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A phase II study of dose-dense and dose-intense ABVD (ABVDDD-DI) without consolidation radiotherapy in patients with advanced Hodgkin lymphoma

Authors :
Annamaria Bonelli
Franco Ionna
Tindaro Gatani
Elisabetta De Lutio
Cristina Becchimanzi
Gaetano Corazzelli
Gianpaolo Marcacci
Antonello Pinto
Rosaria De Filippi
Annarosaria De Chiara
Ferdinando Frigeri
Secondo Lastoria
Gaetana Capobianco
Filippo Russo
Francesco Volzone
Daniela Donnarumma
Luigi Aloj
Russo, F
Corazzelli, G
Frigeri, F
Capobianco, G
Aloj, L
Volzone, F
De Chiara, A
Bonelli, A
Gatani, T
Marcacci, G
Donnarumma, D
Becchimanzi, C
de Lutio, E
Ionna, F
DE FILIPPI, Rosaria
Lastoria, S
Pinto, A.
Source :
British Journal of Haematology. 166:118-129
Publication Year :
2014
Publisher :
Wiley, 2014.

Abstract

Summary We explored activity and safety of a dose-dense/dose-intense adriamycin, bleomycin, vinblastine and dacarbazine regimen (ABVDDD-DI) in 82 patients with advanced Hodgkin Lymphoma. Patients entered a two-stage Bryant-Day Phase II study to receive six cycles of ABVDDD-DI without consolidation radiotherapy. Cycles were supported with granulocyte colony-stimulating factor and delivered every 21 d; drugs were administered on days 1 and 11 at the same doses of standard ABVD except for doxorubicin (35 mg/m2; first four cycles only). Co-primary endpoints were complete response (CR) rate and severe acute cardiopulmonary toxicity; secondary endpoints were event-free (EFS) and disease-free survival (DFS). All patients received the four doxorubicin-intensified courses and 96% concluded all six cycles (82·3% within the intended 18 weeks). This translated into a 66·9% increase of received dose-intensity for doxorubicin and 31·8% for the other agents over standard ABVD. The CR rate was 95·1% (78/82) and 87·8% (72/82) achieved a metabolic CR after two cycles. Cardiopulmonary toxicity never exceeded grade 2 and affected 14·6% of patients. Most frequent toxicities were grade 4 neutropenia (10%) and anaemia (9%), grade 3 infection (17%) and grade 2 mucocutaneous changes (30%). Five-year EFS and DFS was 88·3% and 93·7%, respectively. ABVDDD-DI regimen was well-tolerated and ensured substantial CR and EFS rates without radiotherapy.

Details

ISSN :
00071048
Volume :
166
Database :
OpenAIRE
Journal :
British Journal of Haematology
Accession number :
edsair.doi.dedup.....6b5b6f9402ad058109a6b707d717a227
Full Text :
https://doi.org/10.1111/bjh.12862