Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma

Umberto Vitolo, Marek Trneny, David Belada, John M. Burke, Angelo Michele Carella, Neil Chua, Pau Abrisqueta, J. Demeter, Ian Flinn, Xiaonan Hong, Won Seog Kim, Antonio Pinto, Yuan Kai Shi, Yoichi Tatsumi, Mikkel Z. Oestergaard, Michael Wenger, Gunter Fingerle-Rowson, Olivier Catalani, Tina Nielsen, Maurizio MartelliLaurie H. Sehn

Research output: Article

78 Citations (Scopus)

Abstract

Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5%) and R (215; 30.2%), stratified hazard ratio was 0.92 (95% CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70% and 67%, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7% v 64.7%, respectively) and serious AEs (42.6% v 37.6%, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8% for G-CHOP and 4.3% for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3%; R-CHOP, 40.7%), infusion-related reactions (G-CHOP, 36.1%; R-CHOP, 23.5%), nausea (G-CHOP, 29.4%; R-CHOP, 28.3%), and constipation (G-CHOP, 23.4%; R-CHOP, 24.5%). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.

Original languageEnglish
Pages (from-to)3529-3537
Number of pages9
JournalJournal of Clinical Oncology
Volume35
Issue number31
DOIs
Publication statusPublished - nov. 1 2017

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Lymphoma, Large B-Cell, Diffuse
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Disease-Free Survival
B-Lymphocytes
Research Personnel
Germinal Center
Constipation
Standard of Care
Neutropenia
Nausea
Rituximab
obinutuzumab
Survival Rate
Biomarkers
Monoclonal Antibodies
Observation
Safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma. / Vitolo, Umberto; Trneny, Marek; Belada, David; Burke, John M.; Carella, Angelo Michele; Chua, Neil; Abrisqueta, Pau; Demeter, J.; Flinn, Ian; Hong, Xiaonan; Kim, Won Seog; Pinto, Antonio; Shi, Yuan Kai; Tatsumi, Yoichi; Oestergaard, Mikkel Z.; Wenger, Michael; Fingerle-Rowson, Gunter; Catalani, Olivier; Nielsen, Tina; Martelli, Maurizio; Sehn, Laurie H.

In: Journal of Clinical Oncology, Vol. 35, No. 31, 01.11.2017, p. 3529-3537.

Research output: Article

Vitolo, U, Trneny, M, Belada, D, Burke, JM, Carella, AM, Chua, N, Abrisqueta, P, Demeter, J, Flinn, I, Hong, X, Kim, WS, Pinto, A, Shi, YK, Tatsumi, Y, Oestergaard, MZ, Wenger, M, Fingerle-Rowson, G, Catalani, O, Nielsen, T, Martelli, M & Sehn, LH 2017, 'Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma', Journal of Clinical Oncology, vol. 35, no. 31, pp. 3529-3537. https://doi.org/10.1200/JCO.2017.73.3402
Vitolo, Umberto ; Trneny, Marek ; Belada, David ; Burke, John M. ; Carella, Angelo Michele ; Chua, Neil ; Abrisqueta, Pau ; Demeter, J. ; Flinn, Ian ; Hong, Xiaonan ; Kim, Won Seog ; Pinto, Antonio ; Shi, Yuan Kai ; Tatsumi, Yoichi ; Oestergaard, Mikkel Z. ; Wenger, Michael ; Fingerle-Rowson, Gunter ; Catalani, Olivier ; Nielsen, Tina ; Martelli, Maurizio ; Sehn, Laurie H. / Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 31. pp. 3529-3537.
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title = "Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma",
abstract = "Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5{\%}) and R (215; 30.2{\%}), stratified hazard ratio was 0.92 (95{\%} CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70{\%} and 67{\%}, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7{\%} v 64.7{\%}, respectively) and serious AEs (42.6{\%} v 37.6{\%}, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8{\%} for G-CHOP and 4.3{\%} for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3{\%}; R-CHOP, 40.7{\%}), infusion-related reactions (G-CHOP, 36.1{\%}; R-CHOP, 23.5{\%}), nausea (G-CHOP, 29.4{\%}; R-CHOP, 28.3{\%}), and constipation (G-CHOP, 23.4{\%}; R-CHOP, 24.5{\%}). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.",
author = "Umberto Vitolo and Marek Trneny and David Belada and Burke, {John M.} and Carella, {Angelo Michele} and Neil Chua and Pau Abrisqueta and J. Demeter and Ian Flinn and Xiaonan Hong and Kim, {Won Seog} and Antonio Pinto and Shi, {Yuan Kai} and Yoichi Tatsumi and Oestergaard, {Mikkel Z.} and Michael Wenger and Gunter Fingerle-Rowson and Olivier Catalani and Tina Nielsen and Maurizio Martelli and Sehn, {Laurie H.}",
year = "2017",
month = "11",
day = "1",
doi = "10.1200/JCO.2017.73.3402",
language = "English",
volume = "35",
pages = "3529--3537",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
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}

TY - JOUR

T1 - Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma

AU - Vitolo, Umberto

AU - Trneny, Marek

AU - Belada, David

AU - Burke, John M.

AU - Carella, Angelo Michele

AU - Chua, Neil

AU - Abrisqueta, Pau

AU - Demeter, J.

AU - Flinn, Ian

AU - Hong, Xiaonan

AU - Kim, Won Seog

AU - Pinto, Antonio

AU - Shi, Yuan Kai

AU - Tatsumi, Yoichi

AU - Oestergaard, Mikkel Z.

AU - Wenger, Michael

AU - Fingerle-Rowson, Gunter

AU - Catalani, Olivier

AU - Nielsen, Tina

AU - Martelli, Maurizio

AU - Sehn, Laurie H.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5%) and R (215; 30.2%), stratified hazard ratio was 0.92 (95% CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70% and 67%, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7% v 64.7%, respectively) and serious AEs (42.6% v 37.6%, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8% for G-CHOP and 4.3% for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3%; R-CHOP, 40.7%), infusion-related reactions (G-CHOP, 36.1%; R-CHOP, 23.5%), nausea (G-CHOP, 29.4%; R-CHOP, 28.3%), and constipation (G-CHOP, 23.4%; R-CHOP, 24.5%). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.

AB - Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5%) and R (215; 30.2%), stratified hazard ratio was 0.92 (95% CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70% and 67%, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7% v 64.7%, respectively) and serious AEs (42.6% v 37.6%, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8% for G-CHOP and 4.3% for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3%; R-CHOP, 40.7%), infusion-related reactions (G-CHOP, 36.1%; R-CHOP, 23.5%), nausea (G-CHOP, 29.4%; R-CHOP, 28.3%), and constipation (G-CHOP, 23.4%; R-CHOP, 24.5%). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.

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U2 - 10.1200/JCO.2017.73.3402

DO - 10.1200/JCO.2017.73.3402

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JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

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