Περίληψη:
The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity. © 2017 John Wiley & Sons Ltd
Συγγραφείς:
Dimopoulos, M.A.
Lonial, S.
White, D.
Moreau, P.
Palumbo, A.
San-Miguel, J.
Shpilberg, O.
Anderson, K.
Grosicki, S.
Spicka, I.
Walter-Croneck, A.
Magen, H.
Mateos, M.-V.
Belch, A.
Reece, D.
Beksac, M.
Bleickardt, E.
Poulart, V.
Sheng, J.
Sy, O.
Katz, J.
Singhal, A.
Richardson, P.
Λέξεις-κλειδιά:
bortezomib; dexamethasone; elotuzumab; lenalidomide; M protein; thalidomide; antineoplastic agent; dexamethasone; elotuzumab; immunoglobulin; lenalidomide; M-proteins (Myeloma); monoclonal antibody; thalidomide, adult; anemia; Article; cancer mortality; cancer recurrence; constipation; coughing; diarrhea; drug efficacy; drug safety; drug withdrawal; fatigue; fever; follow up; hazard ratio; human; major clinical study; multiple myeloma; muscle spasm; neutropenia; overall survival; phase 3 clinical trial (topic); post hoc analysis; priority journal; progression free survival; randomized controlled trial (topic); risk reduction; stem cell transplantation; treatment response; tumor growth; aged; analogs and derivatives; blood; clinical trial; controlled study; female; Kaplan Meier method; male; middle aged; multiple myeloma; pathology; phase 3 clinical trial; randomized controlled trial; recurrent disease, Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Follow-Up Studies; Humans; Immunoglobulins; Kaplan-Meier Estimate; Male; Middle Aged; Multiple Myeloma; Recurrence; Thalidomide
