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Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia:a subgroup analysis of the TITAN trial

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Asian Journal of Andrology 2022年第2期24卷 161-166页

作者： Byung Ha Chung Jian Huang Zhang-Qun Ye Da-Lin He hirotsugu uemura Gaku Arai Choung Soo Kim Yuan-Yuan Zhang Yusoke Koroki SuYeon Jeong Suneel Mundle Spyros Triantos Sharon McCarthy Kim N Chi Ding-Wei Ye Department of Urology Gangnam Severance HospitalYonsei University College of Medicine211 Eonju-roGangnam-guSeoul 135-271Korea Sun Yat-Sen Memorial Hospital Sun Yat-sen UniversityGuangzhou 510120China Wuhan Tongji Hospital Tongji Medical CollegeWuhan 430030China First Affiliated Hospital of Xi’an Jiaotong University Xi’an 719054China Kindai University Hospital Ōsakasayama 589-8511Japan Dokkyo Medical University Saitama Medical Center Saitama 2-1-50Japan Asian Medical Center University of UlsanSeoul 138-040Korea Janssen Medical Affairs Department Beijing 100025China Janssen Medical Affairs Department Tokyo 101-0065Japan Janssen Medical Affairs Department Seoul 140-012Korea Janssen Global Medical Affairs Department HorshamPA 08869USA Janssen Research and Development Spring HousePA 19477USA Janssen Research and Development RaritanNJ 08869USA BC Cancer and Vancouver Prostate Centre VancouverBC V5Z 1G1Canada Fudan University Shanghai Cancer Center Shanghai 200032China

Ethnicity might be associated with treatment outcomes in advanced prostate *** study aimed to evaluate the efficacy and safety of androgen deprivation therapy(ADT)combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer(mCSPC).The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen(TITAN)trial was conducted at 260 sites in 23 *** subgroup analysis included patients enrolled in 62 participating centers in China,Japan,and *** progression-free survival(PFS),time to prostate-specific antigen(PSA)progression,and PSA changes from baseline were compared between groups in the East Asian *** intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups,*** 24-month radiographic PFS rates were 76.1%and 52.3%in the apalutamide and placebo groups,respectively(apalutamide vs placebo:hazard ratio[HR]=0.506;95%confidence interval[CI],0.302–0.849;P=0.009).Median time to PSA progression was more favorable with apalutamide than placebo(HR=0.210;95%CI,0.124–0.357;P<0.001).Median maximum percentages of PSA decline from baseline were 99.0%and 73.9%in the apalutamide and placebo groups,*** most common adverse event(AE)was rash in the apalutamide group,with a higher rate than that in the placebo group(37.3%vs 9.1%).The most common grade 3 or 4 AEs were rash(12[10.9%])and hypertension(12[10.9%])for *** efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.

关键词： apalutamide East Asia metastasis prostatic neoplasm survival

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Apalutamide for metastatic castration-sensitive prostate cancer:final analysis of the Asian subpopulation in the TITAN trial

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Asian Journal of Andrology 2023年第6期25卷 653-661页

作者： Byung Ha Chung Jian Huang Hiroji uemura Young Deuk Choi Zhang-Qun Ye Hiroyoshi Suzuki Taek Won Kang Da-Lin He Jae Young Joung Sabine D Brookman-May Sharon McCarthy Amitabha Bhaumik Anildeep Singh Suneel Mundle Simon Chowdhury Neeraj Agarwal Ding-Wei Ye Kim N Chi hirotsugu uemura Gangnam Severance Hospital Yonsei University College of MedicineSeoul 06273South Korea Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityGuangzhou 510123China Yokohama City University Medical Center Minami-kuYokohamaKanagwa 232-0024Japan Severance Hospital Yonsei University College of MedicineSeoul 03722South Korea Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Toho University Sakura Medical Center Chiba 285-0841Japan Chonnam National University Hospital and Medical School Gwangju 61469South Korea Department of Urology The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’an 710061China Prostate Cancer Center National Cancer CenterGoyang 10408South Korea Janssen Research and Development Spring HousePA 19002USA Ludwig Maximilians University Munich 80539Germany Janssen Research and Development RaritanNJ 08869USA Janssen Medical Affairs Asia PacificSingapore 118222Singapore Guy’s and St Thomas’NHS Foundation Trust London SE14YBUK University of Utah Huntsman Cancer Institute Salt Lake CityUT 84112USA Fudan University Shanghai Cancer Center Shanghai 200032China Vancouver Prostate Centre University of British ColumbiaVancouverBritish Columbia V6H 3Z6Canada Kindai University Faculty of MedicineOsaka-Sayama 589-8511Japan

The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen(TITAN)trial showed improvement in overall survival(OS)and other efficacy endpoints with apalutamide plus androgen deprivation therapy(ADT)versus ADT alone in patients with metastatic castration-sensitive prostate cancer(mCSPC).As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer,a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian ***-driven endpoints were OS,and time from randomization to initiation of castration resistance,prostate-specific antigen(PSA)progression,and second progression-free survival(PFS2)on first subsequent therapy or *** endpoints were assessed using the Kaplan–Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for *** Asian patients received once-daily apalutamide 240 mg(n=111)or placebo(n=110)plus *** a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide,apalutamide reduced the risk of death by 32%(hazard ratio[HR]:0.68;95%confidence interval[CI]:0.42–1.13),risk of castration resistance by 69%(HR:0.31;95%CI:0.21–0.46),PSA progression by 79%(HR:0.21;95%CI:0.13–0.35)and PFS2 by 24%(HR:0.76;95%CI:0.44–1.29)relative to *** outcomes were comparable between subgroups with low-and high-volume disease at *** new safety issues were *** provides valuable clinical benefits to Asian patients with mCSPC,with an efficacy and safety profile consistent with that in the overall patient population.

关键词： apalutamide Asia event-driven analysis metastatic castration-sensitive prostate cancer overall survival

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Zoledronic acid combined with androgendeprivation therapy may prolong time to castration-resistant prostate cancer in hormone-naı¨ve metastatic prostate cancer patients e A propensity scoring approach

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Asian Journal of Urology 2016年第1期3卷 33-38页

作者： Kazuhiro Nagao Hideyasu Matsuyama Masahiro Nozawa Isao Hara Tsukasa Nishioka Takahiro Komura Atsunobu Esa Shigeya Uejima Masaaki Imanishi Yasunari Uekado Takatoshi Ogawa Hiroshi Kajikawa hirotsugu uemura Department of Urology Graduate School of MedicineYamaguchi UniversityJapan Department of Urology Kinki University Faculty of MedicineJapan Department of Urology Wakayama Medical University School of MedicineJapan Department of Urology Sakai HospitalKinki University Faculty of MedicineJapan Department of Urology Naga HospitalJapan Department of Urology NTT Osaka HospitalJapan Department of Urology National Hospital Organization Osaka Minami Medical CenterJapan Department of Urology Nara Hospital Kinki University Faculty of MedicineJapan Department of Urology Tondabayashi HospitalJapan Department of Urology Wakayama Rosai HospitalJapan Department of Urology Kainan Municipal HospitalJapan Department of Urology Izumiotsu Municipal HospitalJapan

Objective:To clarify the oncological benefit of zoledronic acid for hormone-naive metastatic prostate cancer,patient outcome of androgen deprivation therapy with zoledronic acid(ADT+Z)and androgen deprivation therapy alone(ADT)was ***:Fifty-two patients with pathologically confirmed metastatic prostate cancer were prospectively enrolled and treated with combined androgen blockade(goserelin and bicalutamide)with zoledronic acid(4 mg every 4 weeks for 24 months).A propensity score-match with logistic regression analysis was applied to select 50 pair-matched cohorts(both from ADT+Z and from historical control cohorts who had undergone ADT alone),and patient outcomes were ***:Patients with ADT+Z had significantly longer time to progression(TTP)than those with ADT(median TTP;24.2 vs.14.0 months,p=0.0092),while no significant difference of overall survival between two groups(p=0.1502).Multivariate analysis for biochemical recurrence revealed treatment with ADT was the sole independent prognostic factor(HR:1.724,95%CI:1.06-2.86,p=0.0297).Conclusion:Combination of zoledronic acid with ADT may prolong time to castration resistant prostate cancer.

关键词： Zoledronic acid Hormone-naive prostate cancer Biochemical recurrence Propensity scorematch analysis

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Efficacy and Safety of Axitinib as First-Line Therapy in Japanese Patients with Metastatic Renal Cell Carcinoma

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Journal of Cancer Therapy 2015年第8期6卷 670-678页

作者： Takeshi Namekawa Satoshi Fukasawa Atsushi Komaru Masayuki Kobayashi Takayuki Ohzeki Yosuke Sato Junryo Rii hirotsugu uemura Tomohiko Ichikawa Takeshi Ueda Prostate Center and Division of Urology Chiba Cancer Center Chiba Japan Department of Urology Kinki University Hospital Osaka Japan Department of Urology Graduate School of Medicine Chiba University Chiba Japan

Previous study reported that patients treated with axitinib as second-line therapy had longer median progression-free survival than those treated with sorafenib for metastatic renal cell carcinoma (mRCC). In this study, we reviewed our experience of axitinib as a first-line therapy for mRCC in Japanese patients, focusing on its efficacy and safety. We retrospectively assessed 26 patients treated with axitinib as a first-line therapy for mRCC from July 2010 to July 2014 at Chiba Cancer Center and Kinki University Hospital. Observation period was 24.6 ± 18.3 months. The objective response rate was 50.0%, and the median progression-free survival was 27.5 months. Overall survival was not estimable. Common grade 3 adverse events were hypertension in 19 patients and proteinuria in 5 patients. Axitinib demonstrated significant efficacy as a first-line therapy in Japanese patients with mRCC. Careful monitoring and management of the adverse effects may help to control its toxicities.

关键词： Axitinib Renal Cell Carcinoma First Line

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Consensus on safety management of novel hormonal therapy for advanced prostate cancer

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UroPrecision 2023年第2期1卷 53-71,I0005页

作者： Sujun Han Shudong Cheng Degang Ding Jianming Guo Zhisong He Baiye Jin Zhigang Ji Tianxin Lin Yuanjie Niu Weijun Qin Benkang Shi Jinkai Shao Xi'nan Sheng Qiang Wei Xin Wang Xinghuan Wang Shujie Xia Wanhai Xu Qing Zou Xiongbing Zu Renu Eapen Chi‐Fai Ng hirotsugu uemura Hiroji uemura Cheol Kwak Jae Young Joung Marniza Saad Edmund Chiong Nianzeng Xing National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina The First People's Hospital of Jinzhong JinzhongChina Henan Provincial People's Hospital ZhengzhouChina Zhongshan Hospital Fudan UniversityShanghaiChina Peking University First Hospital BeijingChina The First Affiliated Hospital Zhejiang University School of MedicineHangzhouChina Peking Union Medical College Hospital BeijingChina Sun Yat‐sen Memorial Hospital Sun Yat‐sen UniversityGuangzhouChina The Second Hospital of Tianjin Medical University TianjinChina Xijing Hospital of Air Force Military Medical University Xi'anChina Qilu Hospital of Shandong University JinanChina Shanxi Provincial People's Hospital TaiyuanChina Beijing Cancer Hospital BeijingChina West China Hospital Sichuan UniversityChengduChina Zhongnan Hospital of Wuhan University WuhanChina Shanghai General Hospital ShanghaiChina Fourth Affiliated Hospital of Harbin Medical University HarbinChina Jiangsu Cancer Hospital NanjingChina Xiangya Hospital of Central South University ChangshaChina Peter MacCallum Cancer Centre VictoriaAustralia The Chinese University of Hong Kong Hong KongChina Kindai University Faculty of Medicine Graduate School of Medical Sciences OsakaJapan Yokohama City University Medical Center KanagawaJapan Seoul National University Hospital SeoulKorea National Cancer Center Gyeonggi‐doKorea University of Malaya Medical Centre Wilayah PersekutuanMalaysia National University Hospital SingaporeSingapore

Prostate cancer(PCa)is one of the most prevalent malignant tumors in men,accompanied by high incidence and mortality *** hormonal therapy(NHT)has emerged as the primary treatment for advanced PCa,providing noticeable clinical ***,the diverse range of adverse events(AEs)associated with NHT may influence both treatment efficacy and patients'quality of *** light of the latest international clinical research evidence and recommendations from domestic and foreign guidelines,this consensus aims to provide a comprehensive overview of the common AEs experienced during NHT for advanced PCa ***,it seeks to develop a hierarchical approach to more efficiently manage AEs,presenting valuable insights for clinical medication and adverse reaction management.

关键词： adverse event novel hormonal therapy prostate cancer safety management

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