TRANSLATE

The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

Subgroup analysis of outcomes in patients with AML-MRC who achieved remission with CPX-351 versus 7+3

Mar 17, 2020


Acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) is associated with poor prognosis after induction therapy. CPX-351, a liposomal combination of daunorubicin (D) plus cytarabine (C), demonstrated a significantly improved median overall survival (OS) compared to a standard 7+3 regimen in older patients (60–75 years of age) with newly diagnosed high-risk or secondary AML.1 An interview with Jeffrey E. Lancet discussing results of the trial is available here. You can also read about the impact of gene mutations on the efficacy of combination here.

Daniel H.Ryan and colleagues conducted an exploratory subgroup analysis of a phase III study (NCT01696084) comparing outcomes in patients who achieved complete remission (CR) or CR with an incomplete neutrophil/platelet recovery (CRi) across treatment groups.2 These data were presented at the Transplantation & Cellular Therapy Meeting February, 19–23, 2020, Florida, US.

Methods2

  • Patients were randomized to one or two induction cycles with
    • CPX-351 – 100 units/m2 of C, 100 mg/m2 + D, 44 mg/m2 infusions on Days 1, 3, and 5 (2nd induction: Days 1 and 3)
    • 7+3 – C 100 mg/m2 daily continuously for seven days (2nd induction: 5 days) + D 60 mg/m2 on Days 1–3 (2nd induction: Days 1–2)
  • Patients in CR or CRi could receive two consolidation cycles with CPX-351 (65 units/m2 of C, 65 mg/m2 + D 29 mg/m2 on Days 1 and 3) or 5 + 2 (as in 2nd induction). Hematopoietic cell transplantation (HCT) was allowed at the physician's discretion

Results2

  • In total, 246/309 of patients (80%) were diagnosed with AML-MRC, with 123 per treatment group
  • There were more patients in CR + CRi in the CPX-351 group compared to the 7 + 3 group (48% vs 33%, respectively; odds ratio, 1.83; 95% CI, 1.09–3.09)
  • Patients with AML-MRC, who achieved CR + CRi had longer median OS with CPX-351 vs 7+3 (19.5 vs 11.58; HR, 0.58; 95% CI, 0.34–0.96)
  • OS from date of HCT was also higher in patients who received CPX-351 vs 7+3 (NR vs 14.09; HR, 0.61; 95% CI, 0.27–1.40)
  • The HCT rate in AML-MRC patients with CR + CRi was higher with CPX-351 than with 7+3 (54% vs 43%, respectively; relative risk, 1.18; 95% CI, 0.79–1.76)
  • The safety profile was similar between treatment groups, except there was a longer recovery of neutrophils and platelets with CPX-351 (35 vs 29 days and 37 vs 28 days, respectively) compared to the 7+3 regimen (Table 1)
    • No deaths were reported within 60 days post treatment

Table 1. Treatment-emergent adverse events

TEAE, treatment-emergent adverse event

TEAE

CPX-351
(n = 59)

7+3
(n = 40)

TEAEs in ≥ 50% of patients in either group, %

Febrile neutropenia

Constipation

Nausea

Peripheral edema

Fatigue

Diarrhea

 

78

58

53

49

47

37

 

80

55

53

65

50

78

Serious TEAEs in ≥ 10% of patients in either group, %

Febrile neutropenia

Decreased ejection fraction

 

10

8

 

13

10

Conclusions

The authors demonstrated improved median OS with CPX-351 compared to 7+3 chemotherapy in patients with AML-MRC who achieved CR + CRi. The safety profile in this subgroup was consistent with the overall study population.1,2

References

Please indicate your level of agreement with the following statements:

The content was clear and easy to understand

The content addressed the learning objectives

The content was relevant to my practice

I will change my clinical practice as a result of this content