Faculty Collaboration Database

A retrospective comparison of venetoclax alone or in combination with an anti-CD20 monoclonal antibody in R/R CLL. Blood Adv 2019 May 28;3(10):1568-1573

Date

05/19/2019

Pubmed ID

31101647

Pubmed Central ID

PMC6538868

DOI

10.1182/bloodadvances.2019000180

Scopus ID

2-s2.0-85067043385 (requires institutional sign-in at Scopus site)   25 Citations

Abstract

Venetoclax (VEN) is approved for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as monotherapy (VENmono) or in combination with rituximab. Whether VEN plus anti-CD20 (VENcombo) is superior to VENmono is unknown. We conducted a multicenter, retrospective cohort analysis comparing 321 CLL patients treated with VENmono vs VENcombo across the United States and the United Kingdom. We examined demographics, baseline characteristics, dosing, adverse events, response rates, and outcomes. The primary endpoints were progression-free survival (PFS) and overall survival (OS), estimated by Kaplan-Meier method, in patients treated with VENmono vs VENcombo. Univariate and bivariate analyses were performed with COX regression. Three hundred twenty-one CLL patients were included (3 median prior treatments, 78% prior ibrutinib). The overall response rates (ORRs) were similar (VENmono, 81% ORR, 34% complete remission [CR] vs VENcombo, 84% ORR, 32% CR). With a median follow-up of 13.4 months, no differences in PFS and OS were observed between the groups. In unadjusted analyses, the hazard ratios (HRs) for PFS and OS for VENmono vs VENcombo were HR 1.0 (95% confidence interval [CI], 0.6-1.8; P = .7) and HR 1.2 (95% CI, 0.6-2.3; P = .5), respectively. When adjusting for differences between the cohorts, the addition of an anti-CD20 antibody in combination with VEN did not impact PFS (HR, 1.0; 95% CI, 0.5-2.0; P = .9) or OS (HR, 1.1; 95% CI, 0.4-2.6; P = .8). We demonstrate comparable efficacy between VENmono and VENcombo in a heavily pretreated, high-risk, retrospective cohort, in terms of both response data and survival outcomes. Prospective studies are needed to validate these findings.

Author List

Mato AR, Roeker LE, Eyre TA, Nabhan C, Lamanna N, Hill BT, Brander DM, Barr PM, Lansigan F, Cheson BD, Singavi AK, Yazdy MS, Shah NN, Allan JN, Bhavsar EB, Rhodes J, Kennard K, Schuster SJ, Williams AM, Skarbnik AP, Goy AH, Goodfriend JM, Dorsey C, Coombs CC, Tuncer H, Ujjani CS, Jacobs R, Winter AM, Pagel JM, Bailey N, Schuh A, Shadman M, Sitlinger A, Weissbrot H, Muralikrishnan S, Zelenetz A, Kirkwood AA, Fox CP

Author

Nirav N. Shah MD Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Combined Chemotherapy Protocols
Bridged Bicyclo Compounds, Heterocyclic
Female
Humans
Leukemia, Lymphocytic, Chronic, B-Cell
Male
Middle Aged
Retrospective Studies
Sulfonamides