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Indirect comparison between abiraterone acetate and enzalutamide for the treatment of metastatic castration-resistant prostate cancer： a systematic review

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Asian Journal of Andrology 2017年第2期19卷 196-202页

作者： Wei Zhang Teng-Yun Wu Qi Chen Xiao-Lei Shi Guang-An Xiao Lin Zhao Chuan-Liang Xu Tie Zhou Ying-Hao Sun Department of Urology Changhai Hospital Second Military Medical University Shanghai China Air Force General Hospital of Chinese People's Liberation Army Beijing China Department of Health Statistics Faculty of Health Service Second Military Medical University Shanghai China

This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate （AA） and enzalutamide （Enz） for metastatic castration-resistant prostate cancer （mCRPC）. A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA （active comparator） and Enz （true placebo） randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings （HR. 0.90, 95% CI, 0.73-1.11; HR： 0.85, 95% CI, 0.68-1.07）. Compared with AA, Enz may better outperform control arms in treating mCRPC both before and after chemotherapy regarding secondary endpoints based on indirect comparisons： time to prostate-specific antigen （PSA） progression （HR. 0.34, 95% CI, 0.28-0.42; HR： 0.40, 95% CI, 0.30-0.53）, radiographic progression-free survival （HR： 0.37, 95% CI, 0.28-0.48; HR： 0.61, 95% CI, 0.50-0.74）, and PSA response rate （OR： 18.29, 95% CI, 11.20-29.88; OR： 10.69, 95% CI, 3.92-29.20）. With regard to the effectiveness of Enz following AA or AA following Enz, recent retrospective case series reported overall survival and secondary endpoints for patients with mCRPC progression after chemotherapy. However, confirmatory head-to-head trials are necessary to determine the optimal sequencing of these agents.

关键词： abiraterone acetate enzalutamide indirect comparison metastatic castration-resistant prostate cancer sequential therapy

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前列腺癌治疗药醋酸阿比特龙(abiraterone acetate)

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世界临床药物 2014年第6期 400-401页

1商品名Zytiga2开发与上市厂商本品由英国癌症研究院和BTG公司联合开发,是一种口服甾体17α-羟化酶/C17-20裂解酶(P450C17)抑制剂,于2011年8月首次在美国上市。随后于2011年11月在英国上市。2004年4月强生子公司Cougar生物技术公司从BT... 详细信息

1商品名Zytiga2开发与上市厂商本品由英国癌症研究院和BTG公司联合开发,是一种口服甾体17α-羟化酶/C17-20裂解酶(P450C17)抑制剂,于2011年8月首次在美国上市。随后于2011年11月在英国上市。2004年4月强生子公司Cougar生物技术公司从BTG公司获得本品的全球开发权和商业化权。

关键词：阿比特龙前列腺癌 abiraterone acetate 本品

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High IL-23^(+)cells infiltration correlates with worse clinical outcomes and abiraterone effectiveness in patients with prostate cancer

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Asian Journal of Andrology 2022年第2期24卷 147-153页

作者： Zheng Liu Jun-Yu Zhang Yun-Jie Yang Kun Chang Qi-Feng Wang Yun-Yi Kong Bo Dai Department of Urology Fudan University Shanghai Cancer CenterShanghai 200032China Department of Oncology Shanghai Medical CollegeFudan UniversityShanghai 200032China Department of Pathology Fudan University Shanghai Cancer CenterShanghai 200032China

Individualized treatment of prostate cancer depends on an accurate stratification of patients who are sensitive to various treatments.Interleukin-23(IL-23)was reported to play a significant role in prostate cancer.Here,we aimed to explore the clinical value of IL-23-secreting(IL-23^(+))cells in prostate cancer patients.We evaluated interleukin-23A(IL-23A)expression in The Cancer Genome Atlas database and retrospectively enrolled 179 treatment-naive metastatic prostate cancer patients diagnosed in our institute between June 2012 and December 2014.IL-23^(+)cells were stained and evaluated via immunohistochemistry.Further,survival and multivariate Cox regression analyses were conducted to explore the prognostic value of IL-23^(+)cells.We found that IL-23A expression correlated with disease progression,while IL-23^(+)cells were clearly stained within prostate cancer tissue.Patients with higher Gleason scores and multiple metastatic lesions tended to have more IL-23^(+)cell infiltration.Further analyses showed that patients with higher levels of IL-23^(+)cells had significantly worse overall survival(hazard ratio[HR]=2.996,95%confidence interval[95%CI]:1.812–4.955;P=0.001)and a higher risk of developing castration resistance(HR=2.725,95%CI:1.865–3.981;P=0.001).Moreover,subgroup analyses showed that when patients progressed to a castration-resistant status,the prognostic value of IL-23^(+)cells was observed only in patients treated with abiraterone instead of docetaxel.Therefore,we showed that high IL-23^(+)cell infiltration is an independent prognosticator in patients with metastatic prostate cancer.IL-23^(+)cell infiltration may correlate with abiraterone effectiveness in castration-resistant prostate cancer patients.

关键词： abiraterone acetate interleukin-23 prognosis prostate cancer

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Predictors of efficacy of corticosteroid switching from abiraterone plus prednisone to dexamethasone in patients with metastatic castration-resistant prostate cancer

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Asian Journal of Andrology 2022年第2期24卷 154-160页

作者： Yu-Chao Ni Jin-Ge Zhao Meng-Ni Zhang Yi-Jun Zhang Zhen-Yu Yang Ni Chen Jun-Ru Chen Peng-Fei Shen Guang-Xi Sun Xing-Ming Zhang Yong-Hong Li Hao Zeng Department of Urology Institute of UrologyWest China HospitalSichuan UniversityChengdu 610041China Department of Pathology West China HospitalSichuan UniversityChengdu 610041China Department of Pathology Sun Yat-Sen University Cancer CenterGuangzhou 510060China Department of Urology Sun Yat-Sen University Cancer CenterGuangzhou 510060China

Corticosteroid switching can reverse abiraterone resistance in some patients with metastatic castration-resistant prostate cancer(mCRPC).Here,we investigated the potential biomarkers for predicting the efficacy of corticosteroid switching during treatment with abiraterone acetate(AA).We retrospectively analyzed 101 mCRPC patients receiving corticosteroid switching from West China Hospital and Sun Yat-Sen University Cancer Center between January 2016 and December 2018.All cases received AA plus prednisone as first-line therapy during mCRPC.Primary end points were biochemical progression-free survival(bPFS)and overall survival(OS).The risk groups were defined based on multivariate analysis.A total of 42(41.6%)and 25(24.8%)patients achieved 30%and 50%decline in prostate-specific antigen(PSA),respectively,after corticosteroid switching.The median bPFS and median OS on AA plus dexamethasone were 4.9(95%confidence interval[CI]:3.7–6.0)months and 18.8(95%CI:16.2–30.2)months,respectively.Aldo-keto reductase family 1 member C3(AKR1C3)expression(hazard ratio[HR]:2.15,95%Cl:1.22–3.80,P=0.008)and baseline serum alkaline phosphatase(ALP;HR:4.95,95%Cl:2.40–10.19,P160 IU l−1(HR:3.41,95%Cl:1.57–7.38,P=0.002)together with PSA level at switch≥50 ng ml−1(HR:2.59,95%Cl:1.22–5.47,P=0.013)independently predicted poorer OS.Based on the predictive factors in multivariate analysis,we developed two risk stratification tools to select candidates for corticosteroid switching.Detection of serum ALP level,PSA level,and tissue AKR1C3 expression in mCRPC patients could help make clinical decisions for corticosteroid switching.

关键词： abiraterone acetate alkaline phosphatase corticosteroid switching dexamethasone metastatic castration-resistant prostate cancer

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External validation and newly development of a nomogram to predict overall survival of abiraterone-treated, castration-resistant patients with metastatic prostate cancer

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Asian Journal of Andrology 2018年第2期20卷 184-188页

作者： Yun-Jie Yang Guo-Wen Lin Gao-Xiang Li Bo Dai Ding-Wei Ye Jun-Long Wu Hu-Yang Xie Yao Zhu Department of Urology Fudan University Shanghai Cancer Center Shanghai 200032 China Department of Oncology Shanghai Medical College Fudan University Shanghai 200032 China

abiraterone acetate is approved for the treatment of castration-resistant prostate cancer （CRPC）; however, its effects vary. An accurate prediction model to identify patient groups that will benefit from abiraterone treatment is therefore urgently required. The Chi model exhibits a good profile for risk classification, although its utility for the chemotherapy-naive group is unclear. This study aimed to externally validate the Chi model and develop a new nomogram to predict overall survival （OS）. We retrospectively analyzed a cohort of 110 patients. Patients were distributed among good-, intermediate-, and poor-risk groups, according to the Chi model. The good-, intermediate-, and poor-risk groups had a sample size of 59 （53.6%）, 34 （30.9%）, and 17 （15.5%） in our dataset, and a median OS of 48.4, 29.1, and 10.5 months, respectively. The C-index of external validation of Chi model was 0.726. Univariate and multivariate analyses identified low hemoglobin concentrations （〈110 g l^-1）, liver metastasis, and a short time interval from androgen deprivation therapy to abiraterone initiation （〈36 months） as predictors of OS. Accordingly, a new nomogram was developed with a C-index equal to 0.757 （95% CI, 0.678-0.836）. In conclusion, the Chi model predicted the prognosis of abiraterone-treated, chemotherapy-naive patients with mCRPC, and we developed a new nomogram to predict the overall survival of this group of patients with less parameters.

关键词： abiraterone acetate castration-resistant prostate cancer external validation nomogram surviva

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Androgen receptor variant-7： an important predictive biomarker in castrate resistant prostate cancer

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Asian Journal of Andrology 2015年第3期17卷 439-440页

作者： Oliver Sartor Yan Dong Department of Medicine and Urology Tulane Cancer Center Tulane University School of Medicine New Orleans LA USA Department of Structural and Cellular Biology Tulane Cancer Center Tulane University School of Medicine New Orleans LA USA National Engineering Laboratory for AIDS Vaccine College of Life Sciences Jilin University Changchun Jilin. China

The recent manuscript in New England Journal of Medicine by Antonarakis et al. has important clinical implications. This study evaluates mRNA expression of a particular androgen receptor splice variant-7 （AR-V7）, in circulating tumor cells （CTCs） from metastatic castrate-resistant prostate cancer （mCRPC） patients receiving enzalutamide or abiraterone. The findings were striking, none of the 18 patients with detectable AR-V7 in CTCs had prostate-specific antigen （PSA） responses.

关键词： ENZALUTAMIDE MDV3100 abiraterone acetate ANTITUMOR-ACTIVITY SPLICE VARIANTS DOCETAXEL THERAPY

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Intracrine androgen biosynthesis and drug resistance

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Cancer Drug Resistance 2020年第4期3卷 912-929页

作者： Trevor M.Penning Irfan A.Asangani Cynthia Sprenger Stephen Plymate Department of Systems Pharmacology&Translational Therapeutics Perelman School of MedicineUniversity of PennsylvaniaPhiladelphiaPA 19104USA Department Cancer Biology Perelman School of MedicineUniversity of PennsylvaniaPhiladelphiaPA 19104USA Division of Gerontology&Geriatric Medicine Department of MedicineUniversity of WashingtonSeattleWA 98109USA Geriatric Research Education and Clinical Center(GRECC) VA Puget Sound Health Care SystemSeattleWA 98108USA

Castration-resistant prostate cancer is the lethal form of prostate cancer and most commonly remains dependent on androgen receptor(AR)signaling.Current therapies use AR signaling inhibitors(ARSI)exemplified by abiraterone acetate,a P450c17 inhibitor,and enzalutamide,a potent AR antagonist.However,drug resistance to these agents occurs within 12-18 months and they only prolong overall survival by 3-4 months.Multiple mechanisms can contribute to ARSI drug resistance.These mechanisms can include but are not limited to germline mutations in the AR,post-transcriptional alterations in AR structure,and adaptive expression of genes involved in the intracrine biosynthesis and metabolism of androgens within the tumor.This review focuses on intracrine androgen biosynthesis,how this can contribute to ARSI drug resistance,and therapeutic strategies that can be used to surmount these resistance mechanisms.

关键词： Prostate cancer abiraterone acetate enzalutamide aldo-keto reductase 1C3 androgen biosynthesis

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Metastatic hormone-sensitive prostate cancer:How should it be treated?

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World Journal of Clinical Oncology 2021年第2期12卷 43-49页

作者： Fernando López-Campos Carmen González-San Segundo Antonio JoséConde-Moreno Felipe Couñago Department of Radiation Oncology Hospital Universitario Ramón y CajalMadrid 28034Spain Department of Radiation Oncology HGU Gregorio MarañonComplutense UniversityMadrid 28007Spain Department of Radiation Oncology Hospital Universitario y Politécnico La Fe.CEU Cardenal Herrera UniversityValencia 46026Spain Department of Radiation Oncology Hospital Universitario Quirón Salud MadridHospital La LuzUniversidad Europea de Madrid(UEM)Madrid 28223Spain

The number of treatment options for metastatic hormone-sensitive prostate cancer has increased substantially in recent years.The classic treatment approach for these patients—androgen-deprivation therapy alone—is now considered suboptimal.Several randomized phase III clinical trials have demonstrated significant clinical benefits—including significantly better overall survival and quality of life—for treatments that combine androgen-deprivation therapy with docetaxel,abiraterone acetate,enzalutamide,apalutamide,and/or radiotherapy to the primary tumour.As a result,these approaches are now included in treatment guidelines and considered standard of care.However,the different treatment strategies have not been directly compared,and thus treatment selection remains at the discretion of the individual physician or,ideally,a multidisciplinary team.Given the range of available treatment approaches with varying toxicity profiles,treatment selection should be individualized based on the patient’s clinical characteristics and preferences,which implies active patient participation in the decision-making process.In the present document,we discuss the changing landscape of the management of patients with metastatic hormonesensitive prostate cancer in the context of several recently-published landmark randomized trials.In addition,we discuss several unresolved issues,including the optimal sequencing of systemic treatments and the incorporation of local treatment of the primary tumour and metastases.

关键词： Metastatic hormone-sensitive prostate cancer Androgen-receptor signaling inhibitors abiraterone acetate Enzalutamide Apalutamide Docetaxel

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