A phase III randomized study of surgery alone or surgery plus preoperative gemcitabine-cisplatin in early-stage non-small cell lung cancer (NSCLC): Follow-up data of Ch.E.S.

摘要: 7508 Background: This phase III study tested the hypothesis whether 3 preoperative cycles of gemcitabine-cisplatin followed by radical surgery provides a reduction in risk progression compared with alone patients (pts) stage IB- IIIA NSCLC. Methods: Chemotherapy naive pts clinical T2N0, T1–2N1, or T3N0–1 received either preoperatively cisplatin (75 mg/m2, day 1) and gemcitabine (1,250 days 1&8), q3week (C+S) (S). In 2004 enrollment was closed early after inclusion 270 out 700 planned because investigators felt it unethical to complete treating due positive adjuvant studies. Results: From September 2000 December 2004, 141 were randomized S 129 C+S. Median age 63/61 years, most male (89%/78%). Stage IB/IIA disease reported 55% 46%, respectively. The commonest histology squamous cell carcinoma (45%/37%) adenoca...