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.
authors.affiliation: Haematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS, Naples, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Russo
authors.forename: Gaetano
authors.initials: G
authors.lastname: Corazzelli
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Frigeri
authors.forename: Gaetana
authors.initials: G
authors.lastname: Capobianco
authors.forename: Luigi
authors.initials: L
authors.lastname: Aloj
authors.forename: Francesco
authors.initials: F
authors.lastname: Volzone
authors.forename: Annarosaria
authors.initials: A
authors.lastname: De Chiara
authors.forename: Annamaria
authors.initials: A
authors.lastname: Bonelli
authors.forename: Tindaro
authors.initials: T
authors.lastname: Gatani
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Marcacci
authors.forename: Daniela
authors.initials: D
authors.lastname: Donnarumma
authors.forename: Cristina
authors.initials: C
authors.lastname: Becchimanzi
authors.forename: Elisabetta
authors.initials: E
authors.lastname: de Lutio
authors.forename: Franco
authors.initials: F
authors.lastname: Ionna
authors.forename: Rosaria
authors.initials: R
authors.lastname: De Filippi
authors.forename: Secondo
authors.initials: S
authors.lastname: Lastoria
authors.forename: Antonello
authors.initials: A
authors.lastname: Pinto
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D001761:Bleomycin; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin
keywords: ABVD; Hodgkin lymphoma; dose intensity; doxorubicin; radiotherapy