Regorafenib plus modified FOLFOX6 as first-line treatment of metastatic colorectal cancer: A phase II trial

Autor: Josep Tabernero, Iain R. Macpherson, Eric Van Cutsem, Al B. Benson, Carmen Guillen Ponce, Andrea Wagner, Dirk Strumberg, Fernando Rivera, Mark P Saunders, Julia Grunert, Stefano Cascinu, Fortunato Ciardiello, Guillem Argiles, Vittorio Luigi Garosi, John Zalcberg, Claus-Henning Köhne, Alberto Sobrero
Přispěvatelé: Argilés, Guillem, Saunders, Mark P., Rivera, Fernando, Sobrero, Alberto, Benson, Al, Guillén Ponce, Carmen, Cascinu, Stefano, Van Cutsem, Eric, Macpherson, Iain R., Strumberg, Dirk, Köhne, Claus-Henning, Zalcberg, John, Wagner, Andrea, Luigi Garosi, Vittorio, Grunert, Julia, Tabernero, Josep, Ciardiello, Fortunato, Köhne, Claus Henning
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Oncology
Male
Survival rate
Cancer Research
Organoplatinum Compounds
Pyridines
medicine.medical_treatment
Pyridine
Leucovorin
Phases of clinical research
Colorectal Neoplasm
chemistry.chemical_compound
FOLFOX
Antineoplastic Combined Chemotherapy Protocols
80 and over
Neoplasm Metastasis
Treatment outcome
Neoadjuvant therapy
Colorectal neoplasms
Fluorouracil
Oxaliplatin
Regorafenib
Safety
Adenocarcinoma
Adult
Aged
Aged
80 and over
Colorectal Neoplasms
Female
Historically Controlled Study
Humans
Middle Aged
Neoadjuvant Therapy
Phenylurea Compounds
Treatment Outcome
Medicine (all)
Neoplasm Metastasi
Tolerability
medicine.drug
Human
Phenylurea Compound
medicine.medical_specialty
Internal medicine
medicine
Antineoplastic Combined Chemotherapy Protocol
business.industry
Organoplatinum Compound
chemistry
business
Popis: Background The oral multikinase inhibitor regorafenib improves overall survival (OS) in patients with metastatic colorectal cancer (CRC) for which all standard treatments have failed. This study investigated regorafenib plus modified FOLFOX (mFOLFOX6) as first-line treatment of metastatic CRC. Methods In this single-arm, open-label, multicentre, phase II study, patients received mFOLFOX6 on days 1 and 15, and regorafenib 160 mg orally once daily on days 4-10 and 18-24 of each 28-day cycle. The primary end-point was centrally assessed objective response rate (ORR). Secondary end-points included disease control rate (DCR), OS, progression-free survival (PFS) and safety. Results Median overall treatment duration with any study drug was 9.9 months (range 0.6-19.6); median treatment duration with regorafenib was 7.7 months (range 0.1-19.5); six patients remained on regorafenib for more than 1 year. Fifty-three patients received at least one dose of regorafenib. ORR was 43.9% (all partial responses); DCR was 85.4%; median OS was not reached; median PFS was 8.5 months. Treatment-emergent adverse events were experienced by all patients but were manageable with dose modifications. Conclusion Regorafenib + mFOLFOX6 as first-line treatment in patients with metastatic CRC did not improve ORR over historical controls. Regorafenib plus mFOLFOX6 did not appear to be associated with a markedly worse tolerability profile versus mFOLFOX6 alone. ClinicalTrials.gov identifier: NCT01289821.
Databáze: OpenAIRE
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