Interim Analysis of a Phase III Trial Comparing Cisplatin, Gemcitabine, and Vinorelbine vs. Either Cisplatin and Gemcitabine or Cisplatin and Vinorelbine in Advanced Non–Small …

In a previous phase II randomized study, a cisplatin/gemcitabine/vinorelbine (PGV) regimen produced a 50-week median survival time (MST) in advanced non–small-cell lung cancer (NSCLC) patients. The present trial was planned to randomly compare the outcome of patients treated with this new triplet regimen with those of patients receiving either cisplatin plus vinorelbine (PV) or cisplatin plus gemcitabine (PG) doublet combinations. One hundred eighty patients with stage IIIB (76) or IV (104) disease, aged ≤ 70 years, and with Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1, were randomly allocated to receive: cisplatin, 50 mg/m2 plus gemcitabine, 1000 mg/m2 plus vinorelbine, 25 mg/m2 (PGV) on days 1 and 8 every 3 weeks; cisplatin, 100 mg/m2 on day 1 plus gemcitabine, 1000 mg/m2 (PG) on days 1, 8, and 15 every 4 weeks; cisplatin, 120 mg/m2 on days 1 and 29 plus …