Among patients with Waldenström’s macroglobulinemia, the use of ibrutinib–rituximab resulted in significantly higher rates of progression-free survival than the use of placebo–rituximab, both among those who had received no previous treatment and among those with disease recurrence. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. 3. DOI: 10.1056/NEJMoa1802917, Tap into groundbreaking research and clinically relevant insights. The rates of serious AEs were 43% versus 33% in the ibrutinib versus control arms, respectively. Phase 3 trial of ibrutinib plus rituximab in Waldenström’s macroglobulinemia [published online June 1, 2018). Whether you or someone you love has cancer, knowing what to expect can help you cope. Data were unknown, missing, or could not be evaluated for 4 patients in the ibrutinib–rituximab group and for 2 patients in the placebo–rituximab group. Leblond V, Johnson S, Chevret S, et al. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. 28. After 4 weeks of treatment, the median IgM level was reduced from baseline by 56% with ibrutinib–rituximab as compared with an increase of 6% with placebo–rituximab (Fig. This article was published on June 1, 2018, at NEJM.org. 10. Grade ≥3 treatment-emergent AEs occurring more frequently in the rituximab-alone arm included IgM flare (3% vs 0%) and infusion-related reactions (16% vs 1%). Morel P, Duhamel A, Gobbi P, et al. — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P. The mutational status of MYD88 and CXCR4 was assessed in bone marrow samples. Semin Hematol 1997;34:Suppl 2:13-19. Buske C, Leblond V, Dimopoulos M, et al. Together, we’re making a difference – and you can, too. The primary reason for ibrutinib discontinuation was progressive disease (n = 7), followed by adverse events (AEs; n = 4). The median patient age was 69 and 33% were aged ≥75 years. The trial was sponsored by Pharmacyclics and designed by the sponsor in collaboration with the investigators and Janssen Research and Development; the two companies provided funding for the trial. The rapid reduction in IgM levels, especially in patients with high IgM levels at baseline, indicated that the addition of ibrutinib to rituximab can prevent IgM flare. The approval is based on findings from the phase III iNNOVATE (PCYC-1127) trial presented at the 2018 ASCO Annual Meeting and published in the New England Journal of Medicine.1,2 In the study the ibrutinib/rituximab combination lowered the risk of disease progression or death by 80% versus rituximab alone in patients with Waldenström macroglobulinemia. The rate of major response was higher with ibrutinib–rituximab than with placebo–rituximab (72% vs. 32%, P<0.001). Percentages may not total 100 because of rounding. Blood 2009;113:4163-4170. The characteristics of the patients at baseline were generally well balanced (Table 1). In the overall population, the ORR was 92% with the ibrutinib combination versus 47% with rituximab alone (P <.0001). S2A in the Supplementary Appendix). These drugs are most often used to treat multiple myeloma, but they might also be helpful in treating WM. Randomized phase 3 trial of ibrutinib/rituximab vs placebo/rituximab in Waldenström's macroglobulinemia. A complete list of the members of the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia is provided in the Supplementary Appendix, available at NEJM.org. Eligible patients had received a centrally confirmed diagnosis of Waldenström’s macroglobulinemia that required treatment, according to criteria that have been reported previously.2,7 Patients could be receiving treatment for the first time or after relapse. We couldn’t do what we do without our volunteers and donors. Among these patients, there was a history of atrial fibrillation in 27% of those in the ibrutinib–rituximab group and in none of those in the placebo–rituximab group. Br J Haematol 2014;165:316-333. Events of grade 3 or higher that occurred more frequently with ibrutinib–rituximab than with placebo–rituximab included atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%); those that occurred less frequently included infusion reactions (1% vs. 16%) and any grade of IgM flare (8% vs. 47%). The addition of ibrutinib appeared to lower the occurrence of these key toxic effects associated with rituximab, which could potentially result from ibrutinib-mediated inhibition of cytokine secretion.26,27 Additional analyses after longer-term follow-up will help to determine the risk of lymphoproliferative disorders with this regimen. Primary therapy of Waldenstrom macroglobulinemia (WM) with weekly bortezomib, low-dose dexamethasone, and rituximab (BDR): long-term results of a phase 2 study of the European Myeloma Network (EMN). 5th ed. Byrd JC, Furman RR, Coutre SE, et al. American Cancer Society medical information is copyrighted material. Learn more about these partnerships and how you too can join us in our mission to save lives, celebrate lives, and lead the fight for a world without cancer. is a newer IMiD that generally cause less severe side effects than thalidomide. 24. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397. ); Dana–Farber Cancer Institute, Boston (S.P.T. Mazzucchelli M., Frustaci A.M., Deodato M., Cairoli R., Tedeschi A. Waldenstrom’s macroglobulinemia: an update.
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