Phase II study of nedaplatin and docetaxel in patients with advanced squamous cell carcinoma of the lung

Ann Oncol. 2011 Nov;22(11):2471-2475. doi: 10.1093/annonc/mdq781. Epub 2011 Mar 4.

Abstract

Background: The treatment of squamous cell carcinoma of the lung has not advanced sufficiently. Nedaplatin is a second-generation platinum compound that is active against squamous cell carcinoma of the lung, with a response rate of ~40%.

Patients and methods: Eligible patients with advanced squamous cell carcinoma of the lung were treated with docetaxel (60 mg/m(2)) and nedaplatin (100 mg/m(2)) administered i.v. on day 1; these doses were determined in an earlier phase I study. The treatment cycles were repeated every 3 weeks. The primary end point was the response rate, and the secondary end points were overall survival, progression-free survival, and toxicity.

Results: Twenty-one patients were enrolled. Eighteen of the patients were male, and the median age was 67 years. The objective response rate was 62%. The median progression-free survival time was 7.4 months. The median survival time was 16.1 months, and the 1-year survival rate was 66.7% (95% confidence interval 46.5% to 86.8%). The most common adverse event was neutropenia (grade 3/4, 86%). Non-hematological toxic effects were relatively mild. One patient died of sepsis.

Conclusions: Combination chemotherapy with nedaplatin and docetaxel is highly active and has an acceptable toxicity. Further investigation of nedaplatin and docetaxel is warranted.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Disease-Free Survival
  • Docetaxel
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Survival Rate
  • Taxoids / administration & dosage
  • Taxoids / adverse effects

Substances

  • Organoplatinum Compounds
  • Taxoids
  • Docetaxel
  • nedaplatin