Although docetaxel monotherapy has shown clinical benefits for previously treated patients with advanced non-small cell lung cancer (NSCLC), the efficacy of salvage docetaxel chemotherapy for elderly patients or patients with poor performance status (PS) is controversial. Therefore, we conducted a phase II trial to evaluate the safety and efficacy of weekly low-dose docetaxel monotherapy in these patients. Forty NSCLC patients, who had been previously treated with one or more chemotherapy regimens, received docetaxel at a dose of 25 mg/m(2) weekly on days 1, 8, and 15 of a 28-day cycle. All patients were >or=65 yr or had a PS of grade 2 in the cases of <65 yr. Weekly low-dose docetaxel was well-tolerated. Grade 3/4 non-hematologic toxicities were rare; fatigue in 3 patients (8%), anorexia in 3 patients (8%) and stomatitis in 2 patients (5%). Grade 3/4 neutropenia was noted in only one patient (3%). By intent-to-treat analysis, nine patients (23%) had partial responses and eleven patients (28%) demonstrated stable disease. The median progression-free survival and overall survival were 9.9 weeks and 37.7 weeks, respectively. Weekly low-dose docetaxel therapy provides a reasonable alternative for NSCLC salvage treatment in pretreated elderly patients or in patients with a reduced PS.
Keywords: Aged; Carcinoma, Non-small-Cell Lung; Second-Line Therapy; Weekly Docetaxel.