Аннотация:Background: The purpose of the study was to compare the results of neoadjuvant polychemoimmunotherapy (nPCIT) and conventional neoadjuvant polychemotherapy (nPCT) in patients with NSCLC. Methods: 64 pts with NSCLC were divided into 2 groups: main group – 32 pts, 2 nPCIT cycles (cisplatin 80 mg/m2 on day 1, gemcitabine 1200 mg/m2 on days 1 and 8 with i.v. infusions of the recombinant hybrid protein of tumor necrosis factor-alpha-thymosin-alpha1 100 000 IU on days 0, 3 and 6); control group – 32 pts, nPCT with the same cytostatics. Central cancer in 17(53.1%) pts of the main group (cT1NX-6.2%, cT2NX-37.5%, cT3NX-3.1%) and 20 (62.5%) (cT1NX-9.4%, cT2NX-40.6%) controls, peripheral cancer in 15(46.9%) (cT2b NX-9.4%, cT3> 7 NX-21.8%, cT3NX-18.7%, cT4NX-3.1%) and 12(37.5%) (cT2b NX-12.5%, cT3NX-34.3%, cT4NX-3.1%), respectively. Squamous cell carcinoma in 17(53.2%) and 14(43.8%), adenocarcinoma in 7(21.8%) and 5(15.6%), non-small cell carcinoma in 8(25%) and 13(40.6%) pts, respectively. Results: CR in 3 (9.4%) and 2 (6.2%), PR - 14 (43.7%) and 13 (40.6%), SD - 13 (40.6%) and 14 (43.7%), PD - 2 (6.2%) and 3 (9.4%). Objective overall response rate was 53.1% in nPCIT vs 46.8% in nPCT, CR+PR+SD was 93.7% and 90.6%, respectively. 29 (90.6%) pts in each group received surgery. Extended lobectomy/bilobectomy in 14 (48.2%) pts in each group, extended pneumonectomy in 7 (24.1%) in nPCIT and 8 (27.5%) in nPCT. N2 disease in 10 (34.5%) and 13 (44.8%) pts, respectively. Post-surgical restaging: st. 0 – 10.3% vs 6.9%, st. I - 34.5% vs 31%, st. II - 20.7% vs 17.2%, st. IIIА - 34.5% vs 44.7%. Median survival in the main group - not reached, in controls – 23 months. OS was studied in pts with st. 0-II and st. IIIAN2 NSCLC; 3-year OS in early stages was 72% in the main group vs 49% in controls (p = 0.0735). Conclusions: The direct results were similar in nPCIT and nPCT, but 2-year EFS was 72% and 44%, respectively, with a tendency to improvement (p = 0.05421). 2-year OS in pts with st. IIIAN2 NSCLC improved to 55% in the main group vs 32% in controls (p = 0.031777).