Real-world data on efficacy and safety of obinutuzumab plus
chlorambucil, rituximab plus chlorambucil, and rituximab plus
bendamustine in the frontline treatment of chronic lymphocytic
leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group

J 2020

Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group

PANOVSKÁ, Anna, Lucie BEZDĚKOVÁ, Lucie NEKVINDOVÁ, Martin SPACEK, Martin SIMKOVIC et. al.

Basic information

Original name

Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group

Authors

PANOVSKÁ, Anna (203 Czech Republic, belonging to the institution), Lucie BEZDĚKOVÁ (203 Czech Republic, belonging to the institution), Lucie NEKVINDOVÁ (203 Czech Republic), Martin SPACEK (203 Czech Republic), Martin SIMKOVIC (203 Czech Republic), Tomas PAPAJIK (203 Czech Republic), Martin BREJCHA (203 Czech Republic), Daniel LYSAK (203 Czech Republic), Jana ZUCHNICKA (203 Czech Republic), Jan NOVAK (203 Czech Republic), David STAROSTKA (203 Czech Republic), Hynek POUL (203 Czech Republic), Filip VRBACKY (203 Czech Republic), Pavel VODAREK (203 Czech Republic), Renata URBANOVA (203 Czech Republic), Karla PLEVOVÁ (203 Czech Republic, belonging to the institution), Šárka POSPÍŠILOVÁ (203 Czech Republic, belonging to the institution), Stanislava MASLEJOVA (203 Czech Republic), Yvona BRYCHTOVÁ (203 Czech Republic, belonging to the institution), Eva KORIŤÁKOVÁ (203 Czech Republic), Lukas SMOLEJ (203 Czech Republic) and Michael DOUBEK (203 Czech Republic, guarantor, belonging to the institution)

Edition

Hematological Oncology, MALDEN, USA, WILEY-BLACKWELL, 2020, 0278-0232

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.271

RIV identification code

RIV/00216224:14740/20:00116170

Organization unit

Central European Institute of Technology

DOI

http://dx.doi.org/10.1002/hon.2744

UT WoS

000539416600001

Keywords in English

CIRS; CLL; frontline treatment; obinutuzumab-chlorambucil; rituximab-bendamustine; rituximab-chlorambucil

Abstract

V originále

Until recently, a combination of anti-CD20 antibody plus less intensive chemotherapy was a standard of care in elderly population with previously untreated chronic lymphocytic leukemia (CLL). The aim of this observational study was to retrospectively assess efficacy and safety of obinutuzumab + chlorambucil (G-Clb), rituximab + chlorambucil (R-Clb), and bendamustine + rituximab (BR) given as the frontline therapy within routine practice. The final analyzed dataset included 398 consecutive CLL patients from 10 hematology centers cooperating within the Czech CLL Study Group: 63 treated with G-Clb, 78 with R-Clb, and 257 with BR. There were no significant differences in prognostic and predictive markers among the groups. On the contrary, median age at the start of therapy and cumulative illness rating scale (CIRS) score was significantly higher in R-Clb group. Obinutuzumab plus chlorambucil regimen was preferably offered to elderly patients (compared to BR) with less severe comorbidities and lower CIRS score (compared to R-Clb). A time period when a treatment was indicated had also a strong impact on the choice of the regimen. The overall response rate reached 76% (30% complete remissions, CRs) in G-Clb, 75% (22% CRs) in R-Clb, and 85% (47% CRs) in BR group. Median event-free survival was 49.0 months for G-Clb, 20.3 months for R-Clb, and 37.0 months for BR group. Neutropenia grade >= 3 developed in 43% of G-Clb, 31% of R-Clb and in 49% of BR patients, grade >= 3 infections were recorded in 17% of G-Clb, 6.4% of R-Clb, and 17% of BR patients. In conclusion, real-world therapeutic activity of G-Clb appears to be at least comparable to prospective clinical trial data. R-Clb yields relatively good results in very old and severely comorbid patients.

Links

LQ1601, research and development project

Name: CEITEC 2020 (Acronym: CEITEC2020)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

PANOVSKÁ, Anna, Lucie BEZDĚKOVÁ, Lucie NEKVINDOVÁ, Martin SPACEK, Martin SIMKOVIC, Tomas PAPAJIK, Martin BREJCHA, Daniel LYSAK, Jana ZUCHNICKA, Jan NOVAK, David STAROSTKA, Hynek POUL, Filip VRBACKY, Pavel VODAREK, Renata URBANOVA, Karla PLEVOVÁ, Šárka POSPÍŠILOVÁ, Stanislava MASLEJOVA, Yvona BRYCHTOVÁ, Eva KORIŤÁKOVÁ, Lukas SMOLEJ and Michael DOUBEK. Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group. Hematological Oncology. MALDEN, USA: WILEY-BLACKWELL, 2020, vol. 38, No 4, p. 509-516. ISSN 0278-0232. Available from: https://dx.doi.org/10.1002/hon.2744.

@article{1673757,
   author = {Panovská, Anna and Bezděková, Lucie and Nekvindová, Lucie and Spacek, Martin and Simkovic, Martin and Papajik, Tomas and Brejcha, Martin and Lysak, Daniel and Zuchnicka, Jana and Novak, Jan and Starostka, David and Poul, Hynek and Vrbacky, Filip and Vodarek, Pavel and Urbanova, Renata and Plevová, Karla and Pospíšilová, Šárka and Maslejova, Stanislava and Brychtová, Yvona and Koriťáková, Eva and Smolej, Lukas and Doubek, Michael},
   article_location = {MALDEN, USA},
   article_number = {4},
   doi = {http://dx.doi.org/10.1002/hon.2744},
   keywords = {CIRS; CLL; frontline treatment; obinutuzumab-chlorambucil; rituximab-bendamustine; rituximab-chlorambucil},
   language = {eng},
   issn = {0278-0232},
   journal = {Hematological Oncology},
   title = {Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group},
   url = {https://onlinelibrary.wiley.com/doi/full/10.1002/hon.2744},
   volume = {38},
   year = {2020}
}

TY  - JOUR
ID  - 1673757
AU  - Panovská, Anna - Bezděková, Lucie - Nekvindová, Lucie - Spacek, Martin - Simkovic, Martin - Papajik, Tomas - Brejcha, Martin - Lysak, Daniel - Zuchnicka, Jana - Novak, Jan - Starostka, David - Poul, Hynek - Vrbacky, Filip - Vodarek, Pavel - Urbanova, Renata - Plevová, Karla - Pospíšilová, Šárka - Maslejova, Stanislava - Brychtová, Yvona - Koriťáková, Eva - Smolej, Lukas - Doubek, Michael
PY  - 2020
TI  - Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group
JF  - Hematological Oncology
VL  - 38
IS  - 4
SP  - 509-516
EP  - 509-516
PB  - WILEY-BLACKWELL
SN  - 02780232
KW  - CIRS
KW  - CLL
KW  - frontline treatment
KW  - obinutuzumab-chlorambucil
KW  - rituximab-bendamustine
KW  - rituximab-chlorambucil
UR  - https://onlinelibrary.wiley.com/doi/full/10.1002/hon.2744
L2  - https://onlinelibrary.wiley.com/doi/full/10.1002/hon.2744
N2  - Until recently, a combination of anti-CD20 antibody plus less intensive chemotherapy was a standard of care in elderly population with previously untreated chronic lymphocytic leukemia (CLL). The aim of this observational study was to retrospectively assess efficacy and safety of obinutuzumab + chlorambucil (G-Clb), rituximab + chlorambucil (R-Clb), and bendamustine + rituximab (BR) given as the frontline therapy within routine practice. The final analyzed dataset included 398 consecutive CLL patients from 10 hematology centers cooperating within the Czech CLL Study Group: 63 treated with G-Clb, 78 with R-Clb, and 257 with BR. There were no significant differences in prognostic and predictive markers among the groups. On the contrary, median age at the start of therapy and cumulative illness rating scale (CIRS) score was significantly higher in R-Clb group. Obinutuzumab plus chlorambucil regimen was preferably offered to elderly patients (compared to BR) with less severe comorbidities and lower CIRS score (compared to R-Clb). A time period when a treatment was indicated had also a strong impact on the choice of the regimen. The overall response rate reached 76% (30% complete remissions, CRs) in G-Clb, 75% (22% CRs) in R-Clb, and 85% (47% CRs) in BR group. Median event-free survival was 49.0 months for G-Clb, 20.3 months for R-Clb, and 37.0 months for BR group. Neutropenia grade >= 3 developed in 43% of G-Clb, 31% of R-Clb and in 49% of BR patients, grade >= 3 infections were recorded in 17% of G-Clb, 6.4% of R-Clb, and 17% of BR patients. In conclusion, real-world therapeutic activity of G-Clb appears to be at least comparable to prospective clinical trial data. R-Clb yields relatively good results in very old and severely comorbid patients.
ER  -

PANOVSKÁ, Anna, Lucie BEZDĚKOVÁ, Lucie NEKVINDOVÁ, Martin SPACEK, Martin SIMKOVIC, Tomas PAPAJIK, Martin BREJCHA, Daniel LYSAK, Jana ZUCHNICKA, Jan NOVAK, David STAROSTKA, Hynek POUL, Filip VRBACKY, Pavel VODAREK, Renata URBANOVA, Karla PLEVOVÁ, Šárka POSPÍŠILOVÁ, Stanislava MASLEJOVA, Yvona BRYCHTOVÁ, Eva KORIŤÁKOVÁ, Lukas SMOLEJ and Michael DOUBEK. Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil, and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: TheGO-CLLEARStudy by the CzechCLLStudy Group. \textit{Hematological Oncology}. MALDEN, USA: WILEY-BLACKWELL, 2020, vol.~38, No~4, p.~509-516. ISSN~0278-0232. Available from: https://dx.doi.org/10.1002/hon.2744.

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