ASH2023 - Sheba 2.0, page-23

chatgpt numerical analysis

The study included 20 patients with a median age of 48 years, predominantly male (55%). The majority had de novo AML (14 patients), and the rest secondary AML. Patients were heavily pre-treated, with a median of 4 prior lines of therapy.Key numerical findings from the study are:

- **Dose Limitation**: The maximum tolerated infusion duration was established at 4 days, due to significant liver toxicity at higher durations.

- **Liver Toxicity**: 10 patients developed liver toxicity of varying severity (grades 1-3), which was transient and resolved in all cases.

- **Infection Rates**: High infection rates were noted, with 18 patients developing neutropenic fever, and instances of bacteremia, pneumonia, fungal infections, and sepsis were reported.

- **Mortality**: 5 patients died before response evaluation, with deaths attributable to sepsis, cerebral venous sinus thrombosis, and other complications.

- **Response Rate**: Out of the 15 evaluable patients, 6 responded to the treatment (5 complete responses, 1 partial response), representing a 40% response rate.

- **Transplantation**: Following treatment, 5 patients proceeded to HSCT, which was performed 1-3 months after the combination therapy.

- **Post-Transplant Outcomes**: 3 post-transplant patients died due to complications, while 2 remained in complete remission at the time of the report.

The study's conclusion emphasises the treatment's feasibility and encourages further exploration. The response rate is particularly notable given the advanced stage of disease in the patient population. However, the high rate of infections and early deaths underscores the vulnerability of this patient group and the need for careful management.