Five year experience in ibrutinib therapy for relapsed and refractory mantle cell lymphoma in real world Russian clinical practice
- Authors: Vorobyev V.I.1, Gemdzhian E.G.2, Fedorova L.V.3, Mikhailova N.B.3, Ilyasov R.K.4, Kaleikina L.P.5, Trubyakova O.S.6, Kaplanov K.D.1, Melnichenko E.V.7, Martynova E.V.8, Yakovleva E.P.9, Li O.Y.10, Tarasenko E.V.11, Chumakova E.P.12, Bulieva N.B.13, Nesterova E.S.2, Margolin O.V.2, Zherebtsova V.A.1, Butaev L.S.1, Ptushkin V.V.1
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Affiliations:
- Botkin City Clinical Hospital
- National Research Center for Hematology
- Pavlov First Saint Petersburg State Medical University
- Efetov Crimean Republican Oncological Clinical Dispensary
- Republican Oncological Dispensary
- Vladimir City Clinical Hospital №5
- Novosibirsk Hematology Center
- Krasnoyarsk Regional Clinical Hospital
- Regional Clinical Hospital
- Sakhalin Regional Clinical Hospital
- Pirogov City hospital №1
- Perm Regional Clinical Hospital
- Regional Clinical Hospital of the Kaliningrad Region
- Issue: Vol 93, No 7 (2021)
- Pages: 770-777
- Section: Original articles
- URL: https://journals.rcsi.science/0040-3660/article/view/76311
- DOI: https://doi.org/10.26442/00403660.2021.07.200930
- ID: 76311
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Abstract
Background. Mantle cell lymphoma (MCL) is a rare and clinically aggressive lymphoma subtype. Current approaches have greatly improved patients’ outcomes, but relapse is inevitable. In phase II–III clinical trials, ibrutinib has shown significant activity in patients with relapsed or refractory (R/R) MCL.
Aim. To assess efficacy and toxicity of ibrutinib monotherapy in patients with R/R MCL in routine practice outside of clinical trials.
Materials and methods. The study enrolled patients with confirmed R/R MCL who had received at least one line of previous chemotherapy. ECOG 2–4, cytopenia, infectious complications, hemorrhagic syndrome were not exclusion criteria. Patients received daily oral ibrutinib 560 mg until progression or unacceptable toxicity.
Results. From May 2015 to September 2020 ibrutinib therapy was started in 106 patients with R/R MCL in 16 regions of Russia. The median age was 66 years; ECOG>2 – 18%, blastoid variant (or Ki67>40% or WBC>50×109/l) – 43%. The median number of previous treatment lines was 2 (1–11). The ORR was 78.4% (CRR – 27.4%). The median PFS was 13.6 months and OS 23.2 months. In the blastoid group the median PFS was 4.4 months vs 36.5 months in the alternative group (p<0.001), the median OS – 9.0 vs 41.0 (p=0.001). The median OS of patients after progression on ibrutinib was 3.2 months.
The common complications are hemorrhages (63%), diarrhea (62%), myalgia and muscle cramps (60%), infections (31%), skin and nail toxicity – 15%, arrhythmia – 8%. None of recipients had to completely discontinue ibrutinib therapy due to complications.
Conclusion. Ibrutinib is effective and well tolerated in routine practice of R/R MCL treatment and our results are consistent with international clinical trials. The favorable toxicity profile and the high response rate made it possible to prescribe ibrutinib in severe somatic status, cytopenia, and even in the presence of infectious complications.
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##article.viewOnOriginalSite##About the authors
Vladimir I. Vorobyev
Botkin City Clinical Hospital
Author for correspondence.
Email: morela@mail.ru
ORCID iD: 0000-0002-2692-8961
канд. мед. наук, врач-гематолог, зав. отд-нием трансплантации костного мозга и гемопоэтических стволовых клеток №56
Russian Federation, MoscowEduard G. Gemdzhian
National Research Center for Hematology
Email: morela@mail.ru
ORCID iD: 0000-0002-8357-977X
ст. науч. сотр. лаб. биостатистики
Russian Federation, MoscowLiudmila V. Fedorova
Pavlov First Saint Petersburg State Medical University
Email: morela@mail.ru
ORCID iD: 0000-0002-3275-219X
врач-гематолог отд. клинической онкологии НИИ детской онкологии, гематологии и трансплантологии им. Р.М. Горбачевой
Russian Federation, Saint PetersburgNatalia B. Mikhailova
Pavlov First Saint Petersburg State Medical University
Email: morela@mail.ru
ORCID iD: 0000-0002-8153-8122
канд. мед. наук, врач-гематолог, рук. отд. клинической онкологии НИИ детской онкологии, гематологии и трансплантологии им. Р.М. Горбачевой
Russian Federation, Saint PetersburgRidvan K. Ilyasov
Efetov Crimean Republican Oncological Clinical Dispensary
Email: morela@mail.ru
ORCID iD: 0000-0003-0626-697X
врач-гематолог, зав. отд-нием гематологии
Russian Federation, SimferopolLiliia P. Kaleikina
Republican Oncological Dispensary
Email: morela@mail.ru
врач-онколог
Russian Federation, SaranskOlga S. Trubyakova
Vladimir City Clinical Hospital №5
Email: morela@mail.ru
врач-гематолог
Russian Federation, VladimirKamil D. Kaplanov
Botkin City Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0001-6574-0518
канд. мед. наук, врач-гематолог, зав. отд-нием гематологии №11
Russian Federation, MoscowElena V. Melnichenko
Novosibirsk Hematology Center
Email: morela@mail.ru
врач-гематолог
Russian Federation, NovosibirskElena V. Martynova
Krasnoyarsk Regional Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-7004-7432
врач-гематолог отд-ния гематологии
Russian Federation, KrasnoyarskElena P. Yakovleva
Regional Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-8284-7832
врач-гематолог
Russian Federation, BarnaulOlga Yu. Li
Sakhalin Regional Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-1237-6107
врач-гематолог, зав. отд-нием гематологии
Russian Federation, Yuzhno-SakhalinskElena V. Tarasenko
Pirogov City hospital №1
Email: morela@mail.ru
ORCID iD: 0000-0002-1356-736X
врач-гематолог
Russian Federation, SevastopolElena P. Chumakova
Perm Regional Clinical Hospital
Email: morela@mail.ru
врач-гематолог, зав. отд-нием гематологии
Russian Federation, PermNatalia B. Bulieva
Regional Clinical Hospital of the Kaliningrad Region
Email: morela@mail.ru
ORCID iD: 0000-0002-4824-9484
врач-гематолог, зав. гематологическим отд-нием
Russian Federation, KaliningradEkaterina S. Nesterova
National Research Center for Hematology
Email: morela@mail.ru
ORCID iD: 0000-0002-6035-9547
канд. мед. наук, врач-гематолог отд-ния интенсивной высокодозной химиотерапии гемобластозов с круглосуточным и дневным стационаром
Russian Federation, MoscowOleg V. Margolin
National Research Center for Hematology
Email: morela@mail.ru
ORCID iD: 0000-0002-6211-5677
канд. мед. наук, врач-гематолог отд-ния интенсивной высокодозной химиотерапии гемобластозов с круглосуточным и дневным стационаром
Russian Federation, MoscowVera A. Zherebtsova
Botkin City Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-3052-269X
канд. мед. наук, врач-гематолог отд-ния трансплантации костного мозга и гемопоэтических стволовых клеток №56
Russian Federation, MoscowLev S. Butaev
Botkin City Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-1060-3804
врач-гематолог отд-ния трансплантации костного мозга и гемопоэтических стволовых клеток №56
Russian Federation, MoscowVadim V. Ptushkin
Botkin City Clinical Hospital
Email: morela@mail.ru
ORCID iD: 0000-0002-9368-6050
д-р мед. наук, врач-гематолог, зам. глав. врача по медицинской части (гематологии)
Russian Federation, MoscowReferences
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