Optimising CPX-351 (liposomal cytarabine-daunorubicin) treatment for t-AML/AML-MRC patients in the outpatient setting: a modified Delphi consensus

CPX-351 (liposomal cytarabine-daunorubicin) is used to treat patients with therapy-related acute myeloid leukaemia (t-AML) and AML with myelodysplasia-related changes (AML-MRC), and it can be administered in both inpatient and outpatient settings. An increased adoption of outpatient treatment is being reported in clinical practice. This project aimed to gain clinical consensus on recommendations for CPX-351 treatment in the outpatient setting. A steering group (SG) of nine haematologists with experience in outpatient treatment of AML with CPX-351 across Europe and Australia developed a series of consensus statements, classified into six key domains. Agreed statements were incorporated into an online survey to be validated by a wider panel of 200 haematologists (Australia, France, Germany, Italy, UK and Spain) with experience in intensive chemotherapy and outpatient care for AML patients, by testing their agreement through a 4-point Likert scale. For each statement, consensus was set at ≥ 75% agreement. Forty-two of 43 statements (98%) achieved consensus, with 31 achieving ≥ 90% agreement. High alignment was achieved concerning suitable patient identification and treatment setting definitions. Among CPX-351 outpatient treatment benefits, the highest agreement was reached on potential hospital resourcing advantages, and improvements in patients’ physical and psychological status and quality of life. Survey results highlighted significant agreement on key patient/caregiver requirements, such as cognitive and physical abilities, communication and hospital access, and healthcare system requirements, including hospital protocols, available resources and complications management. Consensus was also achieved on practical measures to optimise CPX-351 outpatient treatment, such as patient assessment tools, patient monitoring and feedback collection, staff training, multidisciplinary team coordination and best practice sharing. Although challenges may be unique across countries and healthcare settings, this consensus provides clear guidance on safe and effective outpatient administration, being a useful resource for those less experienced in outpatient delivery of CPX-351 treatment. Trial registration: This consensus was not prospectively registered.