Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study
IntroductionEffective treatment during the metastatic hormone-sensitive prostate cancer (mHSPC) stage is crucial for delaying disease progression. Due to the lack of a head-to-head comparison of darolutamide (DARO) and abiraterone acetate plus prednisone (AAP) doublet regimen, this study aims to com...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-06-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1608339/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850117804234113024 |
|---|---|
| author | Ting Hu Ting Hu Fang Zhou Yang Zheng Yang Zheng Bohan Luo Bohan Luo Yongliang Zhang Chengpeng Gu Chengpeng Gu Guopeng Wang Guopeng Wang Jinze Zhang Jingzhi Tian Yu Nie Yunlin Feng Shangqing Ren Wenjia Di Dong Wang |
| author_facet | Ting Hu Ting Hu Fang Zhou Yang Zheng Yang Zheng Bohan Luo Bohan Luo Yongliang Zhang Chengpeng Gu Chengpeng Gu Guopeng Wang Guopeng Wang Jinze Zhang Jingzhi Tian Yu Nie Yunlin Feng Shangqing Ren Wenjia Di Dong Wang |
| author_sort | Ting Hu |
| collection | DOAJ |
| description | IntroductionEffective treatment during the metastatic hormone-sensitive prostate cancer (mHSPC) stage is crucial for delaying disease progression. Due to the lack of a head-to-head comparison of darolutamide (DARO) and abiraterone acetate plus prednisone (AAP) doublet regimen, this study aims to compare the efficacy and safety of DARO + ADT and AAP + ADT in the treatment of mHSPC in the real world.MethodsThis study retrospectively analyzed patients with mHSPC who received DARO or AAP treatment in Sichuan Provincial People’s Hospital from January 2022 to June 2024, with follow-up until December 2024. The clinical data and prostate-specific antigen (PSA) changes of patients were collected. The primary endpoint was time to metastatic castration-resistant prostate cancer (mCRPC), and the secondary endpoints were overall survival (OS), radiological progression-free survival (rPFS), time to PSA progression, time to pain progression, and time to subsequent prostate cancer therapy.ResultsA total of 178 patients were included, with 96 in the DARO group and 82 in the AAP group. The baseline characteristics of the two groups were comparable. The median follow-up time and interquartile ranges of the DARO and AAP groups were 12.0 [7.9–17.6] months and 17.4 [9.3–23.8] months, respectively. For the primary endpoint, DARO significantly delayed the time to mCRPC versus AAP [HR, 0.41 (95%CI, 0.23 to 0.71); P < 0.005]. And the DARO group significantly benefited in all secondary endpoints. DARO significantly led to deeper PSA reduction compared to AAP, with higher median reduction rates, better PSA50 and PSA90 remission rates, and a higher proportion of patients reaching lower PSA values. The incidence of adverse reactions was similar in the two groups, and there was no grade 3 or above drug-related adverse reactions.ConclusionIn the treatment of mHSPC, DARO + ADT was associated with significant improvement of clinical outcomes versus AAP + ADT, while their safety is comparable. |
| format | Article |
| id | doaj-art-0d12c7ce19fc451ea4bed0003de73687 |
| institution | OA Journals |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-0d12c7ce19fc451ea4bed0003de736872025-08-20T02:36:01ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-06-011610.3389/fphar.2025.16083391608339Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective studyTing Hu0Ting Hu1Fang Zhou2Yang Zheng3Yang Zheng4Bohan Luo5Bohan Luo6Yongliang Zhang7Chengpeng Gu8Chengpeng Gu9Guopeng Wang10Guopeng Wang11Jinze Zhang12Jingzhi Tian13Yu Nie14Yunlin Feng15Shangqing Ren16Wenjia Di17Dong Wang18School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaSchool of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaSchool of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaOrgan Transplantation Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaDepartment of Information, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaClinical Medical College, Southwest Medical University, Luzhou, ChinaSchool of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaSchool of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaDepartment of Nephrology, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaOrgan Transplantation Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaRobotic Minimally Invasive Surgery Center, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaIntroductionEffective treatment during the metastatic hormone-sensitive prostate cancer (mHSPC) stage is crucial for delaying disease progression. Due to the lack of a head-to-head comparison of darolutamide (DARO) and abiraterone acetate plus prednisone (AAP) doublet regimen, this study aims to compare the efficacy and safety of DARO + ADT and AAP + ADT in the treatment of mHSPC in the real world.MethodsThis study retrospectively analyzed patients with mHSPC who received DARO or AAP treatment in Sichuan Provincial People’s Hospital from January 2022 to June 2024, with follow-up until December 2024. The clinical data and prostate-specific antigen (PSA) changes of patients were collected. The primary endpoint was time to metastatic castration-resistant prostate cancer (mCRPC), and the secondary endpoints were overall survival (OS), radiological progression-free survival (rPFS), time to PSA progression, time to pain progression, and time to subsequent prostate cancer therapy.ResultsA total of 178 patients were included, with 96 in the DARO group and 82 in the AAP group. The baseline characteristics of the two groups were comparable. The median follow-up time and interquartile ranges of the DARO and AAP groups were 12.0 [7.9–17.6] months and 17.4 [9.3–23.8] months, respectively. For the primary endpoint, DARO significantly delayed the time to mCRPC versus AAP [HR, 0.41 (95%CI, 0.23 to 0.71); P < 0.005]. And the DARO group significantly benefited in all secondary endpoints. DARO significantly led to deeper PSA reduction compared to AAP, with higher median reduction rates, better PSA50 and PSA90 remission rates, and a higher proportion of patients reaching lower PSA values. The incidence of adverse reactions was similar in the two groups, and there was no grade 3 or above drug-related adverse reactions.ConclusionIn the treatment of mHSPC, DARO + ADT was associated with significant improvement of clinical outcomes versus AAP + ADT, while their safety is comparable.https://www.frontiersin.org/articles/10.3389/fphar.2025.1608339/fullmetastatic hormone-sensitive prostate cancerdarolutamideabiraterone acetateandrogen deprivation therapyefficacysafety |
| spellingShingle | Ting Hu Ting Hu Fang Zhou Yang Zheng Yang Zheng Bohan Luo Bohan Luo Yongliang Zhang Chengpeng Gu Chengpeng Gu Guopeng Wang Guopeng Wang Jinze Zhang Jingzhi Tian Yu Nie Yunlin Feng Shangqing Ren Wenjia Di Dong Wang Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study Frontiers in Pharmacology metastatic hormone-sensitive prostate cancer darolutamide abiraterone acetate androgen deprivation therapy efficacy safety |
| title | Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study |
| title_full | Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study |
| title_fullStr | Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study |
| title_full_unstemmed | Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study |
| title_short | Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study |
| title_sort | efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with adt for mhspc a real world clinical retrospective study |
| topic | metastatic hormone-sensitive prostate cancer darolutamide abiraterone acetate androgen deprivation therapy efficacy safety |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1608339/full |
| work_keys_str_mv | AT tinghu efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT tinghu efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT fangzhou efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT yangzheng efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT yangzheng efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT bohanluo efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT bohanluo efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT yongliangzhang efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT chengpenggu efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT chengpenggu efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT guopengwang efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT guopengwang efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT jinzezhang efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT jingzhitian efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT yunie efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT yunlinfeng efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT shangqingren efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT wenjiadi efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy AT dongwang efficacyandsafetyofdarolutamideversusabirateroneacetateplusprednisoneincombinationwithadtformhspcarealworldclinicalretrospectivestudy |