Phase II study of the combination of vinorelbine and cisplatin in advanced non-small-cell lung cancer

Cancer Chemother Pharmacol. 2004 Feb;53(2):129-32. doi: 10.1007/s00280-003-0707-8. Epub 2003 Nov 7.

Abstract

Purpose: To evaluate the efficacy and safety of combination chemotherapy with cisplatin and vinorelbine for the treatment of previously untreated patients with advanced non-small-cell lung cancer (NSCLC).

Patients and methods: Eligible patients were those with measurable NSCLC. They were treated with two or more cycles of a regimen consisting of vinorelbine 25 mg/m(2) on days 1 and 8 and cisplatin 80 mg/m(2) on day 1 every 3 weeks.

Results: A total of 45 patients were enrolled. The response rate was 51.1% (23/45; 95% CI 35.8% to 66.3%). The median survival was 286 days with a 1-year survival rate of 40%. The median number of treatment cycles was 2. The major toxic effect was neutropenia of grade 3 or higher (84%). Nonhematological toxicities, including vomiting (62%), were mild (grade 2 or less). There were no treatment-related deaths.

Conclusion: The high response rate and good tolerability proved this combination therapy to be a safe and effective treatment for advanced NSCLC.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Cisplatin / administration & dosage
  • Female
  • Humans
  • Leukopenia / chemically induced
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Survival Rate
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives*
  • Vinorelbine

Substances

  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Vinblastine
  • Cisplatin
  • Vinorelbine