Phase II study of adoptive immunotherapy for advanced melanoma / 肿瘤

ABSTRACT

Objective: To observe the efficacy and safety of chemotherapy combined with cytokine-induced killer (CIK) cells in the treatment of metastatic melanoma (MM). Methods: Fifty three chemotherapy-naive MM patients were administered fotemustine at 100 mg/m2 on d 1-5; dacarbazine were given at 400 mg/d on d 2-6; CIK were infused on d 7, d 14, d 16. Twenty-eight days were regarded as one cycle. The clinical efficay was evaluated every 2 cycles. Results: Thirty-four out of 53 patients were eligible to be evaluated. The overall response rate (ORR) was 23.5% including 1 case with complete response (CR) (2.9%) and 7 cases with partial response (PR) (20.6%). Fourteen cases had stable disease (44%). The clinical benefit response was 67.5%. Median progression free survival (PFS) was 8 months. Median overall survival (OS) was 11 months. The patients with normal lactate dehydrogenase (LDH) had longer OS; those with stable disease had longer PFS and OS. Adverse reaction included grade III/IV thrombopenia (41%), decrease in the number of WBC (23.5%), and hyperreactivity (2 cases). No treatment-related death occurred. Conclusion: Chemotherapy followed by the infusion of CIK was tolerable. The response rate was higher than common chemotherapy. It could prolong the survival time of tumor patients with elevated LDH and non progression disease. Phase III study is needed to confirm the results.