Objective:This double-blind,placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate+prednisone(abiraterone)to prednisone alone in chemotherapy-naı¨ve,asymptomatic or mi...Objective:This double-blind,placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate+prednisone(abiraterone)to prednisone alone in chemotherapy-naı¨ve,asymptomatic or mildly symptomatic metastatic castrationresistant prostate cancer(mCRPC)patients from China,Malaysia,Thailand and Russia.Methods:Adult chemotherapy-naı¨ve patients with confirmed prostate adenocarcinoma,Eastern Cooperative Oncology Group(ECOG)performance status(PS)grade 0e1,ongoing androgen deprivation(serum testosterone<50 ng/dL)with prostate specific antigen(PSA)or radiographic progression were randomized to receive abiraterone acetate(1000 mg,QD)t prednisone(5 mg,BID)or placebo t prednisone(5 mg,BID),until disease progression,unacceptable toxicity or consent withdrawal.Primary endpoint was improvements in time to PSA progression(TTPP).Results:Totally,313 patients were randomized(abiraterone:n Z 157;prednisone:n Z 156);and baseline characteristics were balanced.At clinical cut-off(median follow-up time:3.9 months),80% patients received treatment(abiraterone:n Z 138,prednisone:n Z 112).Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone,attaining 58%reduction in PSA progression risk(HR=0.418;p<0.0001).Abirateronetreated patients had higher confirmed PSA response rate(50%vs.21%;relative odds=2.4;p<0.0001)and were 5 times more likely to achieve radiographic response than prednisonetreated patients(22.9%vs.4.8%,p=0.0369).Median survival was not reached.Most common(≥10% abiraterone vs.prednisone-treated)adverse events:bone pain(7%vs.14%),pain in extremity(6%vs.12%),arthralgia(10%vs.8%),back pain(7%vs.11%),and hypertension(15%vs.14%).Conclusion:Interim analysis confirmed favorable benefit-to-risk ratio of abiraterone in chemotherapy-naı¨ve men with mCRPC,consistent with global study,thus supporting use of abiraterone in this patient population.展开更多
Background and Aims:Large-scale data on the hepatitis D virus(HDV)/hepatitis B virus(HBV)co-infection rate is needed to estimate the current epidemiology of HDV in China.This study aimed to estimate the current epidem...Background and Aims:Large-scale data on the hepatitis D virus(HDV)/hepatitis B virus(HBV)co-infection rate is needed to estimate the current epidemiology of HDV in China.This study aimed to estimate the current epidemiology of HDV.Methods:Patients with chronic HBV infection,with documented serum hepatitis B surface antigen(HBsAg)positivity for more than six months,were enrolled across China.Blood samples were collected at baseline for central evaluations of HDV antibody and HBsAg quantification.Assessments for antibodies of hepatitis A virus,hepatitis C virus,hepatitis E virus,and human immunodeficiency virus,as well as HDV RNA quantification,were performed in patients who tested positive for HDV antibodies.Results:Of the 5,044 enrolled patients between September 24,2021,and December 28,2022,4,936 patients were included in the analysis.The mean age(±standard deviation)was 42.9±9.9 years,and 69.8%of patients were male.The mean alanine aminotransferase level was 34±58 U/L,and 1,509(30.6%)patients were hepatitis B e antigen-positive.The mean(standard deviation)HBsAg level at baseline was 3,535±11,292 IU/mL among 4,842 patients who were HBsAg positive.The rate of HBV infection and HDV antibody positivity was 0.24%(95%confidence interval:0.1–0.4%),and only one patient was HDV RNA positive.Conclusions:The prevalence of HDV antibody positivity was 0.24%in Chinese patients with chronic HBV infection,and only one patient with both anti-HDV antibody and HDV RNA positivity was observed in this study.展开更多
Despite recent progress in multiple myeloma(MM)treatments,most patients will relapse and require additional treatment.Intravenous daratumumab,a human IgGκmonoclonal antibody targeting CD38,has shown good efficacy in ...Despite recent progress in multiple myeloma(MM)treatments,most patients will relapse and require additional treatment.Intravenous daratumumab,a human IgGκmonoclonal antibody targeting CD38,has shown good efficacy in the treatment of MM.A subcutaneous version of daratumumab was formulated to reduce the burden of intravenous infusions.We aimed to investigate the efficacy and safety of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM based on the demonstrated noninferiority of subcutaneous daratumumab to intravenous daratumumab,with a shorter administration time and reduced infusion-related reaction rate in global studies.This phase 1,multicenter study(MMY1010;ClinicalTrials.gov Identifier:NCT04121260)evaluated subcutaneous daratumumab in Chinese patients with relapsed/refractory MM after 1 prior line(n=1)or≥2 prior lines(n=20)of therapy,including a proteasome inhibitor and an immunomodulatory drug.Primary endpoints were pharmacokinetics and safety.Mean(standard deviation)maximum trough concentration of daratumumab was 826(335)μg/mL,which was consistent with prior studies of subcutaneous daratumumab and intravenous daratumumab.Safety was consistent with safety profiles observed in other daratumumab studies,with no new safety concerns identified.Incidences of infusion-related reactions and injection-site reactions were low and consistent with other subcutaneous daratumumab studies.At a median follow-up of 7.5 months,the overall response rate was 57.1%,with a very good partial response or better rate of 38.1%and complete response or better rate of 19.0%.Our results demonstrate a favorable benefit/risk profile of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM,potentially impacting clinical administration of daratumumab in this population.展开更多
文摘Objective:This double-blind,placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate+prednisone(abiraterone)to prednisone alone in chemotherapy-naı¨ve,asymptomatic or mildly symptomatic metastatic castrationresistant prostate cancer(mCRPC)patients from China,Malaysia,Thailand and Russia.Methods:Adult chemotherapy-naı¨ve patients with confirmed prostate adenocarcinoma,Eastern Cooperative Oncology Group(ECOG)performance status(PS)grade 0e1,ongoing androgen deprivation(serum testosterone<50 ng/dL)with prostate specific antigen(PSA)or radiographic progression were randomized to receive abiraterone acetate(1000 mg,QD)t prednisone(5 mg,BID)or placebo t prednisone(5 mg,BID),until disease progression,unacceptable toxicity or consent withdrawal.Primary endpoint was improvements in time to PSA progression(TTPP).Results:Totally,313 patients were randomized(abiraterone:n Z 157;prednisone:n Z 156);and baseline characteristics were balanced.At clinical cut-off(median follow-up time:3.9 months),80% patients received treatment(abiraterone:n Z 138,prednisone:n Z 112).Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone,attaining 58%reduction in PSA progression risk(HR=0.418;p<0.0001).Abirateronetreated patients had higher confirmed PSA response rate(50%vs.21%;relative odds=2.4;p<0.0001)and were 5 times more likely to achieve radiographic response than prednisonetreated patients(22.9%vs.4.8%,p=0.0369).Median survival was not reached.Most common(≥10% abiraterone vs.prednisone-treated)adverse events:bone pain(7%vs.14%),pain in extremity(6%vs.12%),arthralgia(10%vs.8%),back pain(7%vs.11%),and hypertension(15%vs.14%).Conclusion:Interim analysis confirmed favorable benefit-to-risk ratio of abiraterone in chemotherapy-naı¨ve men with mCRPC,consistent with global study,thus supporting use of abiraterone in this patient population.
文摘Background and Aims:Large-scale data on the hepatitis D virus(HDV)/hepatitis B virus(HBV)co-infection rate is needed to estimate the current epidemiology of HDV in China.This study aimed to estimate the current epidemiology of HDV.Methods:Patients with chronic HBV infection,with documented serum hepatitis B surface antigen(HBsAg)positivity for more than six months,were enrolled across China.Blood samples were collected at baseline for central evaluations of HDV antibody and HBsAg quantification.Assessments for antibodies of hepatitis A virus,hepatitis C virus,hepatitis E virus,and human immunodeficiency virus,as well as HDV RNA quantification,were performed in patients who tested positive for HDV antibodies.Results:Of the 5,044 enrolled patients between September 24,2021,and December 28,2022,4,936 patients were included in the analysis.The mean age(±standard deviation)was 42.9±9.9 years,and 69.8%of patients were male.The mean alanine aminotransferase level was 34±58 U/L,and 1,509(30.6%)patients were hepatitis B e antigen-positive.The mean(standard deviation)HBsAg level at baseline was 3,535±11,292 IU/mL among 4,842 patients who were HBsAg positive.The rate of HBV infection and HDV antibody positivity was 0.24%(95%confidence interval:0.1–0.4%),and only one patient was HDV RNA positive.Conclusions:The prevalence of HDV antibody positivity was 0.24%in Chinese patients with chronic HBV infection,and only one patient with both anti-HDV antibody and HDV RNA positivity was observed in this study.
文摘Despite recent progress in multiple myeloma(MM)treatments,most patients will relapse and require additional treatment.Intravenous daratumumab,a human IgGκmonoclonal antibody targeting CD38,has shown good efficacy in the treatment of MM.A subcutaneous version of daratumumab was formulated to reduce the burden of intravenous infusions.We aimed to investigate the efficacy and safety of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM based on the demonstrated noninferiority of subcutaneous daratumumab to intravenous daratumumab,with a shorter administration time and reduced infusion-related reaction rate in global studies.This phase 1,multicenter study(MMY1010;ClinicalTrials.gov Identifier:NCT04121260)evaluated subcutaneous daratumumab in Chinese patients with relapsed/refractory MM after 1 prior line(n=1)or≥2 prior lines(n=20)of therapy,including a proteasome inhibitor and an immunomodulatory drug.Primary endpoints were pharmacokinetics and safety.Mean(standard deviation)maximum trough concentration of daratumumab was 826(335)μg/mL,which was consistent with prior studies of subcutaneous daratumumab and intravenous daratumumab.Safety was consistent with safety profiles observed in other daratumumab studies,with no new safety concerns identified.Incidences of infusion-related reactions and injection-site reactions were low and consistent with other subcutaneous daratumumab studies.At a median follow-up of 7.5 months,the overall response rate was 57.1%,with a very good partial response or better rate of 38.1%and complete response or better rate of 19.0%.Our results demonstrate a favorable benefit/risk profile of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM,potentially impacting clinical administration of daratumumab in this population.
