376O - Randomized, multicenter trial of autologous cytokine-induced killer cell immunotherapy plus chemotherapy for squamous non-small cell lung cancer: NCT01631357

Background

There is no multicenter clinical study about cytokine-induced killer (CIK) cells in lung cancer. This randomized, multicenter trial was designed to evaluate the efficacy of CIK cell immunotherapy combination with chemotherapy in patients with advanced squamous non-small-cell lung cancer (NSCLC).

Methods

In this phase II trial, 90 patients with untreated, stage IIIB/IV squamous NSCLC were randomized to autologous CIK cell immunotherapy plus gemcitabine and cisplatin (CIK-CT group, n = 45), or gemcitabine and cisplatin (CT group, n = 45). The primary endpoint was progression-free survival (PFS) and secondary endpoint was overall survival (OS) evaluated by Kaplan–Meier analyses and treatment hazard ratios (HRs) with the Cox proportional hazards model.

Results

After a median follow-up of 29.3 months, the median PFS was 8.7 months (95% CI, 7.1 to 10.3) in the CIK-CT group and 4.0 months (95% CI, 3.1 to 5.0) in the CT group (HR, 0.26; 95% CI, 0.16 to 0.43; P < .001). The median OS was 21.0 months (95% CI, 17.8 to 24.2) in the CIK-CT group and 10.3 months (95% CI, 7.9 to 12.1) in the CT group (HR, 0.22; 95% CI, 0.13 to 0.40; P < .001). The objective response rate was 62.2% (95% CI, 47.9% to 76.5%) in the CIK-CT group and 31.1% (95% CI, 17.4% to 44.8%) in the CT group (P < .001). The adverse events of grade 3 or higher were 33.3% and 42.2% in the CIK-CT group and CT group, respectively.

Conclusions

These data suggested that the addition of CIK cell immunotherapy to chemotherapy resulted in significantly longer PFS and OS than chemotherapy alone in patients with previously untreated, advanced squamous NSCLC.

Clinical trial identification

NCT01631357.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

The National Key Technologies R&D Program of China grant Awards No. 2015BAI12B12 (to Xiubao Ren).

Disclosure

All authors have declared no conflicts of interest.