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 language | English |
|---|---|
| Pages (from-to) | 879-888 |
| Number of pages | 10 |
| Journal | British Journal of Haematology |
| Volume | 172 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Mar 1 2016 |
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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 journal › Article
}
TY - JOUR
T1 - Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients
T2 - Results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL)
AU - Zallio, Francesco
AU - Tamiazzo, Stefania
AU - Monagheddu, Chiara
AU - Merli, Francesco
AU - Ilariucci, Fiorella
AU - Stelitano, Caterina
AU - Liberati, Anna Marina
AU - Mannina, Donato
AU - Vitolo, Umberto
AU - Angelucci, Emanuele
AU - Rota Scalabrini, Delia
AU - Vallisa, Daniele
AU - Bellei, Monica
AU - Bari, Alessia
AU - Ciccone, Giovannino
AU - Salvi, Flavia
AU - Levis, Alessandro
PY - 2016/3/1
Y1 - 2016/3/1
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.
AB - 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.
KW - Elderly
KW - Hodgkin Lymphoma
KW - Randomized study
UR - http://www.scopus.com/inward/record.url?scp=84960122990&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84960122990&partnerID=8YFLogxK
U2 - 10.1111/bjh.13904
DO - 10.1111/bjh.13904
M3 - Article
C2 - 26763986
AN - SCOPUS:84960122990
VL - 172
SP - 879
EP - 888
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 6
ER -