Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changhai Hospital
- Enrollment
- 411
- Primary Endpoint
- Disease-free survival time
Overview
Brief Summary
Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.
Detailed Description
Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pNETs lesions pathologically classified as WHO grade 2
- •Complete surgical resection (R0 or R1 was achieved)
- •Adjuvant treatment was performed within 12 weeks after surgery
Exclusion Criteria
- •Other oncological history
- •Previous antineoplastic systemic therapy
- •Lack of information/details on recurrence or death.
Arms & Interventions
Octreotide group
Patients in the octreotide group received octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months, with the start of clinical intervention following surgery.
Intervention: Octreotide LAR (Drug)
Outcomes
Primary Outcomes
Disease-free survival time
Time Frame: From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months
Disease-free survival time
Secondary Outcomes
- Overall survival time(From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months)
Investigators
Guo ShiWei
Clinical Professor
Changhai Hospital