Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkin lymphoma: SWOG S0016

Oliver W. Press, Joseph M. Unger, Lisa M Rimsza, Jonathan W. Friedberg, Michael LeBlanc, Myron S. Czuczman, Mark Kaminski, Rita M. Braziel, Catherine S Perry, Ajay K. Gopal, David G. Maloney, Bruce D. Cheson, Shaker R. Dakhil, Thomas P Miller, Richard I. Fisher

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Abstract

Purpose: Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008 Patients and Methods: Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FLof any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT). Results: After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76% on the CHOP-R arm and 80% on the CHOP-RIT arm (P =.11). The 2-year estimate of overall survival (OS) was 97% on the CHOP-R arm and 93% on the CHOP-RIT arm (P =.08) Conclusion: There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.

Original languageEnglish (US)
Pages (from-to)314-320
Number of pages7
JournalJournal of Clinical Oncology
Volume31
Issue number3
DOIs
StatePublished - Jan 20 2013

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Radioimmunotherapy
Follicular Lymphoma
Non-Hodgkin's Lymphoma
Drug Therapy
Disease-Free Survival
Induction Chemotherapy
Survival
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Leukemia
Therapeutics
Rituximab
Safety
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkin lymphoma : SWOG S0016. / Press, Oliver W.; Unger, Joseph M.; Rimsza, Lisa M; Friedberg, Jonathan W.; LeBlanc, Michael; Czuczman, Myron S.; Kaminski, Mark; Braziel, Rita M.; Perry, Catherine S; Gopal, Ajay K.; Maloney, David G.; Cheson, Bruce D.; Dakhil, Shaker R.; Miller, Thomas P; Fisher, Richard I.

In: Journal of Clinical Oncology, Vol. 31, No. 3, 20.01.2013, p. 314-320.

Research output: Contribution to journalArticle

Press, Oliver W. ; Unger, Joseph M. ; Rimsza, Lisa M ; Friedberg, Jonathan W. ; LeBlanc, Michael ; Czuczman, Myron S. ; Kaminski, Mark ; Braziel, Rita M. ; Perry, Catherine S ; Gopal, Ajay K. ; Maloney, David G. ; Cheson, Bruce D. ; Dakhil, Shaker R. ; Miller, Thomas P ; Fisher, Richard I. / Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkin lymphoma : SWOG S0016. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 3. pp. 314-320.
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title = "Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkin lymphoma: SWOG S0016",
abstract = "Purpose: Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008 Patients and Methods: Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FLof any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT). Results: After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76{\%} on the CHOP-R arm and 80{\%} on the CHOP-RIT arm (P =.11). The 2-year estimate of overall survival (OS) was 97{\%} on the CHOP-R arm and 93{\%} on the CHOP-RIT arm (P =.08) Conclusion: There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.",
author = "Press, {Oliver W.} and Unger, {Joseph M.} and Rimsza, {Lisa M} and Friedberg, {Jonathan W.} and Michael LeBlanc and Czuczman, {Myron S.} and Mark Kaminski and Braziel, {Rita M.} and Perry, {Catherine S} and Gopal, {Ajay K.} and Maloney, {David G.} and Cheson, {Bruce D.} and Dakhil, {Shaker R.} and Miller, {Thomas P} and Fisher, {Richard I.}",
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T1 - Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkin lymphoma

T2 - SWOG S0016

AU - Press, Oliver W.

AU - Unger, Joseph M.

AU - Rimsza, Lisa M

AU - Friedberg, Jonathan W.

AU - LeBlanc, Michael

AU - Czuczman, Myron S.

AU - Kaminski, Mark

AU - Braziel, Rita M.

AU - Perry, Catherine S

AU - Gopal, Ajay K.

AU - Maloney, David G.

AU - Cheson, Bruce D.

AU - Dakhil, Shaker R.

AU - Miller, Thomas P

AU - Fisher, Richard I.

PY - 2013/1/20

Y1 - 2013/1/20

N2 - Purpose: Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008 Patients and Methods: Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FLof any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT). Results: After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76% on the CHOP-R arm and 80% on the CHOP-RIT arm (P =.11). The 2-year estimate of overall survival (OS) was 97% on the CHOP-R arm and 93% on the CHOP-RIT arm (P =.08) Conclusion: There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.

AB - Purpose: Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008 Patients and Methods: Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FLof any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT). Results: After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76% on the CHOP-R arm and 80% on the CHOP-RIT arm (P =.11). The 2-year estimate of overall survival (OS) was 97% on the CHOP-R arm and 93% on the CHOP-RIT arm (P =.08) Conclusion: There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.

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