RT Journal Article
T1 Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study.
A1 Van Cutsem, Eric
A1 Martinelli, Erika
A1 Cascinu, Stefano
A1 Sobrero, Alberto
A1 Banzi, Maria
A1 Seitz, Jean-François
A1 Barone, Carlo
A1 Ychou, Marc
A1 Peeters, Marc
A1 Brenner, Baruch
A1 Hofheinz, Ralf Dieter
A1 Maiello, Evaristo
A1 André, Thierry
A1 Spallanzani, Andrea
A1 Garcia-Carbonero, Rocio
A1 Arriaga, Yull E
A1 Verma, Udit
A1 Grothey, Axel
A1 Kappeler, Christian
A1 Miriyala, Ashok
A1 Kalmus, Joachim
A1 Falcone, Alfredo
A1 Zaniboni, Alberto
K1 Metastatic colorectal cancer
K1 Prospective studies
K1 Regorafenib
K1 Toxicities
AB In the phase III CORRECT trial, regorafenib significantly improved survival in treatment-refractory metastatic colorectal cancer (mCRC). The CONSIGN study was designed to further characterize regorafenib safety and allow patients access to regorafenib before market authorization. This prospective, single-arm study enrolled patients in 25 countries at 186 sites. Patients with treatment-refractory mCRC and an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1 received regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle. The primary endpoint was safety. Progression-free survival (PFS) per investigator assessment was the only efficacy evaluation. In total, 2,872 patients were assigned to treatment and 2,864 were treated. Median age was 62 years, ECOG PS 0/1 was 47%/53%, and 74% had received at least three prior regimens for metastatic disease. Median treatment duration was three cycles. Treatment-emergent adverse events (TEAEs) led to dose reduction in 46% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 9%. Grade 5 regorafenib-related TEAEs occurred in  In CONSIGN, the frequency and severity of TEAEs were consistent with the known safety profile of regorafenib. PFS was similar to reports of phase III trials. ClinicalTrials.gov: NCT01538680. Patients with metastatic colorectal cancer (mCRC) who fail treatment with standard therapies, including chemotherapy and monoclonal antibodies targeting vascular endothelial growth factor or epidermal growth factor receptor, have few treatment options. The multikinase inhibitor regorafenib was shown to improve survival in patients with treatment-refractory mCRC in the phase III CORRECT (N = 760) and CONCUR (N = 204) trials. However, safety data on regorafenib for mCRC in a larger number of patients were not available. The CONSIGN trial, carried out prospectively in more than 2,800 patients across 25 countries, confirmed the safety profile of regorafenib from the phase III trials and reinforced the importance of using treatment modifications to manage adverse events.
YR 2018
FD 2018-09-06
LK http://hdl.handle.net/10668/12916
UL http://hdl.handle.net/10668/12916
LA en
DS RISalud
RD Apr 7, 2025