Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients: Results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL)

Francesco Zallio, Stefania Tamiazzo, Chiara Monagheddu, Francesco Merli, Fiorella Ilariucci, Caterina Stelitano, Anna Marina Liberati, Donato Mannina, Umberto Vitolo, Emanuele Angelucci, Delia Rota Scalabrini, Daniele Vallisa, Monica Bellei, Alessia Bari, Giovannino Ciccone, Flavia Salvi, Alessandro Levis

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Abstract

Survival rates for elderly Hodgkin Lymphoma (HL) have not improved substantially in recent years, mainly because of a lack of prospective randomized studies, due to difficulties in enrolling patients. Between 2002 and 2006, 54 untreated HL patients, aged between 65 and 80 years and considered 'non-frail' according to a comprehensive geriatric evaluation, were enrolled into a phase III randomized trial to compare a reduced-intensity regimen (vinblastine, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone, bleomycin; VEPEMB) with standard ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Primary endpoint was progression-free survival (PFS). Seventeen patients were in early stage (I-IIA), while 37 were advanced stage. Median age was 72 years and median follow-up was 76 months. Five-year PFS rates were 48% vs. 70% [adjusted Hazard ratio (HR) = 2·19, 95% confidence interval (CI) = 0·94-5·10, P = 0·068] and 5-year overall survival (OS) rates were 63% vs. 77% (adjusted HR = 1·67, 95% CI = 0·69-4·03, P = 0·254) for VEPEMB compared to ABVD. Overall treatment-related mortality was 4%. World Health Organization grade 4 cardiac and lung toxicity occurred in four patients treated with ABVD versus no cases in the VEPEMB arm. Standard ABVD regimen resulted in better PFS and OS than the VEPEMB, although the differences were not statistically significant. The low toxicity of both treatments was probably attributable to stringent selection of patients based on a Comprehensive Geriatric Assessment that excluded frail patients.

Original languageEnglish
Pages (from-to)879-888
Number of pages10
JournalBritish Journal of Haematology
Volume172
Issue number6
DOIs
Publication statusPublished - Mar 1 2016

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Dacarbazine
Vinblastine
Bleomycin
Hodgkin Disease
Doxorubicin
Disease-Free Survival
Survival Rate
Confidence Intervals
Procarbazine
Geriatric Assessment
Mitoxantrone
Etoposide
Prednisone
Geriatrics
Cyclophosphamide
Patient Selection
Prospective Studies
Lung
Survival
Mortality

Keywords

  • Elderly
  • Hodgkin Lymphoma
  • Randomized study

ASJC Scopus subject areas

  • Hematology

Cite this

Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients : Results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL). / Zallio, Francesco; Tamiazzo, Stefania; Monagheddu, Chiara; Merli, Francesco; Ilariucci, Fiorella; Stelitano, Caterina; Liberati, Anna Marina; Mannina, Donato; Vitolo, Umberto; Angelucci, Emanuele; Rota Scalabrini, Delia; Vallisa, Daniele; Bellei, Monica; Bari, Alessia; Ciccone, Giovannino; Salvi, Flavia; Levis, Alessandro.

In: British Journal of Haematology, Vol. 172, No. 6, 01.03.2016, p. 879-888.

Research output: Contribution to journalArticle

Zallio, F, Tamiazzo, S, Monagheddu, C, Merli, F, Ilariucci, F, Stelitano, C, Liberati, AM, Mannina, D, Vitolo, U, Angelucci, E, Rota Scalabrini, D, Vallisa, D, Bellei, M, Bari, A, Ciccone, G, Salvi, F & Levis, A 2016, 'Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients: Results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL)', British Journal of Haematology, vol. 172, no. 6, pp. 879-888. https://doi.org/10.1111/bjh.13904
Zallio, Francesco ; Tamiazzo, Stefania ; Monagheddu, Chiara ; Merli, Francesco ; Ilariucci, Fiorella ; Stelitano, Caterina ; Liberati, Anna Marina ; Mannina, Donato ; Vitolo, Umberto ; Angelucci, Emanuele ; Rota Scalabrini, Delia ; Vallisa, Daniele ; Bellei, Monica ; Bari, Alessia ; Ciccone, Giovannino ; Salvi, Flavia ; Levis, Alessandro. / Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients : Results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL). In: British Journal of Haematology. 2016 ; Vol. 172, No. 6. pp. 879-888.
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abstract = "Survival rates for elderly Hodgkin Lymphoma (HL) have not improved substantially in recent years, mainly because of a lack of prospective randomized studies, due to difficulties in enrolling patients. Between 2002 and 2006, 54 untreated HL patients, aged between 65 and 80 years and considered 'non-frail' according to a comprehensive geriatric evaluation, were enrolled into a phase III randomized trial to compare a reduced-intensity regimen (vinblastine, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone, bleomycin; VEPEMB) with standard ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Primary endpoint was progression-free survival (PFS). Seventeen patients were in early stage (I-IIA), while 37 were advanced stage. Median age was 72 years and median follow-up was 76 months. Five-year PFS rates were 48{\%} vs. 70{\%} [adjusted Hazard ratio (HR) = 2·19, 95{\%} confidence interval (CI) = 0·94-5·10, P = 0·068] and 5-year overall survival (OS) rates were 63{\%} vs. 77{\%} (adjusted HR = 1·67, 95{\%} CI = 0·69-4·03, P = 0·254) for VEPEMB compared to ABVD. Overall treatment-related mortality was 4{\%}. World Health Organization grade 4 cardiac and lung toxicity occurred in four patients treated with ABVD versus no cases in the VEPEMB arm. Standard ABVD regimen resulted in better PFS and OS than the VEPEMB, although the differences were not statistically significant. The low toxicity of both treatments was probably attributable to stringent selection of patients based on a Comprehensive Geriatric Assessment that excluded frail patients.",
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AU - Monagheddu, Chiara

AU - Merli, Francesco

AU - Ilariucci, Fiorella

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AU - Rota Scalabrini, Delia

AU - Vallisa, Daniele

AU - Bellei, Monica

AU - Bari, Alessia

AU - Ciccone, Giovannino

AU - Salvi, Flavia

AU - Levis, Alessandro

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N2 - Survival rates for elderly Hodgkin Lymphoma (HL) have not improved substantially in recent years, mainly because of a lack of prospective randomized studies, due to difficulties in enrolling patients. Between 2002 and 2006, 54 untreated HL patients, aged between 65 and 80 years and considered 'non-frail' according to a comprehensive geriatric evaluation, were enrolled into a phase III randomized trial to compare a reduced-intensity regimen (vinblastine, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone, bleomycin; VEPEMB) with standard ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Primary endpoint was progression-free survival (PFS). Seventeen patients were in early stage (I-IIA), while 37 were advanced stage. Median age was 72 years and median follow-up was 76 months. Five-year PFS rates were 48% vs. 70% [adjusted Hazard ratio (HR) = 2·19, 95% confidence interval (CI) = 0·94-5·10, P = 0·068] and 5-year overall survival (OS) rates were 63% vs. 77% (adjusted HR = 1·67, 95% CI = 0·69-4·03, P = 0·254) for VEPEMB compared to ABVD. Overall treatment-related mortality was 4%. World Health Organization grade 4 cardiac and lung toxicity occurred in four patients treated with ABVD versus no cases in the VEPEMB arm. Standard ABVD regimen resulted in better PFS and OS than the VEPEMB, although the differences were not statistically significant. The low toxicity of both treatments was probably attributable to stringent selection of patients based on a Comprehensive Geriatric Assessment that excluded frail patients.

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