Prospective multicenter study on infectious complications and clinical outcome of 230 unfit acute myeloid leukemia patients receiving first‐line therapy with hypomethylating agents alone or in combination with Venetoclax
Abstract
To the Editor: Hypomethylating agents (HMAs) are an important therapeutic option for older patients with acute myeloid leukemia (AML) and have become the backbone for combination regimens s1–s5. However, there are very limited real-life prospective studies investigating the infectious complications in AML treated with HMAs ± Venetoclax (VEN) outside of clinical trials. In this prospective study, designed and conducted by the SEIFEM group (Sorveglianza Epidemiologica Infezioni nelle Emopatie), we evaluated the infectious complications in a cohort of patients unfit for intensive chemotherapy, treated in first-line with HMAs alone or in combination with VEN, immediately after the introduction of this combination in clinical practice in Italy (between 2019 and 2020). Methods are reported in the Appendix S1. We enrolled 230 consecutive patients with a median age of 75 years (range 25–94); 157 patients (68%) had ≥2 relevant comorbidities. Patients' and AML characteristics are reported in Table S1. Of the 230 cases, 132 (57%) received first-line therapy with a combination of HMAs+VEN, while 98 (43%) were treated with HMA monotherapy. A total of 1552 HMAs cycles were administered (888/1552 with HMAs+VEN) with a mean number of cycles/patients of 6.7 ± 5.5. Notably, 82.5% (1281/1552) of cycles were administered in an outpatient setting. Table S2A shows the characteristics and duration of therapy. The best responses achieved with HMAs treatment were CR in 44% of cases with an ORR of…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 230 participants or records.
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