Randomized phase II study of two schedules of carboplatin and gemcitabine for stage IIIB and IV advanced non-small cell lung cancer (JACCRO LC-01 study)

Chemotherapy. 2011;57(4):357-62. doi: 10.1159/000330481. Epub 2011 Sep 6.

Abstract

Background: Gemcitabine combined with carboplatin (CG) is one of the regimens used widely for advanced non-small cell lung cancer. Improvement in its toxicity may result in good clinical outcomes.

Methods: A new schedule of gemcitabine and carboplatin (CG8) was compared with the standard one (CG1). Both are 3-weekly regimens, but carboplatin is administered on day 1 in CG1 and on day 8 in CG8.

Results: The response rate of CG1 was 29.2%, which was higher than that of CG8 (22.2%). Median survival times in CG1 and CG8 were 348 and 455.5 days, respectively. Grade ≥3 leukopenia, thrombocytopenia and anemia were observed in 56.0, 72.0 and 36.0% of patients with CG1 and in 33.3, 25.9 and 14.8% of patients with CG8, respectively. Whereas grade ≥3 elevation of asparatate aminotransferase, alanine aminotransferase and alkaline phosphatase was seen mainly in CG8, grade ≥3 non-hematologic toxicities such as febrile neutropenia, infection, appetite loss, diarrhea and eruption were observed only in CG1.

Conclusion: CG1 is superior in response rate, but CG8 shows improved toxicities and a tendency of prolonged survival.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Alanine Transaminase / blood
  • Alkaline Phosphatase / blood
  • Anemia / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols
  • Aspartate Aminotransferases / blood
  • Carboplatin / administration & dosage*
  • Carboplatin / adverse effects
  • Carboplatin / therapeutic use
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Diarrhea / chemically induced
  • Drug Administration Schedule
  • Female
  • Gemcitabine
  • Humans
  • Leukopenia / chemically induced
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neutropenia / chemically induced
  • Thrombocytopenia / chemically induced

Substances

  • Deoxycytidine
  • Carboplatin
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase
  • Gemcitabine