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A phase I trial of adoptive transfer of allogeneic natural killer cells in patients with advanced non-small cell lung cancer
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A phase I trial of adoptive transfer of allogeneic natural killer cells in patients with advanced non-small cell lung cancer
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Journal Article
A phase I trial of adoptive transfer of allogeneic natural killer cells in patients with advanced non-small cell lung cancer
2010
Overview
HLA-mismatched natural killer (NK) cells have shown efficacy in acute myeloid leukemia, and their adoptive transfer in patients with other malignancies has been proven safe. This phase I clinical trial was designed to evaluate safety (primary endpoint) and possible clinical efficacy (secondary endpoint) of repetitive administrations of allogeneic, in vitro activated and expanded NK cells along with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Patients with unresectable, locally advanced/metastatic NSCLC receiving 1st/2nd line chemotherapy were eligible to receive 2–4 doses of activated NK cells from two relative donors. Donor’s CD56
+
cells were cultured for 20–23 days with interleukin-15 (IL-15) and hydrocortisone (HC) and administered intravenously between chemotherapy cycles. Premedication with corticosteroids and/or H1 inhibitors was allowed. Sixteen patients (performance status 0–1) with adenocarcinoma (
n
= 13) or squamous cell carcinoma (
n
= 3) at stage IIIb (
n
= 5) or IV (
n
= 11) receiving 1st (
n
= 13) or 2nd (
n
= 3) line treatment were enrolled. Fifteen patients received 2–4 doses of allogeneic activated NK cells (0.2–29 × 10
6
/kg/dose, median 4.15 × 10
6
/kg/dose). No side effects (local or systemic) were observed. At a median 22-month follow-up (range, 16.5–26 months) 2 patients with partial response and 6 patients with disease stabilization were recorded. Median progression free survival and overall survival were 5.5 and 15 months, respectively. A 56% 1-year survival and a 19% 2-year survival were recorded. In conclusion, repetitive infusions of allogeneic, in vitro activated and expanded with IL-15/HC NK cells, in combination with chemotherapy are safe and potentially clinically effective.
Publisher
Springer-Verlag,Springer,Springer Nature B.V
Subject
/ Adoptive Transfer - adverse effects
/ Aged
/ Biological and medical sciences
/ Carcinoma, Non-Small-Cell Lung
/ Carcinoma, Non-Small-Cell Lung - mortality
/ Carcinoma, Non-Small-Cell Lung - therapy
/ Female
/ Humans
/ Killer Cells, Natural - immunology
/ Male
/ Medicine
/ Non-small cell lung carcinoma
/ Oncology
/ Original
/ Patients
/ Pharmacology. Drug treatments
/ therapy
