A multicenter phase II study of docetaxel and carboplatin combination as front-line treatment in advanced non-small cell lung cancer

Anticancer Res. 2002 Nov-Dec;22(6B):3743-8.


Background: To evaluate the efficacy and safety of docetaxel in combination with carboplatin as first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Patients and methods: Chemotherapy-naive patients with stage IIIB and IV NSCLC, age < 75 years, performance status (WHO) 0-2, were enrolled onto the study. Docetaxel was given at a dose of 100 mg/m2 over an 1-hour i.v. infusion. Carboplatin dosed to an area under the time-concentration curve (AUC) of 6 mg/ml.minute, using the Calvert's formula, was administered over a 30-minute i.v. infusion. The regimen was repeated every 3 weeks.

Results: Thirty-eight patients received a total of 155 chemotherapy cycles (median 4 cycles/patient). All patients were assessable for toxicity and 34 for response. There was one (2.6%) complete and nine (23.7%) partial responses; in an intention-to-treat analysis the overall response rate was 26.6% (95% CI: 12.3%-40.3%). The median duration of response was 7 months (range: 3-29), the median time to tumor progression 7 months (range: 3.5-31), and the median overall survival 9 months (range: 0.5-31.5). The probability for 1-year survival was 44%. Grade 3-4 neutropenia was the main hematological toxicity of the regimen occurring in 19 (50%) patients. Four (10.5%) neutropenic episodes were complicated with fever but there was no septic death. Non-hematological toxicity was generally mild.

Conclusion: These results indicate that the docetaxel-carboplatin combination is a relatively active and well-tolerated front-line regimen for the treatment of patients with advanced or metastatic NSCLC.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carboplatin / adverse effects
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Docetaxel
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Hematologic Diseases / chemically induced
  • Humans
  • Infusions, Intravenous
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Paclitaxel / analogs & derivatives*
  • Taxoids*


  • Taxoids
  • Docetaxel
  • Carboplatin
  • Paclitaxel