High-dose carboplatin plus paclitaxel with granulocyte colony-stimulating factor and peripheral blood stem-cell...

The treatment of non-small-cell lung cancer (NSCLC) has recently undergone major changes due to the availability of new drugs that demonstrate substantial activity in NSCLC patients. Although cure for the majority of stage III NSCLC and effectively all stage IV disease patients remains rare, a number of compounds, including carboplatin, paclitaxel, docetaxel, irinotecan, and vinorelbine, have proved useful in the treatment of these patients. Together with a number of phase II trials, phase I trials utilizing escalating doses of carboplatin and paclitaxel with growth factor or growth factor and blood stem-cell support have shown that substantial increases in dose intensity can be achieved. These studies in small numbers of patients have demonstrated that these regimens have encouraging activity and have formed the basis of a Cancer and Leukemia Group B (CALGB) phase II pilot study. This study will utilize two cycles of high-dose carboplatin and Taxol given at an AUC dose of 18 and a 24-h infusion dose of 250 mg/m2, respectively, with growth factor and stem-cell support to treat stage III NSCLC patients. Patients will also receive multimodality therapy, including radiation with or without surgery. It is hoped that this effort to intensify treatment in patients with limited-stage disease will improve survival and benefit the large number of patients with stage III tumors. This paper outlines the phase I results that formed the basis of the CALGB trial and reviews several recent reports of phase II or phase III trials of single-agent and combination regimens for NSCLC.