The Brown University Oncology Group Experience With FOLFOX + Nab-paclitaxel [FOLFOX-A] for Metastatic and Locally Advanced Pancreatic, BrUOG-292 and BrUOG-318. (23rd August 2022)

• Record Type: Journal Article
• Authors: Breakstone, Rimini; Almhanna, Khaldoun; Raufi, Alexander; Beard, Rachel E.; Leonard, Kara-Lynne; Renaud, Jennifer; Kastura, Michaela; Dionson, Sopha; Wood, Roxanne; Sturtevant, Ashlee; Dipetrillo, Thomas; Olszewski, Adam; Safran, Howard
• Is Part Of: American journal of clinical oncology. Volume 45:Number 8(2022)
• Page Start: 327
• Page End: 332
• Publication Date: 2022-08-23
• Subjects: pancreatic adenocarcinoma -- pancreatic cancer -- locally advanced pancreatic adenocarcinoma -- borderline resectable pancreatic adenocarcinoma -- stage IV pancreatic cancer -- metastatic pancreatic cancer -- FOLFOX-Abraxane; Cancer -- Treatment -- Periodicals; Oncology -- Periodicals; Tumors -- Periodicals; 616.994005
• DOI: 10.1097/COC.0000000000000928
• Languages: English
• ISSNs: 0277-3732

Abstract

Abstract : Objectives: To evaluate response rate, toxicity, and efficacy of the novel combination of nab-paclitaxel, oxaliplatin, 5-fluorouracil, and leucovorin [FOLFOX-A] in patients with advanced pancreatic ductal adenocarcinoma [PDAC]. Methods: BrUOG-292 and BrUOG-318 were two concurrently run, prospective, single-arm phase II studies evaluating FOLFOX-A as first-line therapy in patients with metastatic and locally advanced/borderline resectable PDAC respectively. The FOLFOX-A regimen consisted of 5-fluorouracil, 1200 mg/m 2 /d as a continuous intravenous (IV) infusion over 46 hours, leucovorin 400 mg/m 2 IV, oxaliplatin 85 mg/m 2 IV, and nab-paclitaxel 150 mg/m 2 IV on day 1 every 14 days up to a maximum of 12 cycles. Patients with locally advanced or borderline resectable disease were permitted to stop treatment after 6 cycles and receive radiation therapy and/or surgical exploration if feasible. The primary end point was overall response rate [ORR]. Secondary end points were median progression-free survival [PFS], median overall survival [OS], and safety. Results: Seventy-eight patients with previously untreated PDAC were enrolled between June 2014 and November 2019; 76 patients were evaluable. The median follow-up was 40 months and 32 months, respectively. overall response rate was 34%. Among the patients enrolled on BrUOG-292 [48 patients], the PFS was 5 months and OS was 11 months, respectively. For those enrolled on BrUOG 318 [28 patients], the PFS was 11 months and OS was 22 months. Treatment-related toxicities included grade 3 fatigue [40%], diarrhea [14%], and neuropathy [2%]. Conclusions: The combination of FOLFOX-A has promising activity in PDAC and may represent an alternative to FOLFIRINOX when reduction of gastrointestinal toxicity is required.