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

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.