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

Autor:	Breakstone R; Warren Alpert School of Medicine at Brown University., Almhanna K; Warren Alpert School of Medicine at Brown University., Raufi A; Warren Alpert School of Medicine at Brown University., Beard RE; Warren Alpert School of Medicine at Brown University., Leonard KL; Rhode Island Hospital, The Rhode Island Hospital/Lifespan Cancer Institute and The Brown University Oncology Research Group, Providence, RI., Renaud J; Lifespan Cancer Institute., Kastura M; Lifespan Cancer Institute., Dionson S; Lifespan Cancer Institute., Wood R; Warren Alpert School of Medicine at Brown University., Sturtevant A; Warren Alpert School of Medicine at Brown University., Dipetrillo T; Rhode Island Hospital, The Rhode Island Hospital/Lifespan Cancer Institute and The Brown University Oncology Research Group, Providence, RI., Olszewski A; Warren Alpert School of Medicine at Brown University., Safran H; Warren Alpert School of Medicine at Brown University.
Jazyk:	angličtina
Zdroj:	American journal of clinical oncology [Am J Clin Oncol] 2022 Aug 01; Vol. 45 (8), pp. 327-332. Date of Electronic Publication: 2022 Jun 23.
DOI:	10.1097/COC.0000000000000928
Abstrakt:	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. Competing Interests: The authors declare no conflict of interest. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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