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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Abstract Full text Figures/Tables Video References Cited by

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.	付振濤, 郭曉雷, 張思維, 等. 2015年中國前列腺癌發病與死亡分析. 中華腫瘤雜志, 2020, 42(9): 718-722.
4.	曾浩, 種鐵, 賀大林, 等. 去勢抵抗性前列腺癌最新指南解讀—暨中國西部專家共識. 現代泌尿外科雜志, 2017, 22(2): 85-94.
5.	中國抗癌協會泌尿腫瘤專業委員會. 中國去勢抵抗性前列腺癌診治專家共識. 中華外科雜志, 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.	樊連城, 董柏君, 遲辰斐, 等. 阿比特龍聯合潑尼松治療未經化療轉移性去勢抵抗性前列腺癌的有效性和安全性. 上海交通大學學報(醫學版), 2016, 36(9): 1306-1310.
8.	汪洋, 楊麗, 孔東波, 等. 阿比特龍治療老年去勢抵抗性前列腺癌療效和安全性研究. 中國藥業, 2018, 27(11): 66-68.
9.	冉安鵬, 張立東, 王玉杰, 等. 新疆地區多中心阿比特龍和多西他賽治療轉移性去勢抵抗性前列腺癌的臨床療效和安全性的對比分析. 現代泌尿外科雜志, 2019, 24(4): 262-267.
10.	陳志剛. 阿比特龍聯合強的松治療去勢抵抗性前列腺癌的臨床觀察. 醫學食療與健康, 2019, (23): 95-96.
11.	魏軍, 董銳, 劉飛, 等. 阿比特龍與多西他賽治療去勢抵抗性前列腺癌的對比研究. 腫瘤藥學, 2019, 9(3): 414-417.
12.	喬新. 阿比特龍聯合潑尼松治療轉移性去勢抵抗性前列腺癌的臨床觀察. 中國實用醫藥, 2019, 14(23): 105-106.
13.	王業強, 秦勇, 劉淵, 等. 阿比特龍聯合潑尼松治療雄激素剝奪治療失敗后轉移性去勢抵抗性前列腺癌的可行性探討. 實用藥物與臨床, 2019, 22(9): 937-942.
14.	樓正達, 駱俊峰, 王偉強, 等. 阿比特龍治療轉移性去勢抵抗性前列腺癌臨床療效及安全性. 浙江中西醫結合雜志, 2019, 29(12): 1007-1009.
15.	蘆才廣, 沙文, 紀傳彪, 等. 多西紫杉醇、潑尼松聯合阿比特龍對激素抵抗型前列腺癌血清腫瘤標志物水平的影響觀察. 藥品評價, 2020, 17(13): 56-58.
16.	伊力亞爾·努爾如拉, 吳戈, 沙婭·瑪哈提, 等. 比較醋酸阿比特龍與多西他賽對去勢抵抗性前列腺癌的療效和不良反應. 健康必讀, 2020, (22): 98.
17.	關文峰, 何京偉, 馮能卓, 等. 觀察去勢抵抗性前列腺癌個體化藥物治療的效果. 中國實用醫藥, 2020, 15(15): 4-7.
18.	吳波, 周東言, 楊波. 阿比特龍輔助DP化療治療去勢抵抗性前列腺癌的療效觀察. 中國醫師雜志, 2019, 21(5): 779-781.
19.	趙俊. 阿比特龍聯合潑尼松龍治療多西他賽治療失敗的去勢抵抗性前列腺癌的臨床研究. 實用臨床醫藥雜志, 2015, 19(13): 119-120.
20.	龍振河, 崔娟. 阿比特龍與多西他賽治療轉移性去勢抵抗性前列腺癌的臨床觀察. 蛇志, 2020, 32(2): 185-187.
21.	賈曉鵬, 王偉, 楊士杰, 等. 阿比特龍聯合潑尼松治療去勢抵抗性前列腺癌的臨床研究. 醫藥界, 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-na?ve 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. 付振濤, 郭曉雷, 張思維, 等. 2015年中國前列腺癌發病與死亡分析. 中華腫瘤雜志, 2020, 42(9): 718-722.
4. 曾浩, 種鐵, 賀大林, 等. 去勢抵抗性前列腺癌最新指南解讀—暨中國西部專家共識. 現代泌尿外科雜志, 2017, 22(2): 85-94.
5. 中國抗癌協會泌尿腫瘤專業委員會. 中國去勢抵抗性前列腺癌診治專家共識. 中華外科雜志, 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. 樊連城, 董柏君, 遲辰斐, 等. 阿比特龍聯合潑尼松治療未經化療轉移性去勢抵抗性前列腺癌的有效性和安全性. 上海交通大學學報(醫學版), 2016, 36(9): 1306-1310.
8. 汪洋, 楊麗, 孔東波, 等. 阿比特龍治療老年去勢抵抗性前列腺癌療效和安全性研究. 中國藥業, 2018, 27(11): 66-68.
9. 冉安鵬, 張立東, 王玉杰, 等. 新疆地區多中心阿比特龍和多西他賽治療轉移性去勢抵抗性前列腺癌的臨床療效和安全性的對比分析. 現代泌尿外科雜志, 2019, 24(4): 262-267.
10. 陳志剛. 阿比特龍聯合強的松治療去勢抵抗性前列腺癌的臨床觀察. 醫學食療與健康, 2019, (23): 95-96.
11. 魏軍, 董銳, 劉飛, 等. 阿比特龍與多西他賽治療去勢抵抗性前列腺癌的對比研究. 腫瘤藥學, 2019, 9(3): 414-417.
12. 喬新. 阿比特龍聯合潑尼松治療轉移性去勢抵抗性前列腺癌的臨床觀察. 中國實用醫藥, 2019, 14(23): 105-106.
13. 王業強, 秦勇, 劉淵, 等. 阿比特龍聯合潑尼松治療雄激素剝奪治療失敗后轉移性去勢抵抗性前列腺癌的可行性探討. 實用藥物與臨床, 2019, 22(9): 937-942.
14. 樓正達, 駱俊峰, 王偉強, 等. 阿比特龍治療轉移性去勢抵抗性前列腺癌臨床療效及安全性. 浙江中西醫結合雜志, 2019, 29(12): 1007-1009.
15. 蘆才廣, 沙文, 紀傳彪, 等. 多西紫杉醇、潑尼松聯合阿比特龍對激素抵抗型前列腺癌血清腫瘤標志物水平的影響觀察. 藥品評價, 2020, 17(13): 56-58.
16. 伊力亞爾·努爾如拉, 吳戈, 沙婭·瑪哈提, 等. 比較醋酸阿比特龍與多西他賽對去勢抵抗性前列腺癌的療效和不良反應. 健康必讀, 2020, (22): 98.
17. 關文峰, 何京偉, 馮能卓, 等. 觀察去勢抵抗性前列腺癌個體化藥物治療的效果. 中國實用醫藥, 2020, 15(15): 4-7.
18. 吳波, 周東言, 楊波. 阿比特龍輔助DP化療治療去勢抵抗性前列腺癌的療效觀察. 中國醫師雜志, 2019, 21(5): 779-781.
19. 趙俊. 阿比特龍聯合潑尼松龍治療多西他賽治療失敗的去勢抵抗性前列腺癌的臨床研究. 實用臨床醫藥雜志, 2015, 19(13): 119-120.
20. 龍振河, 崔娟. 阿比特龍與多西他賽治療轉移性去勢抵抗性前列腺癌的臨床觀察. 蛇志, 2020, 32(2): 185-187.
21. 賈曉鵬, 王偉, 楊士杰, 等. 阿比特龍聯合潑尼松治療去勢抵抗性前列腺癌的臨床研究. 醫藥界, 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-na?ve 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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