Impact of venetoclax monotherapy on the quality of life of patients with relapsed or refractory chronic lymphocytic leukemia: results from the phase 3b VENICE II trial

References

• Jaglowski S, Jones JA. Choosing first-line therapy for chronic lymphocytic leukemia. Expert Rev Anticancer Ther. 2011;11(9):1379–1390.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. Cancer Stat Facts: leukemia — chronic lymphocytic leukemia (CLL); 2021 [cited 2021 Jan 11]. Available from: https://seer.cancer.gov/statfacts/html/clyl.html
   Google Scholar
• Hallek M. Chronic lymphocytic leukemia: 2017 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2017;92(9):946–965.
   PubMed Web of Science ®Google Scholar
• Waweru C, Kaur S, Sharma S, et al. Health-related quality of life and economic burden of chronic lymphocytic leukemia in the era of novel targeted agents. Curr Med Res Opin. 2020;36(9):1481–1495.
   PubMed Web of Science ®Google Scholar
• Pulte D, Castro FA, Jansen L, et al. Trends in survival of chronic lymphocytic leukemia patients in Germany and the USA in the first decade of the twenty-first century. J Hematol Oncol. 2016;9:28.
   PubMed Web of Science ®Google Scholar
• Molica S. Quality of life in chronic lymphocytic leukemia: a neglected issue. Leuk Lymphoma. 2005;46(12):1709–1714.
   PubMed Web of Science ®Google Scholar
• Youron P, Singh C, Jindal N, et al. Quality of life in patients of chronic lymphocytic leukemia using the EORTC QLQ-C30 and QLQ-CLL17 Questionnaire. Eur J Haematol. 2020;105(6):755–762.
   PubMed Web of Science ®Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–376.
   PubMed Web of Science ®Google Scholar
• Cramer P, Fraser G, Santucci-Silva R, et al. Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study. Leuk Lymphoma. 2018;59(9):2075–2084.
   PubMed Web of Science ®Google Scholar
• Shanafelt TD, Bowen D, Venkat C, et al. Quality of life in chronic lymphocytic leukemia: an international survey of 1482 patients. Br J Haematol. 2007;139(2):255–264.
   PubMed Web of Science ®Google Scholar
• Holtzer-Goor KM, Schaafsma MR, Joosten P, et al. Quality of life of patients with chronic lymphocytic leukaemia in The Netherlands: results of a longitudinal multicentre study. Qual Life Res. 2015;24(12):2895–2906.
   PubMed Web of Science ®Google Scholar
• Wierda WG, Byrd JC, Abramson JS, et al. Chronic lymphocytic leukemia/small lymphocytic lymphoma, version 4.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020;18(2):185–217.
   PubMed Web of Science ®Google Scholar
• Cimmino A, Calin GA, Fabbri M, et al. miR-15 and miR-16 induce apoptosis by targeting BCL2. Proc Natl Acad Sci USA. 2005;102(39):13944–13949.
   PubMed Web of Science ®Google Scholar
• Calin GA, Cimmino A, Fabbri M, et al. MiR-15a and miR-16-1 cluster functions in human leukemia. Proc Natl Acad Sci U S A. 2008;105(13):5166–5171.
   PubMed Web of Science ®Google Scholar
• Del Poeta G, Venditti A, Del Principe MI, et al. Amount of spontaneous apoptosis detected by bax/bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood. 2003;101(6):2125–2131.
   PubMed Web of Science ®Google Scholar
• Roberts AW, Davids MS, Pagel JM, et al. Targeting BCL2 with venetoclax in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):311–322.
   PubMed Web of Science ®Google Scholar
• Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107–1120.
   PubMed Web of Science ®Google Scholar
• Stilgenbauer S, Eichhorst B, Schetelig J, et al. Venetoclax for patients with chronic lymphocytic leukemia with 17p deletion: results from the full population of a phase II pivotal trial. J Clin Oncol. 2018;36(19):1973–1980.
   PubMed Web of Science ®Google Scholar
• Zinzani P, Jager U, Lustgarten S, et al. Patient-reported outcomes and quality of life in DUO: a randomized trial of duvelisib vs. ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Presented at: European Hematology Association Virtual Congress; 2020.
   Google Scholar
• Ghia P, Coutre SE, Cheson BD, et al. Impact of idelalisib on health-related quality of life in patients with relapsed chronic lymphocytic leukemia in a phase III randomized trial. Haematologica. 2020;105(10):e519.
   PubMed Web of Science ®Google Scholar
• Woyach JA, Blachly JS, Rogers KA, et al. Acalabrutinib plus obinutuzumab in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia. Cancer Discov. 2020;10(3):394–405.
   PubMed Web of Science ®Google Scholar
• Montillo M, Illes A, Robak T, et al. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019;17(1):173.
   PubMed Web of Science ®Google Scholar
• Hillmen P, Janssens A, Babu KG, et al. Health-related quality of life and patient-reported outcomes of ofatumumab plus chlorambucil versus chlorambucil monotherapy in the COMPLEMENT 1 trial of patients with previously untreated CLL. Acta Oncol. 2016;55(9–10):1115–1120.
   PubMed Web of Science ®Google Scholar
• Davids MS, Hallek M, Wierda W, et al. Comprehensive safety analysis of venetoclax monotherapy for patients with relapsed/refractory chronic lymphocytic leukemia. Clin Cancer Res. 2018;24(18):4371–4379.
   PubMed Web of Science ®Google Scholar
• Davids MS, Seymour JF, Roberts AW, et al. Mitigation of tumor lysis syndrome (TLS) complications with venetoclax in CLL. Presented at: American Society of Clinical Oncology; Chicago (IL); 2018.
   Google Scholar
• Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia Updating the National Cancer Institute-Working Group 1996 Guidelines. Blood. 2008;111(12):5446–5456.
   PubMed Web of Science ®Google Scholar
• Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–1736.
   PubMed Web of Science ®Google Scholar
• Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998;16(1):139–144.
   PubMed Web of Science ®Google Scholar
• Osoba D, Zee B, Pater J, et al. Psychometric properties and responsiveness of the EORTC Quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res. 1994;3(5):353–364.
   PubMed Web of Science ®Google Scholar
• Wierda W, Sail K, Noe L, et al. editors. Impact of venetoclax on the quality of life of patients with relapsed/refractory chronic lymphocytic leukemia: results of a phase 2, open-label study of venetoclax (ABT-199/GDC-0199) monotherapy. Presented at: European Hematology Association Congress; Madrid, Spain; 2017.
   Google Scholar
• Wierda W, Sail K, Potluri J, et al., editors. Impact of venetoclax on the quality of life of CLL patients relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor treatment. Presented at: European Hematology Association Congress; Madrid, Spain; 2017.
   Google Scholar
• Cochrane T, Chagorova T, Robak T, et al. Venetoclax improves quality of life for patients with relapsed/refractory chronic lymphocytic leukemia. Presented at: European Hematology Association Congress; Stockholm, Sweden; 2018.
   Google Scholar
• Kater A, Arslan Ö, Demikran F, et al. Efficacy of venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia: primary endpoint analysis of the International Phase 3b Trial (VENICE I). Presented at: European Hematology Association Virtual Congress; 2020.
   Google Scholar
• Stilgenbauer S, Eichhorst B, Schetelig J, et al. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016;17(6):768–778.
   PubMed Web of Science ®Google Scholar
• Efficace F, Kemmler G, Vignetti M, et al. Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials – a systematic review to evaluate the added value in supporting clinical decision making. Eur J Cancer. 2008;44(11):1497–1506.
   PubMed Web of Science ®Google Scholar
• Sharman JP, Cocks K, Nabhan C, et al. Longitudinal health-related quality of life in first-line treated patients with chronic lymphocytic leukemia: results from the Connect® CLL registry. eJHaem. 2020;1(1):188–198.
   PubMedGoogle Scholar