Safety evaluation of immune-cell therapy for malignant tumor in the Cancer Immune-cell Therapy Evaluation Group (CITEG).

BACKGROUND AIMS: With the aim of strengthening the scientific evidence of immune-cell therapy for cancer and further examining its safety, in October 2015, our hospital jointly established the Cancer Immune-Cell Therapy Evaluation Group (CITEG) with 39 medical facilities nationwide. METHODS: Medical information, such as patients' background characteristics, clinical efficacy and therapeutic cell types obtained from each facility, has been accumulated, analyzed and evaluated by CITEG. In this prospective study, we analyzed the adverse events associated with immune-cell therapy until the end of September 2022, and we presented our interim safety evaluation. RESULTS: A total of 3839 patients with malignant tumor were treated with immune-cell therapy, with a median age of 64 years (range, 13-97 years) and a male-to-female ratio of 1:1.08 (1846:1993). Most patients' performance status was 0 or 1 (86.8%) at the first visit, and 3234 cases (84.2%) were advanced or recurrent cases, which accounted for the majority. The total number of administrations reported in CITEG was 31890, of which 960 (3.0%) showed adverse events. The numbers of adverse events caused by treatment were 363 (1.8%) of 19661 administrations of αßT cell therapy, 9 of 845 administrations of γδT-cell therapy (1.1%) and 10 of 626 administrations of natural killer cell therapy (1.6%). The number of adverse events caused by dendritic cell (DC) vaccine therapy was 578 of 10748 administrations (5.4%), which was significantly larger than those for other treatments. Multivariate analysis revealed that αßT cell therapy had a significantly greater risk of adverse events at performance status 1 or higher, and patients younger than 64 years, women or adjuvant immune-cell therapy had a greater risk of adverse events in DC vaccine therapy. Injection-site reactions were the most frequently reported adverse events, with 449 events, the majority of which were associated with DC vaccine therapy. Among all other adverse events, fever (228 events), fatigue (141 events) and itching (131 events) were frequently reported. In contrast, three patients had adverse events (fever, abdominal pain and interstitial pneumonia) that required hospitalization, although they were weakly related to this therapy; rather, it was considered to be the effect of treatment for the primary disease. CONCLUSIONS: Immune-cell therapy for cancer was considered to be a safe treatment without serious adverse events.

Efficacy of Dietitian-instructed Low Iodine Diet for Radioiodine Remnant Tissue Ablation for Thyroid Cancer.

We evaluated the significance of dietary instruction (DI) for patients who are going on a low iodine diet (LID) as a preparation for remnant tissue ablation for thyroid cancer. DI was done by a dietarian using a dedicated handbook we have developed. To assess the effect of LID on depleting body iodine, urinary iodine concentration (UIC) in patients with post-surgical papillary thyroid cancer was measured twice, before and after LID. UIC on the day of radioiodine administration was compared with radioiodine uptake (RU) in the remnant tissue. Additionally, the association between clinical and lifestyle-related features of patients and the outcome of LID were investigated. A questionnaire survey was conducted to determine whether the DI helped patients go on LID. The mean value of UIC after the one-week LID was decreased to about 15% of the baseline value. There was a significant inverse correlation between UIC and RU (r= -0.694). Age and UIC before the start of LID were linked to successful outcome of LID. In the questionnaire survey, 84% of the participants answered that the handbook helped them go on a LID. Likewise, 80% answered that they could manage their LID without using the boil-in-the-bag low iodine food. LID successfully decreased UIC in patients undergoing remnant tissue ablation. DI by a dietitian may make a practice of LID easier.