Background
Sunitinib is approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable, locally advanced or metastatic disease. Safety and efficacy data in Japanese patients are limited. We report outcomes from a post-marketing surveillance study of sunitinib treatment in Japanese patients.
Methods
Sunitinib 37.5 mg once daily was orally administered in Japanese patients aged ≥ 15 years with pNETs. The primary endpoints included adverse events (AEs) occurring during the observation period of 168 days and objective response rate (ORR).
Results
Sunitinib was administered in 62 patients with pNETs. The median duration of treatment was 165 days. At 168 days from the start of treatment, 31 patients were still receiving sunitinib treatment and treatment continuation rate was 50.0%. Of the 31 patients who discontinued treatment, 18 (58.1%) discontinued because of AEs and 16 (51.6%) patients discontinued due to insufficient clinical effect. Of the 18 patients who discontinued due to AEs, 10 did so within 42 days of treatment initiation. The most common all-grade AEs were platelet count decreased (33.9%), diarrhea (29.0%), neutrophil count decreased (27.4%), hypertension (24.2%), and palmar-plantar erythrodysesthesia syndrome (24.2%). In the 51 patients eligible for the efficacy analysis, ORR was 13.7% (95% confidence interval, 5.7–26.3) and clinical benefit rate was 70.6%.
Conclusions
There were no new safety concerns in real-world use of sunitinib in Japanese patients with pNETs. The short treatment duration likely led to low tumor response. Appropriate AEs management through dose interruption/reduction is essential for sunitinib treatment success in this patient population.
In patients with acute myocardial infarction treated with percutaneous coronary intervention (PCI), effective post-hospital care, partially determined by self-care agency, is critical for long-term prognosis. However, the relationship between agency and sociodemographic characteristics requires elucidation. One hundred and six outpatients participated in our study. Self-care agency was assessed with the Self-care Agency Questionnaire (SCAQ). We evaluated its correlation with patients’ sociodemographic characteristics and morale on the Ikigai-9 Questionnaire. Mean SCAQ scores were higher in those who were younger, male, living with someone, and more educated compared to their counterparts. Furthermore, SCAQ scores were correlated with Ikigai-9 scores. Multivariate logistic regression analyses indicated that social participation, employment status, and morale were independent predictors of high SCAQ scores. A comprehensive approach utilizing medical professionals, families, and the local community is needed to promote self-care agency in patients receiving primary PCI.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.