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Votrient-induced hepatotoxicity common in renal cancer patients

Hepatotoxicity due to treatment with Votrient was common in patients with metastatic renal cancer, according to study data presented at the European Society for Medical Oncology’s European Cancer Congress.

“Hepatotoxicity has been observed in about 40% to 50% of renal cancer patients treated with pazopanib in clinical trials,” the researchers wrote. “We have analyzed the incidence of pazopanib-induced liver toxicity in a real-world setting.”

Researchers retrospectively analyzed 89 patients with metastatic renal cancer from two cancer centers in Birmingham, United Kingdom, treated with Votrient (pazopanib, Novartis) between December 2010 and September 2014. The median age of the cohort was 65 years; 59 patients were male, 25% patients had liver metastases, 66% had previous nephrectomy, 75% had performance status (PS) 0-1 renal cancer, and 25% had PS 2-3.

The median duration of treatment was 25.14 weeks, with 34 patients still undergoing therapy and 50 alive at the time of analysis, according to the abstract.

Overall, 30% of patients developed hepatotoxicity (n = 27). The median duration of therapy before hepatotoxicity was 5.9 weeks. The median duration of therapy for patients with hepatotoxicity was 34.4 weeks. Ten patients showed an all grades increase in bilirubin level, and 23 patients had an all grades increase in alanine aminotransferase (ALT). Four patients had a grade 3 or 4 increase in bilirubin; six patients had a grade 3 or 4 increase in ALT.

Overall, five patients stopped therapy with pazopanib, while two temporarily discontinued treatment.

The median duration of hepatotoxicity was 7.71 weeks, and 10 patients with hepatotoxicity remain on treatment. The median overall survival for patients with hepatotoxicity was 17.5 months.

Fifty-three patients discontinued treatment with pazopanib; 36 experienced disease progression, 10 had nonhepatic toxicity and five showed evidence of hepatotoxicity. Two discontinued for other reasons.

“Due to advanced age [and/or] comorbidities, 35 patients commenced treatment at a reduced dose,” the researchers wrote. “In these patients, incidence of liver toxicity did not differ from those treated with a full dose.

The researchers concluded: “Our data shows lower hepatotoxicity rates as compared to clinical trials. Reassuringly, most of the cases were mild and settled without treatment modifications. Frequency of hepatotoxicity was not affected by age, performance status or presence of liver metastases.”

Reference:

Jain A, et al. Abstract 2604. Presented at: European Cancer Congress; Sept. 25-29, 2015; Vienna.

Disclosure: The researchers report no relevant financial disclosures.