TY - JOUR
T1 - Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
AU - Spira, Alexander
AU - Zhou, Xiaolei
AU - Chen, Lei
AU - Gnanasakthy, Ari
AU - Wang, Luqiang
AU - Ungar, David
AU - Curiel, Rafael
AU - Liao, Laura
AU - Radford, John
AU - Kahl, Brad
N1 - Funding Information:
The LOTIS-2 (ADCT-402-201) trial was funded by ADC Therapeutics. The analysis reported here was performed under a research contract between ADC Therapeutics and RTI Health Solutions and was funded by ADC Therapeutics. XZ and AG are employees of RTI Health Solutions. LC, LW, DU, and LL are employees of ADC Therapeutics. RC is a former employee of ADC Therapeutics. BK has received consulting fees from ADC Therapeutics. AS has received institutional research support from ADC Therapeutics. JR has received honoraria from ADC Therapeutics for taking part in advisory boards and is an ADC Therapeutics stockholder.
Publisher Copyright:
© 2021
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - Clinical trial
KW - EQ-5D
KW - FACT-Lym
KW - Non-Hodgkin lymphoma
KW - Patient-reported
UR - http://www.scopus.com/inward/record.url?scp=85117788181&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85117788181&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2021.09.001
DO - 10.1016/j.clml.2021.09.001
M3 - Article
C2 - 34690090
AN - SCOPUS:85117788181
SN - 2152-2650
VL - 22
SP - 158
EP - 168
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 3
ER -