A randomized phase III study of carfilzomib vs low-dose
corticosteroids with optional cyclophosphamide in relapsed and
refractory multiple myeloma (FOCUS)

J 2017

A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)

HÁJEK, R., T. MASSZI, M. T. PETRUCCI, A. PALUMBO, L. ROSIÑOL et. al.

Basic information

Original name

A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)

Authors

Edition

Leukemia, London, Nature Publishing Group, 2017, 0887-6924

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 10.023

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1038/leu.2016.176

UT WoS

000394058700014

Keywords in English

SINGLE-AGENT CARFILZOMIB; OPEN-LABEL; BORTEZOMIB; PREDNISONE; ARM; DEXAMETHASONE; SURVIVAL; SAFETY

Abstract

V originále

This randomized, phase III, open-label, multicenter study compared carfilzomib monotherapy against low-dose corticosteroids and optional cyclophosphamide in relapsed and refractory multiple myeloma (RRMM). Relapsed and refractory multiple myeloma patients were randomized (1:1) to receive carfilzomib (10-min intravenous infusion; 20 mg/m 2 on days 1 and 2 of cycle 1; 27 mg/m 2 thereafter) or a control regimen of low-dose corticosteroids (84 mg of dexamethasone or equivalent corticosteroid) with optional cyclophosphamide (1400 mg) for 28-day cycles. The primary endpoint was overall survival (OS). Three-hundred and fifteen patients were randomized to carfilzomib (n=157) or control (n=158). Both groups had a median of five prior regimens. In the control group, 95% of patients received cyclophosphamide. Median OS was 10.2 (95% confidence interval (CI) 8.4-14.4) vs 10.0 months (95% CI 7.7-12.0) with carfilzomib vs control (hazard ratio=0.975; 95% CI 0.760-1.249; P=0.4172). Progression-free survival was similar between groups; overall response rate was higher with carfilzomib (19.1 vs 11.4%). The most common grade >=3 adverse events were anemia (25.5 vs 30.7%), thrombocytopenia (24.2 vs 22.2%) and neutropenia (7.6 vs 12.4%) with carfilzomib vs control. Median OS for single-agent carfilzomib was similar to that for an active doublet control regimen in heavily pretreated RRMM patients.

Citovat

HÁJEK, R., T. MASSZI, M. T. PETRUCCI, A. PALUMBO, L. ROSIÑOL, A. NAGLER, K. L. YONG, A. ORIOL, J. MINARIK, Luděk POUR, M. A. DIMOPOULOS, V. MAISNAR, D. ROSSI, H. KASPARU, J. Van DROOGENBROECK, D. B. YEHUDA, I. HARDAN, M. JENNER, M. CALBECKA, M. DÁVID, J. de la RUBIA, J. DRACH, Z. GASZTONYI, S. GÓRNIK, X. LELEU, M. MUNDER, M. OFFIDANI, N. ZOJER, K. RAJANGAM, Y.-L. CHANG, J. F. SAN-MIGUEL and H. LUDWIG. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). Leukemia. London: Nature Publishing Group, 2017, vol. 31, No 1, p. 107-114. ISSN 0887-6924. Available from: https://dx.doi.org/10.1038/leu.2016.176.

@article{1369190,
   author = {Hájek, R. and Masszi, T. and Petrucci, M. T. and Palumbo, A. and Rosiñol, L. and Nagler, A. and Yong, K. L. and Oriol, A. and Minarik, J. and Pour, Luděk and Dimopoulos, M. A. and Maisnar, V. and Rossi, D. and Kasparu, H. and Droogenbroeck, J. Van and Yehuda, D. B. and Hardan, I. and Jenner, M. and Calbecka, M. and Dávid, M. and Rubia, J. de la and Drach, J. and Gasztonyi, Z. and Górnik, S. and Leleu, X. and Munder, M. and Offidani, M. and Zojer, N. and Rajangam, K. and Chang, Y.andL. and SanandMiguel, J. F. and Ludwig, H.},
   article_location = {London},
   article_number = {1},
   doi = {http://dx.doi.org/10.1038/leu.2016.176},
   keywords = {SINGLE-AGENT CARFILZOMIB; OPEN-LABEL; BORTEZOMIB; PREDNISONE; ARM; DEXAMETHASONE; SURVIVAL; SAFETY},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)},
   url = {http://dx.doi.org/10.1038/leu.2016.176},
   volume = {31},
   year = {2017}
}

TY  - JOUR
ID  - 1369190
AU  - Hájek, R. - Masszi, T. - Petrucci, M. T. - Palumbo, A. - Rosiñol, L. - Nagler, A. - Yong, K. L. - Oriol, A. - Minarik, J. - Pour, Luděk - Dimopoulos, M. A. - Maisnar, V. - Rossi, D. - Kasparu, H. - Droogenbroeck, J. Van - Yehuda, D. B. - Hardan, I. - Jenner, M. - Calbecka, M. - Dávid, M. - Rubia, J. de la - Drach, J. - Gasztonyi, Z. - Górnik, S. - Leleu, X. - Munder, M. - Offidani, M. - Zojer, N. - Rajangam, K. - Chang, Y.-L. - San-Miguel, J. F. - Ludwig, H.
PY  - 2017
TI  - A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
JF  - Leukemia
VL  - 31
IS  - 1
SP  - 107-114
EP  - 107-114
PB  - Nature Publishing Group
SN  - 08876924
KW  - SINGLE-AGENT CARFILZOMIB
KW  - OPEN-LABEL
KW  - BORTEZOMIB
KW  - PREDNISONE
KW  - ARM
KW  - DEXAMETHASONE
KW  - SURVIVAL
KW  - SAFETY
UR  - http://dx.doi.org/10.1038/leu.2016.176
L2  - http://dx.doi.org/10.1038/leu.2016.176
N2  - This randomized, phase III, open-label, multicenter study compared carfilzomib monotherapy against low-dose corticosteroids and optional cyclophosphamide in relapsed and refractory multiple myeloma (RRMM). Relapsed and refractory multiple myeloma patients were randomized (1:1) to receive carfilzomib (10-min intravenous infusion; 20 mg/m 2 on days 1 and 2 of cycle 1; 27 mg/m 2 thereafter) or a control regimen of low-dose corticosteroids (84 mg of dexamethasone or equivalent corticosteroid) with optional cyclophosphamide (1400 mg) for 28-day cycles. The primary endpoint was overall survival (OS). Three-hundred and fifteen patients were randomized to carfilzomib (n=157) or control (n=158). Both groups had a median of five prior regimens. In the control group, 95% of patients received cyclophosphamide. Median OS was 10.2 (95% confidence interval (CI) 8.4-14.4) vs 10.0 months (95% CI 7.7-12.0) with carfilzomib vs control (hazard ratio=0.975; 95% CI 0.760-1.249; P=0.4172). Progression-free survival was similar between groups; overall response rate was higher with carfilzomib (19.1 vs 11.4%). The most common grade >=3 adverse events were anemia (25.5 vs 30.7%), thrombocytopenia (24.2 vs 22.2%) and neutropenia (7.6 vs 12.4%) with carfilzomib vs control. Median OS for single-agent carfilzomib was similar to that for an active doublet control regimen in heavily pretreated RRMM patients.
ER  -

HÁJEK, R., T. MASSZI, M. T. PETRUCCI, A. PALUMBO, L. ROSIÑOL, A. NAGLER, K. L. YONG, A. ORIOL, J. MINARIK, Luděk POUR, M. A. DIMOPOULOS, V. MAISNAR, D. ROSSI, H. KASPARU, J. Van DROOGENBROECK, D. B. YEHUDA, I. HARDAN, M. JENNER, M. CALBECKA, M. DÁVID, J. de la RUBIA, J. DRACH, Z. GASZTONYI, S. GÓRNIK, X. LELEU, M. MUNDER, M. OFFIDANI, N. ZOJER, K. RAJANGAM, Y.-L. CHANG, J. F. SAN-MIGUEL and H. LUDWIG. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). \textit{Leukemia}. London: Nature Publishing Group, 2017, vol.~31, No~1, p.~107-114. ISSN~0887-6924. Available from: https://dx.doi.org/10.1038/leu.2016.176.

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