The survival benefit of enzalutamide compared with placebo in men with progressive castration-resistant prostate cancer after prior docetaxel-based chemotherapy is accompanied by stabilization of patient HRQoL, as assessed by FACT-P. Application of different analytic methods to the FACT-P data further corroborate the HRQoL benefits observed with enzalutamide in the AFFIRM study.
Background
Treatment with venetoclax + hypomethylating agents (HMAs) is standard-of-care for newly diagnosed (ND) patients with acute myeloid leukemia (AML) aged ≥75 years, or with comorbidities precluding intensive chemotherapy. We describe real-world venetoclax + HMA treatment practices and outcomes in patients with ND AML in the US.
Patients and Methods
This retrospective cohort study used an electronic health record-derived, US nationwide, de-identified database, and included adults with ND AML, initiating venetoclax + HMA treatment ≤30 days from diagnosis (June 1, 2018-January 31, 2020). Venetoclax treatment variables included dosing information, schedule modifications, and drug–drug interactions. The median venetoclax + HMA treatment duration and overall survival (OS) from venetoclax initiation to discontinuation, death, or end of follow-up (August 31, 2020) were examined by Kaplan-Meier analyses.
Results
Overall, 169 patients were included. The median age at diagnosis was 77 years; 85.2% of patients were treated in community practice. Ninety-five of 169 patients (56.2%) had evaluable bone marrow response data following the start of treatment; 53.7% were assessed approximately at the end of cycle 1. Following the first treatment cycle, treatment schedule modifications were recorded in 101 patients and dose changes in 56, primarily due to toxicity. The median treatment duration was 5.2 months; the median OS was 8.6 months (median follow-up was 7.2 months). Venetoclax dose changes did not modify efficacy outcomes, but longer median OS was associated with venetoclax treatment schedule modifications (P = .02).
Conclusions
This study reflects early real-world experience with venetoclax + HMAs in a predominantly community setting and emphasizes the importance of appropriate venetoclax management in optimizing patient outcomes.
The Three Mile Island nuclear release exemplifies why there is public and policy interest in the high-technology, highly visible end of the nuclear cycle. The environmental and health consequences of the early steps in the cycle--mining, milling, and processing of uranium ore--may be less appreciated. We examined 2 large unintended acute releases of uranium--at Kerr McGee's Sequoyah Fuels Corporation in Oklahoma and United Nuclear Corporation's Church Rock uranium mill in New Mexico, which were incidents with comparable magnitude to the Three Mile Island release. We urge exploration of whether there is limited national interest and concern for the primarily rural, low-income, and American Indian communities affected by these releases. More attention should be given to the early stages of the nuclear cycle and their impacts on health and the environment.
Results indicate a modest 1-year budget impact of adopting enzalutamide for chemotherapy-naïve mCRPC patients, partly because of the cost offset of a moderate incidence of adverse events and lack of additional required monitoring.
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