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Oncology

Overall survival of patients with CLL treated with ibrutinib in the first line compared to second-line ibrutinib after chemotherapy/chemoimmunotherapy

, , , , , , , & show all
Received 15 Dec 2023, Accepted 11 Jun 2024, Published online: 01 Jul 2024

References

  • IMBRUVICA® (ibrutinib) [SmPC]. Janssen-Cilag International NV. Beerse, Belgium; 2023.
  • IMBRUVICA® (ibrutinib) [prescribing information]. Pharmacyclics LLC. Sunnyvale, CA: Janssen Biotech, Inc., Horsham, PA; 2023.
  • Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(1):23–33. doi: 10.1016/j.annonc.2020.09.019.
  • Špaček M, Šimkovič M, Pospíšilová Š, et al. 7. Chronická lymfocytární leukemie [Chronic lymphocytic leukemia]. In: Doubek M, Mayer J, editors. Léčebné postupy v hematologii 2023 [Treatments in hematology 2023]. Brno, Czech Republic: Česká hematologická společnost ČLS JEP; 2023.
  • Ghia P, Pluta A, Wach M, et al. Acalabrutinib versus investigator’s choice in relapsed/refractory chronic lymphocytic leukemia: final ASCEND trial results. Hemasphere. 2022;6(12):e801. doi: 10.1097/HS9.0000000000000801.
  • Sharman JP, Egyed M, Jurczak W, et al. Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naive chronic lymphocytic leukemia. Leukemia. 2022;36(4):1171–1175. doi: 10.1038/s41375-021-01485-x.
  • Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031–1043. doi: 10.1016/S1470-2045(22)00293-5.
  • Barr PM, Owen C, Robak T, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6(11):3440–3450. doi: 10.1182/bloodadvances.2021006434.
  • Hernán MA, Robins JM. Using big data to emulate a target trial when a randomized trial is not available. Am J Epidemiol. 2016;183(8):758–764. doi: 10.1093/aje/kwv254.
  • Gomes M, Latimer N, Soares M, et al. Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real-world data: opportunities and challenges. Pharmacoeconomics. 2022;40(6):577–586. doi: 10.1007/s40273-022-01141-x.
  • Merz M, Goldschmidt H, Hari P, et al. Adjusted comparison of outcomes between patients from CARTITUDE-1 versus multiple myeloma patients with prior exposure to PI, IMiD and anti-CD-38 from a German registry. Cancers (Basel). 2021;13(23):5996. doi: 10.3390/cancers13235996.
  • Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425–2437. doi: 10.1056/NEJMoa1509388.
  • Garside J, Healy N, Besson H, et al. PHEDRA: using real-world data to analyze treatment patterns and ibrutinib effectiveness in hematological malignancies. J Comp Eff Res. 2018;7(1):29–38. doi: 10.2217/cer-2017-0046.
  • Salles G, Bachy E, Smolej L, et al. Single-agent ibrutinib in RESONATE-2 and RESONATE versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia. Ann Hematol. 2019;98(12):2749–2760. doi: 10.1007/s00277-019-03830-8.
  • Robins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics. 2000;56(3):779–788. doi: 10.1111/j.0006-341x.2000.00779.x.
  • Latimer NR, Abrams KR, Lambert PC, et al. Adjusting survival time estimates to account for treatment switching in randomized controlled trials–an economic evaluation context: methods, limitations, and recommendations. Med Decis Making. 2014;34(3):387–402. doi: 10.1177/0272989X13520192.
  • Hernán MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000;11(5):561–570. doi: 10.1097/00001648-200009000-00012.
  • Ishak KJ, Proskorovsky I, Korytowsky B, et al. Methods for adjusting for bias due to crossover in oncology trials. Pharmacoeconomics. 2014;32(6):533–546. doi: 10.1007/s40273-014-0145-y.
  • Feyerabend S, Saad F, Perualila NJ, et al. Adjusting overall survival estimates for treatment switching in metastatic, castration-sensitive prostate cancer: results from the LATITUDE study. Target Oncol. 2019;14(6):681–688. doi: 10.1007/s11523-019-00685-x.
  • Hernán MA, Robins JM. Causal inference: what if. Boca Raton, FL: Chapman & Hall/CRC; 2020.
  • Syriopoulou E, Rutherford MJ, Lambert PC. Inverse probability weighting and doubly robust standardization in the relative survival framework. Stat Med. 2021;40(27):6069–6092. doi: 10.1002/sim.9171.
  • Funk MJ, Westreich D, Wiesen C, et al. Doubly robust estimation of causal effects. Am J Epidemiol. 2011;173(7):761–767. doi: 10.1093/aje/kwq439.
  • Doubek M, Smolej ML, Šimkovič M, et al. Single-agent ibrutinib versus real-world (RW) treatments for patients with previously untreated chronic lymphocytic leukemia (CLL): adjusted comparison of RESONATE-2™ with the CLLEAR and Lyon-Sud RW databases. Blood. 2021;138(Supplement 1):4679–4679. doi: 10.1182/blood-2021-147927.
  • Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213–223. doi: 10.1056/NEJMoa1400376.
  • Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517–2528. doi: 10.1056/NEJMoa1812836.
  • Delgado A, Guddati AK. Clinical endpoints in oncology - a primer. Am J Cancer Res. 2021;11(4):1121–1131.
  • Ghia P, Owen C, Barrientos JC, et al. Initiating first-line (1L) ibrutinib (Ibr) in patients (pts) with chronic lymphocytic leukemia (CLL) improves overall survival (OS) outcomes to rates approximating an age-matched population of ≥65 years. Blood. 2022;140(Supplement 1):4159–4161. doi: 10.1182/blood-2022-163257.
  • Shanafelt TD, Wang XV, Hanson CA, et al. Long-term outcomes for ibrutinib-rituximab and chemoimmunotherapy in CLL: updated results of the E1912 trial. Blood. 2022;140(2):112–120. doi: 10.1182/blood.2021014960.
  • Woyach J, Tedeschi A, Munir T, et al. Using ibrutinib in earlier lines of treatment results in better outcomes for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. Leuk Lymphoma. 2021;62(13):3278–3282. doi: 10.1080/10428194.2021.1957871.
  • Huang Q, Deering KL, Harshaw Q, et al. Real-world clinical outcomes of first-line ibrutinib or chemoimmunotherapy in patients with chronic lymphocytic leukemia by risk status. Adv Ther. 2022;39(7):3292–3307. doi: 10.1007/s12325-021-01991-5.
  • Levi S, Bronstein Y, Goldschmidt N, et al. Efficacy of front-line ibrutinib versus fludarabine, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia: a retrospective multicenter “real-world” study. Am J Hematol. 2023;98(2):E24–E27. doi: 10.1002/ajh.26779.
  • Ghosh N, Sharman JP, Barrientos JC, et al. Real-world outcomes with first-line ibrutinib (Ibr) versus chemoimmunotherapy (CIT) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): final analysis results from the InformCLL registry. Blood. 2022;140(Supplement 1):7047–7049. doi: 10.1182/blood-2022-155649.