The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Regorafenib may prolong survival for patients with metastatic colorectal cancer (CRC) even if the disease progresses with a regimen of trifluridine/tipiracil plus bevacizumab (TFTD+B).

Why This Matters

  • Regorafenib and TFTD+B are both standard salvage options for metastatic CRC.

  • The effect of using them sequentially has not previously been reported.

  • The results suggest that regorafenib is a sound option after TFTD+B failure.

Study Design

  • Investigators reviewed outcomes of 34 patients with metastatic CRC who received regorafenib after TFTD+B between April 2017 and June 2020.

  • The median age of the patients was 66.5 years; 11 patients were male; all had an ECOG performance status of 0 or 1; 22 patients had left-sided tumors, 18 had RAS mutations, and one had a BRAF V600E mutation.

Key Results

  • The response rate was 0%, but the disease control rate was 31%.

  • Median progression-free survival was 70 days, and median overall survival was 233 days; the results are in line with previous reports for salvage regorafenib.

  • There was no statistically significant survival difference between patients with RAS-wild disease and those with RAS-mutant disease.

  • For most patients, the initial dose was 120 mg; for the rest of the patients, starting doses were 80 mg or 160 mg, split evenly among them.

  • Overall, 32 patients discontinued treatment; 28 (82%) discontinued because of disease progression.

  • Starting dose did not correlate with effect, but higher doses were linked to more serious adverse events.

  • The major grade 3–4 toxicities were proteinuria (29%), hypertension (26%), hand-foot syndrome (15%), and platelet decrease (6%).

  • There were no new regorafenib safety signals.

Limitations

  • It was a retrospective study with a small sample size.

Disclosures

  • The study received no funding, and the investigators have disclosed no relevant financial relationships.

This is a summary of a preprint research study, “Regorafenib Is Suitable for Advanced Colorectal Cancer Patients Who Have Previously Received Trifluridine/Tipiracil Plus Bevacizumab,” led by Toshihiko Matsumoto of Kobe City Medical Center General Hospital, Japan. The study has not been peer reviewed. The full text can be found at researchsquare.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape and is an MIT Knight Science Journalism fellow. Email: [email protected]

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