High- vs Low-Dose Tranexamic Acid Infusion and Need for Red Blood Cell Transfusion and Adverse Events in Cardiac Surgery—Reply

In Reply In response to the comments by Dr Koster and colleagues, the OPTIMAL trial enrolled patients aged 18 to 70 years, which is the age range of most patients undergoing adult cardiac bypass surgery in China. We agree that our study results, especially regarding seizures, should be interpreted with caution for patients older than 70 years.

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Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor In a recent issue of JAMA Oncology, Shore et al present the results of ENACT, a phase 2 clinical trial randomizing patients with low and favorable intermediate-risk prostate cancer on active surveillance (AS) to receive or not to receive 1 year of antiandrogen treatment with enzalutamide. Findings of this trial suggest a decreased rate of pathologic or therapeutic progression, cancer-positive core rate, and biochemical progression-free survival (bPFS) in the enzalutamide group at 1 year, although no difference in these end points was observed between the groups at 2 years. Based on these results, the authors propose adding enzalutamide to AS for this patient population.

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Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor We applaud Shore et al for their work with the ENACT randomized clinical trial to improve progression-free survival among men on active surveillance (AS) for prostate cancer (PCa). Their addition of enzalutamide monotherapy to the AS regimen represents the latest pharmacological intervention aimed at delaying PCa progression, mirroring previous attempts including use of dutasteride, bicalutamide, and other drugs that disrupt the androgen axis.

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Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor I read with great interest the ENACT randomized clinical trial by Shore et al. This study has recapitulated the same error as the REDEEM study, which is referenced in the Discussion. REDEEM compared dutasteride, a known prostate cytoreductive drug, with placebo in men on active surveillance. The end point of progression included an increase in the volume of grade group 1 (GG1) cancer. The study showed a 38% reduction in progression, but 100% of this was due to differences in volume progression of GG1 disease. In fact, there was a slightly higher rate of grade progression in the dutasteride arm. Rightly, this progression benefit was not considered meaningful by the prostate cancer community. Guidelines do not recommend 5α-reductase inhibitors for men on surveillance to reduce disease progression rates.

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Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer—Reply

In Reply Active surveillance (AS) is the preferred management strategy for low-risk prostate cancer. While AS rates are increasing in clinical practice, its adoption remains suboptimal and is highly variable in the US. The potential benefits of treatments that might provide a durable effect on pathology and delay disease progression in the favorable-risk prostate cancer setting have not been fully elucidated.

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Gennaio 2023