Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR
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Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. / Chng, W-J; Goldschmidt, H; Dimopoulos, M A; Moreau, P; Joshua, D; Palumbo, A; Facon, T; Ludwig, H; Pour, L; Niesvizky, R; Oriol, A; Rosiñol, L; Suvorov, A; Gaidano, G; Pika, T; Weisel, K; Goranova-Marinova, V; Gillenwater, H H; Mohamed, N; Feng, S; Aggarwal, S; Hájek, R.
in: LEUKEMIA, Jahrgang 31, Nr. 6, 06.2017, S. 1368-1374.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR
AU - Chng, W-J
AU - Goldschmidt, H
AU - Dimopoulos, M A
AU - Moreau, P
AU - Joshua, D
AU - Palumbo, A
AU - Facon, T
AU - Ludwig, H
AU - Pour, L
AU - Niesvizky, R
AU - Oriol, A
AU - Rosiñol, L
AU - Suvorov, A
AU - Gaidano, G
AU - Pika, T
AU - Weisel, K
AU - Goranova-Marinova, V
AU - Gillenwater, H H
AU - Mohamed, N
AU - Feng, S
AU - Aggarwal, S
AU - Hájek, R
PY - 2017/6
Y1 - 2017/6
N2 - The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd, n=97 (25%); Vd, n=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd, n=284 (75%); Vd, n=291 (72%)). Median PFS in the high-risk group was 8.8 months for Kd vs 6.0 months for Vd (hazard ratio (HR), 0.65; 95% confidence interval (CI), 0.45-0.92; P=0.0075). Median PFS in the standard-risk group was not estimable for Kd vs 10.2 months for Vd (HR, 0.44; 95% CI, 0.33-0.58; P<0.0001). Overall response rates were 72.2% (Kd) vs 58.4% (Vd) in the high-risk group and 79.2% (Kd) vs 66.0% (Vd) in the standard-risk group. In the high-risk group, 15.5% (Kd) vs 4.4% (Vd) achieved a complete response (CR) or better. In the standard-risk group, 13.0% (Kd) vs 7.9% (Vd) achieved ⩾CR. This preplanned subgroup analysis found that Kd was superior to Vd in relapsed or refractory MM, regardless of cytogenetic risk.
AB - The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd, n=97 (25%); Vd, n=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd, n=284 (75%); Vd, n=291 (72%)). Median PFS in the high-risk group was 8.8 months for Kd vs 6.0 months for Vd (hazard ratio (HR), 0.65; 95% confidence interval (CI), 0.45-0.92; P=0.0075). Median PFS in the standard-risk group was not estimable for Kd vs 10.2 months for Vd (HR, 0.44; 95% CI, 0.33-0.58; P<0.0001). Overall response rates were 72.2% (Kd) vs 58.4% (Vd) in the high-risk group and 79.2% (Kd) vs 66.0% (Vd) in the standard-risk group. In the high-risk group, 15.5% (Kd) vs 4.4% (Vd) achieved a complete response (CR) or better. In the standard-risk group, 13.0% (Kd) vs 7.9% (Vd) achieved ⩾CR. This preplanned subgroup analysis found that Kd was superior to Vd in relapsed or refractory MM, regardless of cytogenetic risk.
KW - Adult
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Biomarkers, Tumor
KW - Bortezomib
KW - Chromosome Aberrations
KW - Cytogenetic Analysis
KW - Dexamethasone
KW - Drug Resistance, Neoplasm
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Multiple Myeloma
KW - Neoplasm Grading
KW - Neoplasm Recurrence, Local
KW - Oligopeptides
KW - Prognosis
KW - Remission Induction
KW - Salvage Therapy
KW - Survival Rate
KW - Clinical Trial, Phase III
KW - Comparative Study
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
U2 - 10.1038/leu.2016.390
DO - 10.1038/leu.2016.390
M3 - SCORING: Journal article
C2 - 28025582
VL - 31
SP - 1368
EP - 1374
JO - LEUKEMIA
JF - LEUKEMIA
SN - 0887-6924
IS - 6
ER -