Omission of dacarbazine or bleomycin, or both, from the ABVD regimen in treatment of early-stage favourable Hodgkin's lymphoma (GHSG HD13): an open-label, randomised, non-inferiority trial

Behringer, Karolin; Goergen, Helen; Hitz, Felicitas; Zijlstra, Josée M.; Greil, Richard; Marková, Jana; Sasse, Stephanie; Fuchs, Michael; Topp, Max S.; Soekler, Martin; Mathas, Stephan; Meißner, Julia; Wilhelm, Martin; Koch, P.; Lindemann, Hans‐Walter; Schalk, Enrico; Semrau, R.; Kříž, Jan; Vieler, Tom; Bentz, Martin; Lange, Elisabeth; Mahlberg, Rolf; Hassler, Andre; Vogelhuber, Martin; Hahn, D; Mezger, J.; Krause, Stefan W.; Skoetz, Nicole; Böll, Boris; Tresckow, Bastian von; Diehl, Volker; Hallek, Michael; Borchmann, Peter; Stein, Harald; Eich, Hans Theodor; Engert, Andreas

doi:10.1016/s0140-6736(14)61469-0

Cited by 161 publications

(83 citation statements)

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“…Alteration of ABVD by omitting any drug including bleomycin was also recently reported as inferior in terms of disease control. 75 However, as approximately 30% of patients with advanced disease relapse after ABVD, a more intensified chemotherapy, BEACOPPesc (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) was developed for these patients. It showed a better progression-free survival (PFS), although it is also associated with more toxicity.…”

Section: European Research Contributionsmentioning

confidence: 99%

The European Hematology Association Roadmap for European Hematology Research: a consensus document

et al. 2016

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T he European Hematology Association (EHA) Roadmap for European Hematology Research highlights major achievements in diagnosis and treatment of blood disorders and identifies the greatest unmet clinical and scientific needs in those areas to enable better funded, more focused European hematology research. Initiated by the EHA, around 300 experts contributed to the consensus document, which will help European policy makers, research funders, research organizations, researchers, and patient groups make better informed decisions on hematology research. It also aims to raise public awareness of the burden of blood disorders on European society, which purely in economic terms is estimated at €23 billion per year, a level of cost that is not matched in current European hematology research funding. In recent decades, hematology research has improved our fundamental understanding of the biology of blood disorders, and has improved diagnostics and treatments, sometimes in revolutionary ways. This progress highlights the potential of focused basic research programs such as this EHA Roadmap. The EHA Roadmap identifies nine 'sections' in hematology: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation. These sections span 60 smaller groups of diseases or disorders. The EHA Roadmap identifies priorities and needs across the field of hematology, including those to develop targeted therapies based on genomic profiling and chemical biology, to eradicate minimal residual malignant disease, and to develop cellular immunotherapies, combination treatments, gene therapies, hematopoietic stem cell treatments, and treatments that are better tolerated by elderly patients.

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Section: European Research Contributionsmentioning

confidence: 99%

The European Hematology Association Roadmap for European Hematology Research: a consensus document

et al. 2016

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“…Тенденцию отказа от блеомицина можно отметить как в работах по лечению ЛХ у пожилых (например, режим PVAG), так и в современных исследованиях по лечению молодых больных с ранними [14] и рас-пространенными стадиями ЛХ. В последнем случае исключение блеомицина сопряжено с эскалацией доз других цитостатических средств (EACOPP-14) или с включением новых препаратов, таких как брентук-симаб ведотин (BreCADD) [15,16].…”

Section: Discussionunclassified

The IVDG Regimen is the Possible Treatment of Choice as First Line Therapy For Hodgkin’s Lymphoma in Elderly Patients with Cardiovascular and Pulmonary Comorbidity

KD¹,

Klitochenko²,

Shipaeva³

et al. 2017

Клиническая онкогематология

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РЕФЕРАТАктуальность. Среди впервые выявленных пациентов с лимфомой Ходжкина (ЛХ) лица пожилого возраста составляют 15-35 %. У пациентов старше 60 лет выбор противоопухолевого лечения в значительно большей степени, чем у молодых, требует индивидуализирован-ного подхода. Приемлемая по эффективности и гема-тологической токсичности программа ABVD характе-ризуется высоким риском легочных осложнений из-за блеомицина. В группе больных 60 лет и старше частота легочных осложнений составляет 24 %, а связанная с ней летальность -18 %. Цель. Оценить эффективность программы IVDG в срав-нении с ABVD по принципу «non-inferiority» (не уступает по эффективности). Материалы и методы. Настоящее одноцентровое проспективное контролируемое рандомизированное исследование начато в 2009 г. В исследование вклю-чались все первичные больные старше 60 лет с вери-фицированной ЛХ вне зависимости от количества и тя-жести сопутствующих заболеваний. Лечение по схеме ABVD проводилось у 17 больных, IVDG -у 20. Медиана возраста в группах АВVD и IVDG составила 67 и 70 лет соответственно. Распространенные стадии ЛХ в группах составили: IVDG -13 (65 %), ABVD -12 (71 %) (p = 0,9). Обе группы сбалансированы по количеству случаев с хро-нической сердечной недостаточностью и хронической обструктивной болезнью легких. В то же время наблю-дений с ишемической болезнью сердца было больше в группе IVDG (n = 16) в сравнении с ABVD (n = 8) (p = 0,04). Результаты. Группы IVDG и ABVD не различались по ча-стоте полных (14 и 10) и частичных (3 и 4) ремиссий. Разли-чия в общей 5-летней выживаемости были незначимы: LYMPHOID TUMORSThe IVDG Regimen is the ABSTRACTBackground. Among the newly diagnosed patients with Hodgkin's lymphoma (HL), the proportion of elderly patients account for 15-35 %. In > 60 age group the choice of antitumor treatment requires an more individualised approach compared to a younger population. The ABVD regimen is acceptable in terms of effi ciency and hematological toxicity, but is associated with a high risk of bleomycine-induced pulmonary complications. In ≥ 60 age group the morbitity and mortality of pulmonary complications account for 24 % and 18 %, respectively. Aim. We aimed to evaluate the effi cacy of the IVDG regimen in comparison with ABVD by the principle of "non-inferiority". Materials & Methods. This single centre, prospective, controlled, randomised study was started in 2009. The study included all primary patients aged ≥ 60 years with verifi ed HL, regardless of the number and severity of comorbidities. The ABVD regimen was administered in 17 patients, and 20 patients received IVDG. The median age in the ABVD and IVDG groups was 67 and 70 years, respectively. The advanced stages of HL were reported in 13 (65 %) patients on IVDG, and in 12 (71 %) patients on ABVD (p = 0.9). Both of the groups were comparable in terms of the prevalence of chronic heart failure and chronic obstructive pulmonary disease. The prevalence of ischemic heart disease was higher in the IVDG group (n = 16) compared to ABVD (n = 8) (p = 0.04). Results. IVDG an...

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“…Based on the results of the GHSG HD10 and HD13 trials in early stage favorable cHL of the German Hodgkin Study Group two cycles of ABVD followed by 20 Gy involved field radiotherapy (IF-RT) are a widely accepted standard of care. Results from these studies showed long-term PFS rates of over 90 % [15,16] with very small room for further improvement. Therefore the innovation and development in treatment technics of radiotherapy have to be evaluated for avoiding long-term side effects [17].…”

Section: Rationale For Use In Early Stage Hodgkin Lymphomamentioning

confidence: 98%

Checkpoint inhibitors and radiation treatment in Hodgkin’s lymphoma

et al. 2016

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Background Patients with classical Hodgkin's lymphoma (cHL) have a good prognosis even in advanced stages. However, combined chemo-and radiotherapy, as the standard of care, is also associated with treatment-related toxicities such as organ damage, secondary neoplasias, infertility, or fatigue and long-term fatigue. Many patients suffer from this burden although their cHL was cured. Therefore, the efficacy of immune checkpoint inhibitors like anti-PD1/PD-L1 antibodies in the treatment of solid cancers and also in HL offers new options. A remarkable and durable response rate with a favorable toxicity profile was observed in heavily pretreated cHL patients. Methods Planning to perform prospective randomized clinical trials in the content of radio-immune treatment in patients with Hodgkin's lymphoma (HL), we transferred the results of preliminary clinical studies and basic research in clinical relevant study concepts. Results Based on these promising early phase trial data, the German Hodgkin Study Group (GHSG) will investigate innovative treatment regimens in upcoming phase II trials.

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Omission of dacarbazine or bleomycin, or both, from the ABVD regimen in treatment of early-stage favourable Hodgkin's lymphoma (GHSG HD13): an open-label, randomised, non-inferiority trial

Cited by 161 publications

References 29 publications

The European Hematology Association Roadmap for European Hematology Research: a consensus document

The European Hematology Association Roadmap for European Hematology Research: a consensus document

The IVDG Regimen is the Possible Treatment of Choice as First Line Therapy For Hodgkin’s Lymphoma in Elderly Patients with Cardiovascular and Pulmonary Comorbidity

Checkpoint inhibitors and radiation treatment in Hodgkin’s lymphoma

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