Abstract
BACKGROUND: Small cell lung cancer (SCLC) relapses rapidly after the initial response to chemotherapy and shows drug-resistance. This study was to investigate the efficacy and safety of cellular immunotherapy (CIT) with autologous natural killer (NK), γδT, and cytokine-induced killer (CIK) cells as maintenance therapy for SCLC patients. METHODS: A pilot prospective cohort study was conducted with SCLC patients who had responded to initial chemotherapy. Patients elected to receive either CIT as maintenance therapy (study group), or to be followed-up without further treatment (control group). Progression-free survival (PFS), overall survival (OS), and adverse effects were investigated. RESULTS: We recruited 58 patients (29 in each group). The patient characteristics of the 2 groups were well balanced. PFS was not significantly different between the groups, but OS was significantly longer in the study group than the control (20 vs. 11.5 months, P = 0.005; hazard ratio [HR], 0.434, 95 % confidence interval [CI], 0.236-0.797, P = 0.007). Among patients with limited-stage disease, there was no difference in PFS between the groups, but OS was longer in the study group compared to the control (26.5 vs. 11.8 months, P = 0.033; HR, 0.405, 95 % CI, 0.169-0.972, P = 0.043). Among patients with extensive-stage disease, both PFS and OS were longer in the study group than the control (5 vs. 2.7 months, P = 0.037; HR, 0.403, 95 % CI, 0.162-1.003, P = 0.051, and 14.5 vs. 9 months, P = 0.038; HR, 0.403, 95 % CI, 0.165-0.987, P = 0.047, respectively). No significant adverse reactions occurred in patients undergoing CIT. CONCLUSIONS: CIT maintenance therapy in SCLC prolonged survival with only minimal side effects. Integrating CIT into current treatment may be a novel strategy for SCLC therapy, although further multi-center randomized studies are needed.