Show simple item record

dc.contributor.authorAlderuccio, J. P.
dc.contributor.authorArdeshna, K.
dc.contributor.authorHess, B.
dc.contributor.authorRadford, John A
dc.contributor.authorLunning, M.
dc.contributor.authorUngar, D.
dc.contributor.authorBurke, M.
dc.contributor.authorWang, L. Q.
dc.contributor.authorSolh, M.
dc.date.accessioned2021-09-30T11:56:11Z
dc.date.available2021-09-30T11:56:11Z
dc.date.issued2021en
dc.identifier.citationAlderuccio JP, Ardeshna K, Hess B, Radford J, Lunning M, Ungar D, et al. Incidence, Onset, and Management of Edema and Effusion in Patients Treated with Loncastuximab Tesirine for R/R DLBCL in the LOTIS Clinical Trial Program. Clinical Lymphoma Myeloma & Leukemia. 2021;21:S397-S8.en
dc.identifier.urihttp://hdl.handle.net/10541/624634
dc.description.abstractContext: Loncastuximab tesirine (Lonca), an antibody-drug conjugate (ADC) comprising an anti-CD19 antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin, is the fi rst FDA approved PBD-containing ADC. Lonca is indicated for relapsed/ refractory DLBCL after ≥2 systemic treatments. Several TEAEs, including edema and effusions, appear to be PBD-related (Saber, et al 2019). Objective: To further characterize edema and effusion by assessing the time to onset, duration, and management in the pivotal LOTIS-2 clinical trial (NCT03589469). Methods: Key safety outcomes: median time to onset and median duration of edema and effusion (April 6, 2020 cutoff date). Missing AE end dates were imputed using the date of new anticancer therapy (NAT), the end of study (EOS), or data cutoff. Partial AE end dates were imputed using the last month or last day of the month bounded by EOS/data cutoff (when EOS is not reached) or NAT date. All AE start dates are complete or partial, with day imputed to the fi rst day of the month, bounded by fi rst dose date. After AE start/ end date imputation, duration was calculated at the patient level. Results: In LOTIS-2 (N=145), dexamethasone pre-medication was administered to reduce the risk of PBD toxicities, based on outcomes from the phase 1, dose-fi nding study (LOTIS-1; NCT02669017). Edema occurred in 27.6% of patients; median time to onset was 40.0 days (range 1–277). Median duration: 50.5 days (2-407). Grade 3 edema occurred in 3.4% of patients. Median time to onset: 106.0 days (9–183); median duration: 5.0 days (3–112).Effusions occurred in 11.0% of patients; median time to onset was 51.5 days (3–203). Median duration: 19.5 days (4–252). Grade 3 effusion occurred in 2.7% of patients. Median time to onset: 118.0 days (17– 277); median duration: 20.5 days (6-82). Five patients (12.5%) with edema and one patient (6.3%) with effusion underwent Lonca re-challenge; diuretics, primarily spironolactone, were commonly used to manage edema and effusion. Conclusions: Edema and effusions in LOTIS-2 were generally reversible and manageable, with dose delays or modifi cations recommended for Grade ≥2 events. Grade ≥3 edema or effusion was uncommon and typically developed later in therapyen
dc.language.isoenen
dc.titleIncidence, onset, and management of edema and effusion in patients treated with loncastuximab tesirine for R/R DLBCL in the LOTIS clinical trial programen
dc.typeOtheren
dc.contributor.departmentSylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USAen
dc.identifier.journalClinical Lymphoma Myeloma & Leukemiaen
dc.description.noteen]


This item appears in the following Collection(s)

Show simple item record