Postoperative adverse events following neoadjuvant therapy and surgery for borderline resectable pancreatic cancer in a phase 2 clinical trial (Alliance A021501) Journal Article
| Authors: | Snyder, R. A.; Zemla, T. J.; Shi, Q.; Segovia, D.; Ahmad, S. A.; O’Reilly, E. M.; Herman, J. M.; Katz, M. H. G. |
| Article Title: | Postoperative adverse events following neoadjuvant therapy and surgery for borderline resectable pancreatic cancer in a phase 2 clinical trial (Alliance A021501) |
| Abstract: | Background: Postoperative adverse events (AEs) in patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PC) treated with neoadjuvant therapy and pancreatectomy in the national cooperative group setting have not been previously characterized. We conducted a preplanned secondary analysis of patients enrolled on the Alliance A021501 clinical trial to quantify perioperative AE rates. Methods: The A021501 phase 2 trial randomized patients with BR-PC to receive 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX and hypofractionated radiotherapy (Arm 2), followed by pancreatectomy (December 31, 2016 to May 31, 2019). Adverse events were assessed 90 days after pancreatectomy. Results: Of 126 enrolled patients, 51 (40%) underwent pancreatectomy (n = 32, Arm 1; n = 19, Arm 2) at 28 institutions. Five (10%) patients required reoperation within 90 days; 56% of patients (n = 27/48) experienced at least one grade 3 or higher AE (50% vs. 67%, p = 0.37). Ninety-day mortality was 2.0%. Readmission was less frequent in Arm 1 (16% vs. 42%, p = 0.05), but there were no differences between study arms in rates of reoperation (13% vs. 5%), pancreatic fistula or intra-abdominal abscess requiring drainage (9% vs. 16%), or wound infection (6% vs. 16%). Pancreatic fistula or intra-abdominal abscess requiring drainage was associated with receipt of adjuvant therapy (p = 0.012). No difference in overall survival was observed based on occurrence of postoperative AEs (hazard ratio = 1.1; 95% confidence interval 0.5–2.6). Conclusions: In this multicenter study, rates of postoperative AEs were consistent with those previously reported. Multimodality trials of preoperative therapy for BR-PC may be performed in the cooperative group setting with careful quality assurance and safety monitoring. Trial Registration: Clinicaltrials.gov identifier: NCT02839343 © Society of Surgical Oncology 2024. |
| Keywords: | adult; cancer survival; controlled study; aged; middle aged; cancer surgery; survival rate; major clinical study; overall survival; clinical trial; fatigue; fluorouracil; diarrhea; multimodality cancer therapy; cancer adjuvant therapy; pancreas cancer; combined modality therapy; neoadjuvant therapy; pancreatic neoplasms; follow up; follow-up studies; antineoplastic agent; pancreaticoduodenectomy; phase 2 clinical trial; sensory neuropathy; tumor volume; randomized controlled trial; antineoplastic combined chemotherapy protocols; abdominal abscess; ca 19-9 antigen; carcinoma, pancreatic ductal; obesity; pathology; irinotecan; postoperative complication; postoperative complications; hypoalbuminemia; multicenter study; folinic acid; pancreas tumor; reoperation; pancreatectomy; surgery; hyperbilirubinemia; pancreatic cancer; hospital readmission; oxaliplatin; stereotactic body radiation therapy; personal experience; perioperative chemotherapy; wound infection; folinate calcium; leucovorin; chemoradiation; disease exacerbation; therapy; distal pancreatectomy; cholestasis; underweight; secondary analysis; etiology; pancreas fistula; pancreatic ductal carcinoma; preoperative radiotherapy; vascular surgery; image guided radiotherapy; preoperative chemotherapy; body weight loss; postoperative nausea; hypofractionated radiotherapy; humans; prognosis; human; male; female; article; folfirinox; multidisciplinary team; ecog performance status; borderline resectable pancreatic cancer |
| Journal Title: | Annals of Surgical Oncology |
| Volume: | 31 |
| Issue: | 10 |
| ISSN: | 1068-9265 |
| Publisher: | Springer |
| Date Published: | 2024-10-01 |
| Start Page: | 7033 |
| End Page: | 7042 |
| Language: | English |
| DOI: | 10.1245/s10434-024-15670-6 |
| PUBMED: | 39008208 |
| PROVIDER: | scopus |
| PMCID: | PMC11566132 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
