scholarly journals PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES

2021 ◽  
Vol 206 (Supplement 3) ◽  
Author(s):  
Neal D. Shore ◽  
Taro Iguchi ◽  
Arnauld Villers ◽  
Antonio Alcaraz ◽  
Francisco Gomez-Veiga ◽  
...  
2020 ◽  
Author(s):  
Yoshiyuki Miyazawa ◽  
Yoshitaka Sekine ◽  
Seiji Arai ◽  
Daisuke Oka ◽  
Hiroshi Nakayama ◽  
...  

Abstract Background To investigate the association between androgen deprivation therapy (ADT) and changes in the estimated glomerular filtration rate (eGFR) in male Japanese prostate cancer patients, based on post-hoc analysis of data from a previous prospective study.Methods From among 103 prostate cancer patients in whom renal function changes were tracked over 5 years, 88 were divided into a group who completed ADT within 3 years (short ADT group; n = 47) and a group who continued with ADT for more than 5 years (continuous ADT group; n = 41). We compared the groups in terms of the eGFR, calculated based on age and serum creatinine (mg/dL), before ADT initiation and every other year over the next 5 years. This study was approved by the Ethics Committee for Clinical Studies of Gunma University Hospital (Approval No: 8 − 5).Results The eGFR decreased by 4.91 and 2.89 ml/min in the short and continuous ATD groups, respectively, over the 5-year period following ADT initiation. The respective decreases in the eGFR were 0.98 and 0.58 ml/min/year. No significant difference in the eGFR was observed between the two groups at any measurement point.Conclusions ADT patients showed a decrease in the eGFR of 0.58–0.98 ml/min/y over a 5-year period, which is about twice as high as that of normal Japanese males. No significant difference in the eGFR by ADT duration was observed.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5071-5071
Author(s):  
Andrew J. Armstrong ◽  
Taro Iguchi ◽  
Arun Azad ◽  
Arnauld Villers ◽  
Boris Alekseev ◽  
...  

5071 Background: In ARCHES (NCT02677896), ENZA + ADT reduced the risk of radiographic progression and improved secondary clinical outcomes in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with variable patterns of disease spread over placebo (PBO) + ADT. This post hoc analysis aimed to evaluate the efficacy of ENZA + ADT in patients with bone oligometastatic mHSPC compared to polymetastatic mHSPC in ARCHES. Methods: Patients with mHSPC (n = 1150) were randomized 1:1 to ENZA (160 mg/day) + ADT or PBO + ADT, stratified by disease volume and prior docetaxel chemotherapy. This post hoc analysis included patients with bone metastases only, categorized as oligometastatic (1–≤5 metastases) or as polymetastatic (≥6 metastases) based on central review at screening. Efficacy outcomes were compared across treatment arms. Results: Of the ARCHES population with bone metastases (n = 512), the largest subgroup included patients with ≤5 metastases (ENZA + ADT, n = 160; PBO + ADT, n = 136). Baseline characteristics were generally comparable between treatment arms and across subgroups. When compared to PBO + ADT, ENZA + ADT improved rPFS and secondary endpoints in patients with ≤5 metastases (Table). Similar results were observed across other oligometastatic subgroups (1–≤4) as well as in polymetastatic disease (≥6). The safety profile of ENZA + ADT versus PBO + ADT was similar across subgroups and consistent with previous findings. Conclusions: This post hoc analysis demonstrates that ENZA + ADT provides clinical benefit across bone oligometastatic as well as polymetastatic mHSPC, supporting the utility of ENZA irrespective of metastatic burden in the ARCHES study. Clinical trial information: NCT02677896. [Table: see text]


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