Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Clinical trial
EQ-5D
FACT-Lym
Non-Hodgkin lymphoma
Patient-reported
Journal
Clinical lymphoma, myeloma & leukemia
ISSN: 2152-2669
Titre abrégé: Clin Lymphoma Myeloma Leuk
Pays: United States
ID NLM: 101525386
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
29
04
2021
revised:
13
07
2021
accepted:
07
09
2021
pubmed:
26
10
2021
medline:
8
4
2022
entrez:
25
10
2021
Statut:
ppublish
Résumé
Loncastuximab tesirine has shown antitumor activity with an acceptable toxicity profile in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were relapsed or refractory after ≥2 prior therapies, including activity in patients with high-risk disease characteristics. This analysis examined health-related quality of life (HRQoL), symptoms, and tolerability in patients receiving loncastuximab tesirine for relapsed or refractory DLBCL. The single-arm, open-label phase II LOTIS-2 study (ADCT-402-201; NCT03589469) enrolled 145 patients aged ≥18 years. Patients received loncastuximab tesirine as a 30-minute intravenous infusion on day 1 of each 3-week treatment cycle. Patient-reported outcomes were measured using EQ-5D and FACT-Lym at baseline, day 1 of each cycle, and the end-of-treatment visit. During the course of treatment, EQ VAS overall health score was improved over time. The adjusted improvement was 0.65 per cycle (95% CI, 0.26-1.04; P = .001), and the adjusted mean change from baseline score was 5.00 (95% CI, 1.75-8.25; P = .003) at cycle 9, day 1. FACT-Lym total scores remained stable during treatment. More patients reported improvement compared to baseline in pain, lumps/swelling, and losing weight for a majority of visits. More than 60% of patients reported being "not at all" or "a little bit" bothered by treatment side effects for all treatment visits. Findings in elderly patients were similar to the population as whole. The findings on HRQoL, symptoms, and tolerability further support the clinical use of loncastuximab tesirine for the treatment of relapsed or refractory DLBCL. This work was funded by ADC Therapeutics SA. Authors affiliated with ADC Therapeutics SA participated in designing the study; in collecting, analyzing, and interpreting the data; in writing the report; and in the decision to submit the article for publication.
Sections du résumé
BACKGROUND
Loncastuximab tesirine has shown antitumor activity with an acceptable toxicity profile in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were relapsed or refractory after ≥2 prior therapies, including activity in patients with high-risk disease characteristics. This analysis examined health-related quality of life (HRQoL), symptoms, and tolerability in patients receiving loncastuximab tesirine for relapsed or refractory DLBCL.
PATIENTS AND METHODS
The single-arm, open-label phase II LOTIS-2 study (ADCT-402-201; NCT03589469) enrolled 145 patients aged ≥18 years. Patients received loncastuximab tesirine as a 30-minute intravenous infusion on day 1 of each 3-week treatment cycle. Patient-reported outcomes were measured using EQ-5D and FACT-Lym at baseline, day 1 of each cycle, and the end-of-treatment visit.
RESULTS
During the course of treatment, EQ VAS overall health score was improved over time. The adjusted improvement was 0.65 per cycle (95% CI, 0.26-1.04; P = .001), and the adjusted mean change from baseline score was 5.00 (95% CI, 1.75-8.25; P = .003) at cycle 9, day 1. FACT-Lym total scores remained stable during treatment. More patients reported improvement compared to baseline in pain, lumps/swelling, and losing weight for a majority of visits. More than 60% of patients reported being "not at all" or "a little bit" bothered by treatment side effects for all treatment visits. Findings in elderly patients were similar to the population as whole.
CONCLUSION
The findings on HRQoL, symptoms, and tolerability further support the clinical use of loncastuximab tesirine for the treatment of relapsed or refractory DLBCL.
FUNDING
This work was funded by ADC Therapeutics SA. Authors affiliated with ADC Therapeutics SA participated in designing the study; in collecting, analyzing, and interpreting the data; in writing the report; and in the decision to submit the article for publication.
Identifiants
pubmed: 34690090
pii: S2152-2650(21)02031-0
doi: 10.1016/j.clml.2021.09.001
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immunoconjugates
0
Benzodiazepines
12794-10-4
loncastuximab tesirine
7K5O7P6QIU
Banques de données
ClinicalTrials.gov
['NCT03589469']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
158-168Informations de copyright
Copyright © 2021. Published by Elsevier Inc.