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

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Abstract

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.

Original languageEnglish
Pages (from-to)118-129
Number of pages12
JournalBritish Journal of Haematology
Volume166
Issue number1
DOIs
Publication statusPublished - 2014

Fingerprint

Hodgkin Disease
Doxorubicin
Radiotherapy
Disease-Free Survival
Dacarbazine
Vinblastine
Bleomycin
Granulocyte Colony-Stimulating Factor
Neutropenia
Anemia
Safety
Infection
Pharmaceutical Preparations

Keywords

  • ABVD
  • Dose intensity
  • Doxorubicin
  • Hodgkin lymphoma
  • Radiotherapy

ASJC Scopus subject areas

  • Hematology

Cite this

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title = "A phase II study of dose-dense and dose-intense ABVD (ABVDDD-DI) without consolidation radiotherapy in patients with advanced Hodgkin lymphoma",
abstract = "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.",
keywords = "ABVD, Dose intensity, Doxorubicin, Hodgkin lymphoma, Radiotherapy",
author = "Filippo Russo and Gaetano Corazzelli and Ferdinando Frigeri and Gaetana Capobianco and Luigi Aloj and Francesco Volzone and {De Chiara}, Annarosaria and Annamaria Bonelli and Tindaro Gatani and Gianpaolo Marcacci and Daniela Donnarumma and Cristina Becchimanzi and {de Lutio}, Elisabetta and Franco Ionna and {De Filippi}, Rosaria and Secondo Lastoria and Antonello Pinto",
year = "2014",
doi = "10.1111/bjh.12862",
language = "English",
volume = "166",
pages = "118--129",
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TY - JOUR

T1 - A phase II study of dose-dense and dose-intense ABVD (ABVDDD-DI) without consolidation radiotherapy in patients with advanced Hodgkin lymphoma

AU - Russo, Filippo

AU - Corazzelli, Gaetano

AU - Frigeri, Ferdinando

AU - Capobianco, Gaetana

AU - Aloj, Luigi

AU - Volzone, Francesco

AU - De Chiara, Annarosaria

AU - Bonelli, Annamaria

AU - Gatani, Tindaro

AU - Marcacci, Gianpaolo

AU - Donnarumma, Daniela

AU - Becchimanzi, Cristina

AU - de Lutio, Elisabetta

AU - Ionna, Franco

AU - De Filippi, Rosaria

AU - Lastoria, Secondo

AU - Pinto, Antonello

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - ABVD

KW - Dose intensity

KW - Doxorubicin

KW - Hodgkin lymphoma

KW - Radiotherapy

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