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Observational Study
. 2022 Sep;116(3):381-392.
doi: 10.1007/s12185-022-03367-z. Epub 2022 May 13.

IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice

Juan-Manuel Sancho  1 , Ana Marín-Niebla  2 , Silvia Fernández  3 , Francisco-Javier Capote  4 , Carolina Cañigral  5 , Carlos Grande  6 , Eva Donato  7 , Izaskun Zeberio  8 , Jose-Manuel Puerta  9 , Alfredo Rivas  10 , Elena Pérez-Ceballos  11 , Ana Vale  12 , Alejandro Martín García-Sancho  13 , Antonio Salar  14 , Eva González-Barca  15 , Anabel Teruel  16 , Carmen Pastoriza  17 , Diego Conde-Royo  18 , Joaquín Sánchez-García  19 , Cristina Barrenetxea  20 , Reyes Arranz  21 , José-Ángel Hernández-Rivas  22 , María-José Ramírez  23 , Aroa Jiménez  24 , Eva Rubio-Azpeitia  24
Affiliations
Observational Study

IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice

Juan-Manuel Sancho et al. Int J Hematol. 2022 Sep.

Abstract

This retrospective study evaluated 66 patients diagnosed with relapsed and/or refractory mantle cell lymphoma (R/R MCL) treated with ibrutinib in Spain in routine clinical practice. At diagnosis, patients had a median age of 64.5 years, 63.6% presented with intermediate/high sMIPI (simplified prognostic index for advanced-stage mantle cell lymphoma), 24.5% had the blastoid variant, and 55.6% had a Ki67 > 30%. Patients had received a median of 2 prior lines of therapy (range 1-2; min-max 1-7). Overall response rate was 63.5%, with 38.1% of patients achieving complete response (CR). With a median duration of ibrutinib exposure of 10.7 months (range 5.2-19.6; min-max 0.3-36), the median progression-free survival (PFS) and overall survival (OS) were 20 months [95% confidence interval (CI) 8.8-31.1] and 32 months (95% CI 22.6-41.3), respectively, and were not reached in patients achieving CR. No grade ≥ 3 cardiovascular toxicity or bleeding was reported. This study supports that treatment with ibrutinib leads to high response rates and favorable survival outcomes in patients with R/R MCL.

Keywords: Clinical practice; Ibrutinib; Mantle-cell lymphoma; Real-world evidence; Relapsed/refractory.

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Conflict of interest statement

JM Sancho: speaker fees for educational events from Roche, Janssen, Gilead-Kite, BMS-Celgene, Novartis, Takeda and Servier; Advisory boards for Roche, Janssen, Gilead-Kite, BMS-Celgene, Novartis, Incyte, Beigene and Lilly. A Marín Niebla: honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen, Takeda, Kiowa Kirin, Gilead, Lilly, Abbvie; Support for attending meetings and/or travel from Janssen, Takeda, Kiowa Kirin. FJ Capote: honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen, Takeda, Roche, BMS, Celgene, Amgen; Support for attending meetings and/or travel from Janssen, Takeda, Roche, BMS, Celgene, Amgen; advisory board for Janssen, Takeda, Roche, BMS, Celgene, Amgen; C Grande: advisory boards, symposia and attending conferences from Janssen. I Zeberio: honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from BMS, Gilead, Novartis, Roche; Support for attending meetings and/or travel from BMS, Gilead, Janssen, Novartis, Roche, Incyte; advisory boards for BMS, Gilead, Janssen, Novartis, Roche, Incyte. JM Puerta: support for attending meetings from Novartis, Roche, Abbvie, Janssen, Astrazeneca, Gilead; Advisory boards for Roche, Novartis, Janssen, BMS; Financial support for research from Novartis, Roche, Pfizer. A Rivas: support for attending meetings and travel from Janssen, Kite and Takeda. E Pérez Ceballos: advisory boards for Takeda, Janssen, Incyte; honoraria for presentations from Takeda and Roche. A Vale: honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Janssen, Astrazeneca. A Martín García-Sancho: consulting fees from Roche, Celgene/BMS, Morphosys, Kyowa Kirin, Clinigen, Eusa Pharma, Novartis, Gilead, Servier, Incyte; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Celgene/BMS, Janssen, Servier, Gilead, Takeda, EUSAPharma; Payment for expert testimony from Gilead, Roche; Support for attending meetings and/or travel from Roche, Servier, Celgene, Janssen, Kern Pharma. A Salar: Grants or contracts from Gilead; Consulting fees from Incyte and Beigene; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, EUSA Pharma, Janssen, BMS/Celgene. E González Barca: Consultancy from Janssen, Abbvie, Gilead, Kiowa, EUSA Pharma, Incyte, Lilly, Beigene, Novartis; Speaker fees: Janssen, Abbvie, Takeda, Roche, EUSA Pharma, Incyte; Travel grants: Janssen, Abbvie, Roche, EUSA Pharma. C. Pastoriza: support for attending meetings and/or travel from Janssen, Amgen and Abbvie. D. Conde-Royo: speaker fees from Janssen, Abbvie, Takeda. J Sánchez-García: honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Janssen, Abbvie, Pfizer. C Barrenetxea: honoraria for lecture fees from Janssen, Alexion and Takeda, and educational events from GSK. R Arranz: advisory Boards for Takeda and EUSA Pharma. JA Hernández-Rivas: grants or contracts from BMS-Celgene, Sanofi; Honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen, Roche, Abbvie, AstraZeneca, Lilly, Gilead, BMS-Celgene, Amgen, Takeda; advisory board for Janssen, Roche, Abbvie, AstraZeneca, Beigene, Lilly, Gilead, BMS-Celgene, Amgen, Takeda, Jazz Pharmaceuticals, Rovi. A Jiménez and E Rubio-Azpeitia are employees of Janssen. S Fernández, C Cañigral, E Donato, A Teruel and MJ Ramirez have nothing to disclosure.

Figures

Fig. 1
Fig. 1
IBRORS-MCL retrospective cohort study flowchart
Fig. 2
Fig. 2
Progression-free survival (a) and overall survival (b) of R/R MCL patients treated with ibrutinib. R/R MCL relapsed and/or refractory mantle cell lymphoma
Fig. 3
Fig. 3
Progression-free survival (a) and overall survival (b) of R/R MCL patients treated with ibrutinib according to CR vs PR. R/R MCL relapsed and/or refractory mantle cell lymphoma, CR complete response, NE not estimable, NR not reached, PR partial response
See this image and copyright information in PMC

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