Objectives:

The objective of the study is to evaluate the effectiveness and safety of daratumumab and carfilzomib in clinical practice, as well as to compare these results with the available literature and the fact sheet.

Material and methods:

Retrospective and observational study which patients were collected on treatment with these drugs until may-2018 out of clinical trial. The progression free survival (PFS) parameter was used to assess the effectiveness, and the classification of the Common Terminology Criteria for Adverse Events and fact sheet to the safety assessment.

Outcomes:

Treatment with daratumumab was analyzed in 14 patients (mean of 3.6 previous treatment lines and 5.1 treatment cycles) and the carfilzomib treatment in 21 patients (mean of 3.1 lines and 5.8 cycles). The median PFS observed was 4.8 months for daratumumab and 5.8 months for carfilzomib. The most common adverse reactions with daratumumab were thrombocytopenia (50%), neutropenia (42.9%) and cough (42.9%), the first two being the most serious. With carfilzomib, they were anemia (95.2%), respiratory infection (61.9%) and cough (61.9%), with thrombocytopenia being the most severe.

Conclusion:

Daratumumab has a literature consistent effectiveness but inferior to the fact sheet. It highlights the higher incidence of thrombocytopenia, including the most severe cases. The effectiveness of carfilzomib is lower than the fact sheet, and its comparison with clinical practice studies is not possible. A lower safety profile is observed, highlighting the higher incidence of cardiotoxicity and thrombocytopenia in the most severe cases. Further studies will be needed to give strength to these findings.

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