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Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study

Authors :
Cuneo, Antonio
Follows, George
Rigolin, Gian Matteo
Piciocchi, Alfonso
Tedeschi, Alessandra
Trentin, Livio
Perez, Angeles Medina
Coscia, Marta
Laurenti, Luca
Musuraca, Gerardo
Farina, Lucia
Delgado, Alfredo Rivas
Orlandi, Ester Maria
Galieni, Piero
Mauro, Francesca Romana
Visco, Carlo
Amendola, Angela
Billio, Atto
Marasca, Roberto
Chiarenza, Annalisa
Meneghini, Vittorio
Ilariucci, Fiorella
Marchetti, Monia
Molica, Stefano
Re, Francesca
Gaidano, Gianluca
Gonzalez, Marcos
Forconi, Francesco
Ciolli, Stefania
Cortelezzi, Agostino
Montillo, Marco
Smolej, Lukas
Schuh, Anna
Eyre, Toby A
Kennedy, Ben
Bowles, Kris M
Vignetti, Marco
de la Serna, Javier
Moreno, Carol
Foà, Robin
Ghia, Paolo
GIMEMA, European Research Initiative on CLL (ERIC) and UK CLL forum
Cuneo, Antonio
Follows, George
Rigolin, Gian Matteo
Piciocchi, Alfonso
Tedeschi, Alessandra
Trentin, Livio
Perez, Angeles Medina
Coscia, Marta
Laurenti, Luca
Musuraca, Gerardo
Farina, Lucia
Delgado, Alfredo Riva
Orlandi, Ester Maria
Galieni, Piero
Mauro, Francesca Romana
Visco, Carlo
Amendola, Angela
Billio, Atto
Marasca, Roberto
Chiarenza, Annalisa
Meneghini, Vittorio
Ilariucci, Fiorella
Marchetti, Monia
Molica, Stefano
Re, Francesca
Gaidano, Gianluca
Gonzalez, Marco
Forconi, Francesco
Ciolli, Stefania
Cortelezzi, Agostino
Montillo, Marco
Smolej, Luka
Schuh, Anna
Eyre, Toby A.
Kennedy, Ben
Bowles, Kris M.
Vignetti, Marco
De La Serna, Javier
Moreno, Carol
Foà, Robin
Ghia, Paolo
Publication Year :
2018

Abstract

We performed an observational study on the efficacy of bendamustine and rituximab (BR) as first salvage regimen in chronic lymphocytic leukemia (CLL). In an intention-to-treat analysis including 237 patients, the median progression-free survival (PFS) was 25 months. The presence of del (17p), unmutated IGHV and advanced stage were associated with a shorter PFS at multivariate analysis. The median time-to-next treatment was 31.3 months. Front-line treatment with a chemoimmunotherapy regimen was the only predictive factor for a shorter time to next treatment at multivariate analysis. The median overall survival (OS) was 74.5 months. Advanced disease stage (i.e. Rai stage III-IV or Binet stage C) and resistant disease were the only parameters significantly associated with a shorter OS. Grade 3-5 infections were recorded in 6.3% of patients. A matched-adjusted indirect comparison with ibrutinib given second-line within Named Patient Programs in the United Kingdom and in Italy was carried out with OS as objective end point. When restricting the analysis to patients with intact 17p who had received chemoimmunotherapy in first line, there was no difference in OS between patients treated with ibrutinib (63% alive at 36 months) and patients treated with BR (74.4% alive at 36 months). BR is an efficacious first salvage regimen in CLL in a real-life population, including the elderly and unfit patients. BR and ibrutinib may be equally effective in terms of OS when used as first salvage treatment in patients without 17p deletion. (Registered at clinicaltrials.gov identifier: 02491398).

Details

Language :
English
Database :
OpenAIRE
Accession number :
edsair.doi.dedup.....d24b88f44e2262e2f6fabc65579c98fe