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)

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