Early PSA response is an independent prognostic factor in patients with metastatic castration-resistant prostate cancer treated with next-generation androgen pathway inhibitors

Fuerea, Alina; Baciarello, Giulia; Patrikidou, Anna; Albigès, Laurence; Massard, Christophe; Palma, Mario Di; Escudier, Bernard; Fizazi, Karim; Loriot, Yohann

doi:10.1016/j.ejca.2016.03.070

Cited by 48 publications

(35 citation statements)

References 28 publications

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“…The cohort of the Fuera's study included patients enrolled in clinical trials of cognate agents, with 78% being of post-docetaxel status. The authors confirmed the observations described above in patients treated with abiraterone acetate outside the clinical trial setting (16). A more recent study found that a very early PSA response (15 days after starting abiraterone acetate) was significantly associated with a better PFS and OS (17).…”

Section: Discussionsupporting

confidence: 81%

“…Patients who did not achieve a 30% PSA decline showed significantly poorer OS. In a clinical trial, Fuera et al (16) showed that a 50% PSA decline after 4 weeks of treatment was significantly associated with a longer PFS and OS in patients on various AR-targeting therapies, including enzalutamide, abiraterone acetate and orteronel. The cohort of the Fuera's study included patients enrolled in clinical trials of cognate agents, with 78% being of post-docetaxel status.…”

Section: Discussionmentioning

confidence: 99%

“…However, no commercial method of detecting AR-V7 in CTCs is yet available. The prognostic significance of an early PSA response was recently evaluated in patients treated with AR-targeting agents, including abiraterone acetate and enzalutamide (15)(16)(17). In the current study, we assessed PSA responses 4 weeks after initiation of enzalutamide in a Japanese population with mCRPC to determine whether such responses were associated with rPFS or OS.…”

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confidence: 99%

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Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Kato

Furuya

Miyazawa

et al. 2016

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Kato

Furuya

Miyazawa

et al. 2016

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“…The results from the AFFIRM trial are, in part, consistent with previous clinical trials in men with mCRPC that demonstrated that PSA declines within 3 months of treatment were associated with improved OS but did not fulfill all surrogacy criteria . These results are also consistent with recent post hoc analyses of clinical trial data in which PSA declines of ≥30% and ≥50% from baseline at day 28 after treatment with enzalutamide, abiraterone acetate, or orteronel were shown to be significantly associated with improved OS in patients with mCRPC . Full surrogacy was not demonstrated in the present study, possibly due to the rarity of PSA declines with placebo treatment and due to discordant results observed in some men between PSA declines and radiographic changes and the development of rapid clinical or radiographic progression in others, despite an early PSA decline.…”

Section: Discussionsupporting

confidence: 86%

Clinical outcomes and survival surrogacy studies of prostate‐specific antigen declines following enzalutamide in men with metastatic castration‐resistant prostate cancer previously treated with docetaxel

Armstrong

Saad

Phung

et al. 2017

Cancer

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BACKGROUNDIn the AFFIRM trial, enzalutamide significantly increased overall survival (OS) for men with metastatic castration‐resistant prostate cancer (mCRPC) after chemotherapy versus placebo and significantly decreased prostate‐specific antigen (PSA) levels. The goal of this post hoc analysis was to associate levels of PSA decline from baseline after enzalutamide with clinical outcomes in the postchemotherapy mCRPC setting.METHODSMen in the AFFIRM trial (n = 1199) were grouped by maximal PSA decline in the first 90 days of treatment. Kaplan‐Meier estimates evaluated the association of defined PSA changes from baseline with OS, progression‐free survival (PFS), radiographic PFS (rPFS), and pain response. Each PSA decline category was assessed for OS surrogacy using Prentice criteria, proportion of treatment effect explained (PTE), and proportion of variation explained.RESULTSMen treated with enzalutamide had improved OS (hazard ratio, 0.63; P < .001) and higher rates of PSA decline (odds ratio, >19.0; P < .001) versus placebo. PSA declines of any, ≥30%, ≥50%, and ≥90% with enzalutamide were strongly associated with greater OS, PSA PFS, rPFS (P < .001), and pain response (P < .026) versus PSA increase/no decline. Any, ≥30%, and ≥50% declines in PSA resulted in the PTE range of 1.07‐1.29, where treatment was no longer significant after adjustment for decline measures (P > .20).CONCLUSIONSPSA declines of any, ≥30%, and ≥50% following enzalutamide were associated with greater clinical and pain response and improvements in PFS and OS. Surrogacy of PSA decline for OS was not fully established, possibly due to lack of PSA declines with placebo, and discordant results between PSA and imaging responses over time, and because some declines were not durable due to rapid resistance development. However, a lack of PSA decline by 90 days following enzalutamide treatment was a poor prognosis indicator in this setting. Conclusions from sensitivity analyses of maximal PSA decline from baseline over the entire treatment period are consistent with PSA declines restricted to the first 90 days. Cancer 2017;123:2303–2311. © 2017 American Cancer Society.

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“…35 Subsequently, several studies reported the clinical value of the PSA decline within 4 weeks from the initiation of ASI (Table 4). 35,[47][48][49][50] Importantly, all these studies showed that patients who did not respond to ASI within 4 weeks had a poor prognosis for not only PFS, but also OS, implying that other agents, such as taxanes, should be considered for these patients rather than trying another ASI.…”

Section: Prognostic Factors To Assist Decision-makingmentioning

confidence: 99%

Current treatment strategies for advanced prostate cancer

et al. 2017

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During the past decade, treatment strategies for patients with advanced prostate cancer involving stage IV (T4N0M0, N1M0 or M1) hormone-sensitive prostate cancer and recurrent prostate cancer after treatment with curative intent, as well as castration-resistant prostate cancer, have extensively evolved with the introduction and approval of several new agents including sipuleucel-T, radium-223, abiraterone, enzalutamide and cabazitaxel, all of which have shown significant improvement on overall survival. The appropriate use of these agents and the proper sequencing of these agents are still not optimized. The results of several recently reported randomized controlled trials and retrospective studies could assist in developing a treatment strategy for advanced prostate cancer. In addition, prospective studies and molecular characterization of tumors to address these issues are ongoing.

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Early PSA response is an independent prognostic factor in patients with metastatic castration-resistant prostate cancer treated with next-generation androgen pathway inhibitors

Cited by 48 publications

References 28 publications

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Clinical outcomes and survival surrogacy studies of prostate‐specific antigen declines following enzalutamide in men with metastatic castration‐resistant prostate cancer previously treated with docetaxel

Current treatment strategies for advanced prostate cancer

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