A Phase III Randomized Trial of Gemcitabine–Oxaliplatin versus Carboplatin–Paclitaxel as First-Line Therapy in Patients with Advanced Non-small Cell Lung Cancer

摘要: Purpose: This phase III study compared the efficacy and tolerability of gemcitabine oxaliplatin (GEMOX) with paclitaxel carboplatin (PCb) in chemotherapy-naive patients stage IIIB/IV non-small cell lung cancer. Patients Methods: aged 18 years or older were randomized to PCb (paclitaxel 225 mg/m 2 followed by area under curve=6 on day 1 every 3 weeks) GEMOX (gemcitabine 1,000 days 8 130 for up six cycles. The primary end point was progression-free survival (PFS), tumor response rate, overall (OS), quality life as secondary points. Results: terminated after 383 had been (371 received treatment) incidence adverse events exceeded protocol-specified safety threshold (≥20% either arm). No formal statistical comparisons conducted. Median PFS 4.44 months 4.67 groups, respectively. Objective rates (complete partial) 15.2% 22.4% arms, OS 9.90 9.24 (PCb); post hoc analyses showed median 70 be similar those younger than years. both groups adenocarcinoma histology, although favored group. Quality improved from baseline groups. Toxicity profiles comparable between Conclusion: PFS, OS, objective PCb. Nevertheless, toxicities limit adoption this regimen routine use advanced