Риск-адаптированная интенсивная индукционная терапия, аутологичная трансплантация стволовых кроветворных клеток и поддерживающая терапия ритуксимабом позволяют достигнуть высоких показателей 7-летней выживаемости у больных лимфомой из клеток мантийной зон
Риск-адаптированная интенсивная индукционная терапия, аутологичная трансплантация стволовых кроветворных клеток и поддерживающая терапия ритуксимабом позволяют достигнуть высоких показателей 7-летней выживаемости у больных лимфомой из клеток мантийной зон
Воробьев В.И., Гемджян Э.Г., Дубровин Е.И. и др. Риск-адаптированная интенсивная индукционная терапия, аутологичная трансплантация стволовых кроветворных клеток и поддерживающая терапия ритуксимабом позволяют достигнуть высоких показателей 7-летней выживаемости у больных лимфомой из клеток мантийной зоны. Терапевтический архив. 2019; 91 (7): 41–51. DOI: 10.26442/00403660.2019.07.000322
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Аннотация
Лимфома из клеток мантийной зоны (ЛКМЗ) является агрессивной В-клеточной лимфомой, диагностируемой преимущественно у мужчин старшей возрастной группы. Применение R-CHOP-подобных схем позволяет у большинства больных достигнуть общий ответ (ОО), но медиана общей выживаемости (ОВ) составляет всего 3–4 года. Добавление к терапии высоких доз цитарабина и аутологичной трансплантации стволовых кроветворных клеток (аутоТСКК) увеличивают частоту достижения полных ремиссий (ПР) и продолжительность жизни, но только у соматически сохранных пациентов. Основываясь на высокой эффективности и безопасности гемцитабин- и оксалиплатинсодержащих схем в терапии рецидивов ЛКМЗ, мы предложили альтернативный курс терапии первой линии R-GIDIOX для пациентов, не являющихся кандидатами для применения высоких доз цитарабина и метотрексата (R-HD-MTX-AraC).
Цель. Оценка эффективности и токсичности схем альтернирующей терапии R-DA-EPOCH/R-HD-MTX-AraC или R-DA-EPOCH/ R-GIDIOX, аутоТСКК и поддерживающей терапии ритуксимабом у вновь заболевших больных ЛКМЗ.
Материалы и методы. В проспективное исследование с апреля 2008 по сентябрь 2013 г. включено 47 пациентов из 6 центров. Медиана возраста – 55 (29–64) лет, отношение мужчины/женщины – 76%/24%. Во всех случаях диагноз подтвержден выявлением t(11;14)(q13;q32); ECOG 0–3; распределение по MIPIb: 28% – низкий, 33% – промежуточный и 39% – высокий риск. В зависимости от переносимости первого курса терапии R-EPOCH пациенты рекрутировались в ветвь более интенсивной терапии R-DA-EPOCH/ R-HD-MTX-AraC или менее интенсивной терапии R-DA-EPOCH/R-GIDIOX. При отсутствии гематологической токсичности 4-й степени более 3 сут, серьезных инфекционных осложнений и признаков почечной недостаточности пациентам проводился курс R-HD-Met-AraC (R 375 мг/м2 в день 0, метотрексат 1000 мг/м2/24 ч в день 1, цитарабин 3000 мг/м2 2 раза в день в дни 2–3). При развитии одного из вышеперечисленных осложнений за первым курсом R-EPOCH следовал курс R-GIDIOX (R 375 мг/м2 в день 0, гемцитабин 800 мг/м2 в дни 1 и 4, ифосфамид 1000 мг/м2 в дни 1–5, дексаметазон 10 мг/м2 внутривенно в дни 1–5, иринотекан 100 мг/м2 в день 3, оксалиплатин 120 мг/м2 в день 2). Далее курсы полихимиотерапии (ПХТ) чередовались в каждом рукаве протокола. В зависимости от времени достижения ПР проводилось от 6 до 8 курсов терапии. При достижении частичной ремиссии (ЧР) и более выполнялась аутоТСКК (BEAM-R). Затем проводилась поддерживающая терапия ритуксимабом в дозе 375 мг/м2 1 раз в 3 мес в течение 3 лет.
Результаты. Включено 29 из 47 пациентов в группу R-HD-MTX-AraC (медиана возраста 50 лет; MIPIb: 35,7% – низкий, 28,6% – промежуточный, 35,7% – высокий риск) и 18 из 47 – в группу R-GIDIOX (медиана возраста 60 лет; MIPIb: 16,7% – низкий, 38,9% – промежуточный, 44,4% – высокий риск). ПР в группе R-HD-MTX-AraC достигнута у 96,5%. Общий ответ и ПР в рукаве R-GIDIOX достигнуты в 94,4 и 77,7% соответственно. Лейкопения 4-й степени развилась после 74,1% курсов R-GIDIOX. Семилетняя ОВ и бессобытийная выживаемость (БСВ) в группе R-HD-MTX-AraC составили 76 и 57% соответственно, а в группе R-GIDIOX – 59 и 44% (при медиане наблюдения 76 мес). Сравниваемые группы статистически значимо не различались как по БСВ (p=0,47), так и по ОВ (p=0,36).
Заключение. Применение риск-адаптированной стратегии позволило в 95,7% случаев достигнуть ответа на терапию, выполнить аутоТСКК и начать поддерживающую терапию ритуксимабом. Никому из больных не потребовалось преждевременного прекращения терапии из-за неприемлемой токсичности. Выполнение аутоТСКК и поддерживающей терапии ритуксимабом позволило частично нивелировать различия в интенсивности индукционной ПХТ и получить сопоставимые результаты лечения в обеих ветвях терапии.
Ключевые слова: лимфома из клеток мантийной зоны, высокие дозы цитарабина, аутологичная трансплантация, поддерживающая терапия ритуксимабом, гемцитабин и оксалиплатин.
Mantle cell lymphoma (MCL) is aggressive B-cell neoplasm diagnosed predominantly among older men. R-CHOP-like regimens allow to achieve high response rate, but the overall survival (OS) are disappointingly short – 3–4 years. An addition of high-dose cytarabine to the upfront therapy and autoSCT significantly improved outcomes but remain feasible largely for medically fit patients. Based on the activity and good tolerance of gemcitabine-oxaliplatin schemes in relapsed and refractory MCL patients, we developed an alternative first-line course for patients who are not eligible for R-HD-MTX-AraC.
Aim. Assess toxicity and efficacy of R-DA-EPOCH/ R-HD-MTX-AraC and R-DA-EPOCH/R-GIDIOX schemes, autoSCT and R-maintenance in untreated MCL patients.
Materials and methods. 47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013. All patients have stage II–V; ECOG 0–3; median age 55 years (29–64); Male/Female 76%/24%. MIPIb: 28% low, 33% intermediate and 39% high risk. Following 1st R-EPOCH patients were assigned to receive either R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen. In the absence of renal failure, hematological toxicity grade 4 more than 3 days and severe infections patients received R-HD-MTX-AraC scheme (R 375 mg/m2 Day 0, Methotrexate 1000 mg/m2/24 hours Day 1, AraC 3000 mg/m2 q 12 hrs Days 2–3). Patients who had at least one of these complications received R-GIDIOX scheme (R 375 mg/m2 day 0, gemcitabine 800 mg/m2 days 1 and 4, ifosfamide 1000 mg/m2 days 1–5, dexamethasone 10 mg/m2 IV days 1–5, irinotecan 100 mg/m2 day 3, oxaliplatin 120 mg/m2 day 2). Subsequently these courses were alternating with R-DA-EPOCH in each arm of the protocol. Depending on the time of achieving CR patients received 6 or 8 courses, unless they progressed on therapy. Those patients who achieved PR/CR/CRu underwent autoSCT (BEAM-R). Post-transplant R-maintenance was administered for 3 years (R – 375 mg/m2 every 3 months).
Results. 29/47 patients were treated on R-HD-MTX-AraC arm (median 50 years; MIPIb: 35.7% low, 28.6% intermediate, 35.7% high risk) and 18/47 patients were on R-GIDIOX arm (median 60 years; MIPIb: 16.7% low, 38.9% intermediate, 44.4% high risk). In R-HD-MTX-AraC arm CR rate was 96.5%. In R-GIDIOX arm OR and CR rates were 94.4% and 77.7% respectively. Main hematological toxicity of R-GIDIOX was leukopenia gr. 4 occurred in 74.1%. With median follow-up of 76 months, the estimated 7-years OS and EFS in R-HD-MTX-AraC arm are 76% and 57% respectively. In R-GIDIOX arm the estimated 7-years OS and EFS are 59% and 44%, respectively. There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms.
Conclusions. The use of a risk-adapted strategy allowed 95.7% of patients achieve PR/CR/CRu, performed autoSCT and begun R-maintenance therapy with rituximab. None of the patients needed a premature discontinuation of therapy because of unacceptable toxicity. The performance of autoSCT and R-maintenance apparently allowed to partially offset differences in the intensity of induction therapy and to maintain comparable results of therapy in both induction arms.
Keywords: mantle cell lymphoma, high dose cytarabine, autoSCT, gemcitabine and oxaliplatin, R-maintenance.
Цель. Оценка эффективности и токсичности схем альтернирующей терапии R-DA-EPOCH/R-HD-MTX-AraC или R-DA-EPOCH/ R-GIDIOX, аутоТСКК и поддерживающей терапии ритуксимабом у вновь заболевших больных ЛКМЗ.
Материалы и методы. В проспективное исследование с апреля 2008 по сентябрь 2013 г. включено 47 пациентов из 6 центров. Медиана возраста – 55 (29–64) лет, отношение мужчины/женщины – 76%/24%. Во всех случаях диагноз подтвержден выявлением t(11;14)(q13;q32); ECOG 0–3; распределение по MIPIb: 28% – низкий, 33% – промежуточный и 39% – высокий риск. В зависимости от переносимости первого курса терапии R-EPOCH пациенты рекрутировались в ветвь более интенсивной терапии R-DA-EPOCH/ R-HD-MTX-AraC или менее интенсивной терапии R-DA-EPOCH/R-GIDIOX. При отсутствии гематологической токсичности 4-й степени более 3 сут, серьезных инфекционных осложнений и признаков почечной недостаточности пациентам проводился курс R-HD-Met-AraC (R 375 мг/м2 в день 0, метотрексат 1000 мг/м2/24 ч в день 1, цитарабин 3000 мг/м2 2 раза в день в дни 2–3). При развитии одного из вышеперечисленных осложнений за первым курсом R-EPOCH следовал курс R-GIDIOX (R 375 мг/м2 в день 0, гемцитабин 800 мг/м2 в дни 1 и 4, ифосфамид 1000 мг/м2 в дни 1–5, дексаметазон 10 мг/м2 внутривенно в дни 1–5, иринотекан 100 мг/м2 в день 3, оксалиплатин 120 мг/м2 в день 2). Далее курсы полихимиотерапии (ПХТ) чередовались в каждом рукаве протокола. В зависимости от времени достижения ПР проводилось от 6 до 8 курсов терапии. При достижении частичной ремиссии (ЧР) и более выполнялась аутоТСКК (BEAM-R). Затем проводилась поддерживающая терапия ритуксимабом в дозе 375 мг/м2 1 раз в 3 мес в течение 3 лет.
Результаты. Включено 29 из 47 пациентов в группу R-HD-MTX-AraC (медиана возраста 50 лет; MIPIb: 35,7% – низкий, 28,6% – промежуточный, 35,7% – высокий риск) и 18 из 47 – в группу R-GIDIOX (медиана возраста 60 лет; MIPIb: 16,7% – низкий, 38,9% – промежуточный, 44,4% – высокий риск). ПР в группе R-HD-MTX-AraC достигнута у 96,5%. Общий ответ и ПР в рукаве R-GIDIOX достигнуты в 94,4 и 77,7% соответственно. Лейкопения 4-й степени развилась после 74,1% курсов R-GIDIOX. Семилетняя ОВ и бессобытийная выживаемость (БСВ) в группе R-HD-MTX-AraC составили 76 и 57% соответственно, а в группе R-GIDIOX – 59 и 44% (при медиане наблюдения 76 мес). Сравниваемые группы статистически значимо не различались как по БСВ (p=0,47), так и по ОВ (p=0,36).
Заключение. Применение риск-адаптированной стратегии позволило в 95,7% случаев достигнуть ответа на терапию, выполнить аутоТСКК и начать поддерживающую терапию ритуксимабом. Никому из больных не потребовалось преждевременного прекращения терапии из-за неприемлемой токсичности. Выполнение аутоТСКК и поддерживающей терапии ритуксимабом позволило частично нивелировать различия в интенсивности индукционной ПХТ и получить сопоставимые результаты лечения в обеих ветвях терапии.
Ключевые слова: лимфома из клеток мантийной зоны, высокие дозы цитарабина, аутологичная трансплантация, поддерживающая терапия ритуксимабом, гемцитабин и оксалиплатин.
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Mantle cell lymphoma (MCL) is aggressive B-cell neoplasm diagnosed predominantly among older men. R-CHOP-like regimens allow to achieve high response rate, but the overall survival (OS) are disappointingly short – 3–4 years. An addition of high-dose cytarabine to the upfront therapy and autoSCT significantly improved outcomes but remain feasible largely for medically fit patients. Based on the activity and good tolerance of gemcitabine-oxaliplatin schemes in relapsed and refractory MCL patients, we developed an alternative first-line course for patients who are not eligible for R-HD-MTX-AraC.
Aim. Assess toxicity and efficacy of R-DA-EPOCH/ R-HD-MTX-AraC and R-DA-EPOCH/R-GIDIOX schemes, autoSCT and R-maintenance in untreated MCL patients.
Materials and methods. 47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013. All patients have stage II–V; ECOG 0–3; median age 55 years (29–64); Male/Female 76%/24%. MIPIb: 28% low, 33% intermediate and 39% high risk. Following 1st R-EPOCH patients were assigned to receive either R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen. In the absence of renal failure, hematological toxicity grade 4 more than 3 days and severe infections patients received R-HD-MTX-AraC scheme (R 375 mg/m2 Day 0, Methotrexate 1000 mg/m2/24 hours Day 1, AraC 3000 mg/m2 q 12 hrs Days 2–3). Patients who had at least one of these complications received R-GIDIOX scheme (R 375 mg/m2 day 0, gemcitabine 800 mg/m2 days 1 and 4, ifosfamide 1000 mg/m2 days 1–5, dexamethasone 10 mg/m2 IV days 1–5, irinotecan 100 mg/m2 day 3, oxaliplatin 120 mg/m2 day 2). Subsequently these courses were alternating with R-DA-EPOCH in each arm of the protocol. Depending on the time of achieving CR patients received 6 or 8 courses, unless they progressed on therapy. Those patients who achieved PR/CR/CRu underwent autoSCT (BEAM-R). Post-transplant R-maintenance was administered for 3 years (R – 375 mg/m2 every 3 months).
Results. 29/47 patients were treated on R-HD-MTX-AraC arm (median 50 years; MIPIb: 35.7% low, 28.6% intermediate, 35.7% high risk) and 18/47 patients were on R-GIDIOX arm (median 60 years; MIPIb: 16.7% low, 38.9% intermediate, 44.4% high risk). In R-HD-MTX-AraC arm CR rate was 96.5%. In R-GIDIOX arm OR and CR rates were 94.4% and 77.7% respectively. Main hematological toxicity of R-GIDIOX was leukopenia gr. 4 occurred in 74.1%. With median follow-up of 76 months, the estimated 7-years OS and EFS in R-HD-MTX-AraC arm are 76% and 57% respectively. In R-GIDIOX arm the estimated 7-years OS and EFS are 59% and 44%, respectively. There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms.
Conclusions. The use of a risk-adapted strategy allowed 95.7% of patients achieve PR/CR/CRu, performed autoSCT and begun R-maintenance therapy with rituximab. None of the patients needed a premature discontinuation of therapy because of unacceptable toxicity. The performance of autoSCT and R-maintenance apparently allowed to partially offset differences in the intensity of induction therapy and to maintain comparable results of therapy in both induction arms.
Keywords: mantle cell lymphoma, high dose cytarabine, autoSCT, gemcitabine and oxaliplatin, R-maintenance.
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20. Hara S, Yokote T, Akioka T, et al. Successful treatment of refractory mantle cell lymphoma with irinotecan. Rinsho Ketsueki. 2005 May;46(5):358-62.
21. Воробьев В.И., Кравченко С.К., Гемджян Э.Г. и др. Мантийноклеточная лимфома: программное лечение первичных больных в возрасте до 65 лет. Клиническая онкогематология. Фундаментальные исследования и клиническая практика. 2013;6(3):274-81 [Vorobyev VI, Kravchenko SK, Gemdzhyan EG, et al. Mantle cell lymphoma: program therapy for untreated patients under 65 years. Clinical oncohematology. Basic research and clinical practice. 2013; 6(3): 274-81 (In Russ.)].
22. Vorobyev VI, Kravchenko SK, Gemdzhian EG, et al. Less Toxic Gemcitabine-Oxaliplatin Based Induction Regimen (R-GIDIOX) Prior to Autologous SCT Produces Outcomes Similar to High-Dose Cytarabine Containing Intensive Induction Regimen in Mantle Cell Lymphoma – a Follow up Report of the Multicenter Study. Blood. 2014;124(21):1726.
23. Воробьев В.И., Лорие Ю.Ю., Мангасарова Я.К. и др. Возможности терапии рецидивов и резистентного течения лимфомы из клеток мантийной зоны. Гематология и трансфузиология. 2011;(1):34-7 [Vorobyev VI, Loriye YuYu, Mangasarova JK, et al. Opportunities of treatment of relapse and resistant mantle cell lymphoma. Hematology and Transfusiology. 2011;(1):34-7 (In Russ.)].
24. Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний под ред. И.В. Поддубной, В.Г. Савченко. М., 2018 [Russian clinical guidelines for the diagnosis and treatment of lymphoproliferative diseases, edited by IV Poddubnaya, VG Savchenko. Moscow, 2018 (In Russ.)].
25. Cheson B, Pfistner B, Juweid M, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-86. doi: 10.1200/JCO.2006.09.2403
26. Geisler CH, Kolstad A, Laurell A, Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025
27. Chihara D, Cheah CY, Westin JR, et al. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantlecell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haemotol. 2016 Jan;172(1):80-8. doi: 10.1111/bjh.13796
28. Delarue R, Haioun C, Ribrag V, et al. CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d’Etude des Lymphomes de l’Adulte. Blood. 2013;121: 48-53. doi: 10.1182/blood-2011-09-370320
29. Eskelund CW, Kolstad A, Jerkeman M, et al.15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016 Nov;175(3):410-8. doi: 10.1111/bjh.14241
30. Robak T, Jin J, Pylypenko H, et al. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1449-58. doi: 10.1016/S1470-2045(18)30685-5
31. Geisler C. Front-line therapy of MCL. Hematologica. 2010;95:1241-3. doi: 10.3324/haematol.2010.025627
32. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7
33. Chang JE, Peterson C, Choi S, et al. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011;155(2):190-7. doi: 10.1111/j.1365-2141.2011.08820.x
34. Kenkre VP, Long WL, Eickhoff JC, et al. Maintenance rituximab following induction chemoimmunotherapy for mantle cell lymphoma: long-term follow-up of a pilot study from the Wisconsin Oncology Network. Leuk Lymphoma. 2011; 52(9):1675-80. doi: 10.3109/10428194.2011.580404
35. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012;367(6):520-31. doi: 10.1056/NEJMoa1200920
36. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017;377: 1250-60. doi: 10.1056/NEJMoa1701769
37. Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017 Oct 26;130(17):1903-10. doi: 10.1182/blood-2017-04-779736
38. Baker J, Giralt S, Hamlin P, Jakubowski A, Castro-Malaspina H, Robinson KS, Papadopoulos EB, Perales M, Sauter C. Allogeneic haematopoietic cell transplantation impacts on outcomes of mantle cell lymphoma with TP53 alterations. Br J Haematol. 2019 Mar;184(6):1006-10. doi: 10.1111/bjh.15721
39. Visco C, Chiappella A, Nassi L, et al. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. Lancet Haematol. 2017 Jan;4(1):e15-e23. doi: 10.1016/S2352-3026(16)30185-5
40. Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770-8. doi: 10.1016/S0140-6736(15)00667-4
41. Trneny M, Lamy T, Walewski J, et al. Phase II randomized, multicenter study of lenalidomide vs best investigator’s choice in relapsed/refractory mantle cell lymphoma: results of the MCL-002 (SPRINT) study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
42. Davids MS, Roberts AW, Seymour JF. Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma. J Clin Oncol. 2017 Mar 10;35(8):826-33. doi: 10.1200/JCO.2016.70.4320
43. Toby A. Eyre, Harriet S. Walter, Sunil Iyengar. Efficacy of venetoclax monotherapy in patients with relapsed, refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor therapy. Haematologica. 2019 Feb;104(2):e68-e71. doi: 10.3324/haematol.2018
44. Martin P. The use of CAR T-cells in diffuse large B-cell lymphoma and mantle cell lymphoma. Clin Adv Hematol Oncol. 2017 Apr;15(4):247-9.
45. Li T, Zhang Y, Peng D. A good response of refractory mantel cell lymphoma to haploidentical CAR T-cell therapy after failure of autologous CAR T-cell therapy. J Immunother Cancer. 2019 Feb 21;7(1):51. doi: 10.1186/s40425-019-0529-9
46. Dreyling M, Aurer I, Cortelazzo S. Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations. Leuk Lymphoma. 2018 Aug;59(8):1814-28. doi: 10.1080/10428194.2017.1403602
47. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-67. doi: 10.1016/S0140-6736(17)33108-2
48. Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus Venetoclax for the Treatment of Mantle-Cell Lymphoma. N Engl J Med. 2018 Mar 29;378(13):1211-23. doi: 10.1056/NEJMoa1715519.
2. Zhou Y, Wang H, Fang W, et al. Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004. Cancer. 2008;113:791-8. doi: 10.1002/cncr.23608
3. Dreyling M, Geisler C, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii83-92. doi: 10.1093/annonc/mdu264
4. Lenz G, Dreyling M, Hoster E, et al. Immunochemotherapy With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Significantly Improves Response and Time to Treatment Failure, But Not Long-Term Outcome in Patients With Previously Untreated Mantle Cell Lymphoma: Results of a Prospective Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005;23:1984-92. doi: 10.1200/JCO.2005.08.133
5. Hoster E, Unterhalt M, Pfreundschuh M, et al. The addition of rituximab to CHOP improves failure-free and overall survival of mantle-cell lymphoma patients – a pooled trials analysis of the German Low-Grade Lymphoma Study Group (GLSG). Blood. 2014;124:1752 (abstr).
6. Howard OM, Gribben JG, Neuberg DS, et al. Rituximab and CHOP induction therapy for newly diagnosed mantle cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol. 2002;20:1288-94. doi: 10.1200/JCO.2002.20.5.1288
7. Dreyling M, Lenz G, Hoster E, et al. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005;105:2677-84. doi: 10.1182/blood-2004-10-3883
8. Romaguera J, Fayad L, Feng L, et al. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. doi: 10.1111/j.1365-2141.2010.08228.x
9. Geisler CH, Kolstad A, Laurell A, et al. Nordic MCL2 trial update: six-year follow-up after intensive immunochemotherapy for untreated mantle celllymphoma followed by BEAM or BEAC + autologous stem-cell support: still very long survival but late relapses do occur. Br J Haematol. 2012 Aug;158(3):355-62. doi: 10.1111/j.1365-2141.2012.09174.x
10. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab maintenance versus wait and watch after four courses of R-DHAP followed by autologous stem cell transplantation in previously untreated young patients with mantle cell lymphoma: first interim analysis of the phase III Prospective Lyma Trial, a Lysa Study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
11. Hermine O, Hoster E, Walewski J, et al. Addition of high-dose cytarabine to immunochemotherapy before autologous stem cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial ofthe European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-х
12. Romaguera JE, Fayad L, Rodriguez MA, et al. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005;23:7013-23. doi: 10.1200/JCO.2005.01.1825
13. Merli F, Luminari S, Ilariucci F, et al. Rituximab plus HyperCVAD alternating with high dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma, a multicenter trial from Gruppo Italiano Studio Linfoni. Br J Haematol. 2012;156(3):346-53. doi: 10.1111/j.1365-2141.2011.08958.x
14. Bernstein SH, Epner E, Unger JM, et al. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013;24:1587-93. doi: 10.1093/annonc/mdt070
15. Rodriguez J, Gutierrez A, Palacios A, et al. Rituximab, gemcitabine and oxaliplatin: An effective regimen in patients with refractory and relapsing mantle cell lymphoma. Leuk Lymphoma. 2007;48:2172-8. doi: 10.1080/10428190701618268
16. Corazzelli G, Capobianco G, Arcamone M, et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemother Pharmacol. 2009;64:907-16. doi: 10.1007/s00280-009-0941-9
17. Corazzelli G, Russo F, Capobianco G, et al. Gemcitabine, ifosfamide, oxaliplatin and rituximab (R-GIFOX), a new effective cytoreductive/mobilizing salvage regimen for relapsed and refractory aggressive non-Hodgkin's lymphoma: results of a pilot study. Ann Oncol. 2006;17(Suppl 4):iv18-24. doi: 10.1093/annonc/mdj994
18. Park BB, Kim WS, Eom HS, et al. Salvage therapy with gemcitabine, ifosfamide, dexamethasone, and oxaliplatin (GIDOX) for B-cell non-Hodgkin's lymphoma: a consortium for improving survival of lymphoma (CISL) trial. Invest New Drugs. 2011;29:154-60. doi: 10.1007/s10637-009-9320-y
19. Suzumiya J, Suzushima H, Maeda K, et al. Phase I study of the combination of irinotecan hydrochloride, carboplatin, and dexamethasone for the treatment of relapsed or refractory malignant lymphoma. Int J Hematol. 2004 Apr;79(3):266-70.
20. Hara S, Yokote T, Akioka T, et al. Successful treatment of refractory mantle cell lymphoma with irinotecan. Rinsho Ketsueki. 2005 May;46(5):358-62.
21. [Vorobyev VI, Kravchenko SK, Gemdzhyan EG, et al. Mantle cell lymphoma: program therapy for untreated patients under 65 years. Clinical oncohematology. Basic research and clinical practice. 2013; 6(3): 274-81 (In Russ.)].
22. Vorobyev VI, Kravchenko SK, Gemdzhian EG, et al. Less Toxic Gemcitabine-Oxaliplatin Based Induction Regimen (R-GIDIOX) Prior to Autologous SCT Produces Outcomes Similar to High-Dose Cytarabine Containing Intensive Induction Regimen in Mantle Cell Lymphoma – a Follow up Report of the Multicenter Study. Blood. 2014;124(21):1726.
23. [Vorobyev VI, Loriye YuYu, Mangasarova JK, et al. Opportunities of treatment of relapse and resistant mantle cell lymphoma. Hematology and Transfusiology. 2011;(1):34-7 (In Russ.)].
24. [Russian clinical guidelines for the diagnosis and treatment of lymphoproliferative diseases, edited by IV Poddubnaya, VG Savchenko. Moscow, 2018 (In Russ.)].
25. Cheson B, Pfistner B, Juweid M, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-86. doi: 10.1200/JCO.2006.09.2403
26. Geisler CH, Kolstad A, Laurell A, Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025
27. Chihara D, Cheah CY, Westin JR, et al. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantlecell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haemotol. 2016 Jan;172(1):80-8. doi: 10.1111/bjh.13796
28. Delarue R, Haioun C, Ribrag V, et al. CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d’Etude des Lymphomes de l’Adulte. Blood. 2013;121: 48-53. doi: 10.1182/blood-2011-09-370320
29. Eskelund CW, Kolstad A, Jerkeman M, et al.15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016 Nov;175(3):410-8. doi: 10.1111/bjh.14241
30. Robak T, Jin J, Pylypenko H, et al. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1449-58. doi: 10.1016/S1470-2045(18)30685-5
31. Geisler C. Front-line therapy of MCL. Hematologica. 2010;95:1241-3. doi: 10.3324/haematol.2010.025627
32. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7
33. Chang JE, Peterson C, Choi S, et al. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011;155(2):190-7. doi: 10.1111/j.1365-2141.2011.08820.x
34. Kenkre VP, Long WL, Eickhoff JC, et al. Maintenance rituximab following induction chemoimmunotherapy for mantle cell lymphoma: long-term follow-up of a pilot study from the Wisconsin Oncology Network. Leuk Lymphoma. 2011; 52(9):1675-80. doi: 10.3109/10428194.2011.580404
35. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012;367(6):520-31. doi: 10.1056/NEJMoa1200920
36. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017;377: 1250-60. doi: 10.1056/NEJMoa1701769
37. Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017 Oct 26;130(17):1903-10. doi: 10.1182/blood-2017-04-779736
38. Baker J, Giralt S, Hamlin P, Jakubowski A, Castro-Malaspina H, Robinson KS, Papadopoulos EB, Perales M, Sauter C. Allogeneic haematopoietic cell transplantation impacts on outcomes of mantle cell lymphoma with TP53 alterations. Br J Haematol. 2019 Mar;184(6):1006-10. doi: 10.1111/bjh.15721
39. Visco C, Chiappella A, Nassi L, et al. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. Lancet Haematol. 2017 Jan;4(1):e15-e23. doi: 10.1016/S2352-3026(16)30185-5
40. Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770-8. doi: 10.1016/S0140-6736(15)00667-4
41. Trneny M, Lamy T, Walewski J, et al. Phase II randomized, multicenter study of lenalidomide vs best investigator’s choice in relapsed/refractory mantle cell lymphoma: results of the MCL-002 (SPRINT) study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
42. Davids MS, Roberts AW, Seymour JF. Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma. J Clin Oncol. 2017 Mar 10;35(8):826-33. doi: 10.1200/JCO.2016.70.4320
43. Toby A. Eyre, Harriet S. Walter, Sunil Iyengar. Efficacy of venetoclax monotherapy in patients with relapsed, refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor therapy. Haematologica. 2019 Feb;104(2):e68-e71. doi: 10.3324/haematol.2018
44. Martin P. The use of CAR T-cells in diffuse large B-cell lymphoma and mantle cell lymphoma. Clin Adv Hematol Oncol. 2017 Apr;15(4):247-9.
45. Li T, Zhang Y, Peng D. A good response of refractory mantel cell lymphoma to haploidentical CAR T-cell therapy after failure of autologous CAR T-cell therapy. J Immunother Cancer. 2019 Feb 21;7(1):51. doi: 10.1186/s40425-019-0529-9
46. Dreyling M, Aurer I, Cortelazzo S. Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations. Leuk Lymphoma. 2018 Aug;59(8):1814-28. doi: 10.1080/10428194.2017.1403602
47. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-67. doi: 10.1016/S0140-6736(17)33108-2
48. Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus Venetoclax for the Treatment of Mantle-Cell Lymphoma. N Engl J Med. 2018 Mar 29;378(13):1211-23. doi: 10.1056/NEJMoa1715519.
2. Zhou Y, Wang H, Fang W, et al. Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004. Cancer. 2008;113:791-8. doi: 10.1002/cncr.23608
3. Dreyling M, Geisler C, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii83-92. doi: 10.1093/annonc/mdu264
4. Lenz G, Dreyling M, Hoster E, et al. Immunochemotherapy With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Significantly Improves Response and Time to Treatment Failure, But Not Long-Term Outcome in Patients With Previously Untreated Mantle Cell Lymphoma: Results of a Prospective Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005;23:1984-92. doi: 10.1200/JCO.2005.08.133
5. Hoster E, Unterhalt M, Pfreundschuh M, et al. The addition of rituximab to CHOP improves failure-free and overall survival of mantle-cell lymphoma patients – a pooled trials analysis of the German Low-Grade Lymphoma Study Group (GLSG). Blood. 2014;124:1752 (abstr).
6. Howard OM, Gribben JG, Neuberg DS, et al. Rituximab and CHOP induction therapy for newly diagnosed mantle cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol. 2002;20:1288-94. doi: 10.1200/JCO.2002.20.5.1288
7. Dreyling M, Lenz G, Hoster E, et al. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005;105:2677-84. doi: 10.1182/blood-2004-10-3883
8. Romaguera J, Fayad L, Feng L, et al. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. doi: 10.1111/j.1365-2141.2010.08228.x
9. Geisler CH, Kolstad A, Laurell A, et al. Nordic MCL2 trial update: six-year follow-up after intensive immunochemotherapy for untreated mantle celllymphoma followed by BEAM or BEAC + autologous stem-cell support: still very long survival but late relapses do occur. Br J Haematol. 2012 Aug;158(3):355-62. doi: 10.1111/j.1365-2141.2012.09174.x
10. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab maintenance versus wait and watch after four courses of R-DHAP followed by autologous stem cell transplantation in previously untreated young patients with mantle cell lymphoma: first interim analysis of the phase III Prospective Lyma Trial, a Lysa Study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
11. Hermine O, Hoster E, Walewski J, et al. Addition of high-dose cytarabine to immunochemotherapy before autologous stem cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial ofthe European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-х
12. Romaguera JE, Fayad L, Rodriguez MA, et al. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005;23:7013-23. doi: 10.1200/JCO.2005.01.1825
13. Merli F, Luminari S, Ilariucci F, et al. Rituximab plus HyperCVAD alternating with high dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma, a multicenter trial from Gruppo Italiano Studio Linfoni. Br J Haematol. 2012;156(3):346-53. doi: 10.1111/j.1365-2141.2011.08958.x
14. Bernstein SH, Epner E, Unger JM, et al. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013;24:1587-93. doi: 10.1093/annonc/mdt070
15. Rodriguez J, Gutierrez A, Palacios A, et al. Rituximab, gemcitabine and oxaliplatin: An effective regimen in patients with refractory and relapsing mantle cell lymphoma. Leuk Lymphoma. 2007;48:2172-8. doi: 10.1080/10428190701618268
16. Corazzelli G, Capobianco G, Arcamone M, et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemother Pharmacol. 2009;64:907-16. doi: 10.1007/s00280-009-0941-9
17. Corazzelli G, Russo F, Capobianco G, et al. Gemcitabine, ifosfamide, oxaliplatin and rituximab (R-GIFOX), a new effective cytoreductive/mobilizing salvage regimen for relapsed and refractory aggressive non-Hodgkin's lymphoma: results of a pilot study. Ann Oncol. 2006;17(Suppl 4):iv18-24. doi: 10.1093/annonc/mdj994
18. Park BB, Kim WS, Eom HS, et al. Salvage therapy with gemcitabine, ifosfamide, dexamethasone, and oxaliplatin (GIDOX) for B-cell non-Hodgkin's lymphoma: a consortium for improving survival of lymphoma (CISL) trial. Invest New Drugs. 2011;29:154-60. doi: 10.1007/s10637-009-9320-y
19. Suzumiya J, Suzushima H, Maeda K, et al. Phase I study of the combination of irinotecan hydrochloride, carboplatin, and dexamethasone for the treatment of relapsed or refractory malignant lymphoma. Int J Hematol. 2004 Apr;79(3):266-70.
20. Hara S, Yokote T, Akioka T, et al. Successful treatment of refractory mantle cell lymphoma with irinotecan. Rinsho Ketsueki. 2005 May;46(5):358-62.
21. Воробьев В.И., Кравченко С.К., Гемджян Э.Г. и др. Мантийноклеточная лимфома: программное лечение первичных больных в возрасте до 65 лет. Клиническая онкогематология. Фундаментальные исследования и клиническая практика. 2013;6(3):274-81 [Vorobyev VI, Kravchenko SK, Gemdzhyan EG, et al. Mantle cell lymphoma: program therapy for untreated patients under 65 years. Clinical oncohematology. Basic research and clinical practice. 2013; 6(3): 274-81 (In Russ.)].
22. Vorobyev VI, Kravchenko SK, Gemdzhian EG, et al. Less Toxic Gemcitabine-Oxaliplatin Based Induction Regimen (R-GIDIOX) Prior to Autologous SCT Produces Outcomes Similar to High-Dose Cytarabine Containing Intensive Induction Regimen in Mantle Cell Lymphoma – a Follow up Report of the Multicenter Study. Blood. 2014;124(21):1726.
23. Воробьев В.И., Лорие Ю.Ю., Мангасарова Я.К. и др. Возможности терапии рецидивов и резистентного течения лимфомы из клеток мантийной зоны. Гематология и трансфузиология. 2011;(1):34-7 [Vorobyev VI, Loriye YuYu, Mangasarova JK, et al. Opportunities of treatment of relapse and resistant mantle cell lymphoma. Hematology and Transfusiology. 2011;(1):34-7 (In Russ.)].
24. Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний под ред. И.В. Поддубной, В.Г. Савченко. М., 2018 [Russian clinical guidelines for the diagnosis and treatment of lymphoproliferative diseases, edited by IV Poddubnaya, VG Savchenko. Moscow, 2018 (In Russ.)].
25. Cheson B, Pfistner B, Juweid M, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-86. doi: 10.1200/JCO.2006.09.2403
26. Geisler CH, Kolstad A, Laurell A, Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025
27. Chihara D, Cheah CY, Westin JR, et al. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantlecell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haemotol. 2016 Jan;172(1):80-8. doi: 10.1111/bjh.13796
28. Delarue R, Haioun C, Ribrag V, et al. CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d’Etude des Lymphomes de l’Adulte. Blood. 2013;121: 48-53. doi: 10.1182/blood-2011-09-370320
29. Eskelund CW, Kolstad A, Jerkeman M, et al.15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016 Nov;175(3):410-8. doi: 10.1111/bjh.14241
30. Robak T, Jin J, Pylypenko H, et al. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1449-58. doi: 10.1016/S1470-2045(18)30685-5
31. Geisler C. Front-line therapy of MCL. Hematologica. 2010;95:1241-3. doi: 10.3324/haematol.2010.025627
32. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7
33. Chang JE, Peterson C, Choi S, et al. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011;155(2):190-7. doi: 10.1111/j.1365-2141.2011.08820.x
34. Kenkre VP, Long WL, Eickhoff JC, et al. Maintenance rituximab following induction chemoimmunotherapy for mantle cell lymphoma: long-term follow-up of a pilot study from the Wisconsin Oncology Network. Leuk Lymphoma. 2011; 52(9):1675-80. doi: 10.3109/10428194.2011.580404
35. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012;367(6):520-31. doi: 10.1056/NEJMoa1200920
36. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017;377: 1250-60. doi: 10.1056/NEJMoa1701769
37. Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017 Oct 26;130(17):1903-10. doi: 10.1182/blood-2017-04-779736
38. Baker J, Giralt S, Hamlin P, Jakubowski A, Castro-Malaspina H, Robinson KS, Papadopoulos EB, Perales M, Sauter C. Allogeneic haematopoietic cell transplantation impacts on outcomes of mantle cell lymphoma with TP53 alterations. Br J Haematol. 2019 Mar;184(6):1006-10. doi: 10.1111/bjh.15721
39. Visco C, Chiappella A, Nassi L, et al. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. Lancet Haematol. 2017 Jan;4(1):e15-e23. doi: 10.1016/S2352-3026(16)30185-5
40. Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770-8. doi: 10.1016/S0140-6736(15)00667-4
41. Trneny M, Lamy T, Walewski J, et al. Phase II randomized, multicenter study of lenalidomide vs best investigator’s choice in relapsed/refractory mantle cell lymphoma: results of the MCL-002 (SPRINT) study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
42. Davids MS, Roberts AW, Seymour JF. Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma. J Clin Oncol. 2017 Mar 10;35(8):826-33. doi: 10.1200/JCO.2016.70.4320
43. Toby A. Eyre, Harriet S. Walter, Sunil Iyengar. Efficacy of venetoclax monotherapy in patients with relapsed, refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor therapy. Haematologica. 2019 Feb;104(2):e68-e71. doi: 10.3324/haematol.2018
44. Martin P. The use of CAR T-cells in diffuse large B-cell lymphoma and mantle cell lymphoma. Clin Adv Hematol Oncol. 2017 Apr;15(4):247-9.
45. Li T, Zhang Y, Peng D. A good response of refractory mantel cell lymphoma to haploidentical CAR T-cell therapy after failure of autologous CAR T-cell therapy. J Immunother Cancer. 2019 Feb 21;7(1):51. doi: 10.1186/s40425-019-0529-9
46. Dreyling M, Aurer I, Cortelazzo S. Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations. Leuk Lymphoma. 2018 Aug;59(8):1814-28. doi: 10.1080/10428194.2017.1403602
47. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-67. doi: 10.1016/S0140-6736(17)33108-2
48. Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus Venetoclax for the Treatment of Mantle-Cell Lymphoma. N Engl J Med. 2018 Mar 29;378(13):1211-23. doi: 10.1056/NEJMoa1715519.
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2. Zhou Y, Wang H, Fang W, et al. Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004. Cancer. 2008;113:791-8. doi: 10.1002/cncr.23608
3. Dreyling M, Geisler C, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii83-92. doi: 10.1093/annonc/mdu264
4. Lenz G, Dreyling M, Hoster E, et al. Immunochemotherapy With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Significantly Improves Response and Time to Treatment Failure, But Not Long-Term Outcome in Patients With Previously Untreated Mantle Cell Lymphoma: Results of a Prospective Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005;23:1984-92. doi: 10.1200/JCO.2005.08.133
5. Hoster E, Unterhalt M, Pfreundschuh M, et al. The addition of rituximab to CHOP improves failure-free and overall survival of mantle-cell lymphoma patients – a pooled trials analysis of the German Low-Grade Lymphoma Study Group (GLSG). Blood. 2014;124:1752 (abstr).
6. Howard OM, Gribben JG, Neuberg DS, et al. Rituximab and CHOP induction therapy for newly diagnosed mantle cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol. 2002;20:1288-94. doi: 10.1200/JCO.2002.20.5.1288
7. Dreyling M, Lenz G, Hoster E, et al. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005;105:2677-84. doi: 10.1182/blood-2004-10-3883
8. Romaguera J, Fayad L, Feng L, et al. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. doi: 10.1111/j.1365-2141.2010.08228.x
9. Geisler CH, Kolstad A, Laurell A, et al. Nordic MCL2 trial update: six-year follow-up after intensive immunochemotherapy for untreated mantle celllymphoma followed by BEAM or BEAC + autologous stem-cell support: still very long survival but late relapses do occur. Br J Haematol. 2012 Aug;158(3):355-62. doi: 10.1111/j.1365-2141.2012.09174.x
10. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab maintenance versus wait and watch after four courses of R-DHAP followed by autologous stem cell transplantation in previously untreated young patients with mantle cell lymphoma: first interim analysis of the phase III Prospective Lyma Trial, a Lysa Study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
11. Hermine O, Hoster E, Walewski J, et al. Addition of high-dose cytarabine to immunochemotherapy before autologous stem cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial ofthe European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-х
12. Romaguera JE, Fayad L, Rodriguez MA, et al. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005;23:7013-23. doi: 10.1200/JCO.2005.01.1825
13. Merli F, Luminari S, Ilariucci F, et al. Rituximab plus HyperCVAD alternating with high dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma, a multicenter trial from Gruppo Italiano Studio Linfoni. Br J Haematol. 2012;156(3):346-53. doi: 10.1111/j.1365-2141.2011.08958.x
14. Bernstein SH, Epner E, Unger JM, et al. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013;24:1587-93. doi: 10.1093/annonc/mdt070
15. Rodriguez J, Gutierrez A, Palacios A, et al. Rituximab, gemcitabine and oxaliplatin: An effective regimen in patients with refractory and relapsing mantle cell lymphoma. Leuk Lymphoma. 2007;48:2172-8. doi: 10.1080/10428190701618268
16. Corazzelli G, Capobianco G, Arcamone M, et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemother Pharmacol. 2009;64:907-16. doi: 10.1007/s00280-009-0941-9
17. Corazzelli G, Russo F, Capobianco G, et al. Gemcitabine, ifosfamide, oxaliplatin and rituximab (R-GIFOX), a new effective cytoreductive/mobilizing salvage regimen for relapsed and refractory aggressive non-Hodgkin's lymphoma: results of a pilot study. Ann Oncol. 2006;17(Suppl 4):iv18-24. doi: 10.1093/annonc/mdj994
18. Park BB, Kim WS, Eom HS, et al. Salvage therapy with gemcitabine, ifosfamide, dexamethasone, and oxaliplatin (GIDOX) for B-cell non-Hodgkin's lymphoma: a consortium for improving survival of lymphoma (CISL) trial. Invest New Drugs. 2011;29:154-60. doi: 10.1007/s10637-009-9320-y
19. Suzumiya J, Suzushima H, Maeda K, et al. Phase I study of the combination of irinotecan hydrochloride, carboplatin, and dexamethasone for the treatment of relapsed or refractory malignant lymphoma. Int J Hematol. 2004 Apr;79(3):266-70.
20. Hara S, Yokote T, Akioka T, et al. Successful treatment of refractory mantle cell lymphoma with irinotecan. Rinsho Ketsueki. 2005 May;46(5):358-62.
21. [Vorobyev VI, Kravchenko SK, Gemdzhyan EG, et al. Mantle cell lymphoma: program therapy for untreated patients under 65 years. Clinical oncohematology. Basic research and clinical practice. 2013; 6(3): 274-81 (In Russ.)].
22. Vorobyev VI, Kravchenko SK, Gemdzhian EG, et al. Less Toxic Gemcitabine-Oxaliplatin Based Induction Regimen (R-GIDIOX) Prior to Autologous SCT Produces Outcomes Similar to High-Dose Cytarabine Containing Intensive Induction Regimen in Mantle Cell Lymphoma – a Follow up Report of the Multicenter Study. Blood. 2014;124(21):1726.
23. [Vorobyev VI, Loriye YuYu, Mangasarova JK, et al. Opportunities of treatment of relapse and resistant mantle cell lymphoma. Hematology and Transfusiology. 2011;(1):34-7 (In Russ.)].
24. [Russian clinical guidelines for the diagnosis and treatment of lymphoproliferative diseases, edited by IV Poddubnaya, VG Savchenko. Moscow, 2018 (In Russ.)].
25. Cheson B, Pfistner B, Juweid M, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-86. doi: 10.1200/JCO.2006.09.2403
26. Geisler CH, Kolstad A, Laurell A, Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025
27. Chihara D, Cheah CY, Westin JR, et al. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantlecell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haemotol. 2016 Jan;172(1):80-8. doi: 10.1111/bjh.13796
28. Delarue R, Haioun C, Ribrag V, et al. CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d’Etude des Lymphomes de l’Adulte. Blood. 2013;121: 48-53. doi: 10.1182/blood-2011-09-370320
29. Eskelund CW, Kolstad A, Jerkeman M, et al.15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016 Nov;175(3):410-8. doi: 10.1111/bjh.14241
30. Robak T, Jin J, Pylypenko H, et al. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1449-58. doi: 10.1016/S1470-2045(18)30685-5
31. Geisler C. Front-line therapy of MCL. Hematologica. 2010;95:1241-3. doi: 10.3324/haematol.2010.025627
32. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7
33. Chang JE, Peterson C, Choi S, et al. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011;155(2):190-7. doi: 10.1111/j.1365-2141.2011.08820.x
34. Kenkre VP, Long WL, Eickhoff JC, et al. Maintenance rituximab following induction chemoimmunotherapy for mantle cell lymphoma: long-term follow-up of a pilot study from the Wisconsin Oncology Network. Leuk Lymphoma. 2011; 52(9):1675-80. doi: 10.3109/10428194.2011.580404
35. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012;367(6):520-31. doi: 10.1056/NEJMoa1200920
36. Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017;377: 1250-60. doi: 10.1056/NEJMoa1701769
37. Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017 Oct 26;130(17):1903-10. doi: 10.1182/blood-2017-04-779736
38. Baker J, Giralt S, Hamlin P, Jakubowski A, Castro-Malaspina H, Robinson KS, Papadopoulos EB, Perales M, Sauter C. Allogeneic haematopoietic cell transplantation impacts on outcomes of mantle cell lymphoma with TP53 alterations. Br J Haematol. 2019 Mar;184(6):1006-10. doi: 10.1111/bjh.15721
39. Visco C, Chiappella A, Nassi L, et al. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. Lancet Haematol. 2017 Jan;4(1):e15-e23. doi: 10.1016/S2352-3026(16)30185-5
40. Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770-8. doi: 10.1016/S0140-6736(15)00667-4
41. Trneny M, Lamy T, Walewski J, et al. Phase II randomized, multicenter study of lenalidomide vs best investigator’s choice in relapsed/refractory mantle cell lymphoma: results of the MCL-002 (SPRINT) study. 56th American Society of Hematology Annual Meeting; San Francisco, CA; Dec 6–9, 2014:124.
42. Davids MS, Roberts AW, Seymour JF. Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma. J Clin Oncol. 2017 Mar 10;35(8):826-33. doi: 10.1200/JCO.2016.70.4320
43. Toby A. Eyre, Harriet S. Walter, Sunil Iyengar. Efficacy of venetoclax monotherapy in patients with relapsed, refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor therapy. Haematologica. 2019 Feb;104(2):e68-e71. doi: 10.3324/haematol.2018
44. Martin P. The use of CAR T-cells in diffuse large B-cell lymphoma and mantle cell lymphoma. Clin Adv Hematol Oncol. 2017 Apr;15(4):247-9.
45. Li T, Zhang Y, Peng D. A good response of refractory mantel cell lymphoma to haploidentical CAR T-cell therapy after failure of autologous CAR T-cell therapy. J Immunother Cancer. 2019 Feb 21;7(1):51. doi: 10.1186/s40425-019-0529-9
46. Dreyling M, Aurer I, Cortelazzo S. Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations. Leuk Lymphoma. 2018 Aug;59(8):1814-28. doi: 10.1080/10428194.2017.1403602
47. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-67. doi: 10.1016/S0140-6736(17)33108-2
48. Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus Venetoclax for the Treatment of Mantle-Cell Lymphoma. N Engl J Med. 2018 Mar 29;378(13):1211-23. doi: 10.1056/NEJMoa1715519.
Авторы
В.И. Воробьев 1, Э.Г. Гемджян 2, Е.И. Дубровин 1, Е.С. Нестерова 2, К.Д. Капланов 3, Е.М. Володичева 4, В.А. Жеребцова 1, С.К. Кравченко 2
1 ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия;
3 ГБУЗ «Волгоградский областной клинический онкологический диспансер», Волгоград, Россия;
4 ГУЗ ТО «Тульская областная клиническая больница», Тула, Россия
1 Botkin Moscow City Clinical Hospital, Moscow, Russia;
2 National Research Center for Hematology, Moscow, Russia;
3 Volgograd Regional Clinical Oncologic Dispensary, Volgograd, Russia;
4 Tula Region Hospital, Tula, Russia
1 ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия;
3 ГБУЗ «Волгоградский областной клинический онкологический диспансер», Волгоград, Россия;
4 ГУЗ ТО «Тульская областная клиническая больница», Тула, Россия
________________________________________________
1 Botkin Moscow City Clinical Hospital, Moscow, Russia;
2 National Research Center for Hematology, Moscow, Russia;
3 Volgograd Regional Clinical Oncologic Dispensary, Volgograd, Russia;
4 Tula Region Hospital, Tula, Russia
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