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Article Dans Une Revue Blood Année : 2021

A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma

Pierre Feugier
  • Fonction : Auteur
Iann W. Flinn
  • Fonction : Auteur
Robin Gasiorowski
  • Fonction : Auteur
Richard Greil
  • Fonction : Auteur
Árpad Illés
  • Fonction : Auteur
Nathalie A. Johnson
  • Fonction : Auteur
Jean-François Larouche
  • Fonction : Auteur
Pieternella J. Lugtenburg
  • Fonction : Auteur
Caterina Patti
  • Fonction : Auteur
Gilles A. Salles
  • Fonction : Auteur
Marek Trněný
  • Fonction : Auteur
Sven de Vos
  • Fonction : Auteur
Farheen Mir
  • Fonction : Auteur
Divya Samineni
  • Fonction : Auteur
Su Y. Kim
  • Fonction : Auteur
Yanwen Jiang
  • Fonction : Auteur
E. Punnoose
  • Fonction : Auteur
A. Sinha
  • Fonction : Auteur
Emma Clark
  • Fonction : Auteur
Nathalie Spielewoy
  • Fonction : Auteur
Kathryn Humphrey
  • Fonction : Auteur
Alexandra Bazeos
  • Fonction : Auteur
Andrew D. Zelenetz
  • Fonction : Auteur

Résumé

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 complete 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.

Dates et versions

hal-04200631 , version 1 (08-09-2023)

Identifiants

Citer

Franck Morschhauser, Pierre Feugier, Iann W. Flinn, Robin Gasiorowski, Richard Greil, et al.. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood, 2021, Blood, 137 (5), pp.600-609. ⟨10.1182/blood.2020006578⟩. ⟨hal-04200631⟩

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