The findings were presented at the 2012 meeting of the European Society of Medical Oncology in Vienna this month.
Lenvatinib, an orally active inhibitor of multiple receptor tyrosine kinases (RTKs) involved in angiogenesis and tumour proliferation, is being investigated for the treatment of recurrent glioblastoma and in combination with everolimus in metastatic renal carcinoma.
The scope of the phase I/II clinical trial was to establish the safety and efficacy of lenvatinib in patients with advanced HCC.
Forty-six patients were enrolled in the trial; they may have had prior treatment for their HCC including sorafenib. The starting dose of lenvatinib was 12mg once daily in 28 days cycles until disease progression or progression of unmanageable toxicities.
The researchers observed that 76% patients required dose adjustments for the management of toxicities (hypertension, palmo-plantar erythrodysaesthesia syndrome, anorexia, proteinuria, fatigue and thrombocytopenia).
They concluded that, although in this study there were no new toxicities associated with TKI class, a weight-based starting dose of 8mg once daily for patients weighing under 60kg may be needed to minimise toxicity while maintaining the 12mg once daily for patients weighing over 60kg.
The median time to progression (TTP) is 7.49 months (95% CI:5.45-9.43) and media overall survival is 13.9 months (95% CI:11.8-).