Τίτλος:
Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
BACKGROUND: The immunostimulatory monoclonal antibody elotuzumab plus lenalidomide and dexamethasone has been shown to be effective in patients with relapsed or refractory multiple myeloma. The immunomodulatory agent pomalidomide plus dexamethasone has been shown to be effective in patients with multiple myeloma that is refractory to lenalidomide and a proteasome inhibitor. METHODS: Patients with multiple myeloma that was refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor were randomly assigned to receive elotuzumab plus pomalidomide and dexamethasone (elotuzumab group) or pomalidomide and dexamethasone alone (control group). The primary end point was investigatorassessed progressionfree survival. RESULTS: A total of 117 patients were randomly assigned to the elotuzumab group (60 patients) or the control group (57 patients). After a minimum followup period of 9.1 months, the median progressionfree survival was 10.3 months in the elotuzumab group and 4.7 months in the control group. The hazard ratio for disease progression or death in the elotuzumab group as compared with the control group was 0.54 (95% confidence interval [CI], 0.34 to 0.86; P=0.008). The overall response rate was 53% in the elotuzumab group as compared with 26% in the control group (odds ratio, 3.25; 95% CI, 1.49 to 7.11). The most common grade 3 or 4 adverse events were neutropenia (13% in the elotuzumab group vs. 27% in the control group), anemia (10% vs. 20%), and hyperglycemia (8% vs. 7%). A total of 65% of the patients in each group had infections. Infusion reactions occurred in 3 patients (5%) in the elotuzumab group. CONCLUSIONS: Among patients with multiple myeloma in whom treatment with lenalidomide and a proteasome inhibitor had failed, the risk of progression or death was significantly lower among those who received elotuzumab plus pomalidomide and dexamethasone than among those who received pomalidomide plus dexamethasone alone. Copyright © 2018 Massachusetts Medical Society.
Συγγραφείς:
Dimopoulos, M.A.
Dytfeld, D.
Grosicki, S.
Moreau, P.
Takezako, N.
Hori, M.
Leleu, X.
LeBlanc, R.
Suzuki, K.
Raab, M.S.
Richardson, P.G.
McKiver, M.P.
Jou, Y.-M.
Shelat, S.G.
Robbins, M.
Rafferty, B.
San-Miguel, J.
Περιοδικό:
The New England journal of medicine
Εκδότης:
Massachussetts Medical Society
Λέξεις-κλειδιά:
creatinine; dexamethasone; diphenhydramine; elotuzumab; lenalidomide; paracetamol; pomalidomide; proteasome inhibitor; ranitidine; antineoplastic agent; dexamethasone; elotuzumab; immunologic factor; monoclonal antibody; pomalidomide; thalidomide, adult; aged; anemia; Article; asthenia; bone pain; breast carcinoma; bronchitis; cancer grading; cancer growth; cancer mortality; cancer recurrence; cancer risk; cancer staging; cancer survival; constipation; controlled study; creatinine blood level; diarrhea; drug efficacy; drug response; drug safety; drug withdrawal; dyspnea; fatigue; female; fever; follow up; hearing impairment; heart disease; herpes zoster; human; hyperglycemia; hypokalemia; infection; infusion related reaction; insomnia; lymphocytopenia; major clinical study; male; malignant neoplasm; median survival time; mortality risk; multicenter study; multiple cycle treatment; multiple myeloma; muscle spasm; neoplasm; neutropenia; open study; peripheral edema; phase 2 clinical trial; pneumonia; priority journal; progression free survival; randomized controlled trial; rash; respiratory tract infection; rhinopharyngitis; risk factor; side effect; thorax pain; thrombocytopenia; upper respiratory tract infection; vascular disease; analogs and derivatives; chemically induced; clinical trial; disease free survival; infection; middle aged; mortality; multiple myeloma; neutropenia; very elderly, Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease-Free Survival; Female; Humans; Immunologic Factors; Infection; Male; Middle Aged; Multiple Myeloma; Neutropenia; Thalidomide
DOI:
10.1056/NEJMoa1805762
