Abstract
Objectives: Patients with relapsed/refractory AL amyloidosis (RRAL) have poor prognosis, but emerging data shows promising results with the use daratumumab. We evaluated daratumumab treatment in RRAL in real-world setting. Methods: A retrospective multisite study of RRAL patients treated with daratumumab alone and in combinations. Results: Forty-nine patients, diagnosed between 1.1.2008 and 1.2.2018 were included; 27% also had multiple myeloma (MM). Revised Mayo score was ≥ 3 in 67%. Hematologic overall response rate was 81%, 64% achieved very good partial response (VGPR) or better. Concurrent active MM was associated with lower rates of VGPR (OR 0.19, 95% CI 0.04-0.81; P =.03) in a multi-variate analysis. Cardiac and renal responses were 74% and 73%, respectively. Median progression-free survival (PFS) was 28.4 months and median overall survival (OS) was not reached; 2-year PFS and OS were 68.6 ± 7.5% and 90.4 ± 4.6%, respectively. Hematologic response correlated with prolonged PFS and OS. Daratumumab was safe and well tolerated, no patients discontinued therapy due to toxicity. Our data was aligned with outcomes from a systematic literature review, which identified 10 case series (n = 517) and 2 clinical trials (n = 62) meeting prespecified criteria. Conclusions: Our data support favorable safety tolerability and efficacy of daratumumab among non-selective RRAL patients in a real-world setting.
Original language | English |
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Pages (from-to) | 184-195 |
Number of pages | 12 |
Journal | European Journal of Haematology |
Volume | 106 |
Issue number | 2 |
DOIs | |
State | Published - 1 Feb 2021 |
Keywords
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal/administration & dosage
- Antineoplastic Agents, Immunological/administration & dosage
- Biomarkers
- Clinical Trials as Topic
- Disease Management
- Female
- Humans
- Immunoglobulin Light-chain Amyloidosis/diagnosis
- Male
- Middle Aged
- Prognosis
- Recurrence
- Retrospective Studies
- Sensitivity and Specificity
- Severity of Illness Index
- Treatment Outcome
- cardiac amyloidosis
- daratumumab
- light-chain amyloidosis
All Science Journal Classification (ASJC) codes
- Hematology