Τίτλος:
Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
In a phase 3 trial of denosumab vs zoledronic acid in patients (n=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an ad hoc overall survival analysis in the multiple myeloma subset of patients (n=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13-4.50; P = 0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90-3.84; P = 0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80-2.15; P = 0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial. © 2016, Nature Publishing Group. All rights reserved.
Συγγραφείς:
Raje, N.
Vadhan-Raj, S.
Willenbacher, W.
Terpos, E.
Hungria, V.
Spencer, A.
Alexeeva, Y.
Facon, T.
Stewart, A.K.
Feng, A.
Braun, A.
Balakumaran, A.
Roodman, G.D.
Περιοδικό:
Blood cancer journal
Εκδότης:
Nature Publishing Group
Λέξεις-κλειδιά:
albumin; amino terminal telopeptide; bortezomib; clodronic acid; cyclophosphamide; denosumab; lenalidomide; melphalan; proteasome inhibitor; thalidomide; zoledronic acid; antineoplastic agent; bisphosphonic acid derivative; bone density conservation agent; denosumab; imidazole derivative; zoledronic acid, adult; Article; bone metastasis; cancer patient; cancer survival; controlled study; double blind procedure; drug efficacy; drug withdrawal; female; follow up; human; hypercalcemia; hypocalcemia; jaw osteonecrosis; major clinical study; male; middle aged; multiple myeloma; outcome assessment; overall survival; patient compliance; phase 3 clinical trial; randomized controlled trial; side effect; solid tumor; stem cell transplantation; survival rate; aged; autotransplantation; Bone Neoplasms; cancer staging; clinical trial; hematopoietic stem cell transplantation; metastasis; mortality; multiple myeloma; neoplasm; pathology; secondary; treatment outcome, Aged; Antineoplastic Combined Chemotherapy Protocols; Bone Density Conservation Agents; Bone Neoplasms; Denosumab; Diphosphonates; Female; Hematopoietic Stem Cell Transplantation; Humans; Imidazoles; Male; Middle Aged; Multiple Myeloma; Neoplasm Metastasis; Neoplasm Staging; Neoplasms; Transplantation, Autologous; Treatment Outcome
