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Evaluation of Regorafenib-induced Pancreatic Enzyme Elevation in Metastatic Colorectal Cancer Treatment.

Ko-Ichi Ohtaki1,2, Riu Takeuchi2, Kuninori Iwayama1,2

  • 1Department of Pharmacology & Therapeutics, Faculty of Pharmaceutical Sciences, Hokkaido University of Science, Sapporo, Japan.

Anticancer Research
|December 30, 2025
PubMed
Summary

Regorafenib frequently causes pancreatic enzyme elevation, mainly lipase, within 28 days of treatment. Prior prolonged anti-VEGF therapy is a key risk factor for this toxicity.

Keywords:
RegorafenibVEGFacute pancreatitisamylaselipasepancreatic enzyme elevationvascular endothelial growth factor

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Area of Science:

  • Oncology
  • Gastroenterology
  • Pharmacology

Background:

  • Regorafenib, a multikinase inhibitor, is a standard treatment for metastatic colorectal cancer (mCRC).
  • Pancreatic enzyme elevation is a known adverse event of regorafenib therapy.
  • Predictors for this adverse event are not well-established in clinical practice.

Purpose of the Study:

  • To identify clinical risk factors for regorafenib-induced pancreatic enzyme elevation.
  • To improve the safe clinical use of regorafenib in mCRC patients.

Main Methods:

  • Retrospective evaluation of 47 mCRC patients treated with regorafenib.
  • Pancreatic enzyme elevation defined by CTCAE grade ≥1 increase in serum lipase or amylase within 28 days.
  • Risk factors assessed via univariate and multivariate logistic regression and sensitivity analyses.

Main Results:

  • Lipase elevation occurred in 48.9% of patients; amylase elevation in 8.5%.
  • Severe elevation (CTCAE grade ≥3) occurred in 17.0% and exclusively involved lipase.
  • Prior anti-VEGF therapy lasting ≥300 days was an independent risk factor (aOR 5.99, p=0.01).

Conclusions:

  • Pancreatic enzyme elevation, primarily lipase, is a common early adverse event of regorafenib.
  • Prolonged anti-VEGF therapy may increase susceptibility to regorafenib-induced pancreatic toxicity.
  • Close patient monitoring is crucial during the initial phase of regorafenib treatment.