Preliminary results of Ch.E.S.T.: A phase III study of surgery alone or surgery plus preoperative gemcitabine-cisplatin in clinical early stages non-small cell lung cancer (NSCLC)

摘要: LBA7023 Background: This phase III study tested the hypothesis whether 3 cycles of gemcitabine-cisplatin administered before radical surgery provides better progression-free survival than alone in patients (pts) with early stages NSCLC. Secondary endpoints include overall survival, assessment response rate to chemotherapy, operative mortality and other chemotherapy-related toxicities. Methods: Chemonaive pts clinical stage T2N0, T1–2N1, or T3N0–1, an ECOG PS 0–1, adequate hematologic, renal hepatic function were randomized receive preoperatively either cisplatin 75 mg/m2 on day 1 gemcitabine 1250 days 8 every weeks for (arm 2) no chemotherapy 1). Pts arm 2 underwent 2–6 after end within randomization. stratified according IB/IIA versus IIB/IIIA disease. The original statistical plan considered following assumptions: 3-year ...