A phase II study directed by a clinical pathway for carboplatin and weekly paclitaxel in previously untreated patients with unresectable non-small cell lung cancer.

The objective of this phase II study was to evaluate the efficacy and safety of carboplatin and weekly paclitaxel in previously untreated patients with unresectable non-small cell lung cancer. In addition, the clinical pathway intensified the management of chemotherapy including the assessment of efficacy, safety and implementation of treatment and patient education. Patients received paclitaxel at a dose of 70 mg/m(2) on days 1, 8 and 15 and carboplatin (area under the curve of 6) on day 1 and every 28th day thereafter. Fifty-eight patients were enrolled. A median of 3 cycles (range 1-6) were administered. Twenty-eight cases showed objective responses (48.2%), including 2 complete (3.4%) and 26 partial responses (44.8%; 95% confidence interval 35.4-61.1). The median survival time was 663 days, and the 1-year survival rate was 59.9%. Nineteen patients (32.8%) had grade 3, and 4 patients (6.9%) had grade 4 neutropenia. Nine patients (15.5%) experienced > or =3 grade nonhematological toxicities. There were no treatment-related deaths due to this study. Carboplatin and weekly paclitaxel combination chemotherapy might be an alternative treatment selection in patients with unresectable non-small cell lung cancer. Copyright 2010 S. Karger AG, Basel.