Trial reportInvestigational new drugs2013
Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor.
Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib.Journal of the National Cancer Institute · 2016Pooled it
- Efficacy and safety of sunitinib in Japanese patients with progressive, advanced/metastatic, well-differentiated, unresectable pancreatic neuroendocrine tumors: final analyses from a Phase II study.Japanese journal of clinical oncology · 2019Trial
- Multicenter validation study of a treatment selection MAP for pancreatic neuroendocrine tumors.Japanese journal of clinical oncology · 2024Article
- A case of erythema multiforme-like rash induced by everolimus in a patient with a pancreatic neuroendocrine tumor.Clinical journal of gastroenterology · 2022Article
- Predicting Novel Drug Candidates for Pancreatic Neuroendocrine Tumors via Gene Signature Comparison and Connectivity Mapping.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2022Article
- Surgery after sunitinib administration to improve survival of patients with advanced pancreatic neuroendocrine neoplasms.Annals of gastroenterological surgery · 2021Article
- Current status of medical treatment for gastroenteropancreatic neuroendocrine neoplasms and future perspectives.Japanese journal of clinical oncology · 2021Review
- A patient with a pancreatic neuroendocrine tumor and multiple liver metastases achieved a long-term partial response to third-line streptozocin treatment.International cancer conference journal · 2020Article
- Does sunitinib have a patient-specific dose without diminishing its antitumor effect on advanced pancreatic neuroendocrine neoplasms?Journal of cancer research and clinical oncology · 2019Article
- Real-world use of sunitinib in Japanese patients with pancreatic neuroendocrine tumors: results from a post-marketing surveillance study.Cancer chemotherapy and pharmacology · 2019Article
- Sunitinib shrinks NET-G3 pancreatic neuroendocrine neoplasms.Journal of cancer research and clinical oncology · 2018Article
- Article
- Everolimus treatment for neuroendocrine tumors: latest results and clinical potential.Therapeutic advances in medical oncology · 2017Review
- Advances in the diagnosis and treatment of pancreatic neuroendocrine neoplasms in Japan.Journal of gastroenterology · 2017Review
- Long-term outcomes and prognostic factors in 78 Japanese patients with advanced pancreatic neuroendocrine neoplasms: a single-center retrospective study.Japanese journal of clinical oncology · 2015Article
- A case of metastatic renal cell carcinoma and bile duct carcinoma treated with a combination of sunitinib and gemcitabine.BMC cancer · 2015Article
- Epidemiological trends of pancreatic and gastrointestinal neuroendocrine tumors in Japan: a nationwide survey analysis.Journal of gastroenterology · 2015Article
- Serum chromogranin A is a useful marker for Japanese patients with pancreatic neuroendocrine tumors.Cancer science · 2014Article
- Therapy for metastatic pancreatic neuroendocrine tumors.Annals of translational medicine · 2014Review
- Pancreatic neuroendocrine tumors: approach to treatment with focus on sunitinib.Therapeutic advances in gastroenterology · 2013Article
Corrections and comments
- Erratum issued
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPancreatic neuroendocrine tumors (NETs) are rare but are frequently diagnosed at advanced stages and require systemic therapy. PATIENTS AND
methodsThis multicenter, open-label, phase II study evaluated sunitinib in Japanese patients with well-differentiated pancreatic NET. Patients received sunitinib 37.5 mg/day on a continuous daily dosing (CDD) schedule. The primary endpoint was clinical benefit rate (CBR; percentage of complete responses [CRs] plus partial responses [PRs] plus stable disease [SD] ≥ 24 weeks). Secondary endpoints included objective response rate (ORR), tumor shrinkage, progression-free survival (PFS) probability, safety, pharmacokinetics, and biomarkers.
resultsTwelve patients received treatment. The CBR was 75 % (95 % confidence interval [CI], 43-94) and included 6 patients with a PR and 3 with SD. The ORR was 50 % (95 % CI, 21-79). PFS probability was 91 % (95 % CI, 54-99) at 6 months and 71 % (95 % CI, 34-90) at 12 months. Commonly reported treatment-emergent (all-causality), any-grade adverse events included diarrhea (n=10), hand-foot syndrome and hypertension (both n=8), fatigue and headache (both n=7), and neutropenia (n=6). No deaths on study were reported; one death due to disease progression occurred >28 days after end of treatment. Sunitinib on a CDD schedule resulted in sustained drug concentrations without accumulation across cycles. Tumor responses in all 12 patients did not appear to correlate with decreases in chromogranin A levels.
conclusionsSunitinib 37.5 mg/day on a CDD schedule demonstrated antitumor activity in Japanese patients with unresectable, well-differentiated pancreatic NET. Commonly reported adverse events were consistent with the known safety profile of sunitinib.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.