RT Journal Article
T1 Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group.
A1 Herishanu, Yair
A1 Shaulov, Adir
A1 Fineman, Riva
A1 Bašić-Kinda, Sandra
A1 Aviv, Ariel
A1 Wasik-Szczepanek, Ewa
A1 Jaksic, Ozren
A1 Zdrenghea, Mihnea
A1 Greenbaum, Uri
A1 Mandac, Inga
A1 Simkovic, Martin
A1 Morawska, Marta
A1 Benjamini, Ohad
A1 Spacek, Martin
A1 Nemets, Anatoly
A1 Bairey, Osnat
A1 Trentin, Livio
A1 Ruchlemer, Rosa
A1 Laurenti, Luca
A1 Stanca Ciocan, Oana
A1 Doubek, Michael
A1 Shvidel, Lev
A1 Dali, Nagib
A1 Mirás, Fátima
A1 De Meûter, Anne
A1 Dimou, Maria
A1 Mauro, Francesca R
A1 Coscia, Marta
A1 Bumbea, Horia
A1 Szász, Róbert
A1 Tadmor, Tamar
A1 Gutwein, Odit
A1 Gentile, Massimo
A1 Scarfò, Lydia
A1 Tedeschi, Alessandra
A1 Sportoletti, Paolo
A1 Gimeno Vázquez, Eva
A1 Marquet, Juan
A1 Assouline, Sarit
A1 Papaioannou, Maria
A1 Braester, Andrei
A1 Levato, Luciano
A1 Gregor, Michael
A1 Rigolin, Gian M
A1 Loscertales, Javier
A1 Medina Perez, Angeles
A1 Nijziel, Marten R
A1 Popov, Viola M
A1 Collado, Rosa
A1 Slavutsky, Irma
A1 Itchaki, Gilad
A1 Ringelstein, Shimrit
A1 Goldschmidt, Neta
A1 Perry, Chava
A1 Levi, Shai
A1 Polliack, Aaron
A1 Ghia, Paolo
AB In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a "real-world" setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a "real-world" setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.
YR 2020
FD 2020-03-14
LK https://hdl.handle.net/10668/26637
UL https://hdl.handle.net/10668/26637
LA en
DS RISalud
RD Apr 8, 2025