Lancet Oncol: Tivantinib effective treatment for patients with advanced hepatocellular carcinoma
Lancet Oncol: Tivantinib effective treatment for patients with advanced hepatocellular carcinoma
Tivantinib (ARQ 197) is a selective oral MET inhibitors, which shows in hepatocellular potential anti-tumor activity, may be single-drug therapy can also be combined sorafenib common treatment. Armando Santoro, designed to evaluate the efficacy and safety of Tivatinib as a second-line treatment options for patients with advanced hepatocellular carcinoma, the study results were published in the journals November.
This study is also multi-center, double-blind, randomized, placebo-controlled clinical phase 2 study, the study has been completed. The researchers included patients with advanced hepatocellular carcinoma patients, progressive Chile-Pugh A cirrhosis, and patients who can not tolerate first-line system for the treatment program. Researchers to patients in accordance with the ratio of 2:1 were randomly divided into two groups, one group received Tivantinib treatment, a dose of 360mg twice a day, and the other group received a placebo treatment until the patient's disease progression. In the course of treatment, patients with treatment-related 3 or more severe neutropenia, the change Tivantinib dose to 240mg, twice daily. Unified through interactive response system for patients randomized to stratify patients according to the organization's general state of the Eastern Cooperative Oncology score and vascular infiltration. The primary focus of this study to the time of disease progression in the group of subjects during the intent-to-treat analysis, application of the Independent Review of imaging evaluation. Researchers also MET expression evaluated tumor samples using immunohistochemical methods, MET high expression defined as more than 50% of the tumor cells express grading = 2 +. In this study, registered in ClinicalTrials.gov.
A total of 71 patients were randomly assigned to receive Tivantinib, 38 twice-daily doses of 360mg Tivantinib 33 twice-daily doses of 240mg Tivantinib, 36 were randomly assigned to receive placebo treatment. During analysis in, Tivantinib group in 65% of patients in the placebo group, 72% of patients with disease progression. , Tivantinib group compared with the placebo group to longer time to disease progression, the time of the two groups were 1.4 months and 1.6 months, the gap between the two groups was statistically significant. Patients compared with the placebo group, patients progress MET high expression later, 22 MET in median time to progression was 2.7 months, of 15 MET median time to progression was 1.4 months, the difference has a significant meaning. The most common Tivantinib group of three or more serious adverse reactions decrease in neutrophils (Tivantinib group 14%, placebo 0%) and anemia (Tivantinib the group was 11%, placebo 0% ). Compared with patients taking 240mg and 360mg patients Tivantinib 21% had three or more serious neutrophils reduced. Tivantinib treatment related severe neutropenia led to the deaths of four patients. Tivantinib group 24 patients and the placebo group, 14 patients with serious adverse events.
As a second-line treatment options, and good in patients with advanced hepatocellular carcinoma Tivantinib decompensated liver cirrhosis, especially in MET high expression tumors. But also the need for the three clinical studies further confirmed that the starting dose for the efficacy and safety of 240mg twice daily regimens.
Medchemexpress Can provide the above product,its website:www.medchemexpress.com
Tivantinib (ARQ 197) is a selective oral MET inhibitors, which shows in hepatocellular potential anti-tumor activity, may be single-drug therapy can also be combined sorafenib common treatment. Armando Santoro, designed to evaluate the efficacy and safety of Tivatinib as a second-line treatment options for patients with advanced hepatocellular carcinoma, the study results were published in the journals November.
This study is also multi-center, double-blind, randomized, placebo-controlled clinical phase 2 study, the study has been completed. The researchers included patients with advanced hepatocellular carcinoma patients, progressive Chile-Pugh A cirrhosis, and patients who can not tolerate first-line system for the treatment program. Researchers to patients in accordance with the ratio of 2:1 were randomly divided into two groups, one group received Tivantinib treatment, a dose of 360mg twice a day, and the other group received a placebo treatment until the patient's disease progression. In the course of treatment, patients with treatment-related 3 or more severe neutropenia, the change Tivantinib dose to 240mg, twice daily. Unified through interactive response system for patients randomized to stratify patients according to the organization's general state of the Eastern Cooperative Oncology score and vascular infiltration. The primary focus of this study to the time of disease progression in the group of subjects during the intent-to-treat analysis, application of the Independent Review of imaging evaluation. Researchers also MET expression evaluated tumor samples using immunohistochemical methods, MET high expression defined as more than 50% of the tumor cells express grading = 2 +. In this study, registered in ClinicalTrials.gov.
A total of 71 patients were randomly assigned to receive Tivantinib, 38 twice-daily doses of 360mg Tivantinib 33 twice-daily doses of 240mg Tivantinib, 36 were randomly assigned to receive placebo treatment. During analysis in, Tivantinib group in 65% of patients in the placebo group, 72% of patients with disease progression. , Tivantinib group compared with the placebo group to longer time to disease progression, the time of the two groups were 1.4 months and 1.6 months, the gap between the two groups was statistically significant. Patients compared with the placebo group, patients progress MET high expression later, 22 MET in median time to progression was 2.7 months, of 15 MET median time to progression was 1.4 months, the difference has a significant meaning. The most common Tivantinib group of three or more serious adverse reactions decrease in neutrophils (Tivantinib group 14%, placebo 0%) and anemia (Tivantinib the group was 11%, placebo 0% ). Compared with patients taking 240mg and 360mg patients Tivantinib 21% had three or more serious neutrophils reduced. Tivantinib treatment related severe neutropenia led to the deaths of four patients. Tivantinib group 24 patients and the placebo group, 14 patients with serious adverse events.
As a second-line treatment options, and good in patients with advanced hepatocellular carcinoma Tivantinib decompensated liver cirrhosis, especially in MET high expression tumors. But also the need for the three clinical studies further confirmed that the starting dose for the efficacy and safety of 240mg twice daily regimens.
Medchemexpress Can provide the above product,its website:www.medchemexpress.com
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