Exploring standards of care in real-world settings with RWD

Cancer develops in countless variations, making it challenging for community oncologists to choose the best possible therapy for each unique situation. And with so many new treatment options introduced every year as science advances at a breakneck pace, it’s becoming even more difficult to gain clarity around which options are most effective – or even which options are most commonly prescribed across the complex healthcare environment.


Real-world data (RWD) can help to illuminate patterns in therapy selection and the correlation to outcomes, giving oncologists and researchers some additional guidance on emerging trends in the oncology community.

At the 2024 American Association for Cancer Research (AACR) Annual Meeting in San Diego, COTA and the FDA are presenting research that does just that, offering critical insight into how real-world patients are being treated for acute myeloid leukemia (AML).


The abstract, entitled “Real world outcomes among patients with newly diagnosed acute myeloid leukemia,” leverages COTA’s RWD database to provide a retrospective analysis of patients with newly-diagnosed AML.


Using the de-identified, longitudinal electronic health record data within the database, the team from COTA and the FDA examined treatments and outcomes for more than 2500 patients with newly diagnosed AML between January 1, 2013, and March 20, 2023.


We found that patients were most commonly prescribed regimens of intensive chemotherapy with cytarabine (IC w/ara-C), hypomethylating agents with venetoclax (HMA+ven), and HMA alone. IC w/ara-C is currently considered the standard of care.


Median overall survival (OS) for the cohort was 16 months. The patients treated with IC w/ara-C achieved one of the highest complete response rates, the highest median OS rate, and some of the lowest thirty-day mortality rates. In comparison, those treated with HMA+ven saw a median OS of 13.5 months.


The research suggests that IC w/ara C remains the standard of care for most patients and provided a high CR rate and median OS, though this analysis was not yet adjusted for important confounding variables such as age.


Variations in patient demographics and clinical characteristics across different treatment groups prevented cross-treatment comparisons without further adjustment, but future analyses will allow researchers to gain more insight into the effectiveness and safety of AML regimens, particularly for populations underrepresented in traditional clinical trials.


Researchers will be presenting the abstract in detail on April 8 at AACR. To learn more about how COTA’s RWD is accelerating vital research into cancer treatment and outcomes, visit our research hub or connect with us for a conversation.