Prospective evaluation of safety of immune-cell therapy for patients with various types of advanced cancer.

Several types of immune-cell therapies, such as alpha beta T-cell, gamma delta T-cell, and dendritic cell (DC) vaccine therapies, are clinically employed for cancer treatment. The safety of immune-cell therapy for the treatment of patients with malignancies should be maintained by continuous assessment of adverse events. In the present study, we surveyed the adverse events associated with immune-cell therapy using large-scale prospective data and analyzed the side-effect profiles. For the assessment of adverse events associated with immune-cell therapy, we evaluated 771 treatment profiles (484 for alpha beta T-cell therapy, 58 for gamma delta T-cell therapy, 206 for DC vaccine therapy, and 23 for concurrent therapy with alpha beta T-cells and DC vaccines) from 144 patients with various malignancies. For the assessment of fever, fatigue, and itching, each of these adverse events was found to be grade 1 or 2 in most of the treated patients, except for one patient who had grade 3 itching. It was suggested that alpha beta T-cell therapy could elicit a more rapid and direct immune reaction in patients than DC vaccine therapy, as shown by the earlier development of fever and higher incidence rate of fatigue. It was found that grade 1 or 2 reaction at the injection site developed in 10.2% of the patients injected with DC vaccines. Most of the grade 3 non-hematological and hematological adverse events were associated with disease progression or side-effects of chemotherapy, and were not considered to be related to immune-cell therapy. In conclusion, immune-cell therapy, such as alpha beta T-cell, gamma delta T-cell, or DC vaccine therapy, was well-tolerated for cancer treatment.