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Proffered paper session on Thoracic cancers

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

Date

21 Nov 2020

Session

Proffered paper session on Thoracic cancers

Presenters

Liang Liu

Citation

Annals of Oncology (2020) 31 (suppl_6): S1386-S1406. 10.1016/annonc/annonc367

Authors

L. Liu1, Q. Gao2, J. Jiang3, J. Zhang4, X. Song5, J. Cui6, Y. Ye7, Z. Wang8, H. Yao5, X. Zhang1, X. Hao1, R. Xiubao1

Author affiliations

  • 1 Department Of Immunology And Biotherapy, Tianjin Medical University Cancer Institute and Hospital, 300060 - Tianjin/CN
  • 2 Department Of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 3 Department Of Tumor Biological Treatment, Third Affiliated Hospital of Soochow University, 213003 - Changzhou/CN
  • 4 Department Of Oncology, Shanxi Bethune Hospital, 030032 - Taiyuan/CN
  • 5 Cancer Biotherapy Center, Third Affiliated Hospital of Kunming Medical University, 650118 - Kunming/CN
  • 6 Cancer Center, First Hospital of Jilin University, 130021 - Changchun/CN
  • 7 Laboratory Of Immuno-oncology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, 350014 - Fuzhou/CN
  • 8 Department Of Immuno-oncology, Fourth Hospital of Hebei Medical University, 050011 - Shijiazhuang/CN
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Abstract 376O

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.

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