Prognostic significance of adoptive immunotherapy with tumor-associated lymphocytes in patients with advanced gastric cancer: a randomized trial.

PURPOSE: We performed adoptive immunotherapy (AIT)with tumor-associated lymphocytes (TALs) in combination with chemotherapy in patients with advanced-stage gastric cancer in a randomized controlled study and investigated whether or not an improved survival effect is observed with AIT. EXPERIMENTAL DESIGN: Forty-four consecutive patients with stage IV gastric cancer [staged according to the International Union against Cancer classification] were prospectively assigned to the control group (chemotherapy alone) or the AIT group (AIT plus chemotherapy). Patients in the AIT group received an adoptive transfer of cultured TALs in combination with low-dose cisplatinum/5-fluorouracil chemotherapy, whereas patients in the control group received chemotherapy alone. RESULTS: The 50% survival rates were 11.5 and 8.3 months in the AIT and control groups, respectively. The overall survival of patients in the AIT group was significantly better than that of patients in the control group, as analyzed by the log-rank test (P < 0.05). Multivariate analysis with Cox's proportional hazards model revealed that AIT provided an independent prognostic factor, indicating that AIT influenced patient survival in a positive manner. CONCLUSIONS: AIT with TALs in combination with chemotherapy was effective in prolonging survival in patients with stage IV gastric cancer.