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Neil Shore, M.D., FACS, U.S. Chief Medical Officer of Surgery and Oncology at GenesisCare USA and Director of the Carolina Urological Research Center, decided to investigate real-world survival outcomes for men who undergo metastatic castration. I will talk about the background of the research I aimed for. Susceptible prostate cancer (mCSPC) treated with either apalutamide (Erleada) or enzalutamide (Xtandi) in the United States.
Researchers in this study used data from the Flatiron Metastatic Prostate Cancer Core Registry Electronic DataMart from January 1, 2013 to May 31, 2023. Patients were divided into two cohorts based on initiation of apalutamide or enzalutamide after December 16, 2019, with 234 patients enrolled in the study and treated with apalutamide and 527 patients treated with enzalutamide. I did.
The median duration of apalutamide treatment was 10.9 months with a median observation period of 13.3 months. For enzalutamide, the median treatment period was 11.1 months and the median observation period was 14.8 months. By 24 months after initiation, patients in the apalutamide cohort had higher survival rates compared to the enzalutamide cohort (85.4% vs. 73.9%), with a statistically significant difference in survival between the two groups in unadjusted analyses. was shown.
Transcription:
0:09 | In some cases, randomized controlled trials may be difficult to accomplish there. We always prefer to do them especially positively. But given the fact that these are both approved and highly effective drugs, from a clinician’s perspective, whether you’re in the community or an academic, our practical experience is I think it would be interesting to know what the data and registry are like. Will the set tell me?
0:39 | This is a retrospective, longitudinal cohort of patients drawn primarily from the Flatiron Registry, which was surveyed from January 1, 2013 to the end of May 31, 2023. Electronic datasets and patient medical records. Patients were required to have medical records confirming metastases. No evidence of castration resistance. We had two cohorts with the earliest initiation of either apalutamide or enzalutamide after the December 2019 index date. Patients were required to have at least 1 year and 12 months of clinical data before index and subsequent follow-up. From the index date to the earliest of 24 months after the index date and the end of clinical activity or the end of the data availability period.
1:48 | We looked at key data indicators such as date of death.
Social Security Death Index, and other verified sources. We employed an analysis called an intention-to-treat approach. Kaplan-Meier analysis is used to describe the proportion of patients who survive 2 years and 24 months after the attack. We also used unadjusted Cox proportional hazards models to describe survival differences between patients starting either apalutamide or enzalutamide.
reference
Bilen MA, Khilfeh I, Rossi C et al. Real-world survival of patients with metastatic castration-sensitive prostate cancer (mCSPC) initiated on apalutamide (APA) or enzalutamide (ENZ) in oncology databases: the ROME study. J Clin Oncor. 2024;42(Supplement 4):58. doi:10.1200/JCO.2024.42.4_suppl.58
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