Randomized phase III study of docetaxel (D) versus vinorelbine (V) for elderly patients (pts) with advanced non-small cell lung cancer (NSCLC): Results of a West Japan Thoracic Oncology Group trial (WJTOG9904)

Abstract

7009 Background: Monotherapy of V is currently the standard treatment for elderly pts with advanced NSCLC based on improved survival and quality of life (QOL). D has also shown promising results against elderly pts in our previous phase II study. We conducted a randomized phase III trial to evaluate whether D provided better OS than V in elderly pts with advanced NSCLC. Methods: Eligibility included more than 70 years old, histologically or cytologically proven NSCLC, stage IIIB or IV, chemotherapy naive, and performance status (PS) of 0 to 2. Pts were randomized to receive either D (60 mg/m2, day 1) or V (25 mg/m2, days 1, 8), repeated every 21 days over four cycles. Results: From May ’00 to Sep. ’03, 182 pts were enrolled; one was ineligible due to double entry. Median age was 76 years (range 70–86 years), and 75.7% were male. Sixty-seven pts (37.0%) were stage IIIB and 96.1% were good PS of 0–1. Baseline characteristics in each treatment arm were well balanced with regard to age, gender, PS, histology, weight loss, stage, and smoking history. Median numbers of treatment cycles were four (range 1–9) and three (range 1–15) in D and V arms, respectively. Major toxicity was neutropenia in both arms. Grade 3–4 neutropenia developed 83.0% and 69.2% in D and V, respectively, which had statistical significance (p=0.031). Toxicity was generally mild and well tolerated in each arm. Response rate were 22.7% and 9.9% in D and V, respectively, which reached statistical significance (p=0.019). OS was significantly prolonged for D (median survival time (MST); 13.9 months, 1-year survival rate; 59.2%) compared with for V (MST; 9.9 months, 1-year survival rate; 36.5%) (Wilcoxon test; p=0.038). The statistically better progression free survival (PFS) was also observed in D arm (Wilcoxon test; p<0.001). In addition, QOL study showed that two (appetite and fatigue) out of 8 items as a disease related symptom were improved in D arm as compared with V arm (appetite; p=0.04, fatigue; p=0.01). Conclusion: This study demonstrated that monotherapy of D provided better OS than V with improvement of disease related symptom in elderly pts with advanced NSCLC. No significant financial relationships to disclose.