Induction paclitaxel/carboplatin in early stage non-small cell lung cancer

In this feasibility study, a 3-hour infusion of 225 mg/m² paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was combined with carboplatin dosed to an area under the concentration-time curve of 6 to treat patients with stage T2N0, T1-2N1, or T3N0-1 (excluding superior sulcus tumors) non-small cell lung cancer. Nineteen of a planned 80 patients have been enrolled. To assure that patients meet the study's criteria for inclusion, rigorous physical and laboratory investigations are performed before, during, and after the preoperative chemotherapy and again before the post-surgical chemotherapy. Treatment includes two cycles of preoperative chemotherapy, followed within 3 to 6 weeks with thoracotomy. Up to three cycles of postoperative chemotherapy are planned, commencing 3 to 8 weeks after surgery, as tolerated. To date, 14 patients have completed induction chemotherapy, nine of whom have undergone surgical resection. Three patients have completed postoperative chemotherapy. The study treatment has been well tolerated with no unexpected toxicities. Very preliminary results suggest that perioperative paclitaxel/carboplatin appears to be a feasible and tolerable regimen in patients with early stage non-small cell lung cancer and warrants further investigation. More mature results may provide the basis for an intergroup randomized trial comparing this regimen with surgery alone for patients with early stage disease.