US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging

Southwest Oncology Group S0816

Oliver W. Press, Hongli Li, Heiko Schöder, David J. Straus, Craig Moskowitz, Michael LeBlanc, Lisa M. Rimsza, Nancy L. Bartlett, Andrew M. Evens, Erik S. Mittra, Ann S. LaCasce, John W. Sweetenham, Paul M. Barr, Michelle A. Fanale, Michael V. Knopp, Ariela Noy, Eric D. Hsi, James R. Cook, Mary Jo Lechowicz, Randy D. Gascoyne & 5 others John P. Leonard, Brad S. Kahl, Bruce D. Cheson, Richard I. Fisher, Jonathan W. Friedberg

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Purpose: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. Patients and Methods: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012. A PET scan was performed after two initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and was labeled PET2. PET2-negative patients (Deauville score 1 to 3) received an additional four cycles of ABVD, whereas PET2-positive patients (Deauville score 4 to 5) were switched to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) for six cycles. Among 336 eligible and evaluable patients, the median age was 32 years (range, 18 to 60 years), with 52% stage III, 48% stage IV, 49% International Prognostic Score 0 to 2, and 51% score 3 to 7. Results: Three hundred thirty-six of the enrolled patients were evaluable. Central review of the interim PET2 scan was performed in 331 evaluable patients, with 271 (82%) PET2-negative and 60 (18%) PET2-positive. Of 60 eligible PET2-positive patients, 49 switched to eBEACOPP as planned and 11 declined. With a median follow-up of 39.7 months, the Kaplan-Meier estimate for 2-year overall survival was 98% (95% CI, 95% to 99%), and the 2-year estimate for progression-free survival (PFS) was 79% (95% CI, 74% to 83%). The 2-year estimate for PFS in the subset of patients who were PET2-positive after two cycles of ABVD was 64% (95% CI, 50% to 75%). Both nonhematologic and hematologic toxicities were greater in the eBEACOPP arm than in the continued ABVD arm. Conclusion: Response-adapted therapy based on interim PET imaging after two cycles of ABVD seems promising with a 2-year PFS of 64% for PET2-positive patients, which is much higher than the expected 2-year PFS of 15% to 30%.

Original languageEnglish (US)
Pages (from-to)2020-2027
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number17
DOIs
StatePublished - Jun 10 2016
Externally publishedYes

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Hodgkin Disease
Positron-Emission Tomography
Disease-Free Survival
Therapeutics
Bleomycin
Doxorubicin
Procarbazine
Dacarbazine
Phase II Clinical Trials
Vinblastine
Fluorodeoxyglucose F18
Kaplan-Meier Estimate
Vincristine
Granulocyte Colony-Stimulating Factor
Etoposide
Prednisone
Combination Drug Therapy
Cyclophosphamide
Neoplasms
Leukemia

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging : Southwest Oncology Group S0816. / Press, Oliver W.; Li, Hongli; Schöder, Heiko; Straus, David J.; Moskowitz, Craig; LeBlanc, Michael; Rimsza, Lisa M.; Bartlett, Nancy L.; Evens, Andrew M.; Mittra, Erik S.; LaCasce, Ann S.; Sweetenham, John W.; Barr, Paul M.; Fanale, Michelle A.; Knopp, Michael V.; Noy, Ariela; Hsi, Eric D.; Cook, James R.; Lechowicz, Mary Jo; Gascoyne, Randy D.; Leonard, John P.; Kahl, Brad S.; Cheson, Bruce D.; Fisher, Richard I.; Friedberg, Jonathan W.

In: Journal of Clinical Oncology, Vol. 34, No. 17, 10.06.2016, p. 2020-2027.

Research output: Contribution to journalArticle

Press, OW, Li, H, Schöder, H, Straus, DJ, Moskowitz, C, LeBlanc, M, Rimsza, LM, Bartlett, NL, Evens, AM, Mittra, ES, LaCasce, AS, Sweetenham, JW, Barr, PM, Fanale, MA, Knopp, MV, Noy, A, Hsi, ED, Cook, JR, Lechowicz, MJ, Gascoyne, RD, Leonard, JP, Kahl, BS, Cheson, BD, Fisher, RI & Friedberg, JW 2016, 'US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging: Southwest Oncology Group S0816', Journal of Clinical Oncology, vol. 34, no. 17, pp. 2020-2027. https://doi.org/10.1200/JCO.2015.63.1119
Press, Oliver W. ; Li, Hongli ; Schöder, Heiko ; Straus, David J. ; Moskowitz, Craig ; LeBlanc, Michael ; Rimsza, Lisa M. ; Bartlett, Nancy L. ; Evens, Andrew M. ; Mittra, Erik S. ; LaCasce, Ann S. ; Sweetenham, John W. ; Barr, Paul M. ; Fanale, Michelle A. ; Knopp, Michael V. ; Noy, Ariela ; Hsi, Eric D. ; Cook, James R. ; Lechowicz, Mary Jo ; Gascoyne, Randy D. ; Leonard, John P. ; Kahl, Brad S. ; Cheson, Bruce D. ; Fisher, Richard I. ; Friedberg, Jonathan W. / US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging : Southwest Oncology Group S0816. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 17. pp. 2020-2027.
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title = "US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging: Southwest Oncology Group S0816",
abstract = "Purpose: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. Patients and Methods: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012. A PET scan was performed after two initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and was labeled PET2. PET2-negative patients (Deauville score 1 to 3) received an additional four cycles of ABVD, whereas PET2-positive patients (Deauville score 4 to 5) were switched to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) for six cycles. Among 336 eligible and evaluable patients, the median age was 32 years (range, 18 to 60 years), with 52{\%} stage III, 48{\%} stage IV, 49{\%} International Prognostic Score 0 to 2, and 51{\%} score 3 to 7. Results: Three hundred thirty-six of the enrolled patients were evaluable. Central review of the interim PET2 scan was performed in 331 evaluable patients, with 271 (82{\%}) PET2-negative and 60 (18{\%}) PET2-positive. Of 60 eligible PET2-positive patients, 49 switched to eBEACOPP as planned and 11 declined. With a median follow-up of 39.7 months, the Kaplan-Meier estimate for 2-year overall survival was 98{\%} (95{\%} CI, 95{\%} to 99{\%}), and the 2-year estimate for progression-free survival (PFS) was 79{\%} (95{\%} CI, 74{\%} to 83{\%}). The 2-year estimate for PFS in the subset of patients who were PET2-positive after two cycles of ABVD was 64{\%} (95{\%} CI, 50{\%} to 75{\%}). Both nonhematologic and hematologic toxicities were greater in the eBEACOPP arm than in the continued ABVD arm. Conclusion: Response-adapted therapy based on interim PET imaging after two cycles of ABVD seems promising with a 2-year PFS of 64{\%} for PET2-positive patients, which is much higher than the expected 2-year PFS of 15{\%} to 30{\%}.",
author = "Press, {Oliver W.} and Hongli Li and Heiko Sch{\"o}der and Straus, {David J.} and Craig Moskowitz and Michael LeBlanc and Rimsza, {Lisa M.} and Bartlett, {Nancy L.} and Evens, {Andrew M.} and Mittra, {Erik S.} and LaCasce, {Ann S.} and Sweetenham, {John W.} and Barr, {Paul M.} and Fanale, {Michelle A.} and Knopp, {Michael V.} and Ariela Noy and Hsi, {Eric D.} and Cook, {James R.} and Lechowicz, {Mary Jo} and Gascoyne, {Randy D.} and Leonard, {John P.} and Kahl, {Brad S.} and Cheson, {Bruce D.} and Fisher, {Richard I.} and Friedberg, {Jonathan W.}",
year = "2016",
month = "6",
day = "10",
doi = "10.1200/JCO.2015.63.1119",
language = "English (US)",
volume = "34",
pages = "2020--2027",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
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TY - JOUR

T1 - US intergroup trial of response-adapted therapy for stage III to IV Hodgkin lymphoma using early interim fluorodeoxyglucose-positron emission tomography imaging

T2 - Southwest Oncology Group S0816

AU - Press, Oliver W.

AU - Li, Hongli

AU - Schöder, Heiko

AU - Straus, David J.

AU - Moskowitz, Craig

AU - LeBlanc, Michael

AU - Rimsza, Lisa M.

AU - Bartlett, Nancy L.

AU - Evens, Andrew M.

AU - Mittra, Erik S.

AU - LaCasce, Ann S.

AU - Sweetenham, John W.

AU - Barr, Paul M.

AU - Fanale, Michelle A.

AU - Knopp, Michael V.

AU - Noy, Ariela

AU - Hsi, Eric D.

AU - Cook, James R.

AU - Lechowicz, Mary Jo

AU - Gascoyne, Randy D.

AU - Leonard, John P.

AU - Kahl, Brad S.

AU - Cheson, Bruce D.

AU - Fisher, Richard I.

AU - Friedberg, Jonathan W.

PY - 2016/6/10

Y1 - 2016/6/10

N2 - Purpose: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. Patients and Methods: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012. A PET scan was performed after two initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and was labeled PET2. PET2-negative patients (Deauville score 1 to 3) received an additional four cycles of ABVD, whereas PET2-positive patients (Deauville score 4 to 5) were switched to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) for six cycles. Among 336 eligible and evaluable patients, the median age was 32 years (range, 18 to 60 years), with 52% stage III, 48% stage IV, 49% International Prognostic Score 0 to 2, and 51% score 3 to 7. Results: Three hundred thirty-six of the enrolled patients were evaluable. Central review of the interim PET2 scan was performed in 331 evaluable patients, with 271 (82%) PET2-negative and 60 (18%) PET2-positive. Of 60 eligible PET2-positive patients, 49 switched to eBEACOPP as planned and 11 declined. With a median follow-up of 39.7 months, the Kaplan-Meier estimate for 2-year overall survival was 98% (95% CI, 95% to 99%), and the 2-year estimate for progression-free survival (PFS) was 79% (95% CI, 74% to 83%). The 2-year estimate for PFS in the subset of patients who were PET2-positive after two cycles of ABVD was 64% (95% CI, 50% to 75%). Both nonhematologic and hematologic toxicities were greater in the eBEACOPP arm than in the continued ABVD arm. Conclusion: Response-adapted therapy based on interim PET imaging after two cycles of ABVD seems promising with a 2-year PFS of 64% for PET2-positive patients, which is much higher than the expected 2-year PFS of 15% to 30%.

AB - Purpose: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. Patients and Methods: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012. A PET scan was performed after two initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and was labeled PET2. PET2-negative patients (Deauville score 1 to 3) received an additional four cycles of ABVD, whereas PET2-positive patients (Deauville score 4 to 5) were switched to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) for six cycles. Among 336 eligible and evaluable patients, the median age was 32 years (range, 18 to 60 years), with 52% stage III, 48% stage IV, 49% International Prognostic Score 0 to 2, and 51% score 3 to 7. Results: Three hundred thirty-six of the enrolled patients were evaluable. Central review of the interim PET2 scan was performed in 331 evaluable patients, with 271 (82%) PET2-negative and 60 (18%) PET2-positive. Of 60 eligible PET2-positive patients, 49 switched to eBEACOPP as planned and 11 declined. With a median follow-up of 39.7 months, the Kaplan-Meier estimate for 2-year overall survival was 98% (95% CI, 95% to 99%), and the 2-year estimate for progression-free survival (PFS) was 79% (95% CI, 74% to 83%). The 2-year estimate for PFS in the subset of patients who were PET2-positive after two cycles of ABVD was 64% (95% CI, 50% to 75%). Both nonhematologic and hematologic toxicities were greater in the eBEACOPP arm than in the continued ABVD arm. Conclusion: Response-adapted therapy based on interim PET imaging after two cycles of ABVD seems promising with a 2-year PFS of 64% for PET2-positive patients, which is much higher than the expected 2-year PFS of 15% to 30%.

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