All patients were assigned randomly to either the CIK cell immunotherapy plus chemotherapy group (CIK-CT group, n = 45) or the chemotherapy group (CT group, n = 45).
CIK cell preparation
PBMC were collected from lung cancer patients after surgery using a Cobe Spectra Apheresis System and cultured in X-VIVO 20 serum-free medium containing 50 ng/mL anti-CD3 antibody (Ab) to stimulate CIK cell growth, 100 U/mL recombinant human interleukin (IL)-1a and 1,000 U/mL recombinant human interferon (IFN)-c, at 37 °C with 5 % CO2 for 24 hours. Then, 300 U/mL recombinant human IL-2 was added to the media. IL-2- and IFN-c-containing medium was added to the culture system every 5 days. On day 14, CIK cells were harvested and analyzed for phenotype and cytotoxicity. Safety testing was performed during the course of cell culture.
In patients of CIK-CT group, the median count of untreated PBMCs was 18.0 × 108 (range, 11.0 × 108 to 31.5 × 108) per cycle. The median count of autologous CIK cells after 15 days of amplification was 198.0 × 108 (range, 105.0 × 108 to 365.0 × 108) per cycle.
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. Subgroup analyses showed that the PFS in CIK-CT group was better than that in CT group in most of the sub-groups analyzed. 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. Subgroup analyses showed that the OS in CIK- CT group was better than that in chemotherapy group in most of the sub- groups analyzed.
The ORR (CR + PR) 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. The median duration of response was 9.6 months (range, 1.5+ to 53.0+) in the CIK-CT group and 5.0 months (range, 1.5 to 10.0) in the CT group.
Adverse events (AEs) of any grade were no difference between in the CT group (100%) and in the CIK- CT group (93.3%) (P = 0.356). AEs of grade 3 or 4 occurred in 42.2% of the patients in the CT group and in 33.3% of the patients in the CIK-CT group (P = 0.296); led to the discontinuation of all treatment components in 15.6 and 4.4%, respectively; and led to dose reduction of chemotherapy in 11.1 and 15.6%.
This phase II study provides evidence for the efficacy and safety of CIK cell immunotherapy plus chemotherapy in patients with previously untreated, advanced squamous NSCLC.
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Scientific article publishing date 10/19/2020
Immucura identifier BSC21_255EN