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Kütüphanede Ara Ara

New Indication: Neoadjuvant FOLFIRINOX for locally advanced rectal cancer

New Indication: Neoadjuvant FOLFIRINOX for locally advanced rectal cancer
Study:
  • Randomized, open-label phase III (UNICANCER-PRODIGE 23)
  • Newly diagnosed cT3/T4M0 rectal adenoCa
  • Arm A: 6 cycles of FOLFIRINOX => Chemoradiotherapy (50 Gy with capecitabine) => Surgery => Adjuvant chemo (mFOLFOX6 or capecitabine) x 3 mos
  • Arm B: Chemoradiotherapy => Surgery => Adjuvant chemo x 6 mos
Efficacy:
  • Metastatic progression @ pre-op CT: 1% vs. 5%
  • Proceeded to surgery: 92% vs. 95%
  • Two patients who refused surgery in Arm A are in CR @ 5 yr follow-up
  • Definitive colostomy: 14% vs. 15%
  • R0 resection: 95% vs. 94%
  • Pathological CR: 28% vs. 12% (p <0.0001)
  • Post-op morbidity rates similar
  • DFS @ 3 yrs: 76% vs. 69% (HR: 0.69 [0.49-0.97])
  • OS @ 3 yrs: 91% vs. 88%
Safety:
  • Grade >=3 AEs during neoadj FOLFIRINOX: Neutropenia (12%), febrile neutropenia (1%), thrombocytopenia (1%), anemia (1%), fatigue (7%), diarrhea (9%), vomiting (4%), neuropathy (2%), thromboembolic event (3%)

Lancet Oncol 2021; 22: 702–15

Conroy T, et al. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial

https://doi.org/10.1016/S1470-2045(21)00079-6

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