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
Cuneo, Antonio (St. Anna University Hospital)
Follows, George (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Rigolin, Gian Matteo (St. Anna University Hospital)
Piciocchi, Alfonso (Fondazione Gruppo Italiano Malattie Ematologiche dell'Adulto)
Tedeschi, Alessandra (Niguarda Cancer Center)
Trentin, Livio (University of Padua)
Perez, Angeles Medina (Hospital Costa del Sol (Marbella))
Coscia, Marta (University of Turin)
Laurenti, Luca (Fondazione Policlinico "A. Gemelli" IRCCS)
Musuraca, Gerardo (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST))
Farina, Lucia (Fondazione IRCCS Istituto Nazionale dei Tumori)
Delgado, Alfredo Rivas (Hospital Clínic i Provincial de Barcelona)
Orlandi, Ester Maria (Fondazione IRCCS Policlinico San Matteo (Itàlia))
Galieni, Piero (Ospedale C. e G. Mazzoni)
Mauro, Francesca Romana (Università degli Studi di Roma "La Sapienza")
Visco, Carlo (San Bortolo Hospital)
Amendola, Angela (San Carlo Hospital)
Billio, Atto (Azienda Sanitaria dell'Alto Adige)
Marasca, Roberto (University of Modena and Reggio Emilia)
Chiarenza, Annalisa (Azienda Universitaria Ospedaliera Policlinico Vittorio Emanuele)
Meneghini, Vittorio (University Hospital)
Ilariucci, Fiorella (Arcispedale Santa Maria Nuova IRCCS (Reggio Emilia, Itàlia))
Marchetti, Monia (Cardinal Massaia Hospital (Asti, Itàlia))
Molica, Stefano (Azienda Ospedaliera Pugliese Ciaccio)
Re, Francesca (University Hospital)
Gaidano, Gianluca (Università del Piemonte Orientale Amedeo Avogadro)
González, Marcos (Centro Nacional de Investigaciones Oncológicas)
Forconi, Francesco (University Hospital National Health Service Trust)
Ciolli, Stefania (Careggi University Hospital (Florència, Itàlia))
Cortelezzi, Agostino (University of Milan)
Montillo, Marco (Niguarda Cancer Center)
Smolej, Lukas (University Hospital)
Schuh, Anna (Oxford University Hospitals NHS Foundation Trust)
Eyre, Toby A. (Oxford University Hospitals NHS Foundation Trust)
Kennedy, Ben (University Hospitals of Leicester NHS Trust)
Bowles, Kris M. (Norwich Medical School)
Vignetti, Marco (Fondazione Gruppo Italiano Malattie Ematologiche dell'Adulto)
De La Serna, Javier (Hospital 12 de Octubre (Madrid))
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau)
Foà, Robin (Università degli Studi di Roma "La Sapienza")
Ghia, Paolo (IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University)
Universitat Autònoma de Barcelona

Data:	2018
Resum:	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).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Haematologica, Vol. 103 Núm. 7 (march 2018) , p. 1209-1217, ISSN 1592-8721

DOI: 10.3324/haematol.2018.189837
PMID: 29674504

9 p, 698.5 KB

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