Randomized Phase III Trial of ABVD Versus Stanford V With or Without Radiation Therapy in Locally Extensive and Advanced-Stage Hodgkin Lymphoma: An Intergroup Study Coordinated by the Eastern Cooperative Oncology Group (E2496)

Mary Gospodarowicz, University of Toronto, Toronto, Ontario, Canada
Journal of Clinical Oncology (Impact Factor: 18.43). 11/2012; 31(6). DOI: 10.1200/JCO.2012.43.4803
Source: PubMed


PURPOSEAlthough ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) has been established as the standard of care in patients with advanced Hodgkin lymphoma, newer regimens have been investigated, which have appeared superior in early phase II studies. Our aim was to determine if failure-free survival was superior in patients treated with the Stanford V regimen compared with ABVD. PATIENTS AND METHODS
The Eastern Cooperative Oncology Group, along with the Cancer and Leukemia Group B, the Southwest Oncology Group, and the Canadian NCIC Clinical Trials Group, conducted this randomized phase III trial in patients with advanced Hodgkin lymphoma. Stratification factors included extent of disease (localized v extensive) and International Prognostic Factors Project Score (0 to 2 v 3 to 7). The primary end point was failure-free survival (FFS), defined as the time from random assignment to progression, relapse, or death, whichever occurred first. Overall survival, a secondary end point, was measured from random assignment to death as a result of any cause. This design provided 87% power to detect a 33% reduction in FFS hazard rate, or a difference in 5-year FFS of 64% versus 74% at two-sided .05 significance level. RESULTS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32). CONCLUSIONABVD remains the standard of care for patients with advanced Hodgkin lymphoma.

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    • ") and from 65% to 78% for those in which 36–62% of the patients were also given radiotherapy (Gobbi et al, 2005; Johnson et al, 2005; Federico et al, 2009; Hoskin et al, 2009; Viviani et al, 2011; Gordon et al, 2013). "
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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/m(2) ; 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.
    British Journal of Haematology 03/2014; 166(1). DOI:10.1111/bjh.12862 · 4.71 Impact Factor
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    • "[9] [10] [11] [12] Early-stage patients, particularly those with bulky disease (most often defined as a mass greater than 10 cm in long-axis diameter or encompassing more than a third of the intrathoracic diameter) are commonly treated with combined modality approaches of varying intensity.[13] Advanced disease is frequently treated with chemotherapy alone with consolidation radiation therapy to sites of bulk [14], although here, intensity of treatment is often dictated by risk prediction. The next generation of clinical trials seeks more individualized and specific ways to tailor treatment intensity, particularly using responseadapted strategies with early restaging functional imaging with 18-fluorodeoxyglucose (FDG) positron emission tomography (PET). "

    Hodgkin's Lymphoma, 02/2012; , ISBN: 978-953-51-0402-5
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    ABSTRACT: Most children and adolescents with newly diagnosed high-risk Hodgkin lymphoma (HL) will achieve remission and cure with conventional chemotherapy with or without radiation therapy. However, these therapies can lead to long-term side effects. Therapy is titrated on the basis of risk group stratification using clinical prognostic factors and, in most cases, then refined through assessment of interim or end of chemotherapy response, primarily using functional imaging with fluorodeoxyglucose positron emission tomography. No study has clearly demonstrated the factors that are sufficient in identifying the patients at highest risk for relapse that may benefit from therapy intensification. This review summarizes recent clinical trials in paediatric high-risk HL, along with key findings from studies in adults with high-risk HL that are applicable to the paediatric population. New directions in prognostic classification and targeted therapies are reviewed. Considerations for clinical practice at the current time outside the clinical trial setting are provided.
    British Journal of Haematology 12/2011; 157(1). DOI:10.1111/j.1365-2141.2011.08975.x · 4.71 Impact Factor
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