The safety and efficacy of surufatinib for the treatment of advanced neuroendocrine tumors: A prospective, multicenter, real-world study
Annals of Oncology
; 33:S958, 2022.
Article
in English
| EMBASE | ID: covidwho-2041540
ABSTRACT
Background:
Surufatinib (a small-molecule inhibitor of VEGFR1-3, FGFR1, and CSF-1R) has exhibited encouraging antitumor activity for the treatment of advanced neuroendocrine tumors (including NEN and NEC) in multiple registration studies. Here, we report the preliminary results of advanced neuroendocrine tumors of an ongoing, multicenter, real-world study of surufatinib + MDT (ChiCTR2100049999). Challenges in tumor clinical trials management in the face of the COVID-19 resurgence period in Shanghai.Methods:
In this multicenter, single-arm real-world study, adults (18-80) with advanced neuroendocrine tumors (including NEN and NEC) were eligible and received surufatinib (300mg orally, QD) with MDT(multidisciplinary collaborative diagnosis and treatment). The primary endpoint was progression-free survival (PFS) per RECIST 1.1. We minimized the interruptions caused by the pandemic using telemedicine platforms for all patients. This included online consultations, follow-up drug distributions, and health management services.Results:
Twenty-three pts were enrolled, with 20 NEN and 3 NEC. At the data cutoff date (April 10, 2022), 15 pts had at least one post-baseline tumor assessment;of them, the confirmed ORR (95%CI) was 20% (4.3-48.1), and DCR (95%CI) was 93.33% (68.1-99.8). Median PFS (mPFS) (95%CI) 10.640 mo (3.796-17.484);median OS not reached and median duration of follow up was 6.870 mo (6.797-6.943). A pNET patient (NO. 010007) was interrupted by asymptomatic COVID-19 infection 9 mo after enrollment. There are no interruptions caused by COVID-19 for other patients. An NEC patient treated with single agent had a 5.85 mo PFS, evaluated as NE, in whom target lesion resected after baseline. In overall pts (n=23), most commonly (≥3 pts) with hemorrhage, anemia, hypertension, proteinuria, and abdominal pain. Three pts had TRAEs that led to treatment discontinuation.Conclusions:
Surufatinib + MDT exhibited promising efficacy and manageable toxicity in pts with advanced neuroendocrine tumors. Now and in the future, it is necessary to design regulatory changes in telehealth adoption for clinical trial design in the pandemic era. Clinical trial identification ChiCTR2100049999. Legal entity responsible for the study The authors.Funding:
Hutchison MediPharma Limited. Disclosure All authors have declared no conflicts of interest.
sulfatinib; abdominal pain; adoption; adult; anemia; asymptomatic coronavirus disease 2019; bleeding; clinical article; clinical trial; conference abstract; consultation; controlled study; coronavirus disease 2019; drug distribution; drug efficacy; drug safety; drug therapy; drug withdrawal; female; follow up; health care management; human; hypertension; male; multicenter study; neuroendocrine tumor; pandemic; preliminary data; progression free survival; prospective study; proteinuria; response evaluation criteria in solid tumors; telehealth; telemedicine
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Observational study
/
Prognostic study
Language:
English
Journal:
Annals of Oncology
Year:
2022
Document Type:
Article
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