Τίτλος:
Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Carfilzomib is an irreversible proteasome inhibitor used for the treatment of relapsed and/or refractory multiple myeloma (RRMM). We evaluated the efficacy and safety of carfilzomib in subgroups of Asian patients in the randomized phase 3 ENDEAVOR and A.R.R.O.W. trials. In ENDEAVOR, patients received carfilzomib twice-weekly (56 mg/m2) plus dexamethasone (Kd; n = 56) or bortezomib plus dexamethasone (Vd; n = 57). In A.R.R.O.W., patients received carfilzomib once-weekly (70 mg/m2, n = 30) or twice-weekly (27 mg/m2, n = 15) plus dexamethasone. Median progression-free survival (PFS) among Asian patients in ENDEAVOR was longer with Kd than with Vd (14.9 versus 8.8 months; HR 0.599); the overall response rate (ORR) was 80.4% versus 70.2%. Median overall survival (Kd versus Vd) was 47.6 versus 38.8 months (HR 0.856). Median PFS among Asian patients in A.R.R.O.W. was longer for once-weekly versus twice-weekly Kd (16.0 versus 8.4 months; HR 0.628); ORR was 76.7% versus 53.3%. Rates of grade ≥ 3 adverse events were 89.1% (Kd) and 89.5% (Vd) in ENDEAVOR, and 76.6% (once-weekly Kd) versus 73.3% (twice-weekly Kd) in A.R.R.O.W. Overall, carfilzomib had a favorable benefit-risk profile across both dosing regimens [once-weekly (Kd 70 mg/m2) and twice-weekly (Kd 56 mg/m2)] in Asian patients with RRMM, which was consistent with the results of both parent studies. Trial registration ClinicalTrials.gov: NCT01568866, NCT02412878. © 2019, Japanese Society of Hematology.
Συγγραφείς:
Dimopoulos, M.A.
Moreau, P.
Iida, S.
Huang, S.-Y.
Takezako, N.
Chng, W.J.
Zahlten-Kumeli, A.
Sersch, M.A.
Li, J.
Huang, M.
Lee, J.H.
Περιοδικό:
International Journal of Hematologic Oncology
Λέξεις-κλειδιά:
bortezomib; carfilzomib; dexamethasone; lenalidomide, acute kidney failure; adult; aged; Article; Asian; controlled study; drug dose reduction; drug efficacy; drug safety; drug withdrawal; evaluation study; female; heart failure; human; hypertension; major clinical study; male; multiple myeloma; overall survival; peripheral neuropathy; progression free survival; randomized controlled trial; risk benefit analysis
DOI:
10.1007/s12185-019-02704-z
