Moxetumomab pasudotox in relapsed/refractory hairy cell
leukemia

J 2018

Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia

KREITMAN, R.J., C. DEARDEN, P.L. ZINZANI, J. DELGADO, L. KARLIN et. al.

Základní údaje

Originální název

Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia

Autoři

KREITMAN, R.J. (840 Spojené státy), C. DEARDEN (826 Velká Británie a Severní Irsko), P.L. ZINZANI (380 Itálie), J. DELGADO (724 Španělsko), L. KARLIN (250 Francie), T. ROBAK (616 Polsko), D.E. GLADSTONE (840 Spojené státy), P. LE COUTRE (276 Německo), S. DIETRICH (276 Německo), M. GOTIC (688 Srbsko), L. LARRATT (124 Kanada), F. OFFNER (56 Belgie), G. SCHILLER (840 Spojené státy), R. SWORDS (840 Spojené státy), L. BACON (372 Irsko), M. BOCCHIA (380 Itálie), K. BOUABDALLAH (250 Francie), D.A. BREEMS (56 Belgie), A. CORTELEZZI (380 Itálie), S. DINNER (840 Spojené státy), Michael DOUBEK (203 Česká republika, domácí), B.T. GJERTSEN (578 Norsko), M. GOBBI (380 Itálie), A. HELLMANN (616 Polsko), S. LEPRETRE (250 Francie), F. MALOISEL (250 Francie), F. RAVANDI (840 Spojené státy), P. ROUSSELOT (250 Francie), M. RUMMEL (276 Německo), T. SIDDIQI (840 Spojené státy), T. TADMOR (376 Izrael), X. TROUSSARD (250 Francie), C.A. YI (250 Francie), G. SAGLIO (380 Itálie), G.J. ROBOZ (840 Spojené státy), K. BALIC (840 Spojené státy), N. STANDIFER (840 Spojené státy), P. HE (840 Spojené státy), S. MARSHALL (840 Spojené státy), W. WILSON (840 Spojené státy), I. PASTAN (840 Spojené státy), N.S. YAO (840 Spojené státy) a F. GILES (840 Spojené státy)

Vydání

Leukemia, London, Nature Publishing Group, 2018, 0887-6924

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 9.944

Kód RIV

RIV/00216224:14110/18:00103867

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1038/s41375-018-0210-1

UT WoS

000441284000009

Klíčová slova anglicky

MINIMAL RESIDUAL DISEASE; TERM-FOLLOW-UP; CLADRIBINE; RITUXIMAB; IMMUNOHISTOCHEMISTRY; ERADICATION; DIAGNOSIS; EFFICACY; PATTERNS; ANTIBODY

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 12. 3. 2019 11:56, Soňa Böhmová

Anotace

V originále

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had >= 2 prior systemic therapies, including >= 1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 mu g/kg intravenously on days 1, 3, and 5 every 28 days for <= 6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Citovat

KREITMAN, R.J., C. DEARDEN, P.L. ZINZANI, J. DELGADO, L. KARLIN, T. ROBAK, D.E. GLADSTONE, P. LE COUTRE, S. DIETRICH, M. GOTIC, L. LARRATT, F. OFFNER, G. SCHILLER, R. SWORDS, L. BACON, M. BOCCHIA, K. BOUABDALLAH, D.A. BREEMS, A. CORTELEZZI, S. DINNER, Michael DOUBEK, B.T. GJERTSEN, M. GOBBI, A. HELLMANN, S. LEPRETRE, F. MALOISEL, F. RAVANDI, P. ROUSSELOT, M. RUMMEL, T. SIDDIQI, T. TADMOR, X. TROUSSARD, C.A. YI, G. SAGLIO, G.J. ROBOZ, K. BALIC, N. STANDIFER, P. HE, S. MARSHALL, W. WILSON, I. PASTAN, N.S. YAO a F. GILES. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. London: Nature Publishing Group, 2018, roč. 32, č. 8, s. 1768-1777. ISSN 0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-018-0210-1.

@article{1443161,
   author = {Kreitman, R.J. and Dearden, C. and Zinzani, P.L. and Delgado, J. and Karlin, L. and Robak, T. and Gladstone, D.E. and le Coutre, P. and Dietrich, S. and Gotic, M. and Larratt, L. and Offner, F. and Schiller, G. and Swords, R. and Bacon, L. and Bocchia, M. and Bouabdallah, K. and Breems, D.A. and Cortelezzi, A. and Dinner, S. and Doubek, Michael and Gjertsen, B.T. and Gobbi, M. and Hellmann, A. and Lepretre, S. and Maloisel, F. and Ravandi, F. and Rousselot, P. and Rummel, M. and Siddiqi, T. and Tadmor, T. and Troussard, X. and Yi, C.A. and Saglio, G. and Roboz, G.J. and Balic, K. and Standifer, N. and He, P. and Marshall, S. and Wilson, W. and Pastan, I. and Yao, N.S. and Giles, F.},
   article_location = {London},
   article_number = {8},
   doi = {http://dx.doi.org/10.1038/s41375-018-0210-1},
   keywords = {MINIMAL RESIDUAL DISEASE; TERM-FOLLOW-UP; CLADRIBINE; RITUXIMAB; IMMUNOHISTOCHEMISTRY; ERADICATION; DIAGNOSIS; EFFICACY; PATTERNS; ANTIBODY},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia},
   url = {https://www.nature.com/articles/s41375-018-0210-1.pdf},
   volume = {32},
   year = {2018}
}

TY  - JOUR
ID  - 1443161
AU  - Kreitman, R.J. - Dearden, C. - Zinzani, P.L. - Delgado, J. - Karlin, L. - Robak, T. - Gladstone, D.E. - le Coutre, P. - Dietrich, S. - Gotic, M. - Larratt, L. - Offner, F. - Schiller, G. - Swords, R. - Bacon, L. - Bocchia, M. - Bouabdallah, K. - Breems, D.A. - Cortelezzi, A. - Dinner, S. - Doubek, Michael - Gjertsen, B.T. - Gobbi, M. - Hellmann, A. - Lepretre, S. - Maloisel, F. - Ravandi, F. - Rousselot, P. - Rummel, M. - Siddiqi, T. - Tadmor, T. - Troussard, X. - Yi, C.A. - Saglio, G. - Roboz, G.J. - Balic, K. - Standifer, N. - He, P. - Marshall, S. - Wilson, W. - Pastan, I. - Yao, N.S. - Giles, F.
PY  - 2018
TI  - Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
JF  - Leukemia
VL  - 32
IS  - 8
SP  - 1768-1777
EP  - 1768-1777
PB  - Nature Publishing Group
SN  - 08876924
KW  - MINIMAL RESIDUAL DISEASE
KW  - TERM-FOLLOW-UP
KW  - CLADRIBINE
KW  - RITUXIMAB
KW  - IMMUNOHISTOCHEMISTRY
KW  - ERADICATION
KW  - DIAGNOSIS
KW  - EFFICACY
KW  - PATTERNS
KW  - ANTIBODY
UR  - https://www.nature.com/articles/s41375-018-0210-1.pdf
N2  - This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had >= 2 prior systemic therapies, including >= 1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 mu g/kg intravenously on days 1, 3, and 5 every 28 days for <= 6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.
ER  -

KREITMAN, R.J., C. DEARDEN, P.L. ZINZANI, J. DELGADO, L. KARLIN, T. ROBAK, D.E. GLADSTONE, P. LE COUTRE, S. DIETRICH, M. GOTIC, L. LARRATT, F. OFFNER, G. SCHILLER, R. SWORDS, L. BACON, M. BOCCHIA, K. BOUABDALLAH, D.A. BREEMS, A. CORTELEZZI, S. DINNER, Michael DOUBEK, B.T. GJERTSEN, M. GOBBI, A. HELLMANN, S. LEPRETRE, F. MALOISEL, F. RAVANDI, P. ROUSSELOT, M. RUMMEL, T. SIDDIQI, T. TADMOR, X. TROUSSARD, C.A. YI, G. SAGLIO, G.J. ROBOZ, K. BALIC, N. STANDIFER, P. HE, S. MARSHALL, W. WILSON, I. PASTAN, N.S. YAO a F. GILES. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. \textit{Leukemia}. London: Nature Publishing Group, 2018, roč.~32, č.~8, s.~1768-1777. ISSN~0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-018-0210-1.

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