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Haematologica. 2018 Jul;103(7):1209-1217. doi: 10.3324/haematol.2018.189837. Epub 2018 Apr 19.

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.

Author information

1
Hematology, Department of Medical Sciences, St. Anna University Hospital, Ferrara, Italy cut@unife.it.
2
UK CLL Forum, Cambridge University Hospitals NHS Foundation Trust, UK.
3
Hematology, Department of Medical Sciences, St. Anna University Hospital, Ferrara, Italy.
4
Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
5
Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
6
Hematology and Clinical Immunology, Department of Medicine, University of Padua, Italy.
7
Hospital Costa del Sol, Marbella, Málaga, Spain.
8
Hematology Unit, Città della Salute e della Scienza, University of Turin, Italy.
9
Hematology, Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, Rome, Italy.
10
Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
11
Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
12
Department of Hematology, Hospital Clinic, Institut Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
13
Hematology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
14
Hematology and Cellular Therapy, "Ospedale C. e G. Mazzoni", Ascoli Piceno, Italy.
15
Hematology, Department of Biomedical Sciences and Hematology, "Sapienza" University, Rome, Italy.
16
Hematology, San Bortolo Hospital, Vicenza, Italy.
17
Hematology, San Carlo Hospital, Potenza, Italy.
18
Hematology and Transplant Unit, San Maurizio Hospital, Azienda Sanitaria dell'Alto Adige, Bolzano, Italy.
19
Hematology Unit, University Hospital, Modena, Italy.
20
Hematology Unit, Azienda Universitaria Ospedaliera Policlinico Vittorio Emanuele, Catania, Italy.
21
Hematology, Department of Cell Therapy and Hematology, University Hospital, Verona, Italy.
22
Hematology Unit, Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
23
Oncology Unit, Cardinal Massaia Hospital, Asti, Italy.
24
Hematology Unit, A. Pugliese Hospital, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, Italy.
25
Hematology, University Hospital, Parma, Italy.
26
Hematology, DIMECS e Dipartimento Oncologico, Università del Piemonte Orientale Amedeo Avogadro, Novara, Italy.
27
Hematology, University Hospital-IBSAL and CIBERONC, Salamanca, Spain.
28
Haematology Department, University Hospital National Health Service Trust, Southampton, UK.
29
Hematology Unit, Careggi Hospital, Florence, Italy.
30
Hematology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy.
31
Department of Hematology, University Hospital, Hradec Kralove, Czech Republic.
32
UK CLL Forum, Oxford University Hospitals NHS Foundation Trust, UK.
33
Oxford University Hospitals NHS Foundation Trust, UK.
34
University Hospitals of Leicester NHS Trust, UK.
35
Norwich Medical School, UK.
36
Hematology Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.
37
Hospital de la Santa Creu i Sant Pau, Barcellona, Spain.
38
Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy.

Abstract

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.

PMID:
29674504
PMCID:
PMC6029555
DOI:
10.3324/haematol.2018.189837
[Indexed for MEDLINE]
Free PMC Article

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