T. Vassilakopoulos, Z. Mellios, G. Papageorgiou, A. Piperidou, E. Verigou, C. Chatzidimitriou, C. Kalpadakis, E. Katodritou, H. Giatra, V. Xanthopoulos, G. Gainaru, E. Vrakidou, T. Leonidopoulou, M. Kotsopoulou, M. Palassopoulou, S. Karakatsanis, M. Tsirogianni, E. Hatzimichael, E. Terpos, P. Zikos, C. Poziopoulos, E. Vervessou, M. Arapaki, A. Kopsaftopoulou, A. Liaskas, P. Katsaouni, J. Assimakopoulos, G. Kourti, D. Koutsiafes, M. Siakantaris, G. Karianakis, A. Symeonidis, D. Grentzelias, V. Pappa, P. Tsirigotis, E. Papadaki, E. Plata, M. Bakiri, G. Pangalis, M. Angelopoulou, M. Bouzani
{"title":"利妥昔单抗剂量调整起始期与利妥昔单抗治疗原发性纵隔大b细胞淋巴瘤","authors":"T. Vassilakopoulos, Z. Mellios, G. Papageorgiou, A. Piperidou, E. Verigou, C. Chatzidimitriou, C. Kalpadakis, E. Katodritou, H. Giatra, V. Xanthopoulos, G. Gainaru, E. Vrakidou, T. Leonidopoulou, M. Kotsopoulou, M. Palassopoulou, S. Karakatsanis, M. Tsirogianni, E. Hatzimichael, E. Terpos, P. Zikos, C. Poziopoulos, E. Vervessou, M. Arapaki, A. Kopsaftopoulou, A. Liaskas, P. Katsaouni, J. Assimakopoulos, G. Kourti, D. Koutsiafes, M. Siakantaris, G. Karianakis, A. Symeonidis, D. Grentzelias, V. Pappa, P. Tsirigotis, E. Papadaki, E. Plata, M. Bakiri, G. Pangalis, M. Angelopoulou, M. Bouzani","doi":"10.1002/hon.70094_346","DOIUrl":null,"url":null,"abstract":"<p><b>Background:</b> Further to the impressive phase 2 NCI results, retrospective comparisons have shown a modest, non-significant benefit in disease control and a reduced need for consolidative radiotherapy (RT) with R-da-EPOCH versus R-CHOP in PMLBCL. However, the numbers of patients were small-to-moderate (<< 100) and the choice of treatment was at the discretion of the treating physician, inevitably introducing systematic bias.</p><p><b>Aims:</b> To evaluate the efficacy of R-da-EPOCH versus R-CHOP with an -as much as possible- unbiased selection of control group patients</p><p><b>Methods:</b> R-da-EPOCH was adopted in all consecutive patients with PMLBCL ≤ 65 years (<i>n</i> = 156) in 18 participating Centers, which were providing R-CHOP as standard of care until that time. The control group of R-CHOP-treated patients was devised from the same Centers’ database, selecting in chronological order (most recent first) an equal number of consecutive patients to those treated with R-da-EPOCH at the same Center, if possible, thus minimizing selection bias. Due to lack of some appropriate controls in a few Centers (< 20 R-CHOP-treated patients less), they were substituted by consecutive patients treated in few of the other centers, which had comparable potential (large or small, public or private centers). R-CHOP-14 was given in 22/156 patients of the control group (14%).</p><p><b>Results:</b> The groups of R-da-EPOCH (<i>n</i> = 156) and R-CHOP-treated patients (<i>n</i> = 156) were absolutely comparable in terms of patients’ characteristics except for more frequent multiple extranodal involvement in R-CHOP (8.4% vs. 16.0%, <i>p</i> = 0.042). The 5-year freedom from progression (FFP), event-free survival (EFS) and overall survival (OS) rates for R-da-EPOCH versus R-CHOP were 87.5% versus 75.5% (<i>p</i> = 0.011), 84.4% versus 75.5% (<i>p</i> = 0.052 counting 4 t-AML cases after R-da-EPOCH as events) and 94.1% versus 86.9% (<i>p</i> = 0.039). Among patients potentially eligible for RT (no progressive disease), RT was administered to 10% versus 70% after R-da-EPOCH or R-CHOP. In multivariate analysis, after adjustment for age, gender, multiple extranodal sites and recently published prognostic models (extranodal and LDH > 2x or bulk) the difference between R-da-EPOCH and R-CHOP remained significant regarding FFP, OS and EFS, when the extranodal-LDH model was assessed, but only for FFP when the extranodal-bulk model was taken into account (0.10 < <i>p</i> < 0.20 for EFS and OS). Only 77 (58%) of 133 patients with currently available data had absolute adherence to R-da-EPOCH protocol, reflecting the real-life situation. These patients had a 5-year FFP of 90.9% and 85.1% (<i>p</i> = 0.30).</p><p><b>Conclusion:</b> Our non-randomized, comparative study is by far the largest one comparing R-da-EPOCH versus R-CHOP and carried the least possible systematic error in the retrospective setting. R-da-EPOCH minimized the need of RT and demonstrated significantly better outcomes. Given the frequent protocol deviations with R-da-EPOCH and the use of R-CHOP-14 in a minority of patients, the difference between the regimens may be larger.</p><p><b>Keywords:</b> aggressive B-cell non-Hodgkin lymphoma; chemotherapy</p><p>No potential sources of conflict of interest.</p>","PeriodicalId":12882,"journal":{"name":"Hematological Oncology","volume":"43 S3","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hon.70094_346","citationCount":"0","resultStr":"{\"title\":\"RITUXIMAB-DOSE-ADJUSTED EPOCH VERSUS RITUXIMAB-CHOP IN PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA\",\"authors\":\"T. Vassilakopoulos, Z. Mellios, G. Papageorgiou, A. Piperidou, E. Verigou, C. Chatzidimitriou, C. Kalpadakis, E. Katodritou, H. Giatra, V. Xanthopoulos, G. 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Due to lack of some appropriate controls in a few Centers (< 20 R-CHOP-treated patients less), they were substituted by consecutive patients treated in few of the other centers, which had comparable potential (large or small, public or private centers). R-CHOP-14 was given in 22/156 patients of the control group (14%).</p><p><b>Results:</b> The groups of R-da-EPOCH (<i>n</i> = 156) and R-CHOP-treated patients (<i>n</i> = 156) were absolutely comparable in terms of patients’ characteristics except for more frequent multiple extranodal involvement in R-CHOP (8.4% vs. 16.0%, <i>p</i> = 0.042). The 5-year freedom from progression (FFP), event-free survival (EFS) and overall survival (OS) rates for R-da-EPOCH versus R-CHOP were 87.5% versus 75.5% (<i>p</i> = 0.011), 84.4% versus 75.5% (<i>p</i> = 0.052 counting 4 t-AML cases after R-da-EPOCH as events) and 94.1% versus 86.9% (<i>p</i> = 0.039). Among patients potentially eligible for RT (no progressive disease), RT was administered to 10% versus 70% after R-da-EPOCH or R-CHOP. In multivariate analysis, after adjustment for age, gender, multiple extranodal sites and recently published prognostic models (extranodal and LDH > 2x or bulk) the difference between R-da-EPOCH and R-CHOP remained significant regarding FFP, OS and EFS, when the extranodal-LDH model was assessed, but only for FFP when the extranodal-bulk model was taken into account (0.10 < <i>p</i> < 0.20 for EFS and OS). Only 77 (58%) of 133 patients with currently available data had absolute adherence to R-da-EPOCH protocol, reflecting the real-life situation. These patients had a 5-year FFP of 90.9% and 85.1% (<i>p</i> = 0.30).</p><p><b>Conclusion:</b> Our non-randomized, comparative study is by far the largest one comparing R-da-EPOCH versus R-CHOP and carried the least possible systematic error in the retrospective setting. 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RITUXIMAB-DOSE-ADJUSTED EPOCH VERSUS RITUXIMAB-CHOP IN PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA
Background: Further to the impressive phase 2 NCI results, retrospective comparisons have shown a modest, non-significant benefit in disease control and a reduced need for consolidative radiotherapy (RT) with R-da-EPOCH versus R-CHOP in PMLBCL. However, the numbers of patients were small-to-moderate (<< 100) and the choice of treatment was at the discretion of the treating physician, inevitably introducing systematic bias.
Aims: To evaluate the efficacy of R-da-EPOCH versus R-CHOP with an -as much as possible- unbiased selection of control group patients
Methods: R-da-EPOCH was adopted in all consecutive patients with PMLBCL ≤ 65 years (n = 156) in 18 participating Centers, which were providing R-CHOP as standard of care until that time. The control group of R-CHOP-treated patients was devised from the same Centers’ database, selecting in chronological order (most recent first) an equal number of consecutive patients to those treated with R-da-EPOCH at the same Center, if possible, thus minimizing selection bias. Due to lack of some appropriate controls in a few Centers (< 20 R-CHOP-treated patients less), they were substituted by consecutive patients treated in few of the other centers, which had comparable potential (large or small, public or private centers). R-CHOP-14 was given in 22/156 patients of the control group (14%).
Results: The groups of R-da-EPOCH (n = 156) and R-CHOP-treated patients (n = 156) were absolutely comparable in terms of patients’ characteristics except for more frequent multiple extranodal involvement in R-CHOP (8.4% vs. 16.0%, p = 0.042). The 5-year freedom from progression (FFP), event-free survival (EFS) and overall survival (OS) rates for R-da-EPOCH versus R-CHOP were 87.5% versus 75.5% (p = 0.011), 84.4% versus 75.5% (p = 0.052 counting 4 t-AML cases after R-da-EPOCH as events) and 94.1% versus 86.9% (p = 0.039). Among patients potentially eligible for RT (no progressive disease), RT was administered to 10% versus 70% after R-da-EPOCH or R-CHOP. In multivariate analysis, after adjustment for age, gender, multiple extranodal sites and recently published prognostic models (extranodal and LDH > 2x or bulk) the difference between R-da-EPOCH and R-CHOP remained significant regarding FFP, OS and EFS, when the extranodal-LDH model was assessed, but only for FFP when the extranodal-bulk model was taken into account (0.10 < p < 0.20 for EFS and OS). Only 77 (58%) of 133 patients with currently available data had absolute adherence to R-da-EPOCH protocol, reflecting the real-life situation. These patients had a 5-year FFP of 90.9% and 85.1% (p = 0.30).
Conclusion: Our non-randomized, comparative study is by far the largest one comparing R-da-EPOCH versus R-CHOP and carried the least possible systematic error in the retrospective setting. R-da-EPOCH minimized the need of RT and demonstrated significantly better outcomes. Given the frequent protocol deviations with R-da-EPOCH and the use of R-CHOP-14 in a minority of patients, the difference between the regimens may be larger.
期刊介绍：
Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged:
-Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders
-Diagnostic investigations, including imaging and laboratory assays
-Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases
-Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies
-Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems.
Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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