BACKGROUND Ibrutinib has been approved by the Food and Drug Administration for the treatment of patients with untreated chronic lymphocytic leukemia (CLL) since 2016 but has not been compared with chemoimmunotherapy. We conducted a phase 3 trial to evaluate the efficacy of ibrutinib, either alone or in combination with rituximab, relative to chemoimmunotherapy. METHODS Patients 65 years of age or older who had untreated CLL were randomly assigned to receive bendamustine plus rituximab, ibrutinib, or ibrutinib plus rituximab. The primary end point was progression-free survival. The Alliance Data and Safety Monitoring Board made the decision to release the data after the protocol-specified efficacy threshold had been met. RESULTS A total of 183 patients were assigned to receive bendamustine plus rituximab, 182 to receive ibrutinib, and 182 to receive ibrutinib plus rituximab. Median progression-free survival was reached only with bendamustine plus rituximab. The estimated percentage of patients with progression-free survival at 2 years was 74% with bendamustine plus rituximab and was higher with ibrutinib alone (87%; hazard ratio for disease progression or death, 0.39; 95% confidence interval [CI], 0.26 to 0.58; P<0.001) and with ibrutinib plus rituximab (88%; hazard ratio, 0.38; 95% CI, 0.25 to 0.59; P<0.001). There was no significant difference between the ibrutinib-plus-rituximab group and the ibrutinib group with regard to progression-free survival (hazard ratio, 1.00; 95% CI, 0.62 to 1.62; P=0.49). With a median follow-up of 38 months, there was no significant difference among the three treatment groups with regard to overall survival. The rate of grade 3, 4, or 5 hematologic adverse events was higher with bendamustine plus rituximab (61%) than with ibrutinib or ibrutinib plus rituximab (41% and 39%, respectively), whereas the rate of grade 3, 4, or 5 nonhematologic adverse events was lower with bendamustine plus rituximab (63%) than with the ibrutinib-containing regimens (74% with each regimen). CONCLUSIONS Among older patients with untreated CLL, treatment with ibrutinib was superior to treatment with bendamustine plus rituximab with regard to progression-free survival. There was no significant difference between ibrutinib and ibrutinib plus rituximab with regard to progression-free survival. (Funded by the National Cancer Institute and Pharmacyclics; ClinicalTrials.gov number, NCT01886872.)
a b s t r a c tObjective: To demonstrate feasibility of performing geriatric assessment (GA) in the National Clinical Trials Network (NCTN) and to explore the utility of GA to characterize treatment tolerance. Materials and methods: We conducted a multisite companion study (CALGB 361006) to CALGB 11001, a phase 2 trial of adults ≥60 years old with newly diagnosed FLT3-mutated AML, testing the efficacy of adding sorafenib to intensive chemotherapy. On 361006, a GA was administered prior to induction and prior to post-remission therapy. The GA is divided into items requiring administration by a health care professional (HCP) and patient selfadministered questionnaires. Feasibility outcomes were recruitment rate, time to GA completion, difficulty with GA administration, percent of patients requiring assistance, and satisfaction. Change in GA measures preand post-induction were compared using Wilcoxon signed rank test and McNemar's tests. Results: The recruitment rate was 80% (N = 43, median age 68 years). Median completion time of the GA was 30 min; (10 and 21 min for HCP and patients, respectively). HCP reported no difficulty completing assessments (100%). Most patients completed questionnaires without assistance (77%), and were satisfied with the length (89%). Self-reported physical function, mental health, social activity and nutritional parameters worsened after induction. Conclusion: GA is feasible to administer in the setting of intensive induction for older adults with AML in the NCTN and provides evidence of the impact of induction therapy on physical and emotional health.
Purpose: To explore whether burnout is an independent predictor of career choice regret among nurses. Methods: In November 2017 we invited a random sample of 89,995 members of the American Nurses Association to participate in an anonymous online survey. The survey collected demographic and professional information and included the Maslach Burnout Inventory–Human Services Survey for Medical Personnel (known as the MBI-HSS [MP]), as well as several items exploring career choice regret. Of the 86,858 nurses who received the e-mail invitation, 8,638 (9.9%) responded. Multivariable logistic regression analysis was conducted for the final sample of 6,933 nurses who provided complete responses to the MBI-HSS (MP) and the career choice regret survey items. Results: Fifteen percent of the 6,933 participating nurses had career choice regret. On multivariable analysis, experiencing burnout, working unplanned or mandatory overtime, being male, and having a higher academic degree related to nursing were independent predictors of career choice regret. Burnout was the strongest such predictor. Conclusion: Career choice regret among U.S. nurses is relatively common. Of the independent predictors this study identified, burnout had the strongest relationship with career choice regret. Organizational strategies aimed at reducing burnout and supporting nurses' ongoing professional development should be pursued.
Science Cafés, informal venues to promote bidirectional dialog, inquiry and learning about science between community members, scientists, healthcare and service providers, hold promise as an innovative tool for healthcare researchers and community members to improve health outcomes, especially among populations with health disparities. However, the process of optimizing science cafés is under-studied. We describe the pilot evaluation of a series of Science Cafés, called Garden Cafés (n = 9), conducted from September 2015 through April 2016 in Olmsted County, MN and Duval County, FL to connect Mayo Clinic researchers and local service providers with the community. Selection of discussion topics was guided by a county health needs assessment, which identified community priorities. Before leaving the events, community participants completed a brief anonymous survey assessing sociodemographics and their knowledge of research benefits, readiness to participate as a partner in health research, and health and science literacy confidence. Of the 112 attendees who responded, 51% were female and 51% were Black. Respondents reported that participating in the event significantly improved (all at p<0.001) their understanding on all three measures. Preliminary findings suggest that Garden Cafés are an effective forum to increase community understanding and disposition to collaborate in health research, especially in members from diverse backgrounds.
IMPORTANCE Burnout is a pervasive, unrelenting problem among health care workers (HCWs), with detrimental impact to patients. Data on the impact of burnout on workforce staffing are limited and could help build a financial case for action to address system-level contributors to burnout. OBJECTIVE To explore the association of burnout and professional satisfaction with changes in work effort over 24 months in a large cohort of nonphysician HCWs. DESIGN, SETTING, AND PARTICIPANTS This longitudinal cohort study was conducted inRochester
Geriatric assessment (GA) predicts survival among older adults with acute myeloid leukemia (AML) treated intensively. We evaluated the predictive utility of GA among older adults treated with low intensity therapy on a multi-site trial. We conducted a companion study (CALGB 361101) to a randomized phase 2 trial (CALGB 11002) of adults >=60 years considered "unfit" for intensive therapy, testing the efficacy of adding bortezomib to decitabine therapy. On 361101, GA and quality of life (QOL) assessment was administered prior to treatment and every other subsequent cycle. Relationships between baseline GA and QOL measures with survival were evaluated using Kaplan Meier estimation and Cox Proportional Hazards models. One-hundred sixty-five patients enrolled on CALGB 11002 and 96 (52%) of them also enrolled on 361101 (median age, 73.9 years). Among participants, 85.4% completed ≥1 baseline assessment. In multivariate analyses, greater comorbidity (Hematopoietic Cell Transplantation-specific Comorbidity Index >3), worse cognition (Blessed Orientation Memory Concentration score > 4), and lower European Organization for Research and Treatment of Cancer global QOL scores at baseline were significantly associated with shorter overall survival (OS) (p<0.05 each) after adjustment for Karnofsky Performance Status, age and treatment arm. Dependence in Instrumental Activities of Daily Living and cognitive impairment were associated with 6 month mortality (HR 3.5, CI 1.2-10.4, and HR 3.1 CI 1.1-8.6 respectively). GA measures evaluating comorbidity, cognition, and self-reported function were associated with survival and represent candidate measures for screening older adults planned to receive lower intensity AML therapies.
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