The Brown University Oncology Group Experience With FOLFOX + Nab-paclitaxel [FOLFOX-A] for Metastatic and Locally Advanced Pancreatic, BrUOG-292 and BrUOG-318

• Published in: American journal of clinical oncology Vol. 45; no. 8; pp. 327 - 332
• Main 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
• Format: Journal Article
• Language: English
• Published: United States Lippincott Williams & Wilkins 01-08-2022
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Albumins; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Fluorouracil; Humans; Leucovorin; Organoplatinum Compounds; Original : Gastrointestinal; Oxaliplatin; Paclitaxel - therapeutic use; Pancreatic Neoplasms; Pancreatic Neoplasms - pathology; Prospective Studies
• ISSN: 0277-3732; 1537-453X
• DOI: 10.1097/COC.0000000000000928

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].
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.
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%].
The combination of FOLFOX-A has promising activity in PDAC and may represent an alternative to FOLFIRINOX when reduction of gastrointestinal toxicity is required.