{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:27:33Z","timestamp":1791919653809,"version":"4.3.4"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,12,8]],"date-time":"2020-12-08T00:00:00Z","timestamp":1607385600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Urology"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of apalutamide\u00a0+\u00a0androgen deprivation therapy versus androgen deprivation therapy alone in Japanese patients with metastatic castration\u2010sensitive prostate cancer from the phase 3, randomized, global TITAN study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Men with metastatic castration\u2010sensitive prostate cancer randomly (1:1) received 240\u00a0mg apalutamide\u00a0+\u00a0androgen deprivation therapy or matching placebo\u00a0+\u00a0androgen deprivation therapy. The primary efficacy endpoints were radiographic progression\u2010free survival and overall survival. Secondary efficacy endpoints were time to cytotoxic chemotherapy, pain progression, chronic opioid use, and skeletal\u2010related events. Safety was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 1052 patients included in the TITAN study, 51 (4.85%) were Japanese (apalutamide group,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a028; placebo group,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a023). In all, 81.8% of patients in the apalutamide and 71.8% in the placebo group did not experience radiographic progression or death, and the hazard ratio for radiographic progression\u2010free survival favored treatment with apalutamide (hazard ratio 0.712, 95% confidence interval 0.205\u20132.466;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.59). At 24\u00a0months, 85.7% of patients in the apalutamide group and 81.5% in the placebo group were alive, and the hazard ratio for overall survival favored apalutamide (hazard ratio 0.840, 95% confidence interval 0.210\u20133.361;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.805). In the interim analysis, the median radiographic progression\u2010free survival and overall survival were not reached in the apalutamide group and time to cytotoxic chemotherapy was delayed following apalutamide treatment. The safety profile of apalutamide in the Japanese subpopulation was comparable with that of the global population, except for skin rash.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The results of the present analyses suggest that apalutamide\u00a0+\u00a0androgen deprivation therapy in Japanese patients had favorable efficacy compared with androgen deprivation therapy alone, and these findings are comparable to those in the overall population. Apalutamide\u00a0+\u00a0androgen deprivation therapy can be considered as one of the therapeutic options for a broad spectrum of metastatic castration\u2010sensitive prostate cancer regardless of prior treatment and disease extent in Japanese patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/iju.14447","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T01:27:14Z","timestamp":1607563634000},"page":"280-287","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Apalutamide for metastatic, castration\u2010sensitive prostate cancer in the Japanese population: A subgroup analysis of the randomized, double\u2010blind, placebo\u2010controlled phase 3 TITAN study"],"prefix":"10.1111","volume":"28","author":[{"given":"Hirotsugu","family":"Uemura","sequence":"first","affiliation":[{"name":"Department of Urology Kindai University Hospital Osakasayama Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaku","family":"Arai","sequence":"additional","affiliation":[{"name":"Department of Urology Dokkyo Medical University Saitama Medical Center Koshigaya Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroji","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Urology and Renal Transplantation Yokohama City University Medical Center Yokohama Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyoshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Urology Toho University Sakura Medical Center Sakura Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuyoshi","family":"Iijima","sequence":"additional","affiliation":[{"name":"Department of Urology Nagano Municipal Hospital Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Nishimura","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka International Cancer Institute Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Fujii","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. 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