Safety and Efficacy of First-Line Treatments for Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Indirect Comparison

Zheng, Haofeng; Chen, Jialiang; Qiu, Wenhan; Lin, Sijie; Chen, Yanxiong; Liang, Guancan; Fang, Youqiang

doi:10.1155/2017/3941217

Cited by 17 publications

(13 citation statements)

References 35 publications

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“…In addition, we comprehensively explore the safety of abiraterone and enzalutamide by showing that AR inhibitors could lead to higher rates of any-grade AE occurrence, virtually significantly lower rates of high-grade (grade >=3) AE, and similar rates of AE leading to death or discontinuation. In Zheng's study 11 , they also evaluated the safety of abiraterone and enzalutamide, although less AEs were involved. Also, given that only COU-AA-302 trial and PREVAIL trial were respectively included for analysis in their study, the statistical power was relatively low.…”

Section: Discussionmentioning

confidence: 99%

“…However, few meta-analyses have included all the related RCTs and directly pooled the HR of OS and PFS by these two agents. In addition, although some previous studies have tried to investigate the efficacy and safety of abiraterone and enzalutamide, evidence regarding AR inhibitors as a whole was scanty and their analysis was either indirect or subjected to bias caused by non-RCTs [11][12][13][14] . Moreover, comparison of the occurrence high-grade AEs (grade ≥3) between the AR inhibitor and control groups has been lacking.…”

Section: Introductionmentioning

confidence: 99%

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Survival Benefits of Androgen Receptor Signaling-Axis Inhibitor’s at The Cost of Adverse Event Occurrence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Zheng

Zhao

et al. 2019

Preprint

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Background: Previous evidence directly evaluating the efficacy and safety of the treatment for castration-resistant prostate cancer (CRPC) by androgen receptor (AR) signaling-axis inhibitors was limited by the quantity of randomized controlled trials (RCT) and biased by non-RCTs. We aim to comprehensively assess the efficacy and safety of abiraterone and enzalutamide using only RCTs. Patients and methods: We systematically searched Pubmed, Embase, MEDLINE and ClinicalTrial.gov for RCTs providing data of treatment outcomes by AR inhibitors (abiraterone and enzalutamide). Pooled hazard ratios (HR) with 95%CI for survival benefits were calculated using STATA 12.0. Comparison of prostate-specific antigen (PSA) response rate, aggregated adverse event (AE) statistics, any grade AE, high-grade AE (grade ≥3), AE of special interest between the treatment and control groups were performed by RevMan 5.3 and STATA 12.0. Results: Eight eligible RCTs with 6296 patients were selected. Pooled HR were 0.72 for overall survival, 0.45 for radiographic progression-free survival and 0.36 for PSA PFS. AR inhibitors could significantly increase the rate of PSA response (OR=8.67, 95%CI 4.42-17.04) and AE occurrence (OR=1.98, 95%CI 1.46-2.68). The treatment group had a higher occurrence of any-grade fatigue (OR=1.34, 95%CI 1.20-1.49), back pain (OR=1.15, 95%CI 1.01-1.15), hot flush (OR=1.76, 95%CI 1.50-2.06), diarrhea (OR=1.22, 95%CI 1.07-2.40) and arthralgia (OR=1.34, 95%CI 1.16-1.54). Particularly, the outcomes for AEs of special interest including any grade hypertension (OR=2.06, 95%CI 1.71-2.47), hypokalemia (OR=1.80, 95%CI 1.42-2.30) and fluid retention or edema (OR=1.38, 95%CI 1.17-1.63) also favored the control group. In terms of high-grade AEs, a higher occurrence of hypertension (OR=2.60, 95%CI 1.79-3.79) and pain in extremity (OR=4.46, 95%CI 2.81-7.07) was observed in the treatment group. There was no significant difference regarding other AEs analyzed in this study. Conclusion: The survival benefits by AR inhibitors for CRPC were evident and promising at the cost of acceptably higher risk of AEs occurrence.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Survival Benefits of Androgen Receptor Signaling-Axis Inhibitor’s at The Cost of Adverse Event Occurrence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Zheng

Zhao

et al. 2019

Preprint

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“…Study by Smit et al suggested a higher PSA response rate was associated with longer survival . Interestingly a meta‐analyses also found that ENZ had greater benefits in PFS but not in OS though number of study included in the analyses were small . A recently published systemic review has indicated ENZ group had a significantly higher PSA response rate…”

Section: Application Within “Real World”mentioning

confidence: 99%

Abiraterone acetate plus prednisone/prednisolone compared with enzalutamide in metastatic castration resistant prostate cancer before or after chemotherapy: A retrospective study of real-world data (ACES).

Das

Price²,

Jones

et al. 2019

JCO

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Background Abiraterone acetate combined with Prednisone/Prednisolone (AA+P) and Enzalutamide (ENZ) have proven survival benefit in men with metastatic castration‐resistant prostate cancer (mCRPC) in chemotherapy‐naïve and prior chemotherapy patients. There have been no studies directly comparing the effectiveness of ENZ to AA+P in mCRPC patients. Methods A retrospective, survival analysis study of 143 real‐world mCRPC patients (90 in AA+P and 53 in ENZ group) was conducted. Patients who started their treatment between February 2012 and May 2016 were included. The primary end point was biochemical progression‐free survival (bPFS). Secondary end points were radiological progression‐free survival (rPFS) and overall survival (OS). Toxicity data were also collected. Data were analyzed using Cox proportional hazards (PH) models, adjusting for covariates: prior radical treatment; Gleason score; prostate‐specific antigen; age; and chemotherapy naïve or not. Results After median follow‐up of 15 months (interquartile range 7 to 23), 112 events of biochemical progression were observed (71 in AA+P and 41 in ENZ). About 41% in AA+P group and 30% patients in ENZ group received prior chemotherapy. The chance of biochemical progression was significantly lower among ENZ patients than AA+P patients, when adjusting for all covariates in the Cox PH model (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.35 to 0.82, P = .004). There was a trend implying the chance of rPFS could be higher among ENZ patients than AA+P patients (HR 1.24, 95% CI 0.76 to 2.02, P = .4). There is no difference in OS between ENZ and AA+P patients, when adjusting for all covariates in the Cox PH model (HR 0.91, 95% CI 0.59 to 1.41, P = .7). About 38% of ENZ patients reported fatigue compared to 16% of AA+P patients, while hypertension was reported slightly more in AA+P patients. Conclusions This study showed a statistically significant difference in bPFS, favoring ENZ, but no significant difference in rPFS or OS.

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“…Poor tolerance to previous chemotherapy generally guides the selection of a different drug class for subsequent treatment lines. 28,29 Nevertheless, as ABI and ENZ are also associated with undesirable effects, clinicians must be familiar with the diagnosis and management of these undesirable effects. 29 Recommendation 11.…”

Section: Paɵents With Mcrpcmentioning

confidence: 99%

Expert recommendations on the management of patients with metastatic castration-resistant prostate cancer who progress after CHAARTED or LATITUDE

et al. 2020

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Objective: Our aim was to provide practical recommendations on the management of patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after docetaxel plus androgen-deprivation therapy (ADT) or abiraterone plus ADT. Methods: Systematic literature review (SLR), nominal group meeting, and Delphi process. A panel of 12 experts was established who defined the scope, users, and sections of the document. We performed an SLR in order to assess the efficacy and safety of available drugs in patients with mCRPC. Abstracts from the American Society of Oncology and European Society for Medical Oncology meetings were also examined. The results were discussed during an expert meeting in which 14 recommendations were generated. The level of agreement with the recommendations was also tested by 13 additional experts following the Delphi process. Recommendations were voted by means of scores ranging from 0 (total disagreement) to 10 (total agreement). We defined agreement when at least 70% of the experts voted ⩾7. Next, we assigned a level of evidence and grade to the recommendation using the Oxford Centre for Evidence-based Medicine Levels of Evidence, following which the final document was drafted. Results: The literature search did not find any articles meeting the inclusion criteria. Finally, 13 out of 14 recommendations were accepted after two Delphi rounds (two were modified after the first round). They pertain to general and individual case-based treatment recommendations. Conclusions: In mCRPC patients who have progressed after docetaxel or abiraterone plus ADT in the metastatic hormone-sensitive prostate cancer setting, these recommendations may support treatment decision-making, due to the lack of evidence or other globally accepted sequencing algorithms.

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Safety and Efficacy of First-Line Treatments for Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Indirect Comparison

Cited by 17 publications

References 35 publications

Survival Benefits of Androgen Receptor Signaling-Axis Inhibitor’s at The Cost of Adverse Event Occurrence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Survival Benefits of Androgen Receptor Signaling-Axis Inhibitor’s at The Cost of Adverse Event Occurrence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abiraterone acetate plus prednisone/prednisolone compared with enzalutamide in metastatic castration resistant prostate cancer before or after chemotherapy: A retrospective study of real-world data (ACES).

Expert recommendations on the management of patients with metastatic castration-resistant prostate cancer who progress after CHAARTED or LATITUDE

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