Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study

Background: To compare adverse event (AE) profiles between patients with prostate cancer receiving triplet therapy (docetaxel, androgen receptor signaling inhibitors [ARSIs], and androgen deprivation therapy [ADT]) and those receiving docetaxel-based therapy (docetaxel and ADT). Additionally, we sou...

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Main Authors: Fumihiko Urabe, Hirokazu Kagawa, Takafumi Yanagisawa, Hidetsugu Takahashi, Masaki Hashimoto, Shuhei Hara, Wataru Fukuokaya, Yu Imai, Kosuke Iwatani, Taro Igarashi, Mahito Atsuta, Kojiro Tashiro, Masaya Murakami, Shunsuke Tsuzuki, Brendan A. Yanada, Toshihiro Yamamoto, Kenichi Hata, Hiroki Yamada, Jun Miki, Takahiro Kimura
Format: Article
Language:English
Published: Elsevier 2025-03-01
Series:Prostate International
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Online Access:http://www.sciencedirect.com/science/article/pii/S2287888224000850
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author Fumihiko Urabe
Hirokazu Kagawa
Takafumi Yanagisawa
Hidetsugu Takahashi
Masaki Hashimoto
Shuhei Hara
Wataru Fukuokaya
Yu Imai
Kosuke Iwatani
Taro Igarashi
Mahito Atsuta
Kojiro Tashiro
Masaya Murakami
Shunsuke Tsuzuki
Brendan A. Yanada
Toshihiro Yamamoto
Kenichi Hata
Hiroki Yamada
Jun Miki
Takahiro Kimura
author_facet Fumihiko Urabe
Hirokazu Kagawa
Takafumi Yanagisawa
Hidetsugu Takahashi
Masaki Hashimoto
Shuhei Hara
Wataru Fukuokaya
Yu Imai
Kosuke Iwatani
Taro Igarashi
Mahito Atsuta
Kojiro Tashiro
Masaya Murakami
Shunsuke Tsuzuki
Brendan A. Yanada
Toshihiro Yamamoto
Kenichi Hata
Hiroki Yamada
Jun Miki
Takahiro Kimura
author_sort Fumihiko Urabe
collection DOAJ
description Background: To compare adverse event (AE) profiles between patients with prostate cancer receiving triplet therapy (docetaxel, androgen receptor signaling inhibitors [ARSIs], and androgen deprivation therapy [ADT]) and those receiving docetaxel-based therapy (docetaxel and ADT). Additionally, we sought to identify risk factors for severe AEs associated with these treatment regimens. Materials and methods: In this retrospective, multicenter study, we included 359 patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) who were treated with docetaxel. We analyzed patient demographics, hematologic and non-hematologic AEs, and risk factors for severe AEs. Logistic regression models were used to assess risk factors. Results: There were no significant differences in the incidence of ≥ grade 3 neutropenia or febrile neutropenia (FN) between the triplet and docetaxel-based therapy groups when stratified by the use of primary prophylaxis. Non-hematologic AEs, especially fatigue, were more frequent in the mCRPC group compared to the triplet therapy group. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) significantly reduced the risk of severe neutropenia (odds ratio [OR] 0.092, P < 0.001) and FN (OR 0.13, P = 0.007). Conclusion: This study represents the first real-world analysis comparing the adverse event profiles of triplet therapy and docetaxel-based therapy in Japanese patients with mCSPC, as well as docetaxel-based therapy in those with mCRPC. No significant difference in severe AEs was observed between the therapies. Primary prophylaxis with G-CSF proved critical in reducing severe neutropenia and FN, underscoring its importance in enhancing the safety and efficacy of docetaxel-based therapies.
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spelling doaj-art-92e59aabfd4b4e35b17f803f56330d4d2025-08-20T03:44:17ZengElsevierProstate International2287-88822025-03-01131414810.1016/j.prnil.2024.11.003Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective studyFumihiko Urabe0Hirokazu Kagawa1Takafumi Yanagisawa2Hidetsugu Takahashi3Masaki Hashimoto4Shuhei Hara5Wataru Fukuokaya6Yu Imai7Kosuke Iwatani8Taro Igarashi9Mahito Atsuta10Kojiro Tashiro11Masaya Murakami12Shunsuke Tsuzuki13Brendan A. Yanada14Toshihiro Yamamoto15Kenichi Hata16Hiroki Yamada17Jun Miki18Takahiro Kimura19Department of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jike the 3rd Hospital, Tokyo, Japan; Corresponding author. Department of Urology, The Jikei University School of Medicine, Tokyo, Japan.Department of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Kashiwa Hospital, Chiba, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Katsushika Medical Center, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Katsushika Medical Center, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Fuji City General Hospital, Shizuoka, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jike the 3rd Hospital, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Kashiwa Hospital, Chiba, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Katsushika Medical Center, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Fuji City General Hospital, Shizuoka, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Surgery, The University of Melbourne, Parkville, Victoria, AustraliaDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Atsugi City Hospital, Kanagawa, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Katsushika Medical Center, Tokyo, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan; Department of Urology, Jikei Kashiwa Hospital, Chiba, JapanDepartment of Urology, The Jikei University School of Medicine, Tokyo, JapanBackground: To compare adverse event (AE) profiles between patients with prostate cancer receiving triplet therapy (docetaxel, androgen receptor signaling inhibitors [ARSIs], and androgen deprivation therapy [ADT]) and those receiving docetaxel-based therapy (docetaxel and ADT). Additionally, we sought to identify risk factors for severe AEs associated with these treatment regimens. Materials and methods: In this retrospective, multicenter study, we included 359 patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) who were treated with docetaxel. We analyzed patient demographics, hematologic and non-hematologic AEs, and risk factors for severe AEs. Logistic regression models were used to assess risk factors. Results: There were no significant differences in the incidence of ≥ grade 3 neutropenia or febrile neutropenia (FN) between the triplet and docetaxel-based therapy groups when stratified by the use of primary prophylaxis. Non-hematologic AEs, especially fatigue, were more frequent in the mCRPC group compared to the triplet therapy group. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) significantly reduced the risk of severe neutropenia (odds ratio [OR] 0.092, P < 0.001) and FN (OR 0.13, P = 0.007). Conclusion: This study represents the first real-world analysis comparing the adverse event profiles of triplet therapy and docetaxel-based therapy in Japanese patients with mCSPC, as well as docetaxel-based therapy in those with mCRPC. No significant difference in severe AEs was observed between the therapies. Primary prophylaxis with G-CSF proved critical in reducing severe neutropenia and FN, underscoring its importance in enhancing the safety and efficacy of docetaxel-based therapies.http://www.sciencedirect.com/science/article/pii/S2287888224000850Adverse eventDocetaxelmCSPCNeutropeniaTriplet therapy
spellingShingle Fumihiko Urabe
Hirokazu Kagawa
Takafumi Yanagisawa
Hidetsugu Takahashi
Masaki Hashimoto
Shuhei Hara
Wataru Fukuokaya
Yu Imai
Kosuke Iwatani
Taro Igarashi
Mahito Atsuta
Kojiro Tashiro
Masaya Murakami
Shunsuke Tsuzuki
Brendan A. Yanada
Toshihiro Yamamoto
Kenichi Hata
Hiroki Yamada
Jun Miki
Takahiro Kimura
Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
Prostate International
Adverse event
Docetaxel
mCSPC
Neutropenia
Triplet therapy
title Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
title_full Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
title_fullStr Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
title_full_unstemmed Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
title_short Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic prostate cancer: a multicenter retrospective study
title_sort comparative adverse event profiles of triplet therapy versus docetaxel based therapy in patients with metastatic prostate cancer a multicenter retrospective study
topic Adverse event
Docetaxel
mCSPC
Neutropenia
Triplet therapy
url http://www.sciencedirect.com/science/article/pii/S2287888224000850
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