Clinical and biological effects of tumor-associated lymphocytes in the presence or absence of chemotherapy for malignant ascites in ovarian cancer patients.

Tumor-associated lymphocytes (TALs) have been successfully isolated from ascites and solid tumors, however the clinical use of TALs in treating ovarian cancer (OC) has not yet been reported. The present study investigated the efficacy and toxicity of TALs in the presence or absence of chemotherapy in OC patients with malignant ascites (MA). A total of 32 patients were enrolled in this study. A total of 8 patients received treatment with TALs alone (TALs group), 11 patients received combined treatment of TALs and chemotherapy (combination group) and 13 patients received chemotherapy alone (chemotherapy group). The endpoints included Karnofsky performance status (KPS), ascites-associated symptoms (AAS), time to progression (TTP) and overall survival (OS). Compared with the TALs and chemotherapy group, the KPS and AAS in the combination group significantly improved following treatment. Patients in the TALs group (37.5%) and chemotherapy group (53.8%) achieved significantly fewer objective response rates of ascites compared with those in the combination group (90.9%). Furthermore, combination therapy significantly extended TTP (13 months) compared with TALs alone (1 month, P<0.001), and chemotherapy alone (6 months, P=0.027). Similar results were observed for OS between the combination group and the TALs group (25 vs. 7 months, P<0.001). The present study therefore demonstrates that combined therapy of TALs and chemotherapy is safe, feasible, and more effective than chemotherapy or TALs alone in controlling MA and improving the quality of life for OC patients.