|The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Apatinib, a tyrosine kinase inhibitor targeting VEGFR-2, significantly prolonged progression-free and overall survival in Chinese patients with advanced hepatocellular carcinoma (HCC), according to results of a phase 3 study presented during the ASCO20 Virtual Scientific Program.
Median overall survival was almost 2 months longer for patients who received apatinib compared with patients receiving placebo (hazard ratio [HR], 0.785; 95% CI, 0.617-0.998; P =.0476). Median progression-free survival was more than 2 months longer in patients assigned apatinib (HR, 0.471; 95% CI, 0.369-0.601; P <.0001).
“China has almost one-half of HCC patients in the world,” said, Qiu Li, of West China Hospital Sichuan University, who presented the results. “Chinese HCC patients have special features in etiology, biological behavior, treatment strategy, and prognosis.”
In China there is currently only one second-line therapy for advanced HCC. This phase 3 trial was designed to assess efficacy and safety of apatinib in patients with HCC who had previously been treated with sorafenib and/or systemic chemotherapy.
The study included patients with HCC who had received at least 1 line of systemic therapy and Child-Pugh liver function class A or B (7 points or less). Patients were randomly assigned 2:1 to receive either 750 mg apatinib or placebo.
At follow-up, the median overall survival was 8.7 months for the apatinib arm compared with 6.8 months for the placebo arm. The 12-month overall survival was 36.8% for apatinib compared with 28.9% for placebo. Subgroup analysis for overall survival showed a consistent benefit for apatinib except for the subgroup of patients older than 65 years.
“There were only 30 patients in this subgroup so the results needs further verification,” Dr Li said.
Median progression-free survival was 4.5 months compared with 1.9 months for placebo. The objective response rate was 10.7% with assignment to apatinib compared with 1.5% in the placebo arm. Median duration of response was 6.5 months for apatinib compared with not applicable for placebo.
Treatment-related adverse events occurred in 97.3% of patients assigned to apatinib and 70.8% of patients assigned to placebo. The most common treatment-related adverse events of grade 3 or worse included hypertension (27.6% in the apatinib arm vs 2.3% in the placebo arm), hand-foot syndrome (17.9% for apatinib vs 0 for placebo), decreased platelet count (10.5% for apatinib vs 0 for placebo).
There were 24 patient deaths in the group that received apatinib and 13 in patients receiving placebo, however none were deemed treatment-related by investigators.
Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.
Li Q, Qin S, Gu S, et al. Apatinib as second-line therapy in Chinese patients with advanced hepatocellular carcinoma: A randomized, placebo-controlled, double-blind, phase III study. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 4507.