Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (Nsclc) Patients With Operable Stage Iiib Disease. A Phase Ii Trial Of The Swiss Group For Clinical Cancer Research (Sakk)

18021 Background and Methods: Outcome of patients (pts) with locally advanced NSCLC treated with radio- or chemoradiotherapy is poor. This two-stage phase II trial (planned sample size 46) aimed at evaluating feasibility and outcome of a tri-modality concept of neoadjuvant chemotherapy (CT), radiotherapy (RT) followed by definitive surgery in operable, stage IIIB NSCLC pts. Treatment consisted of 3 cycles of cisplatin (100 mg/m2) and docetaxel (85 mg/m2) followed by accelerated, concomitant boost RT (44 Gy/22 fx) and surgery. Primary endpoint is event-free survival at 1 year. Operable pts up to age 75 and a performance status of 0–1 with stage IIIB NSCLC (pleural effusion excluded) were eligible. Results: Forty-five eligible pts (46 accrued) with a median age was 60 years (range 28–70) were treated between September 2001 and May 2006. Tumor location was right-sided in 28 pts and left-sided in 17 pts. Histology was squamous cell 42%, large cell 11%, adeno-13% and undifferentiated carcinoma 33%. N3-disease was present in 29%, T4 stage in 78%. CT (45 pts) and RT (34 pts) were delivered as prescribed in >80% of cycles. The median time from enrollment to surgery was 3.7 months (2.8 - 5.2). The objective response rate after CT was 53% (95% c.i. 38–68%), after additional RT 67% (51–80%). Surgery (pneumonectomy in 17) was performed in 31 pts (69%), with an R0 resection in 24 pts. Median duration of hospitalization was 12 days (8–134). Two pts died in the perioperative phase due to ARDS and a cerebro-vascular event, respectively. Mature results of the primary endpoint and overall survival will be available at the ASCO meeting. Conclusions: Combined multimodality treatment strategy is feasible in a subgroup of patients, with acceptable toxicity. About two thirds of patients responded to the induction therapy, and were able to undergo subsequent surgery. No significant financial relationships to disclose.