Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: results of a prospective, randomized phase III trial

Purpose and methods: Docetaxel second-line chemotherapy for non-small-cell lung cancer (NSCLC) has previously been shown to improve survival significantly compared with best supportive care (BSC). This multicenter phase III trial prospectively investigated quality of life QOL) in NSCLC patients treated with either second-line docetaxel or BSC. Patients with stage IIIB/IV NSCLC, performance status less than or equal to2, and adequate biochemistry and hematology were eligible if they had received greater than or equal to1 platinum-based chemotherapy regimens. Patients were randomized to docetaxel 100 mg/m(2) (n = 49) or, after protocol amendment, to docetaxel 75 mg/m(2) (n = 55), or to BSC (n = 100), with Lung Cancer Symptom Scale (LCSS) and/or QLQ-C30 (with LC13 module) assessment every 3 weeks. Results: Longitudinal analysis including all available assessments over time showed statistically significant differences in patient-rated pain scores in favor of docetaxel overall (P = 0.005) or docetaxel 100 mg/m(2) (P = 0.003) compared to BSC. Trends in favor of docetaxel were noted on observer-rated scales for fatigue and pain for all docetaxel patients, and for total LCSS score, appetite and fatigue with docetaxel 100 mg/m(2). Changes from baseline to the last available assessment (end point) showed significantly (P < 0.05) less deterioration in LCSS pain score in patients with docetaxel. (75 and 100 mg/m(2) combined) than with BSC. An improved mean pain score with docetaxel 100 mg/m(2) was contrasted with a deterioration in mean pain score with BSC (P < 0.01). There was also significantly less deterioration in the global QOL today score with docetaxel 100 mg/m(2) (P < 0.01). Similar trends were recorded with QLQ-C30 assessments. Conclusions: Second-tine docetaxel therapy for advanced NSCLC significantly improves survival with a trend towards less deterioration in QOL compared with BSC. (C) 2003 Elsevier Ireland Ltd. All rights reserved.