title: Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study.
abstract: OBJECTIVE
  A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m(2) days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial.
  
  
  RESULTS
  Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4).
  
  
  CONCLUSIONS
  Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.
authors: Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy. cgridelli@sirio-oncology.it
authors: Cesare
authors: C
authors: Gridelli
authors: Antonio
authors: A
authors: Rossi
authors: Emiddio
authors: E
authors: Barletta
authors: Nicola
authors: N
authors: Panza
authors: Luigi
authors: L
authors: Brancaccio
authors: Riccardo
authors: R
authors: Cioffi
authors: Tonino
authors: T
authors: Pedicini
authors: Giovanni Pietro
authors: GP
authors: Ianniello
authors: Elena
authors: E
authors: Piazza
authors: Nestore
authors: N
authors: Rossi
authors: Rosario Vincenzo
authors: RV
authors: Iaffaioli
authors: Paolo
authors: P
authors: Maione
authors: Massimo
authors: M
authors: Di Maio
authors: Ciro
authors: C
authors: Gallo
authors: Francesco
authors: F
authors: Perrone
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine