title: Carboplatin plus vinorelbine, a new well-tolerated and active regimen for the treatment of extensive-stage small-cell lung cancer: a phase II study. Gruppo Oncologico Centro-Sud-Isole.
abstract: OBJECTIVE
  To evaluate the activity and toxicity of the combination carboplatin plus vinorelbine in extensive small-cell lung cancer (SCLC).
  
  
  METHODS
  A two-stage optimal Simon design was applied. To proceed after the first stage, responses from 8 of 11 treated patients were needed. Overall, 31 responses of 43 treated patients were required to comply with the design parameters. Inclusion criteria were cytohistologically proven SCLC; extensive disease; age of 70 years or less; Eastern Cooperative Oncology group performance status (ps ECOG) of 2 or less; normal cardiac, hepatic, renal, and bone marrow functions; and no previous chemotherapy. Patients were staged by physical examination; biochemistry; chest radiograph; brain, thoracic; and abdominal computed tomographic (CT) scans, and bone scan. All patients received carboplatin 300 mg/m2 intravenously (i.v.) day 1 and vinorelbine 25 mg/m2 i.v. on days 1 and 8 every 4 weeks up to six cycles. Of 43 enrolled patients, 36 were men and 7 women, with a median age of 63 years (range, 46 to 70 years).
  
  
  RESULTS
  All patients were assessable for response and toxicity. We observed 32 (74%) objective responses, with 23% complete responses. Median time to progression was 25 weeks, and median survival was 37 weeks. The treatment was well tolerated. The reported main toxicities were leukopenia grade 3 in 21% of patients and grade 4 in 5% of patients, anemia grade 2 in 11% of patients and grade 3 in 2% of patients, and thrombocytopenia grade 3 in 7% of patients.
  
  
  CONCLUSIONS
  These data show that carboplatin plus vinorelbine is an active and well-tolerated regimen in extensive SCLC. In view of the activity, low toxicity, and ease of administration, it may be a reasonable alternative to more toxic cisplatin-containing regimens.
authors.affiliation: Divisione di Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: G P
authors.initials: GP
authors.lastname: Ianniello
authors.forename: L
authors.initials: L
authors.lastname: Brancaccio
authors.forename: R V
authors.initials: RV
authors.lastname: Iaffaioli
authors.forename: C
authors.initials: C
authors.lastname: Curcio
authors.forename: M
authors.initials: M
authors.lastname: D'Aprile
authors.forename: R
authors.initials: R
authors.lastname: Cioffi
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
authors.forename: A
authors.initials: A
authors.lastname: Rossi
authors.forename: G
authors.initials: G
authors.lastname: Palazzolo
authors.forename: E
authors.initials: E
authors.lastname: Veltri
authors.forename: M
authors.initials: M
authors.lastname: Pergola
authors.forename: S
authors.initials: S
authors.lastname: De Placido
authors.forename: C
authors.initials: C
authors.lastname: Gallo
authors.forename: S
authors.initials: S
authors.lastname: Monfardini
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine