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

We explored activity and safety of a dose-dense/dose-intense adriamycin, bleomycin, vinblastine and dacarbazine regimen ( ABVD_DD-DI) in 82 patients with advanced Hodgkin Lymphoma. Patients entered a two-stage Bryant- Day Phase II study to receive six cycles of ABVD_DD-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. ABVD_DD-DI regimen was well-tolerated and ensured substantial CR and EFS rates without radiotherapy. [ABSTRACT FROM AUTHOR]