Cargando…
Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials
Objective: The study aimed to compare the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone or docetaxel versus ADT alone as neoadjuvant therapy in patients with very-high-risk localized prostate cancer. Methods: This was a pooled analysis of two single-center, randomized, c...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10331422/ https://www.ncbi.nlm.nih.gov/pubmed/37435500 http://dx.doi.org/10.3389/fphar.2023.1217303 |
_version_ | 1785070249200058368 |
---|---|
author | Zhuang, Junlong Wang, Yuwen Zhang, Shun Fu, Yao Huang, Haifeng Lyu, Xiaoyu Zhang, Shiwei Marra, Giancarlo Xu, Linfeng Qiu, Xuefeng Guo, Hongqian |
author_facet | Zhuang, Junlong Wang, Yuwen Zhang, Shun Fu, Yao Huang, Haifeng Lyu, Xiaoyu Zhang, Shiwei Marra, Giancarlo Xu, Linfeng Qiu, Xuefeng Guo, Hongqian |
author_sort | Zhuang, Junlong |
collection | PubMed |
description | Objective: The study aimed to compare the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone or docetaxel versus ADT alone as neoadjuvant therapy in patients with very-high-risk localized prostate cancer. Methods: This was a pooled analysis of two single-center, randomized, controlled, phase II clinical trials (ClinicalTrials.gov: NCT04356430 and NCT04869371) conducted from December 2018 to March 2021. Eligible participants were randomly assigned to the intervention (ADT plus abiraterone or docetaxel) and control (ADT alone) groups at a 2:1 ratio. Efficacy was evaluated by pathological complete response (pCR), minimal residual disease (MRD), and 3-year biochemical progression-free survival (bPFS). Safety was also analyzed. Results: The study included 42 participants in the ADT group, 47 in the ADT plus docetaxel group, and 48 in the ADT plus abiraterone group. A total of 132 (96.4%) participants had very-high-risk prostate cancer, and 108 (78.8%) had locally advanced disease. The ADT plus docetaxel group (28%) and ADT plus abiraterone group (31%) had higher rates of pCR or MRD (p = 0.001 and p < 0.001) compared with the ADT group (2%). The 3-year bPFS was 41.9% (95% CI: 26.6–57.2), 51.1% (95% CI: 36.8–65.4), and 61.2% (95% CI: 45.5–76.9), respectively. Significant difference was found among groups in terms of bPFS (p = 0.037). Conclusion: Compared with ADT alone, neoadjuvant therapy with ADT plus docetaxel or abiraterone could achieve better pathological outcomes (pCR or MRD) for very-high-risk localized prostate cancer. The ADT plus abiraterone group showed longer bPFS than ADT alone. The combination regimens were tolerable. |
format | Online Article Text |
id | pubmed-10331422 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-103314222023-07-11 Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials Zhuang, Junlong Wang, Yuwen Zhang, Shun Fu, Yao Huang, Haifeng Lyu, Xiaoyu Zhang, Shiwei Marra, Giancarlo Xu, Linfeng Qiu, Xuefeng Guo, Hongqian Front Pharmacol Pharmacology Objective: The study aimed to compare the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone or docetaxel versus ADT alone as neoadjuvant therapy in patients with very-high-risk localized prostate cancer. Methods: This was a pooled analysis of two single-center, randomized, controlled, phase II clinical trials (ClinicalTrials.gov: NCT04356430 and NCT04869371) conducted from December 2018 to March 2021. Eligible participants were randomly assigned to the intervention (ADT plus abiraterone or docetaxel) and control (ADT alone) groups at a 2:1 ratio. Efficacy was evaluated by pathological complete response (pCR), minimal residual disease (MRD), and 3-year biochemical progression-free survival (bPFS). Safety was also analyzed. Results: The study included 42 participants in the ADT group, 47 in the ADT plus docetaxel group, and 48 in the ADT plus abiraterone group. A total of 132 (96.4%) participants had very-high-risk prostate cancer, and 108 (78.8%) had locally advanced disease. The ADT plus docetaxel group (28%) and ADT plus abiraterone group (31%) had higher rates of pCR or MRD (p = 0.001 and p < 0.001) compared with the ADT group (2%). The 3-year bPFS was 41.9% (95% CI: 26.6–57.2), 51.1% (95% CI: 36.8–65.4), and 61.2% (95% CI: 45.5–76.9), respectively. Significant difference was found among groups in terms of bPFS (p = 0.037). Conclusion: Compared with ADT alone, neoadjuvant therapy with ADT plus docetaxel or abiraterone could achieve better pathological outcomes (pCR or MRD) for very-high-risk localized prostate cancer. The ADT plus abiraterone group showed longer bPFS than ADT alone. The combination regimens were tolerable. Frontiers Media S.A. 2023-06-26 /pmc/articles/PMC10331422/ /pubmed/37435500 http://dx.doi.org/10.3389/fphar.2023.1217303 Text en Copyright © 2023 Zhuang, Wang, Zhang, Fu, Huang, Lyu, Zhang, Marra, Xu, Qiu and Guo. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Zhuang, Junlong Wang, Yuwen Zhang, Shun Fu, Yao Huang, Haifeng Lyu, Xiaoyu Zhang, Shiwei Marra, Giancarlo Xu, Linfeng Qiu, Xuefeng Guo, Hongqian Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title | Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title_full | Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title_fullStr | Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title_full_unstemmed | Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title_short | Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials |
title_sort | androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase ii trials |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10331422/ https://www.ncbi.nlm.nih.gov/pubmed/37435500 http://dx.doi.org/10.3389/fphar.2023.1217303 |
work_keys_str_mv | AT zhuangjunlong androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT wangyuwen androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT zhangshun androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT fuyao androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT huanghaifeng androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT lyuxiaoyu androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT zhangshiwei androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT marragiancarlo androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT xulinfeng androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT qiuxuefeng androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials AT guohongqian androgendeprivationtherapyplusabirateroneordocetaxelasneoadjuvanttherapyforveryhighriskprostatecancerapooledanalysisoftwophaseiitrials |