Efficacy and safety of abiraterone acetate in the treatment of castration-resistant prostate cancer: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

CHONG Yuliang ¹ , MENG Yong ¹ ,  XIA Xiaomei ²

1. Central Hospital Affiliated to Shandong First Medical University (Shandong Academy of Medical Sciences), Jinan 250014, P. R. China;
2. The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Jinan 250014, P. R. China;

Corresponding author：

XIA Xiaomei, Email: 850578902@qq.com

Keywords：

Abiraterone acetate; Castration-resistant prostate cancer; Efficacy; Safety; Meta-analysis

DOI：

10.7507/1672-2531.202111018

Video：

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Objective To systematically review the efficacy and safety of abiraterone acetate in the treatment of castration-resistant prostate cancer. Methods CNKI, WanFang Data, VIP, Web of Science, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect randomized controlled trials on abiraterone in the treatment of castration-resistant prostate cancer from inception to December 31^st, 2020. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 25 randomized controlled trials involving 8 654 patients were included. Meta-analysis results showed that the median radiographic progression-free survival (MD=5.81, 95%CI 3.58 to 8.03, P<0.01), PSA response rate (RR=2.77, 95%CI 1.65 to 4.65, P<0.01), median overall survival (MD=6.44, 95%CI 4.54 to 8.33, P<0.01), median time to PSA progression (MD=2.57, 95%CI 1.30 to 3.84, P<0.01), median PSA progressionfree survival (MD=6.74, 95%CI 5.08 to 8.39, P<0.01), testosterone level control (MD=−0.41, 95%CI −0.68 to −0.14, P<0.01), PSA level control (MD=−8.06, 95%CI −13.82 to −2.31, P<0.01), effective rate (RR=2.94, 95%CI 1.89 to 4.58, P<0.01), complete remission (RR=1.66, 95%CI 1.02 to 2.72, P<0.05), granulocytopenia (RR=0.18, 95%CI 0.07 to 0.45, P<0.01) and KPS score (MD=4.29, 95%CI 4.06 to 4.52, P<0.01) were significantly superior to non-abiraterone treatment group. The incidence of hypertension (RR=2.04, 95%CI 1.62 to 2.57, P<0.01), heart disease (RR=2.27, 95%CI 1.80 to 2.86, P<0.01) and hypokalemia (RR=2.89, 95%CI 1.59 to 5.26, P<0.01) adverse reactions were significantly higher than those in non-abiraterone group. The number of drug withdrawals caused by adverse reactions (RR=1.26, 95%CI 0.98 to 1.61, P>0.05), fluid retention or edema (RR=1.23, 95%CI 0.73 to 2.09, P>0.05), liver function damage (RR=1.66, 95%CI 0.93 to 2.97, P>0.05), fatigue and weakness (RR=0.97, 95%CI 0.73 to 1.29, P>0.05), anemia (RR=0.86, 95%CI 0.64 to 1.16, P>0.05) and elevated blood glucose (RR=1.51, 95%CI 0.96 to 2.36, P>0.05), were not significantly different between the two groups. Conclusion Abiraterone acetate can effectively delay the progression of castration-resistant prostate cancer, prolong the survival period, and improve the quality of life. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.

Citation： CHONG Yuliang, MENG Yong, XIA Xiaomei. Efficacy and safety of abiraterone acetate in the treatment of castration-resistant prostate cancer: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2022, 22(3): 276-283. doi: 10.7507/1672-2531.202111018 Copy

1.	Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin, 2019, 69(1): 7-34.
2.	Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2018, 68(6): 394-424.
3.	付振涛, 郭晓雷, 张思维, 等. 2015年中国前列腺癌发病与死亡分析. 中华肿瘤杂志, 2020, 42(9): 718-722.
4.	曾浩, 种铁, 贺大林, 等. 去势抵抗性前列腺癌最新指南解读—暨中国西部专家共识. 现代泌尿外科杂志, 2017, 22(2): 85-94.
5.	中国抗癌协会泌尿肿瘤专业委员会. 中国去势抵抗性前列腺癌诊治专家共识. 中华外科杂志, 2016, 54(7): 481-484.
6.	Gan Y, Li L, Zhang L, et al. Association between shift work and risk of prostate cancer: a systematic review and meta-analysis of observational studies. Carcinogenesis, 2018, 39(2): 87-97.
7.	樊连城, 董柏君, 迟辰斐, 等. 阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌的有效性和安全性. 上海交通大学学报(医学版), 2016, 36(9): 1306-1310.
8.	汪洋, 杨丽, 孔东波, 等. 阿比特龙治疗老年去势抵抗性前列腺癌疗效和安全性研究. 中国药业, 2018, 27(11): 66-68.
9.	冉安鹏, 张立东, 王玉杰, 等. 新疆地区多中心阿比特龙和多西他赛治疗转移性去势抵抗性前列腺癌的临床疗效和安全性的对比分析. 现代泌尿外科杂志, 2019, 24(4): 262-267.
10.	陈志刚. 阿比特龙联合强的松治疗去势抵抗性前列腺癌的临床观察. 医学食疗与健康, 2019, (23): 95-96.
11.	魏军, 董锐, 刘飞, 等. 阿比特龙与多西他赛治疗去势抵抗性前列腺癌的对比研究. 肿瘤药学, 2019, 9(3): 414-417.
12.	乔新. 阿比特龙联合泼尼松治疗转移性去势抵抗性前列腺癌的临床观察. 中国实用医药, 2019, 14(23): 105-106.
13.	王业强, 秦勇, 刘渊, 等. 阿比特龙联合泼尼松治疗雄激素剥夺治疗失败后转移性去势抵抗性前列腺癌的可行性探讨. 实用药物与临床, 2019, 22(9): 937-942.
14.	楼正达, 骆俊峰, 王伟强, 等. 阿比特龙治疗转移性去势抵抗性前列腺癌临床疗效及安全性. 浙江中西医结合杂志, 2019, 29(12): 1007-1009.
15.	芦才广, 沙文, 纪传彪, 等. 多西紫杉醇、泼尼松联合阿比特龙对激素抵抗型前列腺癌血清肿瘤标志物水平的影响观察. 药品评价, 2020, 17(13): 56-58.
16.	伊力亚尔·努尔如拉, 吴戈, 沙娅·玛哈提, 等. 比较醋酸阿比特龙与多西他赛对去势抵抗性前列腺癌的疗效和不良反应. 健康必读, 2020, (22): 98.
17.	关文峰, 何京伟, 冯能卓, 等. 观察去势抵抗性前列腺癌个体化药物治疗的效果. 中国实用医药, 2020, 15(15): 4-7.
18.	吴波, 周东言, 杨波. 阿比特龙辅助DP化疗治疗去势抵抗性前列腺癌的疗效观察. 中国医师杂志, 2019, 21(5): 779-781.
19.	赵俊. 阿比特龙联合泼尼松龙治疗多西他赛治疗失败的去势抵抗性前列腺癌的临床研究. 实用临床医药杂志, 2015, 19(13): 119-120.
20.	龙振河, 崔娟. 阿比特龙与多西他赛治疗转移性去势抵抗性前列腺癌的临床观察. 蛇志, 2020, 32(2): 185-187.
21.	贾晓鹏, 王伟, 杨士杰, 等. 阿比特龙联合泼尼松治疗去势抵抗性前列腺癌的临床研究. 医药界, 2019, 9(18): 134.
22.	James ND, de Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med, 2017, 377(4): 338-351.
23.	Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med, 2017, 377(4): 352-360.
24.	Hu Z, Ye Z, Zeng H, et al. Abiraterone acetate in men with metastatic castration-resistant prostate cancer and no prior chemotherapy: a double-arm, multiple-centre, phase III clinical study. Ann Oncol, 2020, 31(3): S530.
25.	Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol, 2012, 13(10): 983-992.
26.	Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol, 2015, 16(2): 152-160.
27.	Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol, 2014, 66(5): 815-825.
28.	Ye D, Huang Y, Zhou F, et al. A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia. Asian J Urol, 2017, 4(2): 75-85.
29.	Sun Y, Zou Q, Sun Z, et al. Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study. Int J Urol, 2016, 23(5): 404-411.
30.	Chang LW, Hung SC, Wang SS, et al. Abiraterone acetate and enzalutamide: similar efficacy in treating post docetaxel metastatic castration-resistant prostate cancer: single center experience. Anticancer Res, 2019, 39(7): 3901-3908.
31.	Miyake H, Hara T, Terakawa T, et al. Comparative assessment of clinical outcomes between abiraterone acetate and enzalutamide in patients with docetaxel-naive metastatic castration-resistant prostate cancer: experience in real-world clinical practice in Japan. Clin Genitourin Cancer, 2017, 15(2): 313-319.
32.	Sydes MR, Spears MR, Mason MD, et al. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol, 2018, 29(5): 1235-1248.
33.	Faiena I, Salmasi A, Pantuck AJ, et al. Re: Abiraterone for prostate cancer not previously treated with hormone therapy. Eur Urol, 2018, 73(6): 981.
34.	Attard G, Borre M, Gurney H, et al. Abiraterone alone or in combination with enzalutamide in metastatic castration-resistant prostate cancer with rising prostate-specific antigen during enzalutamide treatment. J Clin Oncol, 2018, 36(25): 2639-2646.
35.	Njar VC, Brodie AM. Discovery and development of Galeterone (TOK-001 or VN/124-1) for the treatment of all stages of prostate cancer. J Med Chem, 2015, 58(5): 2077-2087.
36.	Roviello G, Sigala S, Danesi R, et al. Incidence and relative risk of adverse events of special interest in patients with castration resistant prostate cancer treated with CYP-17 inhibitors: a meta-analysis of published trials. Crit Rev Oncol Hematol, 2016, 101: 12-20.

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin, 2019, 69(1): 7-34.
2. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2018, 68(6): 394-424.
3. 付振涛, 郭晓雷, 张思维, 等. 2015年中国前列腺癌发病与死亡分析. 中华肿瘤杂志, 2020, 42(9): 718-722.
4. 曾浩, 种铁, 贺大林, 等. 去势抵抗性前列腺癌最新指南解读—暨中国西部专家共识. 现代泌尿外科杂志, 2017, 22(2): 85-94.
5. 中国抗癌协会泌尿肿瘤专业委员会. 中国去势抵抗性前列腺癌诊治专家共识. 中华外科杂志, 2016, 54(7): 481-484.
6. Gan Y, Li L, Zhang L, et al. Association between shift work and risk of prostate cancer: a systematic review and meta-analysis of observational studies. Carcinogenesis, 2018, 39(2): 87-97.
7. 樊连城, 董柏君, 迟辰斐, 等. 阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌的有效性和安全性. 上海交通大学学报(医学版), 2016, 36(9): 1306-1310.
8. 汪洋, 杨丽, 孔东波, 等. 阿比特龙治疗老年去势抵抗性前列腺癌疗效和安全性研究. 中国药业, 2018, 27(11): 66-68.
9. 冉安鹏, 张立东, 王玉杰, 等. 新疆地区多中心阿比特龙和多西他赛治疗转移性去势抵抗性前列腺癌的临床疗效和安全性的对比分析. 现代泌尿外科杂志, 2019, 24(4): 262-267.
10. 陈志刚. 阿比特龙联合强的松治疗去势抵抗性前列腺癌的临床观察. 医学食疗与健康, 2019, (23): 95-96.
11. 魏军, 董锐, 刘飞, 等. 阿比特龙与多西他赛治疗去势抵抗性前列腺癌的对比研究. 肿瘤药学, 2019, 9(3): 414-417.
12. 乔新. 阿比特龙联合泼尼松治疗转移性去势抵抗性前列腺癌的临床观察. 中国实用医药, 2019, 14(23): 105-106.
13. 王业强, 秦勇, 刘渊, 等. 阿比特龙联合泼尼松治疗雄激素剥夺治疗失败后转移性去势抵抗性前列腺癌的可行性探讨. 实用药物与临床, 2019, 22(9): 937-942.
14. 楼正达, 骆俊峰, 王伟强, 等. 阿比特龙治疗转移性去势抵抗性前列腺癌临床疗效及安全性. 浙江中西医结合杂志, 2019, 29(12): 1007-1009.
15. 芦才广, 沙文, 纪传彪, 等. 多西紫杉醇、泼尼松联合阿比特龙对激素抵抗型前列腺癌血清肿瘤标志物水平的影响观察. 药品评价, 2020, 17(13): 56-58.
16. 伊力亚尔·努尔如拉, 吴戈, 沙娅·玛哈提, 等. 比较醋酸阿比特龙与多西他赛对去势抵抗性前列腺癌的疗效和不良反应. 健康必读, 2020, (22): 98.
17. 关文峰, 何京伟, 冯能卓, 等. 观察去势抵抗性前列腺癌个体化药物治疗的效果. 中国实用医药, 2020, 15(15): 4-7.
18. 吴波, 周东言, 杨波. 阿比特龙辅助DP化疗治疗去势抵抗性前列腺癌的疗效观察. 中国医师杂志, 2019, 21(5): 779-781.
19. 赵俊. 阿比特龙联合泼尼松龙治疗多西他赛治疗失败的去势抵抗性前列腺癌的临床研究. 实用临床医药杂志, 2015, 19(13): 119-120.
20. 龙振河, 崔娟. 阿比特龙与多西他赛治疗转移性去势抵抗性前列腺癌的临床观察. 蛇志, 2020, 32(2): 185-187.
21. 贾晓鹏, 王伟, 杨士杰, 等. 阿比特龙联合泼尼松治疗去势抵抗性前列腺癌的临床研究. 医药界, 2019, 9(18): 134.
22. James ND, de Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med, 2017, 377(4): 338-351.
23. Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med, 2017, 377(4): 352-360.
24. Hu Z, Ye Z, Zeng H, et al. Abiraterone acetate in men with metastatic castration-resistant prostate cancer and no prior chemotherapy: a double-arm, multiple-centre, phase III clinical study. Ann Oncol, 2020, 31(3): S530.
25. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol, 2012, 13(10): 983-992.
26. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol, 2015, 16(2): 152-160.
27. Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol, 2014, 66(5): 815-825.
28. Ye D, Huang Y, Zhou F, et al. A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia. Asian J Urol, 2017, 4(2): 75-85.
29. Sun Y, Zou Q, Sun Z, et al. Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study. Int J Urol, 2016, 23(5): 404-411.
30. Chang LW, Hung SC, Wang SS, et al. Abiraterone acetate and enzalutamide: similar efficacy in treating post docetaxel metastatic castration-resistant prostate cancer: single center experience. Anticancer Res, 2019, 39(7): 3901-3908.
31. Miyake H, Hara T, Terakawa T, et al. Comparative assessment of clinical outcomes between abiraterone acetate and enzalutamide in patients with docetaxel-naive metastatic castration-resistant prostate cancer: experience in real-world clinical practice in Japan. Clin Genitourin Cancer, 2017, 15(2): 313-319.
32. Sydes MR, Spears MR, Mason MD, et al. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol, 2018, 29(5): 1235-1248.
33. Faiena I, Salmasi A, Pantuck AJ, et al. Re: Abiraterone for prostate cancer not previously treated with hormone therapy. Eur Urol, 2018, 73(6): 981.
34. Attard G, Borre M, Gurney H, et al. Abiraterone alone or in combination with enzalutamide in metastatic castration-resistant prostate cancer with rising prostate-specific antigen during enzalutamide treatment. J Clin Oncol, 2018, 36(25): 2639-2646.
35. Njar VC, Brodie AM. Discovery and development of Galeterone (TOK-001 or VN/124-1) for the treatment of all stages of prostate cancer. J Med Chem, 2015, 58(5): 2077-2087.
36. Roviello G, Sigala S, Danesi R, et al. Incidence and relative risk of adverse events of special interest in patients with castration resistant prostate cancer treated with CYP-17 inhibitors: a meta-analysis of published trials. Crit Rev Oncol Hematol, 2016, 101: 12-20.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of abiraterone acetate in the treatment of castration-resistant prostate cancer: a meta-analysis

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