27 research outputs found
Characterizing and prognosticating chronic lymphocytic leukemia in the elderly: prospective evaluation on 455 patients treated in the United States.
BACKGROUND: Median age at diagnosis of patients with chronic lymphocytic leukemia (CLL) is \u3e 70 years. However, the majority of clinical trials do not reflect the demographics of CLL patients treated in the community. We examined treatment patterns, outcomes, and disease-related mortality in patients ≥ 75 years with CLL (E-CLL) in a real-world setting.
METHODS: The Connect® CLL registry is a multicenter, prospective observational cohort study, which enrolled 1494 adult patients between 2010-2014, at 199 US sites. Patients with CLL were enrolled within 2 months of initiating first line of therapy (LOT1) or a subsequent LOT (LOT ≥ 2). Kaplan-Meier methods were used to evaluate overall survival. CLL- and infection-related mortality were assessed using cumulative incidence functions (CIF) and cause-specific hazards. Logistic regression was used to develop a classification model.
RESULTS: A total of 455 E-CLL patients were enrolled; 259 were enrolled in LOT1 and 196 in LOT ≥ 2. E-CLL patients were more likely to receive rituximab monotherapy (19.3 vs. 8.6%; p \u3c 0.0001) and chemotherapy-alone regimens (p \u3c 0.0001) than younger patients. Overall and complete responses were lower in E-CLL patients than younger patients when given similar regimens. With a median follow-up of 3 years, CLL-related deaths were higher in E-CLL patients than younger patients in LOT1 (12.6 vs. 5.1% p = 0.0005) and LOT ≥ 2 (31.3 vs. 21.5%; p = 0.0277). Infection-related deaths were also higher in E-CLL patients than younger patients in LOT1 (7.4 vs. 2.7%; p = 0.0033) and in LOT ≥ 2 (16.2 vs. 11.2%; p = 0.0786). A prognostic score for E-CLL patients was developed: time from diagnosis to treatment \u3c 3 months, enrollment therapy other than bendamustine/rituximab, and anemia, identified patients at higher risk of inferior survival. Furthermore, higher-risk patients experienced an increased risk of CLL- or infection-related death (30.6 vs 10.3%; p = 0.0006).
CONCLUSION: CLL- and infection-related mortality are higher in CLL patients aged ≥ 75 years than younger patients, underscoring the urgent need for alternative treatment strategies for these understudied patients.
TRIAL REGISTRATION: The Connect CLL registry was registered at clinicaltrials.gov: NCT01081015 on March 4, 2010
Real-world clinical experience in the Connect® chronic lymphocytic leukaemia registry: a prospective cohort study of 1494 patients across 199 US centres.
The clinical course of chronic lymphocytic leukaemia (CLL) is heterogeneous, and treatment options vary considerably. The Connect® CLL registry is a multicentre, prospective observational cohort study that provides a real-world perspective on the management of, and outcomes for, patients with CLL. Between 2010 and 2014, 1494 patients with CLL and that initiated therapy, were enrolled from 199 centres throughout the USA (179 community-, 17 academic-, and 3 government-based centres). Patients were grouped by line of therapy at enrolment (LOT). We describe the clinical and demographic characteristics of, and practice patterns for, patients with CLL enrolled in this treatment registry, providing patient-level observational data that represent real-world experiences in the USA. Fluorescence in situ hybridization (FISH) analyses were performed on 49·3% of patients at enrolment. The most common genetic abnormalities detected by FISH were del(13q) and trisomy 12 (45·7% and 20·8%, respectively). Differences in disease characteristics and comorbidities were observed between patients enrolled in LOT1 and combined LOT2/≥3 cohorts. Important trends observed include the infrequent use of genetic prognostic testing, and differences in patient characteristics for patients receiving chemoimmunotherapy combinations. These data represent experiences of patients with CLL in the USA, which may inform treatment decisions in everyday practice
How artists working in academia view artistic practice as research: Implications for tertiary music education
Artistic research output struggles for recognition as ‘legitimate’ research within the highly competitive and often traditional university sector. Often recognition requires the underpinning processes and thinking to be documented in a traditional written format. This article discusses the views of eight arts practitioners working in academia by asking whether or not they view their arts practice as research; and if they do, how it is so. The findings illuminate ways in which artistic practice is understood as research and reveal how the process of analytical and reflective writing impacts artist academics, their artistic and academic identities and their environment. The findings suggest a frame within which to advocate the equivalence of artistic research with traditional scholarly research. They also suggest a rationale for arguing against this, focusing instead (or perhaps as well) on a wider understanding of what constitutes knowledge. This has implications for academics, for students and for universities in recognising the research inherent within arts practice itself, and in recognising the value of practice-led writing in understanding and communicating new knowledge, new methods, and new definitions of research
Effectiveness of bevacizumab exposure beyond disease progression in patients with non-small-cell lung cancer: analyses of the ARIES observational cohort study
Longitudinal health‐related quality of life in first‐line treated patients with chronic lymphocytic leukemia: Results from the Connect® CLL Registry
Abstract Health‐related quality of life (HRQoL) in patients with chronic lymphocytic leukemia (CLL) is important in guiding treatment decisions. However, the impact of CLL treatment initiation on HRQoL is unclear. We assessed HRQoL using the FACT‐Leu and EQ‐5D‐3L questionnaires in the Connect® CLL Registry, a large, US‐based, multicenter, prospective observational study of CLL patients enrolled between 2010 and 2014, prior to the introduction of novel therapies. Among 889 patients initiating first‐line therapy with chemoimmunotherapy or rituximab monotherapy, questionnaire completion rates were 95.7% and 95.8% at enrollment, and 70.8% and 69.4% at 12 months, for FACT‐Leu Total and EQ‐5D‐3L, respectively. For 849 patients completing all five FACT‐Leu components, average total scores were 135.7 at enrollment and 141.6 at 12 months. Among 526 patients with FACT‐Leu Total scores at enrollment and 12 months, clinically meaningful (≥11‐point) improvements or reductions were observed in 179 (34.0%) and 88 (16.7%) patients, respectively. Mean EQ‐5D‐3L index scores were 0.87 at enrollment and 12 months. Among 513 patients completing EQ‐5D‐3L at enrollment and 12 months, clinically meaningful (≥0.06‐point) improvements or reductions were observed in 125 (24.4%) and 116 (22.6%) patients, respectively. In the Connect® CLL Registry, HRQoL remained stable or slightly improved after 12 months of follow‐up
Factors influencing first-line therapy of acute myeloid leukemia (AML) patients (pts) in the Connect MDS/AML Disease Registry.
Heterogeneity of Second-Line Treatment for Patients With Multiple Myeloma in the Connect MM Registry (2010-2016)
Background
The treatment landscape for multiple myeloma (MM) has undergone recent changes with the regulatory approval of several new therapies indicated for second- and later-line disease. Using data from Connect MM, the largest multisite, primarily community-based, prospective, observational registry of MM patients in the United States, selection of second-line treatments was evaluated during a 5-year period from 2010 to 2016.
Patients and Methods
Eligible patients were aged ≥ 18 years, had newly diagnosed MM ≤ 2 months before study entry, and were followed for up to 8 years. Patients who received ≥ 2 lines of therapy were analyzed. “Tepee” plots of stacked area graphs differentiated treatments by color to allow visualization of second-line treatment trends in MM patients.
Results
As of February 2017, 855 of 2897 treated patients had progressed to second-line treatment. Treatment selection was heterogeneous; shifting patterns of treatment choices coincided with the approval status of newer agents. The most common treatment regimens in the early part of the decade were lenalidomide and/or bortezomib, with or without dexamethasone, with increasing use of newer agents (carfilzomib, pomalidomide, daratumumab, and elotuzumab) and triplet combinations over time. The influence of the baseline patient characteristics of age, history of diabetes, peripheral neuropathy, and renal function on treatment choice was also examined.
Conclusion
These findings indicate that community physicians are current in their MM management practices, with uptake of new drugs and acquaintance with results of randomized clinical trials using combinations almost concurrent with their regulatory approval and publication
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Real-world clinical experience in the Connect® chronic lymphocytic leukaemia registry: a prospective cohort study of 1494 patients across 199 US centres.
The clinical course of chronic lymphocytic leukaemia (CLL) is heterogeneous, and treatment options vary considerably. The Connect® CLL registry is a multicentre, prospective observational cohort study that provides a real-world perspective on the management of, and outcomes for, patients with CLL. Between 2010 and 2014, 1494 patients with CLL and that initiated therapy, were enrolled from 199 centres throughout the USA (179 community-, 17 academic-, and 3 government-based centres). Patients were grouped by line of therapy at enrolment (LOT). We describe the clinical and demographic characteristics of, and practice patterns for, patients with CLL enrolled in this treatment registry, providing patient-level observational data that represent real-world experiences in the USA. Fluorescence in situ hybridization (FISH) analyses were performed on 49·3% of patients at enrolment. The most common genetic abnormalities detected by FISH were del(13q) and trisomy 12 (45·7% and 20·8%, respectively). Differences in disease characteristics and comorbidities were observed between patients enrolled in LOT1 and combined LOT2/≥3 cohorts. Important trends observed include the infrequent use of genetic prognostic testing, and differences in patient characteristics for patients receiving chemoimmunotherapy combinations. These data represent experiences of patients with CLL in the USA, which may inform treatment decisions in everyday practice
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Factors Associated with Early Therapy Initiation in Patients (pts) with Myelodysplastic Syndromes (MDS) in the Connect® MDS/AML Disease Registry
Abstract
Introduction: In prior studies, only 13-22% of lower-risk (LR) MDS pts and 11-69% of higher-risk (HR) MDS pts received potentially disease-modifying therapy despite the proven benefits of reduced blood transfusions and prolonged survival. Pt age, frailty, and comorbidities are commonly assumed to influence therapy choice; however, this has not been proven and other factors may govern treatment (tx) decisions. To identify factors associated with receiving first-line tx for MDS, health services data from the Connect® MDS/AML Registry, which includes MDS pts treated in US academic, community, and government-based centers, were analyzed.
Methods: The Connect MDS/AML Registry (NCT01688011) is an ongoing, prospective observational cohort study of pts with newly diagnosed acute myeloid leukemia (AML) (aged ≥ 55 years) or MDS (aged ≥ 18 years). Local AML and MDS diagnoses are confirmed by an independent central review of all available diagnostic reports. Baseline demographics, disease characteristics, laboratory parameters, and ZIP-code-level per capita income were collected at enrollment on MDS pts from December 2013 to March 2018. Analyses were performed separately for LR-MDS pts, defined as having Low- or Intermediate (Int)-1-risk MDS according to the International Prognostic Scoring System (IPSS), and HR-MDS pts, defined as having Int-2- or High-risk MDS.
Uni- and multivariable logistic regression analyses were used to identify factors associated with early use of first-line tx in MDS pts, defined as chemotherapy or biotherapy initiated ≤ 45 days after diagnosis. Univariable testing was performed for each potential predictor; those with an association of P < 0.15 were included in multivariable analysis. The final multivariable model was derived using a score-based selection method. Pts receiving first-line tx (regardless of intensity) were compared with a combined group of pts receiving best supportive care (BSC) or no tx.
Results: As of March 8, 2018, data from 536 MDS pts (232 HR-MDS and 304 LR-MDS) from 130 institutions (20 academic and 110 community/government) were available for analysis. In the LR-MDS group, median age was 76 years (range 28-95), with 65% male, and 89% white; 19% had private insurance, and the average median ZIP-code-level per capita income was 10,000-26,000 (range 83,000).
In LR-MDS pts, univariable predictors of early first-line therapy initiation included baseline transfusion dependency (defined as ≥ 1 transfusion episode in the 8 weeks prior to diagnosis), comorbidities (higher Adult Comorbidity Evaluation 27 [ACE-27] score), having fluorescence in situ hybridization (FISH) or molecular analyses performed, Int-1 IPSS risk score, primary vs secondary MDS, and higher bone marrow (BM) blast percentage. Multivariable logistic regression analysis identified transfusion dependency (P = 0.001), Int-1 IPSS risk score (P = 0.026), BM blast percentage ≥ 5% (P = 0.002), and having both FISH and molecular genetic testing performed at diagnosis (P = 0.022) as factors significantly associated with early initiation of first-line tx (Table 1).
Univariable analysis of HR-MDS pts showed insurance status, comorbidities (ACE-27 score ≤ 2), High IPSS risk score, primary vs secondary MDS, having flow cytometry analysis performed, lower baseline frailty, and BM blast percentage as univariable correlates associated with early tx. Multivariable logistic regression analysis identified private insurance coverage (P = 0.031) and BM blast percentage ≥ 10% (P = 0.021) as factors significantly associated with early initiation of first-line tx (Table 2).
Conclusions: Early first-line tx in MDS pts was significantly associated with disease severity as indicated by transfusion dependency, higher IPSS risk score, and higher BM blast percentage. However, counter to common assumptions, age, frailty, and comorbidities were not associated with receiving early tx in MDS. Access to care may be an important factor in the tx of MDS pts, as having private health insurance and undergoing genetic testing were also significantly associated with receiving early tx. Additional pt-centered research with prescribing MDS physicians as stakeholders is needed to verify and extend these findings.
Disclosures
Cogle: Celgene: Other: Steering Committee Member of Connect MDS/AML Registry. Grinblatt:Celgene: Membership on an entity's Board of Directors or advisory committees; Alexion: Speakers Bureau; AbbVie: Consultancy. Komrokji:Novartis: Honoraria, Speakers Bureau; Celgene: Honoraria, Research Funding; Novartis: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Celgene: Honoraria, Research Funding. Savona:Boehringer Ingelheim: Consultancy; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees, Research Funding. Scott:Celgene: Consultancy, Honoraria, Research Funding. Sekeres:Celgene: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Opsona: Membership on an entity's Board of Directors or advisory committees; Opsona: Membership on an entity's Board of Directors or advisory committees. Louis:Cellmedica: Patents & Royalties; Celgene: Employment. Flick:Celgene: Employment. Nifenecker:Celgene: Employment. Kiselev:Celgene: Employment, Equity Ownership. Swern:Celgene: Employment, Equity Ownership. Steensma:Takeda: Consultancy; Syros: Research Funding; Otsuka: Membership on an entity's Board of Directors or advisory committees; Onconova: Consultancy; Novartis: Membership on an entity's Board of Directors or advisory committees; Kura: Research Funding; Janssen: Consultancy, Research Funding; H3 Biosciences: Research Funding; Celgene: Research Funding; Amphivena: Membership on an entity's Board of Directors or advisory committees; Acceleron: Consultancy