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[Serum pancreatic enzyme elevation under treatment with sorafenib]
Ichinosuke Hyodo1, Masatoshi Adachi, Taiji Tsukamoto
1Dept. of Gastroenterology, Graduate School of Comprehensive Human Science, University of Tsukuba.
Objective:
Sorafenib is an oral multi-kinase inhibitor of Raf-1, VEGF and PDGF receptors and others, resulting in tumor regression and anti-angiogenesis. We studied serum pancreatic enzyme increase associated with sorafenib treatment.
Patients And Methods:
In a phase II study of Japanese patients with metastatic renal cell carcinoma, a total of 131 patients received sorafenib 400 mg twice per day. Serum levels of lipase and amylase were measured on day 7 and every 3-4 weeks thereafter during treatment period. When grade 3 or 4 enzyme abnormalities were observed, ultrasound or computed tomography scan was performed to detect pancreatitis.
Results:
The incidence of all-grades lipase and amylase increases were 55. 7% and 38. 2%, respectively, while those of grade 3 or 4 were 30. 5% and 5. 3%, respectively. The majority of these events were observed in the first 3 weeks of sorafenib treatment. Grade 3 or 4 lipase increase was detected in 32 patients (24. 4%)on day 7 measurement. These abnormal elevations spontaneously resolved in all patients. Regarding grade 3 lipase increase, the median time to recovery to grade 2 and 1 were 7 and 14 days, respectively. Three patients required interruption of the treatment. No patient showed any clinical manifestation or abnormal imaging finding suggesting pancreatitis.
Conclusion:
Pancreatic enzyme increases observed frequently under sorafenib treatment were transient and asymptomatic. They were not related to symptomatic pancreatitis.
Insights
Sorafenib treatment frequently caused temporary increases in pancreatic enzymes like lipase and amylase in patients with metastatic renal cell carcinoma. These elevations were asymptomatic and did not indicate pancreatitis.
Area of Science:
- Oncology
- Pharmacology
Background:
- Sorafenib is a multi-kinase inhibitor targeting tumor growth and angiogenesis.
- Monitoring serum pancreatic enzymes is crucial during sorafenib therapy.
Purpose of the Study:
- To investigate the incidence and characteristics of serum pancreatic enzyme increases during sorafenib treatment.
- To determine the association between sorafenib and pancreatitis.
Main Methods:
- A Phase II study involved 131 Japanese patients with metastatic renal cell carcinoma receiving sorafenib.
- Serum lipase and amylase levels were monitored regularly.
- Imaging studies were performed for significant enzyme elevations to assess for pancreatitis.
Main Results:
- Elevated lipase and amylase occurred in 55.7% and 38.2% of patients, respectively.
- Grade 3 or 4 elevations were observed in 30.5% (lipase) and 5.3% (amylase), primarily within the first 3 weeks.
- All enzyme elevations were transient and asymptomatic, with no cases of symptomatic pancreatitis.
Conclusions:
- Sorafenib treatment frequently leads to transient and asymptomatic increases in pancreatic enzymes.
- These enzyme elevations are not indicative of symptomatic pancreatitis.
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