使用Apalutamide治療轉移性去勢敏感性攝護腺癌之經驗

江長和¹、黃逸修 ^1,2、鍾孝仁^1,2、林子平^1,2、黃子豪^1,2、陳威任^1,2、黃志賢^1,2

¹臺北榮民總醫院泌尿部

²國立陽明交通大學醫學院泌尿學科 書田泌尿科學研究中心

A real-world experience of using Apalutamide in the treatment of metastatic hormone sensitive prostate cancer

Chang-Ho Chiang¹, Eric Yi-Hsiu Huang^1,2, Hsiao-Jen Chung^1,2,Tzu-Ping Lin^1,2, Tzu-Hao Huang^1,2,Wei-Jen Chen^1,2,William J. Huang^1,2

¹Department of Urology, Taipei Veterans General Hospital,

²Department of Urology, College of Medicine and Shu-Tien Urological Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan

Purpose:

The combination of apalutamide with androgen deprivation therapy (ADT) had been proven effective to improve the overall survival of high risk metastatic castration-sensitive prostate cancer (mCSPC). From March 1^st, 2021, Apalutamide has been reimbursed by the National Health Insurance (NHI) for high risk mCSPC of modified definition. This study aimed to present the experiences of using apalutamide  for the treatment of mCSPC in our real world clinical practice.

Materials and Methods:

During the period from May 2020 to January 2021, we enrolled patients who met the NHI modified definition of high risk mCSPC and received NHI reimbursed apalutamide and ADT in our hospital (VGHTPE). Adverse events (skin event, bone event, cardiac event, brain event) and serum biochemistry parameters were monitored during the whole course of apalutamide at each clinic visit. The clinical response and adverse events (AEs) were reported.

Results

In total, 22 patients were enrolled in our study since March 1st, 2021. Among them, 20 patients (90.9%) were Gleason score ≥8, 19 patients (86.4%) had four or more metastatic bone lesions and at least one at appendicular bone on bone scan, and 6 patients (27.3%) had visceral metastasis (most in lung). There were 3 patients (13.6%) meeting all three high-risk criteria. Interestingly, there were 2 patients who didn’t meet the modified high-risk criteria but got reimbursed. After a median follow-up of 9.2 months (IQR 6.9−12.3), 3 patients discontinued apalutamide due to disease progression and PSA progression. Nineteen patients (86.4%) were still on the treatment until March, 2023 with a median treatment duration of 8.25 moths. The PSA response rate at 3 month, defined as decline of PSA ≥ 50%, was 86.4%. The common AEs were skin rash (N=5, 22.7%), body weight loss (N=4 ,18.2 %), anemia (N=5, 22.7%), blood alkaline phosphatase increased (N=2, 9.1%) and liver function elevation was noted in 4 patients (18.2%). There are only four AEs of CTCAE grade 2 in anemia and no grade 3 adverse events recorded.[EYH1] 

Conclusions

Our preliminary experiences showed high PSA response rate of apalutamide in the treatment of high-risk mCSPC. However, certain patients suffered from treatment related AEs but no patients discontinued the medication. Prolonged follow up is need for further survival outcomes.