Outcomes of 418 Newly Diagnosed AML Patients Since 2017 to 2023 in a Single Institution of Perú: Real-World Data
Authors: Untama José L. , David Lourdes , Salas Ines , Navarro-Cabrera Juan Ramon 
Published: December 2024

Background: Peru is a country with limitations in the healthcare system.The objective of this study is to show real-world data of patients with newly diagnosed AML treated at Hospital Edgardo Rebagliati, which belongs to ESSALUD (Social Security).

Methods: We performed an observational study in AML patients diagnosed between Jan 2017, to Dec 2023, that were treated at the Hematology Adult Service of Rebagliati Hospital. Briefly, we have access to Flow cytometry, conventional Karyotyping, and a molecular panel with 5 recurrent alterations in AML (RUNX::RUNX, CBFb::MYH, FLT3 ITD, FLT3TKD and NPM1), since mid 2022 we have access to a limitated NGS panel. We use the ICAL stratification (adapted from ELN2017) and the ICAL chemoterapy protocol for all AML patients. In pts &gt; 65 yo we reduced doses of AraC 100 mg instead of 200 mg at 1st induction, and 4 days instead of 6 in subsequent cycles. Azacytidine was used for all but one (that used LDAC) non- intensive treatment, venetoclax was added if the patients could afford it (drug not covered). We recorded baseline characteristics, type of therapy and response to treatment.

Results: We obtained data from 461 AML patients older than 14 years. We excluded 43 patients because they were referred to our center after been diagnosed elsewhere. The remaining 418 patients are our cohort to be analyzed.

For all the 418 cases of AML, the mean age was 62.6yo [14-93] and the male/female ratio 1.12. Most of the cases were older than 60yo (259 vs 159).

We found that bone marrow (BM) studies were less frequent in older patients: BM morphological exam 98.7 vs 91.5%, BM karyotyping 96.8 vs 84.2%, Flow cytometry 99.3 vs 82.2%, molecular panel 93.7 vs 68.7%, and NGS 16.3 vs 6%.

We found more favorable-risk patients in the younger group (20 vs 6.9%), and fewer cases of intermediate-risk (38.7 vs 48.5%) and high-risk patients (41 and 44.6%). In 2.5% of cases (4 out of 159) of AML in younger patients the risk was not evaluable against 10% in older patients (26 out of 259).

In the younger group (≤60yo), 23 patients did not start chemo (due to poor condition at diagnosis), 5 patients 131 received intensive chemotherapy (CT) and 5 non-intensive treatment (Azacytidine +/- venetoclax). Meanwhile, for olders than 60yo: 161 received only support measures (palliative care), 50 patients received intensive CT (age range 61 - 72yo) and 48 non-intensive treatment (Azacytidine +/- venetoclax, age range 61-89yo).

In the group that received intensive CT, after the 1st cycle of induction we observed a higher CR rate in younger vs older patients (58 vs 36%), an inferior persistence rate (18.3 vs 34%) and a similar proportion of early deaths (&lt;30 days after induction, 15.2 vs 14%). More patients achieved CR at any time in the younger group (67.9 vs 54% for 131 and 50 patients that started CT), this difference was maintained after excluding the cases that were not evaluable because of death before a BM exam were performed (80.1 vs 64% for 110 and 42 patients evaluated, respectively). We observed a similar Relapse rate for both groups 40.5% (36/89) and 44% (12/27).

Using survival Kaplan- Meier analysis, in younger pts we found a superior median OS (7.8 vs 2.5 months, p 0.00), also a superior estimated OS at 2 years (26.8 vs 10.7%) and at 5 years (23.9 vs 4.8%). After separating the older patients according to the treatment they received we observed an estimated OS for younger patients with CT at 2 and 5 years of 31.6 and 28.2%, for older than 60yo with CT were 24.8 and 17%, for older than 60yo non-intensive were 21.4 and 8.3%, and for those &gt;60yo with only palliative care was 2 and 0%.

Conclusion: Our results show inferior OS in patients without treatment. When age groups were compared, we concluded that patients ≤60yo had better outcomes than patients &gt;60yo. In the long term, some patient &gt;60yo obtained higher OS with CT vs non- intensive treatment. On the basics of these observations, our population including the elderly, benefits from intensive cytarabine based CT. We need to develop tools that could help us to decide which treatment offers a better chance to our patients, we expect a major impact of NGS results in our patients in the next years.