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Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

ABSTRACT: Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The phase 3 RESONATE study showed improved efficacy of single-agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL, including those with high-risk features. Here we report the final analysis from RESONATE with median follow-up on study of 65.3?months (range, 0.3-71.6) in the ibrutinib arm. Median progression-free survival (PFS) remained significantly longer for patients randomized to ibrutinib vs ofatumumab (44.1 vs 8.1?months; hazard ratio [HR]: 0.148; 95% confidence interval [CI]: 0.113-0.196; P?.001). The PFS benefit with ibrutinib vs ofatumumab was preserved in the genomic high-risk population with del(17p), TP53 mutation, del(11q), and/or unmutated IGHV status (median PFS 44.1 vs 8.0?months; HR: 0.110; 95% CI: 0.080-0.152), which represented 82% of patients. Overall response rate with ibrutinib was 91% (complete response/complete response with incomplete bone marrow recovery, 11%). Overall survival, censored for crossover, was better with ibrutinib than ofatumumab (HR: 0.639; 95% CI: 0.418-0.975). With up to 71?months (median 41?months) of ibrutinib therapy, the safety profile remained consistent with prior reports; cumulatively, all-grade (grade??3) hypertension and atrial fibrillation occurred in 21% (9%) and 12% (6%) of patients, respectively. Only 16% discontinued ibrutinib because of adverse events (AEs). These long-term results confirm the robust efficacy of ibrutinib in relapsed/refractory CLL/SLL irrespective of high-risk clinical or genomic features, with no unexpected AEs. This trial is registered at www.clinicaltrials.gov (NCT01578707).

SUBMITTER: Munir T

PROVIDER: S-EPMC6899718 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Munir Talha T Brown Jennifer R JR O'Brien Susan S Barrientos Jacqueline C JC Barr Paul M PM Reddy Nishitha M NM Coutre Steven S Tam Constantine S CS Mulligan Stephen P SP Jaeger Ulrich U Kipps Thomas J TJ Moreno Carol C Montillo Marco M Burger Jan A JA Byrd John C JC Hillmen Peter P Dai Sandra S Szoke Anita A Dean James P JP Woyach Jennifer A JA

American journal of hematology 20191013 12

Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The phase 3 RESONATE study showed improved efficacy of single-agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL, including those with high-risk features. Here we report the final analysis from RESONATE with median follow-up on study of 65.3 months (range, 0. ...[more]

PMID: 31512258

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Project description:BackgroundMentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years.MethodsThis prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure.ResultsPrimary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent.ConclusionThe results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction.Clinical question/level of evidenceTherapeutic, IV.

Dataset Information

Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Publications

Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Similar Datasets

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