AI Article Synopsis

  • A Phase 3 clinical trial (VIALE-C) showed that venetoclax combined with low-dose cytarabine improved outcomes for newly diagnosed acute myeloid leukemia patients who couldn't undergo intensive chemotherapy.
  • Following the trial, an expanded access study in Japan provided this treatment to eligible patients, where they received the same dosages and precautions to prevent tumor lysis syndrome.
  • Of the 14 patients enrolled, the most common serious side effect was neutropenia, and while some adverse events occurred, they were manageable, indicating that patient safety remains a priority despite potentially more severe cases in clinical practice.

Article Abstract

Background: In a Phase 3 international clinical trial (VIALE-C), venetoclax plus low-dose cytarabine improved the response rate and overall survival versus placebo plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia who were ineligible for intensive chemotherapy. After the enrollment period of VIALE-C ended, we conducted an expanded access study to provide preapproval access to venetoclax in combination with low-dose cytarabine in Japan.

Methods: Previously, untreated patients with acute myeloid leukemia who were ineligible for intensive chemotherapy were enrolled according to the VIALE-C criteria. Patients received venetoclax (600 mg, Days 1-28, 4-day ramp-up in Cycle 1) in 28-day cycles and low-dose cytarabine (20 mg/m2, Days 1-10). All patients took tumor lysis syndrome prophylactic agents and hydration. Safety endpoints were assessed.

Results: Fourteen patients were enrolled in this study. The median age was 77.5 years (range = 61-84), with 78.6% over 75 years old. The most common grade ≥ 3 treatment-emergent adverse event was neutropenia (57.1%). Febrile neutropenia was the most frequent serious adverse event (21.4%). One patient developed treatment-related acute kidney injury, leading to discontinuation of treatment. Two patients died because of cardiac failure and disease progression that were judged not related to study treatment. No patients developed tumor lysis syndrome.

Conclusions: The safety outcomes were similar to those in VIALE-C without new safety signals and were well managed with standard medical care. In clinical practice, more patients with severe background disease are expected, in comparison with in VIALE-C, suggesting that it is important to carefully manage and prevent adverse events.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10311156PMC
http://dx.doi.org/10.1093/jjco/hyad027DOI Listing

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