TY - JOUR
T1 - Regorafenib plus modified FOLFOX6 as first-line treatment of metastatic colorectal cancer: A phase II trial
AU - Argiles, Guillem
AU - Saunders, Mark P
AU - Rivera, Fernando
AU - Sobrero, Alberto
AU - Benson III, Al
AU - Ponce, Carmen Guillen
AU - Cascinu, Stefano
AU - Van Cutsem, Eric
AU - Macpherson, Iain R
AU - Strumberg, Dirk
AU - Kohne, Claus-Henning
AU - Zalcberg, John Raymond
AU - Wagner, Andrea
AU - Garosi, Vittorio Luigi
AU - Grunert, Julia
AU - Tabernero, Josep
AU - Ciardiello, Fortunato
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
UR - http://www.sciencedirect.com/science/article/pii/S0959804915002130
U2 - 10.1016/j.ejca.2015.02.013
DO - 10.1016/j.ejca.2015.02.013
M3 - Article
SN - 0959-8049
VL - 51
SP - 942
EP - 949
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - 8
ER -
