Real-World Regorafenib Outcomes Mirror Clinical Trial Results in Metastatic Colorectal Cancer
CORRECT and CONCUR trials demonstrated an improvement in OS for patients receiving regorafenib compared with placebo.
|The following article features coverage from the ESMO World Congress on Gastrointestinal Cancer 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Treatment of metastatic colorectal cancer (CRC) in a real-world setting demonstrated similar rates of treatment-emergent adverse events (AEs) and survival compared with those observed in clinical trials, according to a study presented at the ESMO World Congress on Gastrointestinal Cancer 2018.1
Regorafenib was demonstrated to improve overall survival (OS) compared with placebo among patients with metastatic CRC in the CORRECT and CONCUR trials. The purpose of this study was to determine the safety and efficacy of regorafenib in a real-world setting.
The international, prospective, observational CORRELATE study included 1037 patients with previously treated metastatic CRC who received regorafenib at enrollment. The median age at baseline was 65, most patients had an ECOG performance status of 0 to 1, and 56% harbored a KRAS mutation.
The starting dose of regorafenib included the approved dose of 160 mg daily, as well as 80 and 120 mg per day. Dose reduction and interruption or delay occurred in 40% and 48% of patients, respectively.
Regorafenib-related AEs occurred in 80% of patients, with 36% of patients developing grade 3 or higher events. The most common grade 3 or higher regorafenib-related AEs included fatigue, hand-foot skin reaction, and hypertension. Regorafenib-related grade 5 reactions occurred in 1% of patients.
The disease control rate was 21%, with 3% of patients experiencing a partial response. The median OS was 7.6 months (95% CI, 7.1-8.2) and the median progression-free survival was 2.8 months (95% CI, 2.6-2.8).
The authors concluded that “AEs were generally consistent with the known safety profile of regorafenib in mCRC, although reported incidence rates of some AEs were lower than in clinical trials.” They noted that median OS and progression-free survival were also similar to those observed in phase 3 trials.
Read more of Cancer Therapy Advisor's coverage of the ESMO World Congress on Gastrointestinal Cancer 2018 meeting by visiting the conference page.
- Ducreux M, Petersen L, Öhler L, et al. Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice: Final analysis from the prospective, observational CORRELATE study. Ann Oncol. 2018;29 (suppl 5;abstr O-012):v104. doi: 10.1093/annonc/mdy149.011