TRIPLETE: a randomised phase III study of modified FOLFOXIRI plus panitumumab versus mFOLFOX6 plus panitumumab as initial therapy for patients with unresectable RAS and BRAF wild-type metastatic colorectal cancer.

ESMO Open
Beatrice BorelliAlfredo Falcone

Abstract

FOLFOXIRI plus bevacizumab is considered a standard option in the upfront treatment of clinically selected patients with metastatic colorectal cancer irrespective of RAS and BRAF molecular status. The randomised MACBETH and VOLFI studies showed that a modified FOLFOXIRI regimen in combination with cetuximab or panitumumab, respectively, achieved high therapeutic activity in RAS and BRAF wild-type patients with an acceptable toxicity profile. Drawing from these considerations, we designed TRIPLETE study aiming at comparing two different chemotherapy backbones (mFOLFOXIRI or mFOLFOX6) in combination with panitumumab in the first-line treatment of patients with RAS and BRAF wild-type metastatic colorectal cancer. This is a prospective, open-label, multicentre phase III trial in which initially unresectable and previously untreated RAS and BRAF wild-type metastatic colorectal cancer patients are randomised to receive a standard treatment with mFOLFOX6 plus panitumumab or an experimental regimen with modified FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, L-leucovorin 200 mg/m2, 5-fluoruracil 2400 mg/m2 48-hour continuous infusion) plus panitumumab up to 12 cycles, followed by panitumumab plus 5-fluorouracil and L-leucovorin...Continue Reading

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Citations

May 18, 2020·Cancers·Eleonora LaiMario Scartozzi
Aug 21, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Chiara CremoliniMassimo Di Maio
Nov 15, 2020·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Karen BolhuisCornelis J A Punt
Jan 9, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E MartinelliF Ciardiello
Sep 18, 2021·Expert Opinion on Pharmacotherapy·Jane E Rogers, Arvind Dasari

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Clinical Trials Mentioned

NCT03231722

Software Mentioned

VOLFI

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