1.Long-Term Response in PD-L1-Negative Advanced Non-Small Cell Lung Carcinoma With Discontinued and Restarted Nivolumab Therapy Due to Immune-Related Adverse Event
Tomoshige CHIAKI ; Soichi MARUYAMA ; Shinya FUJII
Journal of the Japanese Association of Rural Medicine 2020;68(6):797-
The patient was 67-year-old woman with non-small cell lung carcinoma (squamous cell carcinoma, T2bN2M1a, Stage IVA) who was started on fifth-line therapy with nivolumab, an immune checkpoint inhibitor. Although tumor biopsy was negative for programmed cell death ligand 1 (PD-L1), the tumor size decreased. Nivolumab had to be discontinued due to suspected immune-related adverse events (i.e., skin rash and enteritis symptoms), but the tumor size reduction persisted after discontinuation and complete response was maintained for ≥ 8 months. After disease recurrence, nivolumab therapy was restarted. The tumor size decreased, and partial response was achieved and maintained. The disease was successfully controlled for ≥ 2 years (27 courses of nivolumab), when nivolumab therapy was again discontinued due to skin rash. Despite the PD-L1-negative status, the patient achieved long-term response to nivolumab therapy. The immune-related adverse events in this case were comparable between the initial and reintroduced nivolumab therapy, suggesting that nivolumab is safe to administer over the long term.
2.Surveys on Suspected Adverse Effects Related to Coronavirus Disease 2019 Vaccination and the Impact of Early Publication of Results
Go MORIKAWA ; Ken KUBOTA ; Katsuko OKAZAWA ; Takemasa MARUYAMA ; Tomoshige CHIAKI
Japanese Journal of Drug Informatics 2024;26(1):28-35
Objective: The coronavirus disease 2019 (COVID-19) vaccine was a specially approved pharmaceutical in Japan in February 2021. However, several people were concerned about its safety. Therefore, we conducted a survey on our hospital staff with suspected adverse effects related to COVID-19 vaccines and promptly published the results on our website. Methods: The current study included hospital staff who received the COVID-19 vaccine. A questionnaire survey on suspected adverse effects was conducted after each vaccination from the first to the fifth dose. Data on the survey results were promptly posted on the hospital’s website. The number of hits and time spent on the site were also evaluated. Then, we examined. the media (newspapers and television) that reported our findings and the content of their coverage. Results: There were no new findings regarding suspected adverse effects of the COVID-19 vaccines. An article published on our website on June 18, 2021, received more than 9,000 page views with an average time spent of > 3 min. Four media outlets reported on our hospital’s articles from June to July 2021, when public interest in the first and second doses of the vaccine was high. Conclusion: The early release of the survey results has provided a source of information for people who want to obtain safety information regarding the adverse effects of the COVID-19 vaccine.