A multicenter, retrospective observational study investigating baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer treated with primary androgen deprivation therapy

Author:

Taguchi Satoru123ORCID,Onozawa Mizuki34ORCID,Hinotsu Shiro35,Kawai Taketo36,Mitomi Takeshi7,Uno Satoshi8,Kume Haruki123

Affiliation:

1. Department of Urology , Graduate School of Medicine, , Tokyo , Japan

2. The University of Tokyo , Graduate School of Medicine, , Tokyo , Japan

3. Japan Study Group of Prostate Cancer (J-CaP) Research Society , Japan

4. Department of Urology, International University of Health and Welfare Ichikawa Hospital , Ichikawa , Japan

5. Department of Biostatistics, Sapporo Medical University , Sapporo , Japan

6. Department of Urology, Teikyo University School of Medicine , Tokyo , Japan

7. Medical Oncology, Astellas Pharma Inc. , Tokyo , Japan

8. Data Science, Astellas Pharma Inc. , Tokyo , Japan

Abstract

Abstract Objective This multicenter, retrospective, observational study investigated baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer who received primary androgen deprivation therapy, using Japan Study Group of Prostate Cancer registry data. Methods Among patients in the Japan Study Group of Prostate Cancer registry, those who initiated primary androgen deprivation therapy and were aged 20 years or older were enrolled in this study. The primary endpoint was time to disease progression, defined as time from primary androgen deprivation therapy initiation to either prostate-specific antigen or clinical progression. Secondary endpoints included prostate-specific antigen progression-free survival, prostate-specific antigen response (90% or greater reduction from baseline) and distribution of second-line treatment. Results Of the 2494 patients (goserelin, n = 564; leuprorelin, n = 1148; surgical castration, n = 161; degarelix, n = 621), those who received degarelix had higher prostate-specific antigen levels and Gleason scores and were at a more advanced clinical stage than those receiving goserelin or leuprorelin. The median time to disease progression (identical to the prostate-specific antigen progression-free survival result) was not reached for goserelin and leuprorelin, 52.7 months for surgical castration and 54.0 months for degarelix. Although baseline prostate-specific antigen values in the degarelix cohort were higher than those of the leuprorelin or goserelin cohorts, prostate-specific antigen responses were not different among the three cohorts. Regarding second-line treatment, the largest patient group received degarelix followed by leuprorelin (n = 195). Conclusions This study clarified patient characteristics and long-term effectiveness of primary androgen deprivation therapy in real-world clinical practice. Japanese urologists appear to select appropriate primary androgen deprivation therapy based on patient background and tumour characteristics, with degarelix largely reserved for higher risk patients.

Funder

Astellas Pharma Inc.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Radiology, Nuclear Medicine and imaging,Oncology,General Medicine

Reference15 articles.

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3. Committee for establishment of the evidenced-based clinical practice guideline for prostate cancer of the Japanese Urological Association. Evidenced-based clinical practice guideline for prostate cancer (summary: Japanese Urological Association, 2016 edition);Kakehi;Int J Urol,2017

4. New hormonal therapy in prostatic carcinoma: combined treatment with an LHRH agonist and an antiandrogen;Labrie;Clin Invest Med,1982

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