Περίληψη:
In the POLLUX study, daratumumab plus lenalidomide/dexamethasone significantly reduced risk of progression/death versus lenalidomide/ dexamethasone alone in relapsed/refractory multiple myeloma. We provide one additional year of follow up and include the effect on minimal residual disease and in clinically relevant subgroups. After 25.4 months of follow up, daratumumab plus lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone alone (median not reached vs. 17.5 months; hazard ratio, 0.41; 95% confidence interval, 0.31-0.53; P<0.0001). The overall response rate was 92.9% versus 76.4%, and 51.2% versus 21.0% achieved a complete response or better, respectively (both P<0.0001). At the 10–5 sensitivity threshold, 26.2% versus 6.4% were minimal residual disease–negative, respectively (P<0.0001). Post hoc analyses of clinically relevant patient subgroups demonstrated that progression-free survival was significantly prolonged for daratumumab plus lenalidomide/dexamethasone versus lenalidomide/dexamethasone regardless of number of prior lines of therapy. Patients previously treated with lenalidomide or thalidomide and those refractory to bortezomib received similar benefits (all P<0.01). Treatment benefit with daratumumab plus lenalidomide/dexamethasone was maintained in high-risk patients (median progression-free survival 22.6 vs. 10.2 months; hazard ratio, 0.53; 95% confidence interval, 0.25-1.13; P=0.0921) and patients with treatment-free intervals of >12 and ≤12 months and >6 and ≤6 months. No new safety signals were observed. In relapsed/refractory multiple myeloma patients, daratumumab plus lenalidomide/dexamethasone continued to improve progression-free survival and deepen responses versus lenalidomide/dexamethasone. © 2018 Ferrata Storti Foundation.
Συγγραφείς:
Dimopoulos, M.A.
San-Miguel, J.
Belch, A.
White, D.
Benboubker, L.
Cook, G.
Leiba, M.
Morton, J.
Joy Ho, P.
Kim, K.
Takezako, N.
Moreau, P.
Kaufman, J.L.
Sutherland, H.J.
Lalancette, M.
Magen, H.
Iida, S.
Kim, J.S.
Miles Prince, H.
Cochrane, T.
Oriol, A.
Bahlis, N.J.
Chari, A.
O’Rourke, L.
Wu, K.
Schecter, J.M.
Casneuf, T.
Chiu, C.
Soong, D.
Kate Sasser, A.
Khokhar, N.Z.
Avet-Loiseau, H.
Usmani, S.Z.
Λέξεις-κλειδιά:
bortezomib; daratumumab; dexamethasone; lenalidomide; syndecan 1; thalidomide; antineoplastic agent; daratumumab; dexamethasone; lenalidomide; monoclonal antibody, adult; aged; anemia; Article; clinical feature; constipation; controlled study; coughing; cytogenetics; diarrhea; disease exacerbation; drug exposure; drug withdrawal; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; European Quality of Life 5 Dimensions 5 Level questionnaire; fatigue; febrile neutropenia; follow up; general condition improvement; high risk patient; human; kidney failure; lung embolism; lymphocytopenia; major clinical study; minimal residual disease; multicenter study; multiple cycle treatment; multiple myeloma; muscle spasm; nausea; neutropenia; next generation sequencing; overall survival; phase 3 clinical trial; pneumonia; progression free survival; randomized controlled trial; rhinopharyngitis; thrombocytopenia; treatment outcome; treatment response; treatment response time; upper respiratory tract infection; very elderly; clinical trial; drug resistance; female; Kaplan Meier method; male; middle aged; minimal residual disease; multiple myeloma; outcome assessment; pathology; procedures; tumor recurrence, Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Female; Humans; Kaplan-Meier Estimate; Lenalidomide; Male; Middle Aged; Multiple Myeloma; Neoplasm Recurrence, Local; Neoplasm, Residual; Outcome Assessment (Health Care)
