Preoperative paclitaxel plus carboplatin for patients with intermediate-risk non-small cell lung cancer

A multi-institutional phase II trial of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 225 mg/m2 over 3 hours and carboplatin dosed to an area under the concentration-time curve of 6 by the Calvert formula given preoperatively every 3 weeks for two cycles in patients with intermediate-risk non-small cell lung cancer is described. Patients must be surgical candidates with T2N0, T1-2N1, or T3N0 disease determined by a combination of surgical (mediastinum) and clinical (hilum) staging. The outcome for patients in this intermediate-risk group is significantly worse than that for T1N0 patients, but is good enough to warrant their routine consideration as surgical candidates. The conceptual framework of the study is based on a limited amount of animal data, the suggestion of benefit in several other diseases, and recent results of trials of preoperative therapy for patients with stage IIIA non-small cell lung cancer who also appear to demonstrate clinical benefit.