Τίτλος:
Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone (Ld) in relapsed/refractory multiple myeloma (RRMM), and to date, has the longest follow-up of any monoclonal antibody in patients with RRMM. Methods: In this extended 4-year follow-up of the ELOQUENT-2 trial, the coprimary endpoints of progression-free survival (PFS) and overall response rate as well as the secondary endpoint of overall survival were assessed. In the absence of head-to-head trials comparing Ld-based triplet regimens to guide treatment selection, 4 randomized controlled trials—ELOQUENT-2, ASPIRE, TOURMALINE-MM1, and POLLUX—were indirectly compared to provide insight into the relative efficacy of these regimens in RRMM. Results: Data at 4 years were consistent with 2- and 3-year follow-up data: ELd reduced the risk of disease progression/death by 29% versus Ld (hazard ratio, 0.71) while maintaining safety. The greatest PFS benefit among the assessed subgroups was observed in patients at the median time or further from diagnosis (≥3.5 years) with 1 prior line of therapy, who had a 44% reduction in the risk of progression/death, and in patients in the high-risk category, who had a 36% reduction in favor of ELd. This regimen also showed a relative PFS benefit that was maintained beyond 50 months. Conclusions: The sustained PFS benefit and long-term safety of ELd at 4 years, similar to those observed at 2 and 3 years, support ELd as a valuable therapeutic option for the long-term treatment of patients with RRMM. © 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society
Συγγραφείς:
Dimopoulos, M.A.
Lonial, S.
Betts, K.A.
Chen, C.
Zichlin, M.L.
Brun, A.
Signorovitch, J.E.
Makenbaeva, D.
Mekan, S.
Sy, O.
Weisel, K.
Richardson, P.G.
Εκδότης:
John Wiley and Sons Inc
Λέξεις-κλειδιά:
dexamethasone; elotuzumab; lenalidomide; antineoplastic agent; dexamethasone; elotuzumab; lenalidomide; monoclonal antibody, adult; anemia; Article; backache; cancer mortality; cancer registry; cancer risk; cancer staging; cardiovascular disease; constipation; controlled study; coughing; diarrhea; disease course; drug efficacy; drug safety; fatigue; fever; follow up; gastrointestinal disease; hazard ratio; herpes zoster; human; infection; long term care; lymphocytopenia; multiple myeloma; muscle spasm; neutropenia; pneumonia; priority journal; progression free survival; randomized controlled trial; relapsed refractory multiple myeloma; relapsed refractory multiple myeloma; risk reduction; sepsis; thrombocytopenia; treatment outcome; vascular disease; aged; clinical trial; disease exacerbation; drug effect; drug resistance; female; male; middle aged; mortality; multicenter study; multiple myeloma; pathology; survival analysis; time factor; tumor recurrence; very elderly, Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease Progression; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Humans; Lenalidomide; Male; Middle Aged; Multiple Myeloma; Neoplasm Recurrence, Local; Progression-Free Survival; Survival Analysis; Time Factors; Treatment Outcome
