Abstract
BackgroundSunitinib 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.MethodsSunitinib 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).ResultsSunitinib 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%.ConclusionsThere 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.
Highlights
Pancreatic neuroendocrine tumors are considered rare, but their incidence worldwide is increasing annually [1,2,3,4]
We report the outcomes from this post-marketing surveillance (PMS) study, including adverse drug reactions and efficacy associated with sunitinib in Japanese patients with pancreatic neuroendocrine tumors (pNETs), and how sunitinib treatment is managed in clinical practice in Japan
The study was conducted between August 10, 2012 and February 2017 in 20 centers in Japan specializing in the treatment of pNETs
Summary
Pancreatic neuroendocrine tumors (pNETs) are considered rare, but their incidence worldwide is increasing annually [1,2,3,4]. Prognosis for patients with pNETs is dependent on the histology and disease stage at diagnosis. The outcome in patients with poorly differentiated pNETs is worse, depending on the disease stage [3]. Sunitinib is approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable, locally advanced or metastatic disease. 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. 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
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