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On May 7, 2021, the "Prospective, randomized, double-blind, double-blind, second-line apatinib treatment of advanced hepatocellular carcinoma (HCC) for the second-line and above apatinib treatment of advanced hepatocellular carcinoma (HCC), led by Professor Qin Shukui of Nanjing Jinling Hospital The placebo-controlled national multi-center Phase III clinical trial (AHELP) was published in full online in the top international academic journal THE LANCET Gastroenterology & Hepatology.
HCC is the most common tissue type of liver cancer, accounting for 75% to 85% of liver cancer.
According to statistics, 72% of HCC cases occur in Asia, and more than 50% of cases occur in China.
Most Chinese patients with HCC have a late stage, hepatitis B virus infection, and higher levels of alpha-fetoprotein, resulting in a worse prognosis.
Therefore, based on the clinical research data of liver cancer patients in China, it is very important for the diagnosis and treatment of liver cancer in China and the world.
The AHELP study was presented orally at the ASCO conference in 2020.
In the same year, apatinib was recommended for the second-line treatment of liver cancer by the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (Class I recommendation, Class 1A evidence).
AHELP study included a total of 393 patients with advanced HCC who had failed or became intolerable after receiving at least first-line systemic treatment in the past.
Compared with other international studies on second-line treatment of hepatocellular carcinoma, patients enrolled in the AHELP study have a later stage and a more complicated condition at baseline, with a positive rate of HBV as high as 80%, and patients with AFP levels >400 µg/L More than 50% of patients have distant metastases and vascular invasion, and nearly 1/5 of patients have received second and third-line treatment.
The enrolled patients were randomized 2:1 to receive apatinib (750 mg, QD) and placebo (750 mg, QD) treatment.
The primary research endpoint is overall survival (OS), and secondary research endpoints include progression-free survival (PFS), time to disease progression (TTP), objective response rate (ORR), duration of response (DoR), disease control rate (DCR) ) And safety and other indicators.
Data with a median follow-up time of 7.
6 months showed that compared with the placebo group, the median OS of the apatinib group was significantly improved (8.
7 months vs 6.
8 months; HR=0.
785 [95%CI 0.
617‒0.
998] , P = 0·048).
OS rates in the apatinib group at 6 months (70.
0% vs 56.
1%) and 12 months (36.
8% vs 28.
9%) were also higher than those in the control group.
The median PFS in the apatinib group was 4.
5 months, which was also significantly higher than the 1.
9 months in the control group, and the risk of disease progression or death was reduced by 52.
9%.
In addition, the ORR of the apatinib group reached 11%, which was significantly higher than the 2% of the control group.
387 patients (257 in the apatinib group and 130 in the placebo group) were evaluated for safety after the study treatment and included in the safety analysis.
The most common treatment-related adverse events of grade 3 or 4 were hypertension (71 cases in the apatinib group [28%], 3 cases in the placebo group [2%]), hand-foot syndrome (46 cases [18%] vs none) and decreased platelet count (34 cases [13%] vs 1 case [1%]).
The AHELP study showed that compared with placebo, apatinib significantly improved the OS of patients with advanced HCC in the subsequent treatment, and has a controllable safety.
Based on the results of the AHELP study, on December 31, 2020, apatinib was officially approved by the National Medical Products Administration (NMPA) for use in patients with advanced HCC who have failed or become intolerable after receiving at least first-line systemic treatment in the past.
Reference: Shukui Qin, et al.
, (2021).
Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
The Lancet Gastroenterology & Hepatology, DOI: https://doi.
org/10.
1016/S2468-1253(21)00109-6
HCC is the most common tissue type of liver cancer, accounting for 75% to 85% of liver cancer.
According to statistics, 72% of HCC cases occur in Asia, and more than 50% of cases occur in China.
Most Chinese patients with HCC have a late stage, hepatitis B virus infection, and higher levels of alpha-fetoprotein, resulting in a worse prognosis.
Therefore, based on the clinical research data of liver cancer patients in China, it is very important for the diagnosis and treatment of liver cancer in China and the world.
The AHELP study was presented orally at the ASCO conference in 2020.
In the same year, apatinib was recommended for the second-line treatment of liver cancer by the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (Class I recommendation, Class 1A evidence).
AHELP study included a total of 393 patients with advanced HCC who had failed or became intolerable after receiving at least first-line systemic treatment in the past.
Compared with other international studies on second-line treatment of hepatocellular carcinoma, patients enrolled in the AHELP study have a later stage and a more complicated condition at baseline, with a positive rate of HBV as high as 80%, and patients with AFP levels >400 µg/L More than 50% of patients have distant metastases and vascular invasion, and nearly 1/5 of patients have received second and third-line treatment.
The enrolled patients were randomized 2:1 to receive apatinib (750 mg, QD) and placebo (750 mg, QD) treatment.
The primary research endpoint is overall survival (OS), and secondary research endpoints include progression-free survival (PFS), time to disease progression (TTP), objective response rate (ORR), duration of response (DoR), disease control rate (DCR) ) And safety and other indicators.
Data with a median follow-up time of 7.
6 months showed that compared with the placebo group, the median OS of the apatinib group was significantly improved (8.
7 months vs 6.
8 months; HR=0.
785 [95%CI 0.
617‒0.
998] , P = 0·048).
OS rates in the apatinib group at 6 months (70.
0% vs 56.
1%) and 12 months (36.
8% vs 28.
9%) were also higher than those in the control group.
The median PFS in the apatinib group was 4.
5 months, which was also significantly higher than the 1.
9 months in the control group, and the risk of disease progression or death was reduced by 52.
9%.
In addition, the ORR of the apatinib group reached 11%, which was significantly higher than the 2% of the control group.
387 patients (257 in the apatinib group and 130 in the placebo group) were evaluated for safety after the study treatment and included in the safety analysis.
The most common treatment-related adverse events of grade 3 or 4 were hypertension (71 cases in the apatinib group [28%], 3 cases in the placebo group [2%]), hand-foot syndrome (46 cases [18%] vs none) and decreased platelet count (34 cases [13%] vs 1 case [1%]).
The AHELP study showed that compared with placebo, apatinib significantly improved the OS of patients with advanced HCC in the subsequent treatment, and has a controllable safety.
Based on the results of the AHELP study, on December 31, 2020, apatinib was officially approved by the National Medical Products Administration (NMPA) for use in patients with advanced HCC who have failed or become intolerable after receiving at least first-line systemic treatment in the past.
Reference: Shukui Qin, et al.
, (2021).
Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
The Lancet Gastroenterology & Hepatology, DOI: https://doi.
org/10.
1016/S2468-1253(21)00109-6
