Background:

First and second line standard treatment in patients with metastatic colorectal cancer (mCRC) is with chemotherapy +/- some monoclonal antibody according to the RAS biomarker report. About 30-40% of them will require a third line of therapy, where regorafenib has been approved due to overall and progression-free survival positive results.

Objective:

The objective of the study was to describe the Mexican experience with the use of regorafenib in patients with mCRC.

Methods:

This was a multi-center, retrospective study where medical records of heavily treatment-experienced mCRC-diagnosed patients who had received at least one cycle of regorafenib were reviewed. Descriptive and inferential statistics were performed, with the Kaplan–Meier method being used for survival calculation using the SPSS v. 23 software.

Results:

Forty-five patients with metastatic colorectal adenocarcinoma were included in the study; 18 were females and 27 males, with a mean age of 51 (± 10.3) years. There was previous history of diabetes mellitus in nine cases and arterial hypertension in four, with an ECOG 1 performance status being found in all patients. Primary tumor sites were the colon (23 patients) and rectum (22). KRAS oncogene determination was obtained in 35 patients, out of which 16 were wild-type (46%). All patients had been previously treated with chemotherapy ± monoclonal antibodies, radical surgery, and radiotherapy (where indicated). Primary metastatic sites were: the liver (24 cases), lung (21), retroperitoneum (10), and peritoneum (7). Mean number of regorafenib cycles was 4 (1-13), with initial doses being 160 mg (20 patients), 120 mg (18), and 80 mg (7), with one daily take for 3 weeks and 1-week rest. In 28 patients, regorafenib was started 18 months after metastatic disease diagnosis. Treatment response was partial in four cases (9%), stable disease in 21 (47%), progressive disease in 15 (33%), and not evaluable in five patients. Median survival for the entire group was 6.0 months (1-16 months). Main identified grade 3-4 toxicities were hand-foot syndrome, fatigue, skin dryness, stomatitis, and diarrhea.

Discussion and Conclusions:

Regorafenib overall survival benefit in heavily treated mCRC in the Mexican population is confirmed and correlates with the 2 Phase II trials CORRECT and CONCUR, with manageable toxicity. In the population with an interval > 18 months since metastasis onset at regorafenib start, with an ECOG 0-1 and no monoclonal antibodies previous use, regorafenib was correlated with higher survival.

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