Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study
ARON-3 is an international, multicenter, retrospective study to collect global experiences in the treatment of patients with advanced prostate cancer. Our results confirm the safety, tolerability, and efficacy of apalutamide in metastatic castration-sensitive prostate cancer in a real-world patient...
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| creator | Santoni, Matteo Büttner, Thomas Rescigno, Pasquale Fiala, Ondrej Cavasin, Nicolò Basso, Umberto Taha, Tarek Massari, Francesco Myint, Zin W. Formisano, Luigi Galli, Luca Scagliarini, Sarah Matrana, Marc R. Facchini, Gaetano Bamias, Aristotelis Messina, Carlo Zacchi, Francesca Manneh, Ray Kopp Roviello, Giandomenico Santini, Daniele Poprach, Alexandr Navratil, Jiri Uher, Michal Calabrò, Fabio Pierce, Erin Berardi, Rossana Aurilio, Gaetano Zakopoulou, Roubini Rizzo, Alessandro Ansari, Jawaher Rizzo, Mimma Bisonni, Renato Mollica, Veronica Incorvaia, Lorena Spinelli, Gianpaolo Jiang, Xue Yan Chandler, Robert Adam Grillone, Francesco Morelli, Franco Buti, Sebastiano Maluf, Fernando C. Marques Monteiro, Fernando Sabino Battelli, Nicola Porta, Camillo Caffo, Orazio Soares, Andrey |
| description | ARON-3 is an international, multicenter, retrospective study to collect global experiences in the treatment of patients with advanced prostate cancer. Our results confirm the safety, tolerability, and efficacy of apalutamide in metastatic castration-sensitive prostate cancer in a real-world patient population.
Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.
We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0.
We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p |
| doi_str_mv | 10.1016/j.euo.2024.11.005 |
| format | Article |
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Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.
We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0.
We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3–4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups.
APA is an effective and tolerable treatment for mCSPC in the real-world setting.
The ARON-3 project collects data for patients with prostate cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide. Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.</description><identifier>ISSN: 2588-9311</identifier><identifier>EISSN: 2588-9311</identifier><identifier>DOI: 10.1016/j.euo.2024.11.005</identifier><identifier>PMID: 39613567</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Androgen receptor pathway inhibitor ; Apalutamide ; ARON-3 trial ; Castration-sensitive prostate cancer ; Hormone sensitive ; Prostate cancer</subject><ispartof>European urology oncology, 2024-11</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39613567$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santoni, Matteo</creatorcontrib><creatorcontrib>Büttner, Thomas</creatorcontrib><creatorcontrib>Rescigno, Pasquale</creatorcontrib><creatorcontrib>Fiala, Ondrej</creatorcontrib><creatorcontrib>Cavasin, Nicolò</creatorcontrib><creatorcontrib>Basso, Umberto</creatorcontrib><creatorcontrib>Taha, Tarek</creatorcontrib><creatorcontrib>Massari, Francesco</creatorcontrib><creatorcontrib>Myint, Zin W.</creatorcontrib><creatorcontrib>Formisano, Luigi</creatorcontrib><creatorcontrib>Galli, Luca</creatorcontrib><creatorcontrib>Scagliarini, Sarah</creatorcontrib><creatorcontrib>Matrana, Marc R.</creatorcontrib><creatorcontrib>Facchini, Gaetano</creatorcontrib><creatorcontrib>Bamias, Aristotelis</creatorcontrib><creatorcontrib>Messina, Carlo</creatorcontrib><creatorcontrib>Zacchi, Francesca</creatorcontrib><creatorcontrib>Manneh, Ray Kopp</creatorcontrib><creatorcontrib>Roviello, Giandomenico</creatorcontrib><creatorcontrib>Santini, Daniele</creatorcontrib><creatorcontrib>Poprach, Alexandr</creatorcontrib><creatorcontrib>Navratil, Jiri</creatorcontrib><creatorcontrib>Uher, Michal</creatorcontrib><creatorcontrib>Calabrò, Fabio</creatorcontrib><creatorcontrib>Pierce, Erin</creatorcontrib><creatorcontrib>Berardi, Rossana</creatorcontrib><creatorcontrib>Aurilio, Gaetano</creatorcontrib><creatorcontrib>Zakopoulou, Roubini</creatorcontrib><creatorcontrib>Rizzo, Alessandro</creatorcontrib><creatorcontrib>Ansari, Jawaher</creatorcontrib><creatorcontrib>Rizzo, Mimma</creatorcontrib><creatorcontrib>Bisonni, Renato</creatorcontrib><creatorcontrib>Mollica, Veronica</creatorcontrib><creatorcontrib>Incorvaia, Lorena</creatorcontrib><creatorcontrib>Spinelli, Gianpaolo</creatorcontrib><creatorcontrib>Jiang, Xue Yan</creatorcontrib><creatorcontrib>Chandler, Robert Adam</creatorcontrib><creatorcontrib>Grillone, Francesco</creatorcontrib><creatorcontrib>Morelli, Franco</creatorcontrib><creatorcontrib>Buti, Sebastiano</creatorcontrib><creatorcontrib>Maluf, Fernando C.</creatorcontrib><creatorcontrib>Marques Monteiro, Fernando Sabino</creatorcontrib><creatorcontrib>Battelli, Nicola</creatorcontrib><creatorcontrib>Porta, Camillo</creatorcontrib><creatorcontrib>Caffo, Orazio</creatorcontrib><creatorcontrib>Soares, Andrey</creatorcontrib><title>Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study</title><title>European urology oncology</title><addtitle>Eur Urol Oncol</addtitle><description>ARON-3 is an international, multicenter, retrospective study to collect global experiences in the treatment of patients with advanced prostate cancer. Our results confirm the safety, tolerability, and efficacy of apalutamide in metastatic castration-sensitive prostate cancer in a real-world patient population.
Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.
We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0.
We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3–4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups.
APA is an effective and tolerable treatment for mCSPC in the real-world setting.
The ARON-3 project collects data for patients with prostate cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide. Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.</description><subject>Androgen receptor pathway inhibitor</subject><subject>Apalutamide</subject><subject>ARON-3 trial</subject><subject>Castration-sensitive prostate cancer</subject><subject>Hormone sensitive</subject><subject>Prostate cancer</subject><issn>2588-9311</issn><issn>2588-9311</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpNkUlPwzAQhS0EoqjwA7ggH7kkeOI6seFUVWxSWcRytpxkIlxlKbYD4t_jqkXiMvNG72k0mo-QU2ApMMgvVimOQ5qxbJYCpIyJPXKUCSkTxQH2_-kJOfF-xRiLWQYsOyQTrnLgIi-OSJivTTsG09kaqe3pAwbjgwm2oosoXFRDn3jsvQ32C-mzGzY2Rrev0F3SF_RjGzxt3NDR8IH0IY62wj6gi6Zpk-_BtTWdvzw9Jpy-hrH-OSYHjWk9nuz6lLzfXL8t7pLl0-39Yr5MEASIBBqBlUQFZaFMnWdKSlkZURQlz5A3yIQpEWdlo1RdmBnmUBohc0CmJCiBfErOt3vXbvgc0QfdWV9h25oeh9FrDnzGOchYp-RsFx3LDmu9drYz7kf_fSoGrrYBjAd_WXTaVxbjD2rrsAq6HqwGpjdo9EpHNHqDRgPoiIb_AlyZgTA</recordid><startdate>20241128</startdate><enddate>20241128</enddate><creator>Santoni, Matteo</creator><creator>Büttner, Thomas</creator><creator>Rescigno, Pasquale</creator><creator>Fiala, Ondrej</creator><creator>Cavasin, Nicolò</creator><creator>Basso, Umberto</creator><creator>Taha, Tarek</creator><creator>Massari, Francesco</creator><creator>Myint, Zin W.</creator><creator>Formisano, Luigi</creator><creator>Galli, Luca</creator><creator>Scagliarini, Sarah</creator><creator>Matrana, Marc R.</creator><creator>Facchini, Gaetano</creator><creator>Bamias, Aristotelis</creator><creator>Messina, Carlo</creator><creator>Zacchi, Francesca</creator><creator>Manneh, Ray Kopp</creator><creator>Roviello, Giandomenico</creator><creator>Santini, Daniele</creator><creator>Poprach, Alexandr</creator><creator>Navratil, Jiri</creator><creator>Uher, Michal</creator><creator>Calabrò, Fabio</creator><creator>Pierce, Erin</creator><creator>Berardi, Rossana</creator><creator>Aurilio, Gaetano</creator><creator>Zakopoulou, Roubini</creator><creator>Rizzo, Alessandro</creator><creator>Ansari, Jawaher</creator><creator>Rizzo, Mimma</creator><creator>Bisonni, Renato</creator><creator>Mollica, Veronica</creator><creator>Incorvaia, Lorena</creator><creator>Spinelli, Gianpaolo</creator><creator>Jiang, Xue Yan</creator><creator>Chandler, Robert 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Santini, Daniele ; Poprach, Alexandr ; Navratil, Jiri ; Uher, Michal ; Calabrò, Fabio ; Pierce, Erin ; Berardi, Rossana ; Aurilio, Gaetano ; Zakopoulou, Roubini ; Rizzo, Alessandro ; Ansari, Jawaher ; Rizzo, Mimma ; Bisonni, Renato ; Mollica, Veronica ; Incorvaia, Lorena ; Spinelli, Gianpaolo ; Jiang, Xue Yan ; Chandler, Robert Adam ; Grillone, Francesco ; Morelli, Franco ; Buti, Sebastiano ; Maluf, Fernando C. ; Marques Monteiro, Fernando Sabino ; Battelli, Nicola ; Porta, Camillo ; Caffo, Orazio ; Soares, Andrey</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-e1515-1f5ec8e91b79ad629888ca577b32e3fe05abee4bf99d7a4e61ba5861e098195e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Androgen receptor pathway inhibitor</topic><topic>Apalutamide</topic><topic>ARON-3 trial</topic><topic>Castration-sensitive prostate cancer</topic><topic>Hormone sensitive</topic><topic>Prostate 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Franco</creatorcontrib><creatorcontrib>Buti, Sebastiano</creatorcontrib><creatorcontrib>Maluf, Fernando C.</creatorcontrib><creatorcontrib>Marques Monteiro, Fernando Sabino</creatorcontrib><creatorcontrib>Battelli, Nicola</creatorcontrib><creatorcontrib>Porta, Camillo</creatorcontrib><creatorcontrib>Caffo, Orazio</creatorcontrib><creatorcontrib>Soares, Andrey</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>European urology oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Santoni, Matteo</au><au>Büttner, Thomas</au><au>Rescigno, Pasquale</au><au>Fiala, Ondrej</au><au>Cavasin, Nicolò</au><au>Basso, Umberto</au><au>Taha, Tarek</au><au>Massari, Francesco</au><au>Myint, Zin W.</au><au>Formisano, Luigi</au><au>Galli, Luca</au><au>Scagliarini, Sarah</au><au>Matrana, Marc R.</au><au>Facchini, Gaetano</au><au>Bamias, Aristotelis</au><au>Messina, Carlo</au><au>Zacchi, Francesca</au><au>Manneh, Ray Kopp</au><au>Roviello, Giandomenico</au><au>Santini, Daniele</au><au>Poprach, Alexandr</au><au>Navratil, Jiri</au><au>Uher, Michal</au><au>Calabrò, Fabio</au><au>Pierce, Erin</au><au>Berardi, Rossana</au><au>Aurilio, Gaetano</au><au>Zakopoulou, Roubini</au><au>Rizzo, Alessandro</au><au>Ansari, Jawaher</au><au>Rizzo, Mimma</au><au>Bisonni, Renato</au><au>Mollica, Veronica</au><au>Incorvaia, Lorena</au><au>Spinelli, Gianpaolo</au><au>Jiang, Xue Yan</au><au>Chandler, Robert Adam</au><au>Grillone, Francesco</au><au>Morelli, Franco</au><au>Buti, Sebastiano</au><au>Maluf, Fernando C.</au><au>Marques Monteiro, Fernando Sabino</au><au>Battelli, Nicola</au><au>Porta, Camillo</au><au>Caffo, Orazio</au><au>Soares, Andrey</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study</atitle><jtitle>European urology oncology</jtitle><addtitle>Eur Urol Oncol</addtitle><date>2024-11-28</date><risdate>2024</risdate><issn>2588-9311</issn><eissn>2588-9311</eissn><abstract>ARON-3 is an international, multicenter, retrospective study to collect global experiences in the treatment of patients with advanced prostate cancer. Our results confirm the safety, tolerability, and efficacy of apalutamide in metastatic castration-sensitive prostate cancer in a real-world patient population.
Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.
We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0.
We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3–4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups.
APA is an effective and tolerable treatment for mCSPC in the real-world setting.
The ARON-3 project collects data for patients with prostate cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide. Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>39613567</pmid><doi>10.1016/j.euo.2024.11.005</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2588-9311 |
| ispartof | European urology oncology, 2024-11 |
| issn | 2588-9311 2588-9311 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3134331834 |
| source | Alma/SFX Local Collection |
| subjects | Androgen receptor pathway inhibitor Apalutamide ARON-3 trial Castration-sensitive prostate cancer Hormone sensitive Prostate cancer |
| title | Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T07%3A10%3A24IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Apalutamide%20in%20Metastatic%20Castration-sensitive%20Prostate%20Cancer:%20Results%20from%20the%20Multicenter%20Real-world%20ARON-3%20Study&rft.jtitle=European%20urology%20oncology&rft.au=Santoni,%20Matteo&rft.date=2024-11-28&rft.issn=2588-9311&rft.eissn=2588-9311&rft_id=info:doi/10.1016/j.euo.2024.11.005&rft_dat=%3Cproquest_pubme%3E3134331834%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3134331834&rft_id=info:pmid/39613567&rft_els_id=S2588931124002530&rfr_iscdi=true |