PMID- 32505213
OWN - NLM
STAT- MEDLINE
DCOM- 20210517
LR  - 20210517
IS  - 1756-8722 (Electronic)
IS  - 1756-8722 (Linking)
VI  - 13
IP  - 1
DP  - 2020 Jun 6
TI  - A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP 
      in patients with previously untreated diffuse large B-Cell lymphoma: final 
      analysis of GOYA.
PG  - 71
LID - 10.1186/s13045-020-00900-7 [doi]
LID - 71
AB  - BACKGROUND: Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and 
      prednisone (CHOP) is the current standard therapy for diffuse large B cell 
      lymphoma (DLBCL). Obinutuzumab (G), a glycoengineered, type II anti-CD20 
      monoclonal antibody, has shown activity and an acceptable safety profile when 
      combined with CHOP (G-CHOP) in patients with advanced DLBCL. We present the final 
      analysis results of the Phase III GOYA study (NCT01287741), which compared the 
      efficacy and safety of G-CHOP versus R-CHOP in patients with previously untreated 
      DLBCL. METHODS: Patients aged >/= 18 years with previously untreated advanced DLBCL 
      were randomly assigned to receive eight 21-day cycles of R or G, plus six or 
      eight cycles of CHOP. The primary endpoint was investigator-assessed 
      progression-free survival (PFS). Secondary endpoints included overall survival, 
      other time-to-event endpoints, and safety; investigator-assessed PFS by cell of 
      origin subgroup was an exploratory endpoint. RESULTS: A total of 1418 patients 
      were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; 
      R-CHOP, N = 710). Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, 
      respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48). The 
      results of the secondary efficacy endpoints did not show a benefit of G-CHOP over 
      R-CHOP. In the exploratory analysis, a trend towards benefit with G-CHOP over 
      R-CHOP was apparent in the patients with germinal center B cell DLBCL. The safety 
      profile of G-CHOP was as expected, and no new safety signals were observed. More 
      grade 3-5 (75.1% vs 65.8%), serious (44.4% vs 38.4%), and fatal (6.1% vs 4.4%) 
      adverse events (AEs) were observed in the G-CHOP arm compared with the R-CHOP 
      arm, respectively, with the most common fatal AEs being infections. A higher 
      incidence of late-onset neutropenia occurred in the G-CHOP arm (8.7%) versus the 
      R-CHOP arm (4.9%). CONCLUSIONS: The final analysis, similar to the primary 
      analysis, did not show a PFS benefit of G-CHOP over R-CHOP in previously 
      untreated patients with DLBCL. The results of the secondary endpoints were 
      consistent with the primary endpoint. Further exploratory analyses and 
      investigation of biomarkers are ongoing.
FAU - Sehn, Laurie H
AU  - Sehn LH
AUID- ORCID: 0000-0003-1860-9765
AD  - BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, 
      Vancouver, BC, Canada. Lsehn@bccancer.bc.ca.
FAU - Martelli, Maurizio
AU  - Martelli M
AD  - Department of Translational and Precision Medicine, Sapienza University of Rome, 
      Rome, Italy.
FAU - Trneny, Marek
AU  - Trneny M
AD  - Charles University General Hospital, Prague, Czech Republic.
FAU - Liu, Wenxin
AU  - Liu W
AD  - Roche Pharma Development, Shanghai, China.
FAU - Bolen, Christopher R
AU  - Bolen CR
AD  - Genentech, Inc., South San Francisco, CA, USA.
FAU - Knapp, Andrea
AU  - Knapp A
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Sahin, Deniz
AU  - Sahin D
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Sellam, Gila
AU  - Sellam G
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Vitolo, Umberto
AU  - Vitolo U
AD  - Candiolo Cancer Institute, FPO-IRCCS, (Turin), Candiolo, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT01287741
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200606
PL  - England
TA  - J Hematol Oncol
JT  - Journal of hematology & oncology
JID - 101468937
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 5J49Q6B70F (Vincristine)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - O43472U9X8 (obinutuzumab)
RN  - VB0R961HZT (Prednisone)
RN  - CHOP protocol
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Cyclophosphamide/administration & dosage/adverse effects
MH  - Doxorubicin/administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prednisone/administration & dosage/adverse effects
MH  - Progression-Free Survival
MH  - Rituximab/administration & dosage/adverse effects
MH  - Vincristine/administration & dosage/adverse effects
MH  - Young Adult
PMC - PMC7276080
OTO - NOTNLM
OT  - Diffuse large B cell lymphoma
OT  - Immunochemotherapy
OT  - Obinutuzumab
OT  - Outcomes
OT  - Rituximab
COIS- C.B is employed by Genentech, Inc. and has equity ownership interests (including 
      stock options) in F. Hoffmann-La Roche. A.K and W.L are employed by F. 
      Hoffmann-La Roche. M.M has received honoraria from F. Hoffmann-La Roche, Celgene, 
      Janssen, Sandoz, Novartis, Gilead, and Servier and is a member of an entity's 
      Board of Directors or advisory committees for F. Hoffmann-La Roche, Celgene, 
      Janssen, Sandoz, Novartis, and Gilead. D.S and G.S are employed by and have 
      equity ownership interests (including stock options) for F. Hoffmann-La Roche. 
      L.S has provided consultancy (including expert testimony) for F. Hoffmann-La 
      Roche, Genentech, Inc., AbbVie, Amgen, Apobiologix, AstraZeneca, Acerta, Celgene, 
      Gilead, Janssen, Kite, Karyopharm, Lundbeck, Merck, Morphosys, Seattle Genetics, 
      Teva, Takeda, TG Therapeutics, Verastem; has received research funding from F. 
      Hoffmann-La Roche and Genentech, Inc.; and has received honoraria from F. 
      Hoffmann-La Roche, Genentech, Inc., AbbVie, Amgen, Apobiologix, AstraZeneca, 
      Acerta, Celgene, Gilead, Janssen, Kite, Karyopharm, Lundbeck, Merck, MorphoSys, 
      Seattle Genetics, Teva, Takeda, TG Therapeutics, Verastem. M.T provides 
      consultancy (including expert testimony) for Takeda, Bristol-Myers Squibb, 
      Incyte, AbbVie, Amgen, F. Hoffmann-La Roche, Gilead Sciences, Janssen, Celgene, 
      and MorphoSys and has received honoraria from Janssen, Gilead Sciences, Takeda, 
      Bristol-Myers Squibb, Amgen, AbbVie, F. Hoffmann-La Roche, MorphoSys, and Incyte. 
      U.V is part of the speaker's bureau for Celgene, F. Hoffmann-La Roche, Janssen, 
      Gilead, AbbVie, and Novartis and a member of advisory committees for Janssen, 
      Celgene, Kite, Juno Therapeutics, Gilead, and Novartis.
EDAT- 2020/06/09 06:00
MHDA- 2021/05/18 06:00
PMCR- 2020/06/06
CRDT- 2020/06/08 06:00
PHST- 2020/02/07 00:00 [received]
PHST- 2020/05/15 00:00 [accepted]
PHST- 2020/06/08 06:00 [entrez]
PHST- 2020/06/09 06:00 [pubmed]
PHST- 2021/05/18 06:00 [medline]
PHST- 2020/06/06 00:00 [pmc-release]
AID - 10.1186/s13045-020-00900-7 [pii]
AID - 900 [pii]
AID - 10.1186/s13045-020-00900-7 [doi]
PST - epublish
SO  - J Hematol Oncol. 2020 Jun 6;13(1):71. doi: 10.1186/s13045-020-00900-7.