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
Por:
Cuneo, A, Follows, G, Rigolin, GM, Piciocchi, A, Tedeschi, A, Trentin, L, Perez, AM, Coscia, M, Laurenti, L, Musuraca, G, Farina, L, Delgado, AR, Orlandi, EM, Galieni, P, Mauro, FR, Visco, C, Amendola, A, Billio, A, Marasca, R, Chiarenza, A, Meneghini, V, Ilariucci, F, Marchetti, M, Molica, S, Re, F, Gaidano, G, Gonzalez, M, Forconi, F, Ciolli, S, Cortelezzi, A, Montillo, M, Smolej, L, Schuh, A, Eyre, TA, Kennedy, B, Bowles, KM, Vignetti, M, de la Seam, J, Moreno, C, Foa, R, Ghia, P, GIMEMA, European Res Initiative CLL ERIC, UK CLL Forum
Publicada:
3 jul 2018
Resumen:
We performed an observational study on the efficacy of ben-damustine 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)
Filiaciones:
Cuneo, A:
St Anna Univ Hosp, Dept Med Sci, Hematol, Ferrara, Italy
Follows, G:
Cambridge Univ Hosp NHS Fdn Trust, UK CLL Forum, Cambridge, England
Rigolin, GM:
St Anna Univ Hosp, Dept Med Sci, Hematol, Ferrara, Italy
Piciocchi, A:
Italian Grp Adult Hematol Dis GIMEMA, Data Ctr & Hlth Outcomes Res Unit, Rome, Italy
Tedeschi, A:
ASST Grande Osped Metropolitano Niguarda, Niguarda Canc Ctr, Hematol, Milan, Italy
Trentin, L:
Univ Padua, Dept Med, Hematol & Clin Immunol, Padua, Italy
Perez, AM:
Hosp Costa Sol, Malaga, Spain
Coscia, M:
Univ Turin, Citta Salute & Sci, Hematol Unit, Turin, Italy
Laurenti, L:
Univ Cattolica Sacro Cuore, Hematol, Policlin A Gemelli, Rome, Italy
Musuraca, G:
Ist Sci Romagnolo Studio & Cura Tumori IRST IRCCS, Hematol Unit, Meldola, Italy
Farina, L:
Fdn IRCCS Ist Nazl Tumori, Hematol Dept, Milan, Italy
Delgado, AR:
IDIBAPS, Dept Hematol, Hosp Clin, Barcelona, Spain
Orlandi, EM:
Fdn IRCCS Policlin San Matteo, Hematol Unit, Pavia, Italy
Galieni, P:
Osped C & G Mazzoni, Hematol & Cellular Therapy, Ascoli Piceno, Italy
Mauro, FR:
Sapienza Univ, Hematol, Dept Biomed Sci & Hematol, Rome, Italy
Visco, C:
San Bortolo Hosp, Hematol, Vicenza, Italy
Amendola, A:
San Carlo Hosp, Hematol, Potenza, Italy
Billio, A:
Azienda Sanit Alto Adige, San Maurizio Hosp, Hematol & Transplant Unit, Bolzano, Italy
Marasca, R:
Univ Hosp, Hematol Unit, Modena, Italy
Chiarenza, A:
Azienda Univ Osped Policlin Vittorio Emanuele, Hematol Unit, Catania, Italy
Meneghini, V:
Univ Hosp, Dept Cell Therapy & Hematol, Hematol, Verona, Italy
Ilariucci, F:
Arcispedale S Maria Nuova, Hematol Unit, Reggio Emilia, Italy
Marchetti, M:
Cardinal Massaia Hosp, Oncol Unit, Asti, Italy
Molica, S:
Azienda Osped Pugliese Ciaccio, A Pugliese Hosp, Hematol Unit, Catanzaro, Italy
Re, F:
Univ Hosp, Hematol, Parma, Italy
Gaidano, G:
Univ Piemonte Orientale Amedeo Avogadro, DIMECS, Hematol, Novara, Italy
Univ Piemonte Orientale Amedeo Avogadro, Dipartimento Oncol, Novara, Italy
Gonzalez, M:
Univ Hosp IBSAL, Hematol, Salamanca, Spain
CIBERONC, Salamanca, Spain
Forconi, F:
Univ Hosp Natl Hlth Serv Trust, Haematol Dept, Southampton, Hants, England
Ciolli, S:
Careggi Hosp, Hematol Unit, Florence, Italy
Cortelezzi, A:
Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Hematol Unit, Milan, Italy
Montillo, M:
ASST Grande Osped Metropolitano Niguarda, Niguarda Canc Ctr, Hematol, Milan, Italy
Smolej, L:
Univ Hosp, Dept Hematol, Hradec Kralove, Czech Republic
Schuh, A:
Oxford Univ Hosp NHS Fdn Trust, UK CLL Forum, Oxford, England
Eyre, TA:
Oxford Univ Hosp NHS Fdn Trust, Oxford, England
Kennedy, B:
Univ Hosp Leicester NHS Trust, Leicester, Leics, England
Bowles, KM:
Norwich Med Sch, Norwich, Norfolk, England
Vignetti, M:
Italian Grp Adult Hematol Dis GIMEMA, Data Ctr & Hlth Outcomes Res Unit, Rome, Italy
de la Seam, J:
Hosp Univ 12 Octubre, Hematol Unit, Madrid, Spain
Moreno, C:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Foa, R:
Sapienza Univ, Hematol, Dept Biomed Sci & Hematol, Rome, Italy
Ghia, P:
IRCCS San Raffaele Sci Inst, Div Expt Oncol, Milan, Italy
Univ Vita Salute San Raffaele, Milan, Italy
Gold, Green Published
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