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- Title
A phase II study of dose-dense and dose-intense ABVD ( ABVD<sub>DD-DI</sub>) without consolidation radiotherapy in patients with advanced Hodgkin lymphoma.
- Authors
Russo, Filippo; Corazzelli, Gaetano; Frigeri, Ferdinando; Capobianco, Gaetana; Aloj, Luigi; Volzone, Francesco; De Chiara, Annarosaria; Bonelli, Annamaria; Gatani, Tindaro; Marcacci, Gianpaolo; Donnarumma, Daniela; Becchimanzi, Cristina; Lutio, Elisabetta; Ionna, Franco; De Filippi, Rosaria; Lastoria, Secondo; Pinto, Antonello
- 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.
- Subjects
HODGKIN'S disease; DOSE-effect relationship in pharmacology; DOXORUBICIN; RADIOTHERAPY; DACARBAZINE; VINBLASTINE
- Publication
British Journal of Haematology, 2014, Vol 166, Issue 1, p118
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.12862