Publications by authors named "Teresa Parli"
Article Synopsis
- Pegozafermin, a new drug being tested for severe hypertriglyceridemia (SHTG) and nonalcoholic steatohepatitis, was evaluated in a phase 2 trial with 85 participants over 8 weeks.
- Results showed that patients taking pegozafermin had a significant reduction in triglycerides (57.3%) compared to those on placebo (11.9%), achieving the trial's main goal.
- Secondary outcomes also indicated improvements in related cholesterol levels and liver fat, with no serious side effects linked to the drug, suggesting it may be a strong candidate for further testing in a phase 3 trial.
Background: In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).
Objective: To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis.
Design, Setting, And Participants: We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms.
Importance: For men with metastatic castration-resistant prostate cancer (mCRPC) whose condition is responding to enzalutamide, new unconfirmed bone lesions detected at posttreatment scinitigraphy may reflect an osteoblastic reaction that represents healing, known as pseudoprogression, which can lead to premature discontinuation of therapy.
Objective: To determine the association between new unconfirmed lesions detected on a follow-up bone scintigram (bone scan) and outcomes in enzalutamide-treated men with mCRPC.
Design, Setting, And Participants: This post hoc, retrospective secondary analysis of 1672 enzalutamide-treated men from 2 phase 3, randomized mCRPC studies (PREVAIL and AFFIRM) before or after treatment with docetaxel was conducted from April 12, 2018, to July 25, 2019.
Background: In the PREVAIL study, enzalutamide provided significant improvements versus placebo in clinical outcomes in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC). The association of post-treatment prostate-specific antigen (PSA) decline with clinical outcomes may provide important prognostic information.
Objective: To evaluate associations between the magnitude of PSA decline from baseline to month 3 and clinical outcomes among enzalutamide recipients.
Importance: Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients.
Objective: To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS.
Article Synopsis
- Metastatic castration-resistant prostate cancer (mCRPC) with low baseline prostate specific antigen (PSA) represents an early phase of disease progression, and this study examined outcomes in affected men treated with the oral drug enzalutamide from the PREVAIL study.
- Out of 1,717 patients, 14.1% had low baseline PSA; enzalutamide significantly reduced the risk of disease progression compared to placebo for all patients, regardless of high or low disease burden.
- The findings suggest that men with mCRPC and low baseline PSA, regardless of whether they have high or low disease burden, may experience improved outcomes with enzalutamide treatment, highlighting the importance of androgen receptor signaling in this
Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument.
Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter.
Unlabelled: Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.
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