Postoperative Adverse Events Following Neoadjuvant Therapy and Surgery for Borderline Resectable Pancreatic Cancer in a Phase 2 Clinical Trial (Alliance A021501)
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Summary
This summary is machine-generated.Postoperative adverse events (AEs) after neoadjuvant therapy and pancreatectomy for borderline resectable pancreatic cancer were characterized. Rates were consistent with prior studies, supporting cooperative group trials with safety monitoring.
Area Of Science
- Oncology
- Surgical Oncology
- Clinical Trials
Background
- Borderline resectable pancreatic ductal adenocarcinoma (BR-PC) management involves neoadjuvant therapy followed by pancreatectomy.
- Postoperative adverse events (AEs) in BR-PC patients undergoing this multimodality treatment in a national cooperative group setting require characterization.
- The Alliance A021501 clinical trial provides data for this secondary analysis.
Purpose Of The Study
- To quantify perioperative adverse event (AE) rates in patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PC) treated with neoadjuvant therapy and pancreatectomy.
- To analyze the safety profile of neoadjuvant mFOLFIRINOX with or without hypofractionated radiotherapy followed by pancreatectomy within a national cooperative group framework.
Main Methods
- A preplanned secondary analysis of the Alliance A021501 phase 2 clinical trial (NCT02839343) was conducted.
- Patients with BR-PC received either mFOLFIRINOX (Arm 1) or mFOLFIRINOX plus hypofractionated radiotherapy (Arm 2) followed by pancreatectomy.
- Adverse events were assessed within 90 days post-pancreatectomy for 51 patients across 28 institutions.
Main Results
- Of 51 patients undergoing pancreatectomy, 56% experienced at least one grade 3 or higher AE; 90-day mortality was 2.0%.
- Reoperation was required in 10% of patients; pancreatic fistula or abscess requiring drainage occurred in 9-16% of patients.
- No significant difference in overall survival was observed based on the occurrence of postoperative AEs.
Conclusions
- Postoperative AE rates in this multicenter study are consistent with previously reported data.
- Multimodality trials for BR-PC can be safely conducted in the cooperative group setting.
- Careful quality assurance and safety monitoring are essential for neoadjuvant therapy trials in BR-PC.
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