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A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma
F. Morschhauser, P. Feugier, IW. Flinn, R. Gasiorowski, R. Greil, Á. Illés, NA. Johnson, JF. Larouche, PJ. Lugtenburg, C. Patti, GA. Salles, M. Trněný, S. de Vos, F. Mir, D. Samineni, SY. Kim, Y. Jiang, E. Punnoose, A. Sinha, E. Clark, N....
Language English Country United States
Document type Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
P30 CA008748
NCI NIH HHS - United States
P50 CA192937
NCI NIH HHS - United States
NLK
Free Medical Journals
from 1946 to 1 year ago
Freely Accessible Science Journals
from 1946 to 1 year ago
Open Access Digital Library
from 1946-01-01
Open Access Digital Library
from 1946-01-01
ROAD: Directory of Open Access Scholarly Resources
- MeSH
- Bridged Bicyclo Compounds, Heterocyclic administration & dosage adverse effects MeSH
- Cyclophosphamide administration & dosage adverse effects MeSH
- Lymphoma, Large B-Cell, Diffuse drug therapy genetics MeSH
- Adult MeSH
- Doxorubicin administration & dosage adverse effects MeSH
- Granulocyte Colony-Stimulating Factor therapeutic use MeSH
- Gastrointestinal Diseases chemically induced MeSH
- Genes, bcl-2 MeSH
- Infections etiology MeSH
- Kaplan-Meier Estimate MeSH
- Hematologic Diseases chemically induced MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Neoplasm Proteins antagonists & inhibitors MeSH
- Prednisone administration & dosage adverse effects MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage adverse effects therapeutic use MeSH
- Proto-Oncogene Proteins c-bcl-2 antagonists & inhibitors MeSH
- Rituximab administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Sulfonamides administration & dosage adverse effects MeSH
- Fatigue chemically induced MeSH
- Vincristine administration & dosage adverse effects MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase I MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
The phase 2 CAVALLI (NCT02055820) study assessed efficacy and safety of venetoclax, a selective B-cell lymphoma-2 (Bcl-2) inhibitor, with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in first-line (1L) diffuse large B-cell lymphoma (DLBCL), including patients demonstrating Bcl-2 protein overexpression by immunohistochemistry (Bcl-2 IHC+). Eligible patients were ≥18 years of age and had previously untreated DLBCL, Eastern Cooperative Oncology Group performance status ≤2, and International Prognostic Index 2 to 5. Venetoclax 800 mg (days 4-10, cycle 1; days 1-10, cycles 2-8) was administered with rituximab (8 cycles) and cyclophosphamide, doxorubicin, vincristine, and prednisone (6-8 cycles) in 21-day cycles. Primary end points were safety, tolerability, and research_plete response (CR) at end of treatment (EOT). Secondary end points were progression-free survival (PFS) and overall survival. Comparative analyses used covariate-adjusted R-CHOP controls from the GOYA/BO21005 study, an appropriate contemporary benchmark for safety and efficacy. Safety and efficacy analyses included 206 patients. CR rate at EOT was 69% in the overall population and was maintained across Bcl-2 IHC+ subgroups. With a median follow-up of 32.2 months, trends were observed for improved investigator-assessed PFS for venetoclax plus R-CHOP in the overall population (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.43-0.87) and Bcl-2 IHC+ subgroups (HR, 0.55; 95% CI, 0.34-0.89) vs R-CHOP. Despite a higher incidence of grade 3/4 hematologic adverse events (86%), related mortality was not increased (2%). Chemotherapy dose intensity was similar in CAVALLI vs GOYA. The addition of venetoclax to R-CHOP in 1L DLBCL demonstrates increased, but manageable, myelosuppression and the potential of improved efficacy, particularly in high-risk Bcl-2 IHC+ patient subgroups.
1st Department of Medicine Charles University General Hospital Prague Czech Republic
Azienda Ospedali Riuniti Villa Sofia Cervello Palermo Italy
CHU de Nancy Université de Lorraine Vandoeuvre lès Nancy France
CHU de Québec Hôpital de l'Enfant Jésus Quebec City QC Canada
Concord Hospital University of Sydney Sydney NSW Australia
David Geffen School of Medicine University of California Los Angeles CA
Department of Hematology Faculty of Medicine University of Debrecen Debrecen Hungary
F Hoffmann La Roche Ltd Basel Switzerland
Genentech Inc South San Francisco CA
Hospices Civils de Lyon Centre Hospitalier Lyon Sud University of Lyon Pierre Bénite France
HOVON Lunenburg Lymphoma Phase 1 2 Consortium Erasmus MC Cancer Institute Rotterdam The Netherlands
Jewish General Hospital Montreal QC Canada
Memorial Sloan Kettering Cancer Center New York NY
Roche Products Limited Welwyn Garden City United Kingdom
Royal Marsden Hospital Sutton Surrey United Kingdom
Sarah Cannon Research Institute Tennessee Oncology Nashville TN
Université de Lille Centre Hospitalier Universitaire Lille France
References provided by Crossref.org
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