Real-world data of AML in Japan: results of JALSG clinical observational study-11 (JALSG-CS-11)

This report covers acute myeloid leukemia (AML) results from a multicenter, prospective observational study of AML, myelodysplastic syndromes, and chronic myelomonocytic leukemia in Japan. From August 2011 to January 2016, 3728 AML patients were registered. Among them, 42% were younger than 65, and the male-to-female ratio was 1.57:1. With a median follow-up time of 1807 days (95% confidence interval [CI]: 1732–1844 days), the estimated 5-year overall survival (OS) rate in AML patients ( n = 3707) was 31.1% (95% CI: 29.5–32.8%). Trial-enrolled patients had a 1.7-fold higher OS rate than non-enrolled patients (5-year OS, 58.9% [95% CI: 54.5–63.1%] vs 35.5% [33.3–37.8%], p < 0.0001). Women had a higher OS rate than men (5-year OS, 34% [95% CI; 31.4–36.7%] vs 27.7% [25.7–29.7%], p < 0.0001). The OS rate was lower in patients aged 40 and older than those under 40, and even lower in those over 65 (5-year OS for ages < 40, 40–64, 65–74, ≥ 75: 74.5% [95% CI; 69.3–79.0%] vs 47.5% [44.4–50.6%] vs 19.3% [16.8–22.0%] vs 7.3% [5.5–9.4%], respectively). This is the first paper to present large-scale data on survival and clinical characteristics in Japanese AML patients.