NEW YORK (Reuters Health) – Apatinib improves both overall and progression-free survival in patients with advanced hepatocellular carcinoma that has progressed after previous treatment, according to a new randomized controlled trial from China.
All secondary endpoints also favored apatinib over placebo, generic augmentin pharm support group without prescription including time to progression and proportion of patients achieving an objective response, researchers report in The Lancet Gastroenterology and Hepatology.
“Treatment options in Asian patients with advanced hepatocellular carcinoma who progress after first-line therapy are scarce,” write Dr. Shukui Qin of the Cancer Center of Bayi Hospital, Nanjing Chinese Medicine University, and colleagues.
“Given that all patients in this study were from non-Japan Asia, in whom the baseline disease characteristics of advanced hepatocellular carcinoma are complex and aggressive, the findings of this study are encouraging,” they conclude.
A highly selective tyrosine-kinase inhibitor, apatinib, also known as rivoceranib, blocks angiogenesis by targeting vascular endothelial growth factor receptor 2. So far, it has only been approved for marketing in China.
The team enrolled 393 patients (median age, 51; 86% male) with advanced HCC in a randomized, double-blind, multicenter placebo-controlled phase-3 trial; 340 patients also had HBV infection. All participants had been refractory or intolerant to at least one line of systemic chemotherapy or targeted therapy.
Participants were randomized 2:1 to receive apatinib (750 mg daily) or placebo in 28-day cycles. Median overall survival with apatinib was 8.7 months with active treatment versus 6.8 months with placebo (P=0.048), whereas progression-free survival was 4.5 months and 1.9 months, respectively, also a significant difference.
The authors note that the 59% of patients who had not received sorafenib “tended to derive more benefit from apatinib than patients who had received sorafenib, which might be explained by the potential cross-resistance among tyrosine kinase inhibitors.”
Treatment-related adverse events occurred in 97% of patients in the apatinib group and 71% of patients in the placebo group. The proportions for serious treatment-related adverse events were 17% and 4%, respectively.
Treatment-related adverse events interrupted treatment in 60% of patients receiving apatinib and 8% of those receiving placebo. Such adverse events led to treatment discontinuation in 12% of patients in the apatinib group, versus none in the placebo group.
At the time the study was designed and begun, the researchers say, “no standard-of-care second-line therapies for advanced hepatocellular carcinoma had been approved by drug regulatory authorities worldwide.”
The results of this study, however, led to apatinib’s approval as second-line treatment in patients with advanced HCC by China’s National Medical Products Administration at the end of 2020, the authors note.
The study was funded by Jiangsu Hengrui Medicine, which makes apatinib. Three of the authors are employees of the company.
SOURCE: https://bit.ly/34ScHom The Lancet Gastroenterology and Hepatology, online May 7, 2021.
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