Evaluation of potential surrogate endpoints for prediction of overall survival in patients with castration-resistant prostate cancer: trial-level meta-analysis

Chen, Wenjun; Li, Liang; Ji, Shuangmin; Song, Xuyang; Lü, Wei; Zhou, Tianyan

doi:10.1007/s00228-019-02736-8

Cited by 4 publications

(3 citation statements)

References 32 publications

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“…Thus, metastasis‐free survival (MFS) has been shown to be a strong surrogate of OS in localized PCa in a meta‐analysis by Xie and colleagues 18 . The same holds true for nonmetastatic castration‐resistant PCa (CRPC), as a strong association of MFS with OS was revealed in a retrospective assessment of 1207 men from the SPARTAN trial by Smith et al 19 In metastatic CRPC, rPFS was proposed to serve as a potential surrogate endpoint of OS in the meta‐analysis by Chen and coauthors 20 . In mHSPC, Martini et al identified progression within 6 months as the best surrogate for OS relying on data of 790 patients from the CHAARTED trial 21 .…”

Section: Discussionmentioning

confidence: 98%

“… 18 The same holds true for nonmetastatic castration‐resistant PCa (CRPC), as a strong association of MFS with OS was revealed in a retrospective assessment of 1207 men from the SPARTAN trial by Smith et al 19 In metastatic CRPC, rPFS was proposed to serve as a potential surrogate endpoint of OS in the meta‐analysis by Chen and coauthors. 20 In mHSPC, Martini et al identified progression within 6 months as the best surrogate for OS relying on data of 790 patients from the CHAARTED trial. 21 Notwithstanding this correlation, the lack of OS difference in our real‐world analysis might be attributable to the factual flimsy difference of the impact of AA+ADT or D+ADT on OS, which might be only unmasked in a sufficiently powered prospective trial.…”

Section: Discussionmentioning

confidence: 99%

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A real‐world comparison of docetaxel versus abiraterone acetate for metastatic hormone‐sensitive prostate cancer

Tsaur¹,

Heidegger

Bektic

et al. 2021

Cancer Medicine

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

A real‐world comparison of docetaxel versus abiraterone acetate for metastatic hormone‐sensitive prostate cancer

Tsaur¹,

Heidegger

Bektic

et al. 2021

Cancer Medicine

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“…Significant association between OS and disease progression has been observed in prostate cancer patients with metastatic hormone-sensitive prostate cancer (mHSPC). The meta-analysis results demonstrated that effective prolongation of metastasis-free survival and time free of disease progression increased OS in patients with limited prostate cancer and those with mHSPC and non-metastatic desmoplastic resistant prostate cancer (nmCRPC) (16)(17)(18). Furthermore, Martini et al conducted a supplementary analysis utilizing outcome data from the CHAARTED trial, which demonstrated that progression within 6 months of dosing had a noteworthy impact on patients' overall survival (19).Therefore although our trial has not yet reached the median OS for apalutamide, analysis of the early progression-free survival data indicates that apalutamide significantly prolongs OS in mHSPC patients compared with bicalutamide.…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of multiple androgen receptor signaling inhibitor medicines with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer: a study in the real world

Lu,

Jiang,

Yang

et al. 2024

Front. Oncol.

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BackgroundThe current treatment strategy for metastatic Hormone-Sensitive Prostate Cancer (mHSPC) is the combination of Androgen Receptor Signaling Inhibitors (ARSIs) medicines with androgen deprivation therapy (ADT). However, there is a lack of real-world data comparing the efficacy of different ARSI pharmaceuticals. Therefore, the objective of this study was to compare the effectiveness and safety of bicalutamide, abiraterone, enzalutamide, and apalutamide in combination with ADT for patients with mHSPC.MethodsWe retrospectively analyzed 82 patients diagnosed with mHSPC, including 18 patients treated with abiraterone acetate with prednisone, 21 patients with enzalutamide, 20 patients with apalutamide, and 23 patients with bicalutamide. We evaluated PSA progression-free survival (PSA-PFS), imaging progression-free survival (r PFS), castration resistance progression-free survival (CRPC-PFS), and overall survival (OS) using Kaplan-Meier survival analyses. Additionally, we explored relevant factors affecting prognosis through univariate and multivariate Cox risk-proportionality models. PSA response rates at 3, 6, and 12 months, nadir PSA levels (nPSA), and time to nadir (TTN) in different medication subgroups after treatment were documented, and we used one-way ANOVA to determine the effect of these measures on patient prognosis.ResultsIn comparison with bicalutamide, both enzalutamide and apalutamide have shown significant advantages in delaying disease progression among mHSPC patients. Specifically, enzalutamide has been found to significantly prolong PSA-PFS (HR 2.244; 95% CI 1.366-3.685, p=0.001), rPFS (HR 2.539; 95% CI 1.181-5.461; p= 0.007), CRPC-PFS (HR 2.131; 95% CI 1.295-3.506; p= 0.003), and OS (HR 2.06; 95% CI 1.183-3.585; P=0.005). Similarly, apalutamide has significantly extended PSA-PFS (HR 5.071; 95% CI 1.711-15.032; P= 0.003) and CRPC-PFS (HR 6.724; 95% CI 1.976-22.878; P=0.002) among patients. On the other hand, the use of abiraterone in combination with ADT did not demonstrate a significant advantage in delaying diseases progression when compared with the other three agents in mHSPC patients. There were no significant differences in overall adverse event rates among the four pharmaceuticals in terms of safety. Additionally, the observation of PSA kinetics revealed that enzalutamide, apalutamide, and abiraterone acetate had a significant advantage in achieving deep PSA response (PSA ≤ 0.2 ng/ml) compared with bicalutamide (p=0.007 at 12 months). Enzalutamide and apalutamide exhibited preeminence efficacy, with no substantial difference observed between the two medications.ConclusionsAbiraterone, enzalutamide, and apalutamide were found to significantly reduce and stabilize PSA levels in mHSPC patients more quickly and thoroughly than bicalutamide. Furthermore, enzalutamide and apalutamide were found to significantly prolong survival and delay disease progression in mHSPC patients compared with bicalutamide. It should be noted that abiraterone did not demonstrate a significant advantage in delaying disease compared with enzalutamide and apalutamide. After conducting drug toxicity analyses, it was determined that there were no significant differences among the four drugs.

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Longitudinal model–based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer

Chen

et al. 2020

Eur J Clin Pharmacol

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Evaluation of potential surrogate endpoints for prediction of overall survival in patients with castration-resistant prostate cancer: trial-level meta-analysis

Cited by 4 publications

References 32 publications

A real‐world comparison of docetaxel versus abiraterone acetate for metastatic hormone‐sensitive prostate cancer

A real‐world comparison of docetaxel versus abiraterone acetate for metastatic hormone‐sensitive prostate cancer

Comparative effectiveness of multiple androgen receptor signaling inhibitor medicines with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer: a study in the real world

Longitudinal model–based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer

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