Carboplatin plus vinorelbine, a new well-tolerated and active regimen for the treatment of extensive-stage small-cell lung cancer: A phase II study

Cesare Gridelli, Francesco Perrone, Giovanni P. Ianniello, Luigi Brancaccio, Rosario Vincenzo laffaioli, Carlo Curcio, Modesto D'Aprile, Riccardo Cioffi, Silvio Cigolari, Antonio Rossi, Giovanni Palazzolo, Enzo Veltri, Mario Pergola, Sabino De Placido, Ciro Gallo, Silvio Monfardini, Angelo Raffaele Bianco

Research output: Contribution to journalArticlepeer-review


Purpose: To evaluate the activity and toxicity of the combination carboplatin plus vinorelbine in extensive small-cell lung cancer (SCLC). Patients and 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 morrow 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 (IV) day 1 and vinorelbine 25 mg/m2 IV 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)1414-1419
Number of pages6
JournalJournal of Clinical Oncology
Issue number4
Publication statusPublished - Apr 1998

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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