First-Line Venetoclax Combinations in Chronic Lymphocytic LeukemiaUniv Duisburg Essen, Germany.
Univ Cologne, Germany.
Univ Cologne, Germany.
Luzerner Kantonsspital, Switzerland.
Lund Univ, Sweden.
Blackrock Hlth Member Hosp, Ireland.
Med Univ Vienna, Austria.
Bnai Zion Med Ctr, Israel.
Helsinki Univ Hosp, Finland.
Copenhagen Univ Hosp, Denmark.
Univ Ulm, Germany.
Zealand Univ Hosp, Denmark.
Grp Practice Hematol & Oncol, Germany.
Hematol Oncol Ctr, Germany.
Hanusch Hosp, Austria.
Univ Ziekenhuis Leuven, Belgium.
Aalborg Univ Hosp, Denmark.
Kantonsspital St Gallen, Switzerland.
Odense Univ Hosp, Denmark.
Amphia Hosp, Netherlands.
Med Univ Vienna, Austria.
Maasstad Ziekenhuis, Netherlands.
Med Ctr Leeuwarden, Netherlands.
Linköping University, Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry and Pharmacology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Haematology.
Specialist Med Practice Hematol & Oncol, Germany.
Bruderhosp St Josef, Germany.
St Antonius Hosp Utrecht, Netherlands.
Rigshosp, Denmark.
Kantonsspital Hosp Winterthur, Switzerland.
Meander Med Ctr, Netherlands.
Univ Hosp Zurich, Switzerland.
Univ Cologne, Germany.
UCL, England.
Univ Cologne, Germany.
Univ Cologne, Germany.
Univ Cologne, Germany.
Ludwig Maximilians Univ Munchen, Germany.
Univ Cologne, Germany.
Univ Hosp Schleswig Holstein, Germany.
Univ Hosp Schleswig Holstein, Germany.
Univ Ulm, Germany.
Albert Schweitzer Hosp, Netherlands.
Univ Amsterdam, Netherlands.
Copenhagen Univ Hosp, Denmark.
Univ Ulm, Germany.
Univ Cologne, Germany.
Show others and affiliations
2023 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 388, no 19, p. 1739-1754Article in journal (Refereed) Published
Abstract [en]
Background Randomized trials of venetoclax plus anti-CD20 antibodies as first-line treatment in fit patients (i.e., those with a low burden of coexisting conditions) with advanced chronic lymphocytic leukemia (CLL) have been lacking. Methods In a phase 3, open-label trial, we randomly assigned, in a 1:1:1:1 ratio, fit patients with CLL who did not have TP53 aberrations to receive six cycles of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) or 12 cycles of venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib. Ibrutinib was discontinued after two consecutive measurements of undetectable minimal residual disease or could be extended. The primary end points were undetectable minimal residual disease (sensitivity, <10(-4) [i.e., <1 CLL cell in 10,000 leukocytes]) as assessed by flow cytometry in peripheral blood at month 15 and progression-free survival. Results A total of 926 patients were assigned to one of the four treatment regimens (229 to chemoimmunotherapy, 237 to venetoclax-rituximab, 229 to venetoclax-obinutuzumab, and 231 to venetoclax-obinutuzumab-ibrutinib). At month 15, the percentage of patients with undetectable minimal residual disease was significantly higher in the venetoclax-obinutuzumab group (86.5%; 97.5% confidence interval [CI], 80.6 to 91.1) and the venetoclax-obinutuzumab-ibrutinib group (92.2%; 97.5% CI, 87.3 to 95.7) than in the chemoimmunotherapy group (52.0%; 97.5% CI, 44.4 to 59.5; P<0.001 for both comparisons), but it was not significantly higher in the venetoclax-rituximab group (57.0%; 97.5% CI, 49.5 to 64.2; P=0.32). Three-year progression-free survival was 90.5% in the venetoclax-obinutuzumab-ibrutinib group and 75.5% in the chemoimmunotherapy group (hazard ratio for disease progression or death, 0.32; 97.5% CI, 0.19 to 0.54; P<0.001). Progression-free survival at 3 years was also higher with venetoclax-obinutuzumab (87.7%; hazard ratio for disease progression or death, 0.42; 97.5% CI, 0.26 to 0.68; P<0.001), but not with venetoclax-rituximab (80.8%; hazard ratio, 0.79; 97.5% CI, 0.53 to 1.18; P=0.18). Grade 3 and grade 4 infections were more common with chemoimmunotherapy (18.5%) and venetoclax-obinutuzumab-ibrutinib (21.2%) than with venetoclax-rituximab (10.5%) or venetoclax-obinutuzumab (13.2%). Conclusions Venetoclax-obinutuzumab with or without ibrutinib was superior to chemoimmunotherapy as first-line treatment in fit patients with CLL.
Place, publisher, year, edition, pages
MASSACHUSETTS MEDICAL SOC , 2023. Vol. 388, no 19, p. 1739-1754
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-196901DOI: 10.1056/NEJMoa2213093ISI: 001003911200004PubMedID: 37163621OAI: oai:DiVA.org:liu-196901DiVA, id: diva2:1791890
Note
Funding Agencies|AbbVie
2023-08-282023-08-282025-02-18