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Comparative Study
. 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

Antonio Cuneo  1 , George Follows  2 , Gian Matteo Rigolin  3 , Alfonso Piciocchi  4 , Alessandra Tedeschi  5 , Livio Trentin  6 , Angeles Medina Perez  7 , Marta Coscia  8 , Luca Laurenti  9 , Gerardo Musuraca  10 , Lucia Farina  11 , Alfredo Rivas Delgado  12 , Ester Maria Orlandi  13 , Piero Galieni  14 , Francesca Romana Mauro  15 , Carlo Visco  16 , Angela Amendola  17 , Atto Billio  18 , Roberto Marasca  19 , Annalisa Chiarenza  20 , Vittorio Meneghini  21 , Fiorella Ilariucci  22 , Monia Marchetti  23 , Stefano Molica  24 , Francesca Re  25 , Gianluca Gaidano  26 , Marcos Gonzalez  27 , Francesco Forconi  28 , Stefania Ciolli  29 , Agostino Cortelezzi  30 , Marco Montillo  5 , Lukas Smolej  31 , Anna Schuh  32 , Toby A Eyre  33 , Ben Kennedy  34 , Kris M Bowles  35 , Marco Vignetti  4 , Javier de la Serna  36 , Carol Moreno  37 , Robin Foà  15 , Paolo Ghia  38 ; GIMEMA, European Research Initiative on CLL (ERIC) and UK CLL forum
Affiliations
Comparative Study

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

Antonio Cuneo et al. Haematologica. 2018 Jul.

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.

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Figures

Figure 1.
Figure 1.
Progression-free survival (PFS) of patients treated with bendamustine and rituximab (BR) second-line. PFS of all 237 patients (A), by fluorescence in situ hybridization (B), IGHV status (C), and interval between first-line and second-line treatments (D).
Figure 2.
Figure 2.
Overall survival (OS) of patients treated with bendamustine and rituximab (BR) second-line. OS of all 237 patients (A), by stage (B) and by response to BR (C).
Figure 3.
Figure 3.
Indirect comparison of overall survival in 39 patients treated second-line with ibrutinib and in 92 patients treated with bendamustine and rituximab (Benda+RTX). All patients had intact 17p and received chemoimmunotherapy as front-line therapy.
See this image and copyright information in PMC

Comment in

References

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