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  • Tabernero, JosepVall dHebron Hosp Campus, Barcelona 08035, Spain.;IOB Quiron, Inst Oncol VHIO, Barcelona, Spain.;UV UCC, Inst Oncol VHIO, IOB Quiron, Barcelona 08035, Spain. (author)

A Randomized Phase III Study of Arfolitixorin versus Leucovorin with 5-Fluorouracil, Oxaliplatin, and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer : The AGENT Trial

  • Article/chapterEnglish2024

Publisher, publication year, extent ...

  • American Association For Cancer Research (AACR),2024
  • electronicrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-527983
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-527983URI
  • https://doi.org/10.1158/2767-9764.CRC-23-0361DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • Purpose:Suboptimal treatment outcomes with 5-fluorouracil (5-FU)/folate, the standard of care for metastatic colorectal cancer (mCRC), have generated interest in optimizing the folate. Arfolitixorin ([6R]-5,10-methylene-tetrahydrofolate) is an immediately active folate and may improve outcomes over the existing standard of care (leucovorin).Experimental Design:AGENT was a randomized, phase III study (NCT03750786). Patients with mCRC were randomized to arfolitixorin (120 mg/m2 given as two intravenous bolus doses of 60 mg/m2) or leucovorin (400 mg/m2 given as a single intravenous infusion) plus 5-FU, oxaliplatin, and bevacizumab. Assessments were performed every 8 weeks. The primary endpoint was the superiority of arfolitixorin for overall response rate (ORR).Results:Between February 2019 and April 2021, 490 patients were randomized (245 to each arm). After a median follow-up of 266 days, the primary endpoint of superiority for ORR was not achieved (48.2% for arfolitixorin vs. 49.4% for leucovorin, Psuperiority = 0.57). Outcomes were not achieved for median progression-free survival (PFS; 12.8 and 11.6 months, P = 0.38), median duration of response (12.2 and 12.9 months, P = 0.40), and median overall survival (23.8 and 28.0 months, P = 0.78). The proportion of patients with an adverse event of grade ≥3 severity was similar between arms (68.7% and 67.2%, respectively), as was quality of life. BRAF mutations and MTHFD2 expression were both associated with a lower PFS with arfolitixorin.Conclusions:The study failed to demonstrate clinical benefit of arfolitixorin (120 mg/m2) over leucovorin. However, it provides some useful insights from the first-line treatment setting, including the effect of gene expression on outcomes.Significance:This phase III study compared arfolitixorin, a direct-acting folate, with leucovorin in FOLFOX plus bevacizumab in mCRC. Arfolitixorin (120 mg/m2) did not improve the ORR, potentially indicating a suboptimal dose.

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  • Yoshino, TakayukiNatl Canc Ctr Hosp East, Dept Gastroenterol & Gastrointestinal Oncol, Kashiwa, Japan. (author)
  • Stintzing, SebastianCharite Univ Med Berlin, Dept Hematol Oncol & Canc Immunol, Berlin, Germany. (author)
  • de Gramont, AimeryInst Hosp Franco Britannique, Oncol Med, Levallois Perret, France. (author)
  • Gibbs, PeterSunshine Hosp, Western Hlth, Med Oncol, St Albans, Vic, Australia. (author)
  • Jonker, Derek J.Univ Ottawa, Ottawa Hosp Res Inst, Ottawa, ON, Canada. (author)
  • Nygren, PeterUppsala universitet,Cancerprecisionsmedicin(Swepub:uu)peterng (author)
  • Papadimitriou, ChristosNatl & Kapodistrian Univ Athens, Aretaieion Univ Hosp, Oncol Unit, Athens, Greece. (author)
  • Prager, Gerald W.Med Univ Wien, Vienna, Austria. (author)
  • Tell, RogerIsofol Med AB, Gothenburg, Sweden. (author)
  • Lenz, Heinz-JosefUniv Southern Calif, Keck Sch Med, Div Med Oncol & Colorectal Canc, Los Angeles, CA USA. (author)
  • Vall dHebron Hosp Campus, Barcelona 08035, Spain.;IOB Quiron, Inst Oncol VHIO, Barcelona, Spain.;UV UCC, Inst Oncol VHIO, IOB Quiron, Barcelona 08035, Spain.Natl Canc Ctr Hosp East, Dept Gastroenterol & Gastrointestinal Oncol, Kashiwa, Japan. (creator_code:org_t)

Related titles

  • In:Cancer Research Communications: American Association For Cancer Research (AACR)4:1, s. 28-372767-9764

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