Seung-Hwan Jeong, Sang Eun Yeon, Su Youn Kim, Tae Gyun Kwon, Seong Soo Jeon, Young Deuk Choi, Dongdeuk Kwon, Byung Ha Chung, Sung-Hoo Hong, Byung Hoon Kim, Hyo Jin Lee, Sang Joon Shin, Woo Suk Choi, Sung Woo Park, Taek Won Kang, Seok Joong Yun, Jin Seon Cho, See Min Choi, Na-Ri Lee, Cheol Kwak
{"title":"一项前瞻性、多中心研究阿比特龙治疗韩国转移性去势抵抗性前列腺癌的临床疗效:化疗前与化疗后。","authors":"Seung-Hwan Jeong, Sang Eun Yeon, Su Youn Kim, Tae Gyun Kwon, Seong Soo Jeon, Young Deuk Choi, Dongdeuk Kwon, Byung Ha Chung, Sung-Hoo Hong, Byung Hoon Kim, Hyo Jin Lee, Sang Joon Shin, Woo Suk Choi, Sung Woo Park, Taek Won Kang, Seok Joong Yun, Jin Seon Cho, See Min Choi, Na-Ri Lee, Cheol Kwak","doi":"10.4111/icu.20230128","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The proper treatment sequence for administering abiraterone acetate plus prednisolone (AAP) and chemotherapeutic agents has not yet been elucidated for metastatic castration-resistant prostate cancer (mCRPC). Hence, this study evaluated the effectiveness and safety of AAP in pre- and post-chemotherapy settings using real-world data.</p><p><strong>Materials and methods: </strong>This prospective, multicenter, open-label, observational study included 506 patients with mCRPC. Patients were classified according to the timing of chemotherapy into pre- and post-chemotherapy groups. The effectiveness and safety of AAP were compared between the groups; the prostate-specific antigen (PSA) response, PSA progression-free survival, and radiologic progression-free survival were assessed; and adverse drug reactions were recorded.</p><p><strong>Results: </strong>Among the included patients, 319 and 187 belonged to the pre- and post-chemotherapy groups, respectively. Risk classification was similar between the two groups. The PSA response was 61.8% in the pre-chemotherapy group and 39.0% in the post-chemotherapy group (p<0.001). The median time to PSA progression (5.00 vs. 2.93 mo, p=0.001) and radiologic progression-free survival (11.84 vs. 9.17 mo, p=0.002) were significantly longer in the pre-chemotherapy group. Chemotherapy status was associated with PSA (hazard ratio [HR] 1.39, 95% confidence interval [CI] 1.09-1.77) and radiologic progression (HR 1.66, 95% CI 1.18-2.33) during AAP treatment. Adverse drug reactions were reported at similar frequencies in both groups.</p><p><strong>Conclusions: </strong>In this postmarketing surveillance, AAP benefited patients with mCRPC, especially in settings before chemotherapy was administered, resulting in a high PSA response and longer PSA and radiologic progression-free survival with tolerable adverse drug reactions.</p>","PeriodicalId":14522,"journal":{"name":"Investigative and Clinical Urology","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fa/bd/icu-64-466.PMC10482671.pdf","citationCount":"1","resultStr":"{\"title\":\"A prospective, multicenter study on the clinical effectiveness of abiraterone in metastatic castration-resistant prostate cancer in Korea: Pre- vs. post-chemotherapy.\",\"authors\":\"Seung-Hwan Jeong, Sang Eun Yeon, Su Youn Kim, Tae Gyun Kwon, Seong Soo Jeon, Young Deuk Choi, Dongdeuk Kwon, Byung Ha Chung, Sung-Hoo Hong, Byung Hoon Kim, Hyo Jin Lee, Sang Joon Shin, Woo Suk Choi, Sung Woo Park, Taek Won Kang, Seok Joong Yun, Jin Seon Cho, See Min Choi, Na-Ri Lee, Cheol Kwak\",\"doi\":\"10.4111/icu.20230128\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The proper treatment sequence for administering abiraterone acetate plus prednisolone (AAP) and chemotherapeutic agents has not yet been elucidated for metastatic castration-resistant prostate cancer (mCRPC). Hence, this study evaluated the effectiveness and safety of AAP in pre- and post-chemotherapy settings using real-world data.</p><p><strong>Materials and methods: </strong>This prospective, multicenter, open-label, observational study included 506 patients with mCRPC. Patients were classified according to the timing of chemotherapy into pre- and post-chemotherapy groups. The effectiveness and safety of AAP were compared between the groups; the prostate-specific antigen (PSA) response, PSA progression-free survival, and radiologic progression-free survival were assessed; and adverse drug reactions were recorded.</p><p><strong>Results: </strong>Among the included patients, 319 and 187 belonged to the pre- and post-chemotherapy groups, respectively. Risk classification was similar between the two groups. The PSA response was 61.8% in the pre-chemotherapy group and 39.0% in the post-chemotherapy group (p<0.001). The median time to PSA progression (5.00 vs. 2.93 mo, p=0.001) and radiologic progression-free survival (11.84 vs. 9.17 mo, p=0.002) were significantly longer in the pre-chemotherapy group. Chemotherapy status was associated with PSA (hazard ratio [HR] 1.39, 95% confidence interval [CI] 1.09-1.77) and radiologic progression (HR 1.66, 95% CI 1.18-2.33) during AAP treatment. Adverse drug reactions were reported at similar frequencies in both groups.</p><p><strong>Conclusions: </strong>In this postmarketing surveillance, AAP benefited patients with mCRPC, especially in settings before chemotherapy was administered, resulting in a high PSA response and longer PSA and radiologic progression-free survival with tolerable adverse drug reactions.</p>\",\"PeriodicalId\":14522,\"journal\":{\"name\":\"Investigative and Clinical Urology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fa/bd/icu-64-466.PMC10482671.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Investigative and Clinical Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4111/icu.20230128\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Investigative and Clinical Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4111/icu.20230128","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
A prospective, multicenter study on the clinical effectiveness of abiraterone in metastatic castration-resistant prostate cancer in Korea: Pre- vs. post-chemotherapy.
Purpose: The proper treatment sequence for administering abiraterone acetate plus prednisolone (AAP) and chemotherapeutic agents has not yet been elucidated for metastatic castration-resistant prostate cancer (mCRPC). Hence, this study evaluated the effectiveness and safety of AAP in pre- and post-chemotherapy settings using real-world data.
Materials and methods: This prospective, multicenter, open-label, observational study included 506 patients with mCRPC. Patients were classified according to the timing of chemotherapy into pre- and post-chemotherapy groups. The effectiveness and safety of AAP were compared between the groups; the prostate-specific antigen (PSA) response, PSA progression-free survival, and radiologic progression-free survival were assessed; and adverse drug reactions were recorded.
Results: Among the included patients, 319 and 187 belonged to the pre- and post-chemotherapy groups, respectively. Risk classification was similar between the two groups. The PSA response was 61.8% in the pre-chemotherapy group and 39.0% in the post-chemotherapy group (p<0.001). The median time to PSA progression (5.00 vs. 2.93 mo, p=0.001) and radiologic progression-free survival (11.84 vs. 9.17 mo, p=0.002) were significantly longer in the pre-chemotherapy group. Chemotherapy status was associated with PSA (hazard ratio [HR] 1.39, 95% confidence interval [CI] 1.09-1.77) and radiologic progression (HR 1.66, 95% CI 1.18-2.33) during AAP treatment. Adverse drug reactions were reported at similar frequencies in both groups.
Conclusions: In this postmarketing surveillance, AAP benefited patients with mCRPC, especially in settings before chemotherapy was administered, resulting in a high PSA response and longer PSA and radiologic progression-free survival with tolerable adverse drug reactions.
期刊介绍:
Investigative and Clinical Urology (Investig Clin Urol, ICUrology) is an international, peer-reviewed, platinum open access journal published bimonthly. ICUrology aims to provide outstanding scientific and clinical research articles, that will advance knowledge and understanding of urological diseases and current therapeutic treatments. ICUrology publishes Original Articles, Rapid Communications, Review Articles, Special Articles, Innovations in Urology, Editorials, and Letters to the Editor, with a focus on the following areas of expertise:
• Precision Medicine in Urology
• Urological Oncology
• Robotics/Laparoscopy
• Endourology/Urolithiasis
• Lower Urinary Tract Dysfunction
• Female Urology
• Sexual Dysfunction/Infertility
• Infection/Inflammation
• Reconstruction/Transplantation
• Geriatric Urology
• Pediatric Urology
• Basic/Translational Research
One of the notable features of ICUrology is the application of multimedia platforms facilitating easy-to-access online video clips of newly developed surgical techniques from the journal''s website, by a QR (quick response) code located in the article, or via YouTube. ICUrology provides current and highly relevant knowledge to a broad audience at the cutting edge of urological research and clinical practice.