Gemcitabine, paclitaxel, and carboplatin for advanced non-small-cell lung cancer

The purpose of this study was to evaluate the combination of gemcitabine (Gemzar), paclitaxel (Taxol), and carboplatin (Paraplatin) in patients with advanced non-small-cell lung cancer (NSCLC). Previously untreated patients with stage IIIB or IV NSCLC were included in this trial. A total of 69 patients from the phase II portion and 8 patients from the phase I portion were treated with gemcitabine 1,000 mg/m2 intravenously (i.v.) on days 1 and 8; paclitaxel 200 mg/m2 as a 1-hour infusion on day 1; and carboplatin at an area under the curve (AUC) dose of 5.0 i.v. on day 1. Treatment courses were repeated every 21 days. The phase II component of the study was completed at 13 community-based practices within the Minnie Pearl Cancer Research Network. Of the 71 fully evaluable patients, 34 had an objective response, for an overall response rate of 48%; 2 patients showed complete responses and 32 patients had partial responses. A total of 25 (35%) patients were stable and 12 (17%) patients progressed. The median response duration was 6 months (range 3 to 14 months), and the median survival was 9.9 months, with a 1-year survival of 47% and a 2-year survival of 21%. These results show that the combination of gemcitabine, paclitaxel, and carboplatin is safe and effective; however, randomized phase III studies are needed to prove this regimen is superior to other regimens.