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

Persistent Link:
http://hdl.handle.net/10150/616995
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
Author:
Press, O. W.; Li, H.; Schoder, H.; Straus, D. J.; Moskowitz, C. H.; LeBlanc, M.; Rimsza, L. M.; Bartlett, N. L.; Evens, A. M.; Mittra, E. S.; LaCasce, A. S.; Sweetenham, J. W.; Barr, P. M.; Fanale, M. A.; Knopp, M. V.; Noy, A.; Hsi, E. D.; Cook, J. R.; Lechowicz, M. J.; Gascoyne, R. D.; Leonard, J. P.; Kahl, B. S.; Cheson, B. D.; Fisher, R. I.; Friedberg, J. W.
Affiliation:
Univ Arizona
Issue Date:
2016-04-11
Publisher:
AMER SOC CLINICAL ONCOLOGY
Citation:
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 2016, 34 (17):2020 Journal of Clinical Oncology
Journal:
Journal of Clinical Oncology
Rights:
© 2016 by American Society of Clinical Oncology
Collection Information:
This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.
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%.
Note:
Published online ahead of print at www.jco.org on April 11, 2016. 12 month embargo.
ISSN:
0732-183X; 1527-7755
DOI:
10.1200/JCO.2015.63.1119
Version:
Final published version
Sponsors:
Public Health Service, Department of Health and Human Services, National Cancer Institute (NCI), National Clinical Trials Network [CA180888, CA180819, CA180821, CA180820, CA180799, CA180816, CA180801, CA180835, CA180858, CA180846, CA180818, CA180828, CA180826, CA180834]; NCI Community Oncology Research Program [CA189830, CA189971, CA189808, CA189854, CA189821, CA189848, CA189858, CA189860, CA189872, CA189856]; National Institutes of Health (NIH)-NCI [CA31946]; NIH American Recovery and Reinvestment [3U10CA032102-30S1]; NCI AIDS Malignancy Clinical Trials Consortium [CA121947]; David and Patricia Giuliani Family Foundation; Lymphoma Foundation; Adam Spector Fund for Hodgkin's Research; Ernest and Jeanette Dicker Charitable Foundation
Additional Links:
http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.63.1119

Full metadata record

DC FieldValue Language
dc.contributor.authorPress, O. W.en
dc.contributor.authorLi, H.en
dc.contributor.authorSchoder, H.en
dc.contributor.authorStraus, D. J.en
dc.contributor.authorMoskowitz, C. H.en
dc.contributor.authorLeBlanc, M.en
dc.contributor.authorRimsza, L. M.en
dc.contributor.authorBartlett, N. L.en
dc.contributor.authorEvens, A. M.en
dc.contributor.authorMittra, E. S.en
dc.contributor.authorLaCasce, A. S.en
dc.contributor.authorSweetenham, J. W.en
dc.contributor.authorBarr, P. M.en
dc.contributor.authorFanale, M. A.en
dc.contributor.authorKnopp, M. V.en
dc.contributor.authorNoy, A.en
dc.contributor.authorHsi, E. D.en
dc.contributor.authorCook, J. R.en
dc.contributor.authorLechowicz, M. J.en
dc.contributor.authorGascoyne, R. D.en
dc.contributor.authorLeonard, J. P.en
dc.contributor.authorKahl, B. S.en
dc.contributor.authorCheson, B. D.en
dc.contributor.authorFisher, R. I.en
dc.contributor.authorFriedberg, J. W.en
dc.date.accessioned2016-07-15T00:47:32Z-
dc.date.available2016-07-15T00:47:32Z-
dc.date.issued2016-04-11-
dc.identifier.citationUS 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 2016, 34 (17):2020 Journal of Clinical Oncologyen
dc.identifier.issn0732-183X-
dc.identifier.issn1527-7755-
dc.identifier.doi10.1200/JCO.2015.63.1119-
dc.identifier.urihttp://hdl.handle.net/10150/616995-
dc.description.abstractPurpose 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%.en
dc.description.sponsorshipPublic Health Service, Department of Health and Human Services, National Cancer Institute (NCI), National Clinical Trials Network [CA180888, CA180819, CA180821, CA180820, CA180799, CA180816, CA180801, CA180835, CA180858, CA180846, CA180818, CA180828, CA180826, CA180834]; NCI Community Oncology Research Program [CA189830, CA189971, CA189808, CA189854, CA189821, CA189848, CA189858, CA189860, CA189872, CA189856]; National Institutes of Health (NIH)-NCI [CA31946]; NIH American Recovery and Reinvestment [3U10CA032102-30S1]; NCI AIDS Malignancy Clinical Trials Consortium [CA121947]; David and Patricia Giuliani Family Foundation; Lymphoma Foundation; Adam Spector Fund for Hodgkin's Research; Ernest and Jeanette Dicker Charitable Foundationen
dc.language.isoenen
dc.publisherAMER SOC CLINICAL ONCOLOGYen
dc.relation.urlhttp://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.63.1119en
dc.rights© 2016 by American Society of Clinical Oncologyen
dc.titleUS Intergroup Trial of Response-Adapted Therapy for Stage III to IV Hodgkin Lymphoma Using Early Interim Fluorodeoxyglucose-Positron Emission Tomography Imaging: Southwest Oncology Group S0816en
dc.typeArticleen
dc.contributor.departmentUniv Arizonaen
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.notePublished online ahead of print at www.jco.org on April 11, 2016. 12 month embargo.en
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
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