Researchers have found that among patients with hepatocellular carcinoma (the most common liver cancer) that is unresectable (cannot be removed by surgery) and Child-Pugh-B liver function (CP-B; meaning they are experiencing moderate to severe liver disease) who are being treated with Stivarga (regorafenib) were more likely to experience serious side effects which could lead to treatment discontinuation, and that patients with poor liver function also have a lower median overall survival (OS; the time following treatment that a patient lives regardless of disease status).
Study findings presented during a poster session at the 2024 Gastrointestinal Cancers Symposium from the observational REFINE study drew on a pool of 1,005 evaluable patients, 123 of whom (12%) were classified as having CP-B. Of those 84 (68%) were specifically classified as having CP-B7. In the overall studied population, the median patient age was 66; 83% were male; 56% were Asian; 82% had an ECOG score of 0 or 1, meaning that they could perform all or most of their daily tasks independently; 62% had stage 3 liver cancer; and metastases were present in 59%.
Median OS was 13.2 months in the overall patient population, 6.3 months among CP-B patients and 6.7 months for patients specifically with CP-B7 disease, according to the poster.
“In this study, researchers observed patients who were prescribed (Stivarga) as part of their liver cancer treatment in real-world clinical practice (i.e., not as part of a controlled clinical trial) and were diagnosed with poor liver function,” the researchers wrote in the poster. “Researchers found that in patients with non-operable primary liver cancer, those with poor liver function were more likely to experience serious side effects, and this led to discontinuation of (Stivarga) treatment in some patients. More research is needed in patients with non-operable primary liver cancer and poor liver function to identify specific patients who could benefit from (Stivarga) treatment.”
Regarding prior treatments received by the overall studied population, 58% (584 patients) had been treated with transarterial chemoembolization, 96% (965 patients) were treated with sorafenib and 10% (97 patients) had received an immune checkpoint inhibitor.
Researchers reported that among CP-B patients, 33%, 15% and 47% initiated Stivarga treatment at 160 mg, 120 mg and 80 mg daily, respectively, with a median duration of Stivarga treatment of 3.7 months overall and 2.3 (range, 0.0 to 32.7) months for CP-B patients.
Treatment-emergent side effects occurred in 92% of patients overall and 93% of CP-B patients, with drug-related side effects occurring in 74% and 70% of patients, respectively, according to the research.
Grades 3 or 4 side effects occurred in 39% of patients overall and 41% of CP-B patients and were drug-related in 26% and 27% of patients, respectively, while serious side effects were observed in 37% of patients overall and 48% of CP-B patients and drug-related in 9% and 11% of patients, respectively. Drug-related side effects resulted in dose modifications for 37% of overall patients and 28% of CP-B patients and permanent treatment discontinuation among 16% of patients overall and 28% of CP-B patients.
The most common side effects among the overall patient population were hand-foot skin reaction, diarrhea, fatigue, decreased appetite, hypertension, abdominal pain and asthenia. Fatigue, decreased appetite and abdominal pain were higher in CP-B patients, while hand-foot skin reaction and hypertension were lower when compared to the general patient population.
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