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HPB

HPB Parallel Session 1

45: Postoperative Complications Following Neoadjuvant Therapy and Surgery in a Phase 2 Borderline Resectable Pancreatic Cancer Clinical Trial (Alliance A021501)

Thursday, March 21, 2024
2:32pm – 2:42pm ET
Location: C101
Disclosure(s):
Rebecca A. Snyder, MD, MPH: No financial relationships to disclose
Syed A. Ahmad, MD: No financial relationships to disclose
Introduction: Postoperative complications in patients with borderline resectable pancreatic cancer treated with neoadjuvant therapy and pancreatectomy in the national cooperative group setting have not been previously characterized. Further, the impact of preoperative hypofractionated radiotherapy on postoperative outcomes is largely unknown. We sought to quantify perioperative morbidity among patients with pancreatic cancer who received neoadjuvant modified FOLFIRINOX chemotherapy with or without hypofractionated radiotherapy on a multicenter clinical trial.


Methods: The A021501 phase 2 trial randomized patients with borderline resectable pancreatic ductal adenocarcinoma to 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX then hypofractionated radiotherapy (Arm 2), followed by pancreatectomy (Dec 31, 2016-Jan 1, 2019). Patients underwent resection according to defined operative standards at enrolling centers without specific requirements for surgeon or hospital volume. Surgical complications and adverse events were assessed and captured at a single time point 90 days after surgery.


Results: Of 126 enrolled patients, 51 (40%) underwent pancreatectomy (n=32, Arm 1; n=19, Arm 2) at 28 institutions. Vascular resection was performed in 19 patients (37%). One patient in Arm 2 died within 90 days after surgery. Rates of any surgical complication were 19% (n=6) in Arm 1 and 42% (n=8) in Arm 2 (p=0.07). Five (10%) patients required reoperation within 90 days. Readmission rates were higher in Arm 2 than Arm 1 (42% vs. 16%, p=0.04) but there were no differences in rates of reoperation, pancreatic fistula or abscess requiring drainage, or wound infection between study arms. 54% of patients (n=26/48) experienced a grade 3 or higher adverse event, with no difference between treatment arms (47% versus 67%, p=0.7). Rates of initiation of adjuvant therapy did not differ between treatment arms (66% vs. 68%, p=0.4). Pancreatic fistula and abscess were associated with adjuvant therapy (p< 0.01). No difference in overall survival was observed based on surgical complications (HR 1.1; 95% CI 0.5-2.6).


Conclusions: In this national cooperative group study of patients with borderline resectable pancreatic cancer, postoperative complications following neoadjuvant therapy were consistent with rates previously reported by high-volume institutions and using large datasets. Multimodality trials of preoperative therapy for locoregionally advanced pancreatic cancer may be safely performed in the cooperative group setting.

Learning Objectives:

  • 1. Summarize rates of postoperative complications following neoadjuvant therapy and surgery for patients with borderline resectable pancreatic cancer treated on clinical trial.
  • 2. Define safety of conducting a surgical clinical trial in the cooperative group setting for patients with locoregionally advanced pancreatic cancer.
  • 3. Compare postoperative outcomes across treatment arms in the recently completed A021501 phase 2 cooperative group randomized clinical trial for patients with borderline resectable pancreatic adenocarcinoma.