Associations Between Treatment Restrictions, Patient-Reported Treatment Burden and Adherence to Tyrosine-Kinase Inhibitor Therapy Among Chronic Myeloid Leukemia Patients in the United States and Europe

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2077-2077
Author(s):  
Shaloo Gupta ◽  
Amir Goren ◽  
Timothy W Victor ◽  
Jonathan Chapnick ◽  
Stephanie Hawthorne ◽  
...  
Keyword(s):  
Research Funding ◽  
Kinase Inhibitor ◽  
The United States ◽  
Current Treatment ◽  
Treatment Regimens ◽  
Dietary Restrictions ◽  
Patient Reported ◽  
Tki Treatment ◽  
The Impact ◽  
Treatment Restrictions

Abstract Abstract 2077 Background: The availability of the tyrosine-kinase inhibitor (TKI), imatinib, and later introduction of second generation TKIs, dasatinib and nilotinib, have not only improved the clinical outcomes of patients with chronic myeloid leukemia (CML), but have also provided multiple therapeutic options for CML patients. Despite the widespread use of these oral therapies, little is known about the impact of different treatment regimens on overall treatment burden and adherence among CML patients. Objective: The objective of this cross-sectional survey conducted in the United States (US) and Europe (EUR) was to assess the overall CML disease management and treatment experience from the patient's perspective. This analysis evaluates the impact of dosing and dietary restrictions on patient-reported adherence and difficulty following oral TKI treatment regimens. Methods: This study included patients identified from the National Health and Wellness Survey and Lightspeed Research Chronic Illness Panel aged ≥18 years from the US and EUR (United Kingdom, Spain, France, Italy, and Germany) who had a diagnosis of CML, were in chronic phase, and were currently on TKI treatment or on a drug holiday. Patients completed a web based self-administered questionnaire. Relevant measures of treatment restrictions, including dietary restrictions (while fasting, with food, without certain foods, with water, at specific time intervals, or without certain non-CML meds) and dosing regimens (once a day, twice a day, two or more pills at one time, or at specific times of day) were compared across TKIs. Outcomes included CML treatment adherence (TKI dose was missed/skipped or taken less than prescribed over the past 4 weeks) and treatment difficulty (patient-reported difficulty in following treatment regimens - Yes/No). A composite score of overall dietary restrictions was constructed for each patient to assess associations with patient-reported treatment difficulty and adherence using a structural equation model (SEM). Results: A total of 303 respondents participated in the study (50% from US), of which 68.6% reported current treatment as imatinib, 12.5% dasatinib and 16.2%nilotinib (2.7% reported other). Mean age was 51.5 years (standard deviation [SD] = 13.6), 46.2% were male, and mean time since diagnosis was 4.8 years (SD = 4.5), with 12.3% of patients within 12 months of diagnosis. The majority of patients reported being adherent to their CML treatment, with 25.4% stating missed doses within the past 4 weeks. Approximately 30% reported difficulty in following treatment regimens; treatment difficulty was substantially higher among nilotinib (63.3%) than among dasatinib (3.7%) or imatinib (22.9%) treated patients (p<0.0001). Overall dietary restriction scores (ranging from -1.33 to 1.60, with positive values indicating greater restrictiveness) were low among dasatinib (mean score= −0.31) and imatinib users (-0.06), whereas overall scores were significantly higher among nilotinib users (mean= 0.61; p<0.0001). Although dietary restrictions were not significantly associated with self-reported adherence (p=0.24), results of the SEM model indicated that higher overall dietary restriction scores were associated with significantly greater difficulty in taking medication as required (beta=0.28, p<0.001). Conclusions: Dietary restrictions were strongly associated with patients reporting difficulty with current treatment regimens. Patients receiving dasatinib and imatinib reported fewer dietary and dosing restrictions than did patients receiving nilotinib. Choosing a regimen that requires fewer overall dosing restrictions may be an important consideration for treatment choice in CML patients. Disclosures: Gupta: Bristol-Myers Squibb: Research Funding. Goren:Bristol-Myers Squibb: Research Funding. Victor:Bristol-Myers Squibb: Research Funding. Chapnick:Bristol-Myers Squibb: Research Funding. Hawthorne:Bristol-Myers Squibb: Research Funding. Hirji:BMS: Employment. Olavarría:Bristol-Myers Squibb: Consultancy. Moadel:Bristol-Myers Squibb: Consultancy. Lemoine:Bristol-Myers Squibb: Consultancy. Davis:Bristol-Myers Squibb: Employment.

scholarly journals Outcomes of Patients with Multiple Myeloma Harboring Gain/Amplification 1q in the Era of Modern Therapy

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 45-46
Author(s):  
Xiao Hu ◽  
Cherng-Horng Wu ◽  
Janet Cowan ◽  
Raymond L. Comenzo ◽  
Cindy Varga
Keyword(s):  
Multiple Myeloma ◽  
Survival Data ◽  
Research Funding ◽  
The United States ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Rank Tests ◽  
Treatment Regimens ◽  
The Impact ◽  
Log Rank Tests

Background: Multiple myeloma (MM) is the second most common hematological malignancy in the United States. Fluorescence in-situ hybridization (FISH) is a popular tool to detect cytogenetic alterations which in turn, can contribute to the risk stratification of patients with MM. Gain or amplification of CKS1B gene at chromosome 1q21 region (gain 1q) is detected in 35-40% of newly diagnosed MM cases, and has been reported to be associated with inferior prognostic outcomes. It also frequently occurs with the deletion of CDKN2C at chromosome 1p32.3 (del 1p). There is a distinct lack of data on patients harboring this cytogenetic alteration in the era of novel agents. We sought to look at outcomes of this patient population at a single institution over the last 5 years. Methods: This retrospective study included all patients with MM as defined by the International Myeloma Working Group (IMWG) with available FISH studies identifying gain 1q between 01/01/2015 to 04/30/2020 at Tufts Medical Center. The study was approved by the Institutional Review Board. Baseline demography, disease characteristics, and treatment history were extracted from the electronic medical records. With death as primary event, overall survival (OS) was defined as the survival time from the discovery of gain 1q to death. Progression free survival (PFS) was defined as the time from discovery of gain 1q to first progression/relapse or death, whichever occurred first. Kaplan-Meier method was used to estimate survival data. Differences in survival between two groups were analyzed by log-rank tests. Multivariable cox regression adjusting for baseline characteristics and significant concurrent cytogenetic alterations were performed to explore the impact of treatment regimens on survival. Results: Of the forty-nine subjects included in this study, the age range was 39 to 85 years; 31 patients (63.3%) were over the age of 65 years, and 28 (57.1%) were male. Twenty-eight (57.1%) subjects with gain 1q were newly diagnosed while the remaining 21 (42.9%) were identified at relapse. Gain 1q was present in more than 20% of clonal cells in 73.5% of subjects and 29.6% had del 1p as well. Patients with gain 1q were more likely to have deletion 13q (65.3%) and hyperdiploidy (61.2%). Regarding treatment, 75.7% of patients received bortezomib, 70.3% received lenalidomide, 38.9% underwent autologous stem cell transplant (ASCT) and 64.9% received daratumumab. At the time of analysis, 41 patients were still alive. For the entire cohort, the estimated median OS was not reached (NR) (95% confidence interval [CI], 24.1-NR), and the estimated median PFS was 15.27 months (95% CI, 4.77-NR). In log-rank tests, presence of extra medullary disease was associated with shorter PFS (4.8 vs 24.1 months, P=0.003), while IGH abnormalities including complex IGH rearrangements or losses were associated with longer PFS (NR vs 8.2 months, P=0.046). Lenalidomide-based treatment was associated with prolonged OS (NR vs 17.2 months, P=0.048). Bortezomib-based therapy and upfront ASCT were associated with improved PFS (15.3 vs 4.7 months, P=0.036; NR vs 4.8 months, P =0.019 respectively). Further multivariate analyses adjusting for age, number of CKS1B copies, International Staging System stage, baseline creatinine, clone size, del 1p, lactate dehydrogenase, extra medullary disease, and IGH abnormalities revealed that administration of daratumumab after the discovery of gain 1q was associated with superior OS (Hazard Ratio [HR]=0.023x10^-2, 95% CI [0.002x10^-4, 0.299], P =0.022) compared with those not receiving this agent; both the use of bortezomib (HR=0.210, 95% CI [0.064, 0.687], P =0.010) and daratumumab (HR=0.126, 95% CI [0.015, 1.036], P =0.054) were associated with prolonged PFS. The use of lenalidomide or upfront ASCT lost prognostic benefit after adjusting for additional variables in multivariate models. Conclusions: The outcomes of MM patients with gain 1q were evaluated according to clinical characteristics, concurrent chromosomal alterations and treatment regimens. In our small cohort, daratumumab and daratumumab-bortezomib combination regimens were found to have a favorable impact on survival. Future prospective clinical trials with larger sample sizes are warranted to confirm the results and further improve the outcomes of MM patients with this cytogenetic alteration. Disclosures Comenzo: Amgen: Consultancy; Takeda: Consultancy, Research Funding; Sanofi: Consultancy; Unum: Consultancy; Caleum: Consultancy; Prothena: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Karyopharm: Consultancy, Research Funding.

scholarly journals SUN-LB102 Development of a Conceptual Model to Present the Impacts of Obesity on Physical Functioning

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Jiat Ling Poon ◽  
Chris Marshall ◽  
Chloe Johnson ◽  
Hannah Pegram ◽  
Maile Hunter ◽  
...  
Keyword(s):  
Conceptual Model ◽  
Physical Functioning ◽  
Content Validity ◽  
Clinical Studies ◽  
Negative Impact ◽  
The United States ◽  
Overweight And Obesity ◽  
Spontaneous Reports ◽  
Patient Reported ◽  
The Impact

Abstract Background. Obesity is a chronic disease with a significant negative impact on health-related quality of life (HRQoL) and specifically, physical functioning, including the ability to complete activities of daily living (ADLs). Weight loss based on lifestyle management (e.g. diet, exercise), surgery, and pharmacotherapy can improve physical functioning; however, there is a need for further qualitative research to support the content validity of patient-reported outcome (PRO) measures for use in clinical studies of obesity and thus inform regulatory decision-making. Objective. To explore the impacts of obesity on physical functioning and develop a conceptual model (a visual representation of the concepts of importance and relevance to the experience of living with obesity) to ultimately support the content validity of PRO measures.Methods. Qualitative semi-structured interviews were conducted in the United States with individuals who have overweight and obesity (Body Mass Index [BMI] ≥ 27.0 kg/m2) with a history of at least one unsuccessful dietary effort to lose body weight. Recruitment quotas targeted a sample with diverse demographic and clinical characteristics, including participants with and without diabetes. Experienced qualitative interviewers used open-ended questions to elicit spontaneous reports of the impact of obesity on individuals’ daily lives, and specific probing questions to explore impacts on physical functioning. Interviews were audio-recorded, transcribed and analyzed using thematic techniques. Results. A total of 33 participants were interviewed (mean BMI of 37.6 kg/m2 [27.4 kg/m2 to 56.6 kg/m2]; mean age of 45 years [19 to 81 years]). The sample included a mix of races (Caucasian: n=12, 36%), education completed (high school: n=17, 51%) and split of gender (female: n=16, 48%). During development of the conceptual model, two separate domains were identified to group the reported impacts on physical functioning: ‘Mobility/Movement’ and ‘ADLs’. The most frequently reported impacts related to Mobility/Movement were ‘running’ (n=31/33, 94%), ‘bending’ (n=27/33, 82%), ‘walking’ (n=26/33, 79%), ‘difficulty standing for prolonged periods’ (n=22/33, 67%), and ‘lifting’ (n=19/33, 58%). All participants reported effects on some aspect of physical functioning, which were often characterized in terms of their direct impact on ADLs such as ‘household chores’ (n=21/33, 64%). Conclusions. The conceptual model will serve as a basis to identify fit-for-purpose PRO measures with strong content validity to evaluate the impact of anti-obesity therapies on physical functioning in future clinical studies. Obesity has a consistent and significant impact on physical functioning, leading to limitations in various aspects of mobility and affecting an individual’s ability to carry out specific daily activities.

scholarly journals The multifaceted impact of anxiety and depression on patients with rheumatoid arthritis

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Steve Peterson ◽  
James Piercy ◽  
Stuart Blackburn ◽  
Emma Sullivan ◽  
Chetan S. Karyekar ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Multinomial Logistic Regression ◽  
The United States ◽  
Anxiety And Depression ◽  
Relative Risk Ratio ◽  
Depression Symptoms ◽  
Patient Anxiety ◽  
Patient Reported ◽  
The Usa ◽  
The Impact

Abstract Background The prevalence of mood disturbances such as anxiety and depression is greater in rheumatoid arthritis (RA) patients than in the general population. Given this association, the primary aim of this study was to assess the incremental impact of anxiety or depression on patients with RA from the United States of America (USA) and Europe, independent of the impact of the underlying RA disease. Methods Rheumatologists (n = 408) from the USA and 5 European countries completed patient record forms for a predetermined number of RA patients who consulted consecutively during the study period; these patients completed patient-reported questionnaires. Descriptive statistics and multivariate regression were used to investigate the relationship between anxiety and depression with treatment and economic outcomes in RA patients. Results Of 1015 physician and patient pairs who completed all relevant questionnaire sections, 390 (38.4%) patients self-reported anxiety or depression, while 180 (17.7%) patients were reported to have anxiety or depression by their physicians. Controlling for age, gender, body mass index and clinical factors (flaring and severity), multiple regression analyses suggested that patients with anxiety or depression more often experienced treatment dissatisfaction (odds ratio [OR] 2.28; P < .001), had greater impairment in work (coefficient [β] = 11.82; P = .001) and usual activity (β = 14.73; P < .001), greater disability (β = .35; P < .001), and more often reported unemployment (OR 1.74; P = .001). Multinomial logistic regression revealed discordance between physician and patient satisfaction with treatment. For patients reporting anxiety or depression, physicians were more often satisfied with achievement of current disease control than patients (relative risk ratio 2.19; P = .002). Conclusion Concomitant anxiety or depression was associated with a significant incremental impact on the health-related quality of life and economic aspects of life of patients with RA. In light of observed differences between physician recognition of patient anxiety and/or depression versus patient reporting of anxiety and/or depression symptoms, further research is warranted to develop optimal screening and management of depression and anxiety in patients with RA.

In Vitro Anti-Myeloma Activity of the Multitargeted Kinase Inhibitor Midostaurin in the Context of Heterotypic Cocultures of Myeloma Cells with Nonmalignant Microenvironmental Accessory Cells

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2923-2923
Author(s):  
Panisinee Lawasut ◽  
Hannah M. Jacobs ◽  
Jake E Delmore ◽  
Joseph Negri ◽  
Douglas W. McMillin ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Research Funding ◽  
Kinase Inhibitor ◽  
Conditioned Media ◽  
Myelogenous Leukemia ◽  
Tumor Type ◽  
Accessory Cells ◽  
The Impact ◽  
Positive Controls

Abstract Abstract 2923 Midostaurin (PKC412; Novartis Pharmaceuticals) is a multi-targeted kinase inhibitor currently being evaluated in clinical trials in acute myelogenous leukemia (AML), because of its potent activity in cells expressing mutant FLT3. Prior preclinical studies from our groups have shown that PKC412 has FLT3-independent anti-MM activity, and the effects on AML cells is suppressed by the presence of conditioned media from bone marrow stromal cells (BMSCs), such as the immortalized BMSC line HS-5 (Weisberg et al. Mol Cancer Ther 2007). In this study, we evaluated whether the microenvironment-dependent drug resistance to PKC412 applies to not only AML cells, but also to cells from MM and other FLT3-negative malignant cells. We tested a panel of cells from MM (n=8), FLT-ITDneg AML (n=1), CML (n=2) and breast cancer (n=2) for their response to PKC412 in the presence or absence of BMSCs and other non-malignant accessory cells using tumor cell compartment-specific bioluminescence imaging (CS-BLI), as in our antecedent studies (McMillin et al. Nat Medicine 2010). We also compared the PKC412 response of the aforementioned neoplastic cells when cultured in vitro in the presence or absence of conditioned media (CM) from different types of BMSCs known to confer PKC412 resistance in FLT3-mutant AML cells. Consistent with our previous studies of PKC412 treatment in conventional cultures of MM cells in isolation, we observed that PKC412 exhibits an anti-proliferative effect within the first 24 hrs of treatment, with major reduction of the numbers of viable cells at 48 and 72 hrs. At sub-micromolar doses that did not significantly affect the viability of non-malignant accessory cells tested, PKC412 had similar (or for some MM cell lines had more pronounced) activity against the MM cells, both in the presence and absence of the non-malignant accessory cells tested (HS-5, HS-27a, NIH-3T3 cells with or without transfection with human CD40L, etc.). In contrast, under the same experimental conditions, coculture with either BMSCs or exposure to their conditional media, decreased the response of MM cells to dexamethasone. These results suggested in contrast to the impact on FLT3mut AML, that the anti-MM activity of PKC412 is preserved (and in some cases slightly enhanced) when the MM cells interact with microenvironmental accessory cells and/or their secreted growth/survival factors. To obtain insight on possible mechanistic foundations of these observations, we examined the pattern of kinases inhibited by PKC412 at sub-μM concentrations (using FLT3 and FGFR3, known targets of PKC412 as positive controls). The results of in vitro kinase activity assays showed that PKC412 potently suppresses the aforementioned positive controls, but also exerts >50% inhibitory effect on the in vitro activity of additional kinases such as Akt2, Pim1, GSK3a, PDK1, p70S6K, SRC and Aurora A. Many of these kinases are known to participate in proliferative/anti-apoptotic signaling cascades downstream of cytokine/growth factor receptors or cell adhesion-mediated events triggered during MM–stromal interactions. We therefore conclude that the influence of the tumor microenvironment on the anti-neoplastic effects of PKC412 may be tumor-type dependent. The anti-MM activity of PKC412 is not subject to drug resistance triggered by non-malignant accessory cells, and conversely is occasionally moderately enhanced by these MM-stromal interactions. Mechanistically, this observation may be attributed in part to the multi-targeted nature of this inhibitor and, in particular, its aggregate impact on several kinases known to mediate stroma-induced proliferative and antipoptotic signaling in MM. Disclosures: Griffin: Novartis Pharmaceuticals: Consultancy, Research Funding. Richardson:Millennium: ; Celgene: ; Johnson & Johnson: ; Novartis: ; Bristol Myers Squibb:. Anderson:Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals, Inc.: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Mitsiades:EMD Serono: Research Funding; AVEO Pharma: Research Funding; Amgen: Research Funding; OSI Pharmaceuticals: Research Funding; PharmaMar: licensing royalties; Amnis Therapeutics: Consultancy, Honoraria; Centocor: Consultancy, Honoraria; Pharmion: Consultancy, Honoraria; Kosan: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Novartis Pharmaceuticals: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals: Consultancy, Honoraria; Sunesis: Research Funding; Gloucester Pharmaceuticals: Research Funding; Genzyme: Research Funding; Johnson & Johnson: Research Funding.

Impact of Mild to Severe Hemophilia B on Quality of Life Including Pain and Functional Abilities in Affected Men/Women and Caregivers of Affected Boys/Girls: Analysis of Patient Reported Outcomes in the Bridging Hemophilia B Experiences Results and Opportunities into Solutions (B-HERO-S) Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 251-251 ◽  
Author(s):  
Tyler W. Buckner ◽  
Michelle Witkop ◽  
Christine Guelcher ◽  
Robert F. Sidonio ◽  
Christopher E. Walsh ◽  
...  
Keyword(s):  
Research Funding ◽  
Hemophilia B ◽  
Depression And Anxiety ◽  
Mild Depression ◽  
On Demand ◽  
Advisory Boards ◽  
Patient Reported ◽  
The Impact

Abstract Introduction: Health-related quality-of-life (HRQoL) is impaired in patients with severe congenital hemophilia due to pain and functional impairment associated with hemophilic arthropathy. The impact of mild or moderate hemophilia on HRQoL and on women with hemophilia in particular is less well characterized. Use of standardized instruments for assessment of pain/depression/anxiety also remains uncommon in patients with hemophilia. Objective: B-HERO-S was designed to characterize factors that affect HRQoL in adult patients with hemophilia B (PWH) and caregivers (CG) of affected children (CWH). Methods:US PWH (either gender, age ≥18 years) and CG (age >18 years) of CWH (either gender, age <18 years) were recruited through 3 patient organizations to complete distinct (PWH/CG) ~1 hour internet-based, IRB-approved surveys. In addition to descriptive surveys, adults completed 4 standardized patient reported outcome (PRO) instruments (EQ5D-5L with VAS [0‒100 scale] and calculated index [-0.11‒1.00], brief pain inventory [BPI SFv2, 0‒10 scale], PHQ9 [0‒27 score], and international physical activity questionnaire [IPAQ, low/moderate/high category]); and one disease-specific PRO (hemophilia activities list [HAL, 0‒100 score for domains]). Caregivers completed 2 standardized PROs for depression and anxiety (PHQ9, GAD7 [0‒21 score]). Results PWH: 213 men and 86 women responded to the survey. Median age of participants was 29 years (range 18‒70 years). Severity was self-reported as mild/moderate/severe/inhibitor (74/189/32/4). Comorbidities associated with hemophilia were arthritis (48%), osteoporosis/fractures (43%/11%), pain (acute/chronic: 29%/13%), anxiety (23%), and depression (22%). Most were educated past high school (87%), employed (81%), and married/in a long-term relationship (54%). Despite the preponderance of mild/moderate PWH, most PWH had some pain (EQ5D-5L) and nearly all had problems with usual activities, anxiety/depression, mobility, and self-care (Table 1). PWH reported moderate pain severity/interference (median 5/5); higher scores were observed for women (7/7), PWH with moderate hemophilia (6/7), and those on routine infusions (6/6). Based upon PHQ9, at least mild depression was observed in >75% of the PWH respondents and more often in moderate and severe PWH. More women than men had depression, and those treated with routine infusions reported higher depression scores than those treated on demand. While 94% reported some physical activity, two-thirds were categorized as moderate or high activity; unexpectedly, there were more mild PWH reporting low activity and more severe PWH categorized as high. There were no apparent differences in upper and lower extremity functional ability (HAL) domains or composite scores across hemophilia severity or by gender; PWH on routine infusions had worse scores than those treated on demand. Results CG:150 CG participants, all parents, included fathers/mothers (34/116) with median age 35 years (range 21‒53 years) describing their oldest children <18 years (boys/girls: 121/29; median age 10 years, range <1‒18 years), with mild/moderate/severe/inhibitor (27/84/33/6). Most CG were educated past high school (86%), employed (86%), and married/in a long-term relationship (89%). Based on PHQ9 results, more than half of CG reported at least mild depression; just under half reported mild anxiety according to the GAD7 scores (Table 2). Compared with the PWH results, the differences in depression and anxiety were much more pronounced in CG of children with moderate hemophilia and in mothers. CG of CWH treated with routine infusions vs. on demand reported more depression and anxiety. Limitations: Voluntary response bias may limit generalizability of these findings as PWH/CG with greater impact may have been more likely to participate. Conclusions: These findings indicate that pain, functional impairment, and depression/anxiety may contribute to the impact of hemophilia B on education, work, activity, and relationships described in prior reports from B-HERO-S. This is the first study to examine HRQoL in PWH of both genders and CG of affected CWH with mild-to-severe hemophilia B using multiple PRO instruments. These results suggest unmet needs particularly in mild/moderate PWH and women. Comparisons between known groups and analysis of HRQoL predictors are underway. Disclosures Buckner: Genentech: Consultancy; Novo Nordisk: Consultancy; Baxalta: Consultancy. Witkop:Novo Nordisk: Consultancy, Other: Advisory Boards, Speakers Bureau; Pfizer: Consultancy, Research Funding, Speakers Bureau; BioEmergent: Consultancy, Speakers Bureau; Baxalta: Consultancy. Guelcher:Novo Nordisk: Other: Advisory Boards, Speakers Bureau; Biogen Idec: Other: Advisory Boards; Baxter/Baxalta: Other: Advisory Boards, Speakers Bureau; Octapharma: Other: Advisory Boards; Grifols: Other: Advisory Boards; Solution Sight: Speakers Bureau. Sidonio:Biogen: Honoraria, Research Funding; CSL Behring: Honoraria; Baxalta: Honoraria, Research Funding; Novo Nordisk: Honoraria; Pfizer: Honoraria; Emergent Solutions: Honoraria. Walsh:Novo Nordisk: Consultancy; Baxalta: Consultancy; Bayer: Consultancy; CSL Behring: Consultancy; Genentech: Consultancy. Kessler:Octapharma: Consultancy, Research Funding; Novo Nordisk: Consultancy, Research Funding; Grifols: Consultancy; Genentech: Consultancy, Research Funding; Biogen: Consultancy; Bayer: Consultancy, Research Funding; Pfizer: Consultancy; LFB: Other: Member of DSMB; Baxalta: Consultancy, Research Funding. Owens:Haplomics Inc.: Consultancy, Equity Ownership. Iyer:Novo Nordisk: Employment. Cooper:Novo Nordisk: Employment.

Scalp cooling to reduce alopecia as a barrier to chemotherapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12537-e12537
Author(s):  
Isabel M. Pupo Wiss ◽  
Dina Hagigeorges ◽  
Chloe J. Walker ◽  
Kelly E. Flanagan ◽  
James T. James ◽  
...  
Keyword(s):  
Hair Loss ◽  
Post Treatment ◽  
Common Disease ◽  
Scalp Cooling ◽  
Treatment Regimens ◽  
Asian Patients ◽  
Patient Reported ◽  
Distress Scale ◽  
The Impact ◽  
To Receive

e12537 Background: Chemotherapy induced alopecia (CIA) is one of the most distressing adverse events reported by patients undergoing chemotherapy, yet there is limited data addressing the impact of CIA on treatment acceptance. Scalp cooling (SC) has been shown to decrease CIA. Here we report our assessment of CIA as a barrier to chemotherapy and the efficacy of SC using pre- and post-treatment surveys of patient reported outcomes. Methods: Patients who received alopecia-inducing chemotherapy and utilized SC between November 2018 and September 2020 at our institution were enrolled in a prospective IRB approved registry. Surveys including the Chemotherapy Induced Alopecia Distress Scale (CADS) were administered before and within two weeks after treatment. Using the CADS survey, patients were asked about their hesitation to receive chemotherapy and the burden they feel about alopecia as a side effect of chemotherapy. Results: Of 90 patients who completed the first or last treatment survey, the most common treatment regimens were docetaxel/cyclophosphamide (TC), docetaxel/carboplatin/trastuzumab/ pertuzumab (TCHP), and paclitaxel/trastuzumab (TH). The most common disease type was breast cancer (92.2%) and all participants were females. Of 74 SC patients who completed the pre-treatment survey, the median age was 50.5 (range 26-75) and included 65 (87.8%) Caucasian, 4 (5.4%) Black, and 3 (4.0%) Asian patients. 89.2% used Paxman SC and 10.8% used Penguin SC. Of those who completed the CADS survey prior to treatment, 8 (10.8%) reported ‘quite a bit’ to ‘very high’ hesitation, and 34 (46.0%) reported feeling that alopecia was either ‘quite’ or ‘very much’ a burden of chemotherapy. All 40 SC patients (median age 53.5, range 31-76) who completed the post-treatment survey were Caucasian and used Paxman SC. Self-reported efficacy of SC in these 40 patients was less than 10% hair loss in 10 (25.0%), 11-25% hair loss in 7 (17.5%), 26-50% hair loss in10 (25.0%), 51-75% hair loss in 9 (22.5%), and 76-100% hair loss in 4 (10%). Overall, 27 (67.5%) patients reported SC limited alopecia ‘a lot’ to ‘perfectly’. Conclusions: In our study, alopecia was identified as a notable burden to nearly half our SC patients and 10.8% hesitated when making their decision to receive chemotherapy. After using SC during treatment, 67.5% of patients reported less than 50% hair loss, and 67.5% reported that SC reduced alopecia ‘a lot’ or ‘perfectly’. Our study highlights the significance of alopecia as a chemotherapy burden and potential barrier to accepting treatment, and suggests SC may be efficacious in decreasing CIA, which may allow patients to feel less hesitation towards chemotherapy.

Assessing the use of low value oncology care following the release of Choosing Wisely guidelines.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18861-e18861
Author(s):  
Alexander Gunn ◽  
Melissa Sarver ◽  
Samantha J Kaplan ◽  
Yousuf Zafar ◽  
Rachel Adams Greenup
Keyword(s):  
Cancer Screening ◽  
Guideline Adherence ◽  
Cancer Care ◽  
Systemic Treatment ◽  
The United States ◽  
Choosing Wisely ◽  
Surveillance Imaging ◽  
Patient Reported ◽  
Oncology Care ◽  
The Impact

e18861 Background: Low -value care contributes to the high costs of cancer treatment. Almost a decade has passed since the American Society of Clinical Oncology (ASCO) Choosing Wisely campaign identified costly diagnostic testing, radiographic imaging, and therapies that are routinely utilized in cancer care despite lacking evidence of benefit. We sought to evaluate the impact of ASCO Choosing Wisely guidelines and to identify barriers to and facilitators of guideline adherence. Methods: A systematic review of published literature from 2012-2021 was performed in accordance with PRISMA guidelines on the trend in use of low value oncology care. All ten of ASCO Choosing Wisely Guidelines were selected for inclusion; these included recommendations focused on cancer screening, staging and surveillance imaging, and systemic treatment and support. The following databases were searched for original research based in the United States: PubMed, CINAHL, Embase, Web of Science, Scopus, and ASCO Meeting abstracts. Eligible studies were examined for information on design, population, and study outcomes, which included guideline adherence and facilitators and barriers to implementation. All citations were independently dual-screened in a blinded fashion by authors (AG, MS). Results: 35 independent studies were identified from 3,590 unique citations and included n = 1,130,216 patients. Data sources captured large claims database analyses (13 studies, n = 1,069,289), institutional studies (14 studies, n = 53,358), patient-reported surveys (2 studies, n = 915), and interventional studies (6 studies, n = 6654). Adherence to ASCO Choosing Wisely guidelines ranged from 13% to 100% overall. Use of low value oncology care varied depending on the area of recommendation, such as cancer screening (44% to 77%), staging and surveillance imaging (30% to 100%), and systemic treatment and support (13% to 100%). Adherence was facilitated by: (a) physician awareness of and education around the recommendations; (b) patient engagement; (c) embedded EHR best practice alerts; (d) guideline alignment with insurance payer requirements; and (e) integrated healthcare systems. Barriers to guideline incorporation included perceived patient anxiety and concerns about patient satisfaction; illness-specific practices; and time needed for patient-provider conversations regarding low value care. Conclusions: Adherence to the ASCO Choosing Wisely guidelines is variable across the cancer care continuum. Health system and policy-level interventions are needed to further reduce the overuse of low value care in oncology.

A New Computational Method to Predict Long-Term Minimal Residual Disease and Molecular Relapse after TKI-Cessation in CML

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3099-3099 ◽  
Author(s):  
Ingmar Glauche ◽  
Hendrik Liebscher ◽  
Christoph Baldow ◽  
Matthias Kuhn ◽  
Philipp Schulze ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitor ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Kinase Inhibitor ◽  
Residual Disease ◽  
Molecular Response ◽  
Tki Treatment

Abstract Predicting minimal residual disease (MRD) levels in tyrosine kinase inhibitor (TKI)-treated chronic myeloid leukemia (CML) patients is of major clinical relevance. The reason is that residual leukemic (stem) cells are the source for both, potential relapses of the leukemicclone but also for its clonal evolution and, therefore, for the occurrence of resistance. The state-of-the art method for monitoring MRD in TKI-treated CML is the quantification of BCR-ABL levels in the peripheral blood (PB) by PCR. However, the question is whether BCR-ABL levels in the PB can be used as a reliable estimate for residual leukemic cells at the level of hematopoietic stem cells in the bone marrow (BM). Moreover, once the BCR-ABL levels have been reduced to undetectable levels, information on treatment kinetics is censored by the PCR detection limit. Clearly, BCR-ABL negativity in the PB suggests very low levels of residual disease also in the BM, but whether the MRD level remains at a constant level or decreases further cannot be read from the BCR-ABL negativity itself. Thus, also the prediction of a suitable time point for treatment cessation based on residual disease levels cannot be obtained from PCR monitoring in the PB and currently remains a heuristic decision. To overcome the current lack of a suitable biomarker for residual disease levels in the BM, we propose the application of a computational approach to quantitatively describe and predict long-term BCR-ABL levels. The underlying mathematical model has previously been validated by the comparison to more than 500 long-term BCR-ABL kinetics in the PB from different clinical trials under continuous TKI-treatment [1,2,3]. Here, we present results that show how this computational approach can be used to estimate MRD levels in the BM based on the measurements in the PB. Our results demonstrate that the mathematical model can quantitatively reproduce the cumulative incidence of the loss of deep and major molecular response in a population of patients, as published by Mahon et al. [4] and Rousselot et al. [5]. Furthermore, to demonstrate how the model can be used to predict the BCR-ABL levels and to estimate the molecular relapse probability of individual patients, we compare simulation results with more than 70 individual BCR-ABL-kinetics. For this analysis we use patient data from different clinical studies (e.g. EURO-SKI: NCT01596114, STIM(s): NCT00478985, NCT01343173) where TKI-treatment had been stopped after prolonged deep molecular response periods. Specifically, we propose to combine statistical (non-linear regression) and mechanistic (agent-based) modelling techniques, which allows us to quantify the reliability of model predictions by confidence regions based on the quality (i.e. number and variance) of the clinical measurements and on the particular kinetic response characteristics of individual patients. The proposed approach has the potential to support clinical decision making because it provides quantitative, patient-specific predictions of the treatment response together with a confidence measure, which allows to judge the amount of information that is provided by the theoretical prediction. References [1] Roeder et al. (2006) Dynamic modeling of imatinib-treated chronic myeloid leukemia: functional insights and clinical implications, Nat Med 12(10):1181-4 [2] Horn et al. (2013) Model-based decision rules reduce the risk of molecular relapse after cessation of tyrosine kinase inhibitor therapy in chronic myeloid leukemia, Blood 121(2):378-84. [3] Glauche et al. (2014) Model-Based Characterization of the Molecular Response Dynamics of Tyrosine Kinase Inhibitor (TKI)-Treated CML Patients a Comparison of Imatinib and Dasatinib First-Line Therapy, Blood 124:4562 [4] Mahon et al. (2010) Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol 11(11):1029-35 [5] Rousselot 
et al. (2014) Loss of major molecular response as a trigger for restarting TKI therapy in patients with CP- CML who have stopped Imatinib after durable undetectable disease, JCO 32(5):424-431 Disclosures Glauche: Bristol Meyer Squib: Research Funding. von Bubnoff:Amgen: Honoraria; Novartis: Honoraria, Research Funding; BMS: Honoraria. Saussele:ARIAD: Honoraria; Novartis: Honoraria, Other: Travel grants, Research Funding; Pfizer: Honoraria, Other: Travel grants; BMS: Honoraria, Other: Travel grants, Research Funding. Mustjoki:Bristol-Myers Squibb: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Ariad: Research Funding; Novartis: Honoraria, Research Funding. Guilhot:CELEGENE: Consultancy. Mahon:NOVARTIS PHARMA: Honoraria, Research Funding; BMS: Honoraria; PFIZER: Honoraria; ARIAD: Honoraria. Roeder:Bristol-Myers Squibb: Honoraria, Research Funding.

Ibrutinib for Bridging to Allogeneic Hematopoietic Stem Cell Transplantation (alloHCT) in Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) Is Safe and Effective: First Results of a Survey By the Chronic Malignancy and the Lymphoma Working Parties of the EBMT

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4657-4657 ◽  
Author(s):  
Peter Dreger ◽  
Mauricette Michallet ◽  
Jennifer Hoek ◽  
Ariane Boumendil ◽  
Mohamad Sobh ◽  
...  
Keyword(s):  
Stem Cell ◽  
Research Funding ◽  
Kinase Inhibitor ◽  
Chronic Gvhd ◽  
Disease Status ◽  
Observation Time ◽  
Lymphocytic Leukemia ◽  
Hematopoietic Stem ◽  
The Impact

Abstract BACKGROUND: The advent of the Bruton's tyrosine kinase inhibitor ibrutinib has improved the outlook of patients with CLL and MCL failing chemoimmunotherapy (CIT). However, the impact of ibrutinib on the feasibility and safety of a subsequent alloHCT is unknown. Here we present results of the ibrutinib cohort of an ongoing EBMT survey on the outcome of alloHCT following prior exposure to pathway inhibitors (PI) in patients with CLL or lymphoma (EBMT study code LWP 2013-N-03/CMWP 44204425). DESIGN: Eligible were patients aged >18 years registered with the EBMT data office for a planned alloHCT for CLL or lymphoma after pre-exposure to ibrutinib at any time before transplant. Baseline patient, disease, and transplant data were collected from MED-A forms. Centers were requested to provide additional treatment and follow-up information. Statistical analysis used Gray's test to assess the impact of baseline characteristics on the cumulative incidence of relapse (REL) in a competing risk framework. RESULTS: As of July 4, 2016, 38 patients (84% male) were evaluable in the ibrutinib cohort. Diagnosis was CLL in 28 patients, MCL in 9 patients, and follicular lymphoma (FL) in 1 patient. The median age was 51 (33-68) years and the median number of treatment lines prior to ibrutinib 2 (1-9). Eight of the 9 patients with MCL but none of the other patients had a prior autoHCT. Patients had been on ibrutinib for a median of 190 (39-432) days. In 2 patients, ibrutinib had been stopped because of disease progression >100d before transplant, whereas the interval between ibrutinib withdrawal and alloHCT was 15-100d in 30%, 4-14d in 51%, and 0-1d in 14% of the patients. Of the CLL patients, 43% had a TP53 lesion, and 87% and 79% met at least one of the 2007 and 2014 EBMT criteria for high-risk CLL, respectively, including PI failure in 29%. Disease status at alloHCT was sensitive in 78% of the CLL patients, and in 60% of the patients with lymphoma. Conditioning was reduced-intensity in 60% of the transplants and included in-vivo T cell depletion with ATG (71%) or alemtuzumab (11%) in the majority of cases. Donors were identical siblings in 26%, matched unrelated in 66%, and partially matched unrelated in 8%, with PBSC (89%) being the predominant stem cell source (bone marrow 8%, cord blood 3%). The median time to reach neutrophils of >0.5/nl and platelets of >20/nl was 17 (10-26) and 15 (10-46) d post transplant, respectively. Acute GVHD grade 2-4 (3-4) was observed in 37% (10%) of 30 evaluable patients, and limited and extensive chronic GVHD occurred in 24% and 16% of 25 patients at risk. With a median observation time of survivors of 8 (1-24) months, there were only 2 non-relapse deaths, translating into a 1-year non-relapse mortality (NRM) of 6% (95%CI 0-15%). 1-year REL, progression-free survival, and overall survival was 36%, 61%, and 73% for CLL, and 14%, 75%, and 75% for lymphoma. In the 25 evaluable patients with CLL, PI-sensitive compared to refractory disease status at alloHCT tended to be associated with a lower 1-y REL (29% vs 60%; p 0.071), whereas prior PI failure, TP53 status, duration of ibrutinib exposure, interval between ibrutinib withdrawal and alloHCT, and conditioning intensity had no significant impact on REL. CONCLUSIONS: Ibrutinib for bridging to alloHCT for CLL and MCL does not appear to adversely affect engraftment, GVHD risk, and NRM. Patients with CLL still responding to ibrutinib at the time of alloHCT might benefit from ibrutinib bridging as our preliminary results indicate that also after PI exposure sensitive disease translates into a lower risk of relapse. Therefore, ibrutinib may improve the perspective of CIT-refractory patients scheduled for alloHCT. The optimum timing of ibrutinib administration in the interrelation to alloHCT in CLL and MCL needs to be defined by additional studies. Disclosures Dreger: Gilead: Consultancy; Janssen: Consultancy; Novartis: Speakers Bureau; Gilead: Speakers Bureau; Novartis: Consultancy; Roche: Consultancy. Michallet:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Astellas Pharma: Consultancy, Honoraria; MSD: Consultancy, Honoraria; Genzyme: Consultancy, Honoraria. Berg:Celgene: Other: Travel Funding; Astellas: Other: Travel Funding; Alexion: Other: Travel Funding. Niederwieser:Novartis Oncology Europe: Research Funding, Speakers Bureau; Amgen: Speakers Bureau. Montoto:Gilead: Research Funding; Roche: Honoraria. Schetelig:Sanofi: Honoraria.

scholarly journals Prospective evaluation of the impact of stress, anxiety, and depression on household income among young women with early breast cancer from the Young and Strong trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Erin E. Cook ◽  
Shoshana M. Rosenberg ◽  
Kathryn J. Ruddy ◽  
William T. Barry ◽  
Mary Greaney ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Young Women ◽  
Household Income ◽  
The United States ◽  
Anxiety And Depression ◽  
Link Type ◽  
Patient Reported ◽  
Household Incomes ◽  
Prospective Longitudinal ◽  
The Impact

Abstract Background Young women with breast cancer tend to report lower quality of life and higher levels of stress than older women with breast cancer, and this may have implications for other psychosocial factors including finances. We sought to determine if stress, anxiety, and depression at diagnosis were associated with changes in household income over 12-months in young women with breast cancer in the United States. Methods This study was a prospective, longitudinal cohort study comprised of women enrolled in the Young and Strong trial. Of the 467 women aged 18–45 newly diagnosed with early-stage breast cancer enrolled in the Young and Strong trial from 2012 to 2013, 356 (76%) answered income questions. Change in household income from baseline to 12 months was assessed and women were categorized as having lost, gained, maintained the same household income <$100,000, or maintained household income ≥$100,000. Patient-reported stress, anxiety, and depression were assessed close to diagnosis at trial enrollment. Adjusted multinomial logistic regression models were used to compare women who lost, gained, or maintained household income ≥$100,000 to women who maintained the same household income <$100,000. Results Although most women maintained household income ≥$100,000 (37.1%) or the same household income <$100,000 (32.3%), 15.4% lost household income and 15.2% gained household income. Stress, anxiety, and depression were not associated with gaining or losing household income compared to women maintaining household incomes <$100,000. Women with household incomes <$50,000 had a higher risk of losing household income compared to women with household incomes ≥$50,000. Women who maintained household incomes ≥$100,000 were less likely to report financial or insurance problems. Among women who lost household income, 56% reported financial problems and 20% reported insurance problems at 12 months. Conclusions Baseline stress, anxiety, and depression were not associated with household income changes for young women with breast cancer. However, lower baseline household income was associated with losing household income. Some young survivors encounter financial and insurance problems in the first year after diagnosis, and further support for these women should be considered. Trial registration Clinicaltrials.gov, NCT01647607; date registered: July 23, 2012.

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