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Efficacy, safety and prognostic subgroups for outcome with regorafenib in patients with refractory metastatic colorectal cancer in the real-world setting: The CORE study
Background
CORRECT trial has shown a survival benefit for regorafenib over placebo in patients with metastatic colorectal cancer (mCRC) that progressed after standard therapies. We evaluated survival, safety and prognostic subgroups in patients treated with regorafenib in a real-life setting.
Methods
Retrospective, multicenter, observational study of patients (pts) with mCRC treated with Regorafenib (REG) after failure to standard therapies as part of routine clinical practice at 7 hospitals from the Galician Research Group on Digestive Tumors (GITuD).
Results
We recorded 130 pts treated with REG between September 2013 to December 2019. Median age was 63 years (range 27-79), 94.6% ECOG PS0-1, 55.4% RASmt and 1.5% BRAFmt, 18% time since initial diagnosis 3 metastatic locations and 75% liver metastases. Prior therapy included a median of 3 lines of treatment (range 2-8), including Trifluridine/Tipiracil in 29.2% of pts. FAS-CORRECT 0-3/4-5/6+ were 32.6%/35.7%/38.1% and Tabernero subgroups BPC/GPC/PPC were 20%/42.3%/37.3%. Median of REG cycles was 3 (range 1-18 cycles). With a median follow up of 23.4 months, median OS was 6.7 months (95% CI, 6.1-7.3 months) with 12- month OS rate 20.8% and median PFS was 2.9 months (95% CI, 2.7-3.0 months) with 6-month PFS rate 14.6%. Overall Response Rate (ORR) and Disease Control Rate (DCR) were 4.6% and 25.4%, respectively. The most common grade 3-4 toxicities were asthenia (12.3%), hyperbilirubinaemia (6.4%), hypertension (3.9%) and hand-foot skin reaction (3.9%). This toxicity was managed with dose reduction in 39.2 % of cases. OS FAS-CORRECT 0-3/4-5/6+ were 9.2 vs. 6.9 vs. 5.3 m (p=0.138) and OS Tabernero subgroups BPC/GPC/PPC were 10.5 vs. 6.9 vs. 5.2 m (p=0.022). DCR FAS-CORRECT 0-3/4-5/6+ were 37.5% vs. 28.5% vs. 22.9% (p=0.121) and DCR Tabernero subgroups BPC/GPC/PPC were 48% vs. 21.1% vs. 24.4% (p=0.004).
Conclusions
OS and PFS observed in our serie were consistent with the CORRECT trial, although in our routine clinical practice they were slightly higher. FAST-CORRECT and, especially, Tabernero's prognostic subgroups identify patients who may benefit from long-term Regorafenib treatment.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosures
A. Fernández Montes: Advisory / Consultancy: Bayer; Speaker Bureau / Expert testimony: Bayer. All other authors have declared no conflicts of interest.
