Randomized phase III trial ofabvdversus stanfordvwith or without radiation therapy in locally extensive and advanced-stage hodgkin lymphoma: An intergroup study coordinated by the eastern cooperative oncology group (E2496)

Leo I. Gordon, Fangxin Hong, Richard I. Fisher, Nancy L. Bartlett, Joseph M. Connors, Randy D. Gascoyne, Henry Wagner, Patrick J. Stiff, Bruce D. Cheson, Mary Gospodarowicz, Ranjana Advani, Brad S. Kahl, Jonathan W. Friedberg, Kristie A. Blum, Thomas M. Habermann, Joseph Tuscano, Richard T. Hoppe, Sandra J. Horning

Research output: Contribution to journalArticle

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Abstract

Purpose Although 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 There was no significant difference in the overall response rate between the two arms, with complete remission and clinical complete remission rates of 73% for ABVD and 69% for Stanford V. At a median follow-up of 6.4 years, there was no difference in FFS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32). Conclusion ABVD remains the standard of care for patients with advanced Hodgkin lymphoma.

Original languageEnglish (US)
Pages (from-to)684-691
Number of pages8
JournalJournal of Clinical Oncology
Volume31
Issue number6
DOIs
StatePublished - Feb 20 2013

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Hodgkin Disease
Radiotherapy
Survival
Standard of Care
Dacarbazine
Vinblastine
Bleomycin
Doxorubicin
Leukemia
Survival Rate
Clinical Trials
Recurrence
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized phase III trial ofabvdversus stanfordvwith or without radiation therapy in locally extensive and advanced-stage hodgkin lymphoma : An intergroup study coordinated by the eastern cooperative oncology group (E2496). / Gordon, Leo I.; Hong, Fangxin; Fisher, Richard I.; Bartlett, Nancy L.; Connors, Joseph M.; Gascoyne, Randy D.; Wagner, Henry; Stiff, Patrick J.; Cheson, Bruce D.; Gospodarowicz, Mary; Advani, Ranjana; Kahl, Brad S.; Friedberg, Jonathan W.; Blum, Kristie A.; Habermann, Thomas M.; Tuscano, Joseph; Hoppe, Richard T.; Horning, Sandra J.

In: Journal of Clinical Oncology, Vol. 31, No. 6, 20.02.2013, p. 684-691.

Research output: Contribution to journalArticle

Gordon, LI, Hong, F, Fisher, RI, Bartlett, NL, Connors, JM, Gascoyne, RD, Wagner, H, Stiff, PJ, Cheson, BD, Gospodarowicz, M, Advani, R, Kahl, BS, Friedberg, JW, Blum, KA, Habermann, TM, Tuscano, J, Hoppe, RT & Horning, SJ 2013, 'Randomized phase III trial ofabvdversus stanfordvwith or without radiation therapy in locally extensive and advanced-stage hodgkin lymphoma: An intergroup study coordinated by the eastern cooperative oncology group (E2496)', Journal of Clinical Oncology, vol. 31, no. 6, pp. 684-691. https://doi.org/10.1200/JCO.2012.43.4803
Gordon, Leo I. ; Hong, Fangxin ; Fisher, Richard I. ; Bartlett, Nancy L. ; Connors, Joseph M. ; Gascoyne, Randy D. ; Wagner, Henry ; Stiff, Patrick J. ; Cheson, Bruce D. ; Gospodarowicz, Mary ; Advani, Ranjana ; Kahl, Brad S. ; Friedberg, Jonathan W. ; Blum, Kristie A. ; Habermann, Thomas M. ; Tuscano, Joseph ; Hoppe, Richard T. ; Horning, Sandra J. / Randomized phase III trial ofabvdversus stanfordvwith or without radiation therapy in locally extensive and advanced-stage hodgkin lymphoma : An intergroup study coordinated by the eastern cooperative oncology group (E2496). In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 6. pp. 684-691.
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abstract = "Purpose Although 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 There was no significant difference in the overall response rate between the two arms, with complete remission and clinical complete remission rates of 73{\%} for ABVD and 69{\%} for Stanford V. At a median follow-up of 6.4 years, there was no difference in FFS: 74{\%} for ABVD and 71{\%} for Stanford V at 5 years (P = .32). Conclusion ABVD remains the standard of care for patients with advanced Hodgkin lymphoma.",
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T1 - Randomized phase III trial ofabvdversus stanfordvwith or without radiation therapy in locally extensive and advanced-stage hodgkin lymphoma

T2 - An intergroup study coordinated by the eastern cooperative oncology group (E2496)

AU - Gordon, Leo I.

AU - Hong, Fangxin

AU - Fisher, Richard I.

AU - Bartlett, Nancy L.

AU - Connors, Joseph M.

AU - Gascoyne, Randy D.

AU - Wagner, Henry

AU - Stiff, Patrick J.

AU - Cheson, Bruce D.

AU - Gospodarowicz, Mary

AU - Advani, Ranjana

AU - Kahl, Brad S.

AU - Friedberg, Jonathan W.

AU - Blum, Kristie A.

AU - Habermann, Thomas M.

AU - Tuscano, Joseph

AU - Hoppe, Richard T.

AU - Horning, Sandra J.

PY - 2013/2/20

Y1 - 2013/2/20

N2 - Purpose Although 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 There was no significant difference in the overall response rate between the two arms, with complete remission and clinical complete remission rates of 73% for ABVD and 69% for Stanford V. At a median follow-up of 6.4 years, there was no difference in FFS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32). Conclusion ABVD remains the standard of care for patients with advanced Hodgkin lymphoma.

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