II study.
  
  
  METHODS
  Twenty-eight chemotherapy-naïve patients (22 men and six women: median age 58 years, range 33-70), including 20 with stage IV disease, received this out-patient combination, with 5-hydroxytryptamine-3-receptor agonists as the only prophylactic measure.
  
  
  RESULTS
  A total of 117 cycles were given, for a median of three per patient (range 1-8). Of 26 eligible patients, nine achieved a partial response (WHO criteria), giving an objective response rate of 35% [95% confidence interval (CI) 17% to 56%]. The median progression free survival was 5.0 months (95% CI 3.1 to 6.9), median overall survival was 9.8 months (95% CI 2.2 to 17.5) and the 1-year survival rate was 37%. Neutropenia was the principal toxicity, grade 4 occurring in 11 patients (39%) and 25 cycles (22%). Four patients (14%) experienced one episode of febrile neutropenia each. Acute oxaliplatin-related neurosensory toxicity was prevalent, but was mild to moderate in the majority of patients (82%) and reversible. Grade 1/2 vomiting (65% of patients) and diarrhea (32% of patients) were easily managed.
  
  
  CONCLUSIONS
  The oxaliplatin-vinorelbine doublet is a safe and active out-patient combination. It may represent an interesting alternative in the management of patients with NSCLC, and serve as a new doublet to which other active agents could be added.
authors.affiliation: Centre Hospitalier Intercommunal, France.
authors.forename: I
authors.initials: I
authors.lastname: Monnet
authors.forename: Cremoux H
authors.initials: CH
authors.lastname: de
authors.forename: P
authors.initials: P
authors.lastname: Soulié
authors.forename: S
authors.initials: S
authors.lastname: Saltiel-Voisin
authors.forename: M
authors.initials: M
authors.lastname: Bekradda
authors.forename: J C
authors.initials: JC
authors.lastname: Saltiel
authors.forename: E
authors.initials: E
authors.lastname: Brain
authors.forename: O
authors.initials: O
authors.lastname: Rixe
authors.forename: Y
authors.initials: Y
authors.lastname: Yataghene
authors.forename: J L
authors.initials: JL
authors.lastname: Misset
authors.forename: E
authors.initials: E
authors.lastname: Cvitkovic
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D015996:Survival Rate; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077235:Vinorelbine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D014747:Vinblastine; D000077235:Vinorelbine