Clinical lymphoma, myeloma & leukemia · 2021
Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Spira Alexander, Zhou Xiaolei, Chen Lei, Gnanasakthy Ari, Wang Luqiang, Ungar David, Curiel Rafael, Liao Laura, Radford John, Kahl Brad
Аннотация
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.
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.