Second Line Therapy in Multiple Myeloma: A SEER Medicare Analysis.

INTRODUCTION: The therapeutic landscape in relapsed/refractory multiple myeloma (RRMM) has changed rapidly, with twenty-two drug approvals since 2012. We characterized population-level trends in RRMM therapy selection, survival and cost outcomes associated with RRMM treatment over time. MATERIALS AND METHODS: Our cohort included adults diagnosed with multiple myeloma (MM) in the SEER-Medicare database from 2007-2017 who received at least one antimyeloma agent. MM-directed therapies and lines of therapy were identified. Changes in 2LT regimens over time were described. Trends in overall survival from 2LT initiation over time were analyzed using a Cox proportional hazards model adjusting for factors associated with survival in MM. Trends in mean inflation-adjusted cost per 12 months of 2LT were analyzed using JoinPoint analysis. RESULTS: A total of 9,822 patients met eligibility criteria, of whom 5,866 (59.7%) received 2LT. By 2018, 46% of 2LT regimens contained at least one agent approved in 2012 or later. Year of 2LT initiation was associated with improved overall survival (HR 0.78 per 5 years, 95% CI 0.74-0.84) after adjustment. Costs associated with 2LT increased over the study period, and the rate of cost increase increased significantly after 2012 (0.89%/year vs. 9.9%/year, P < .001), with higher total costs for regimens containing newer novel agents (mean $224,193 vs. $189,381, P < .001) CONCLUSION: Overall survival after initiation of 2LT has improved, however this has been accompanied by significant increases in costs of RRMM treatment, particularly for patients receiving newer novel agents. These findings provide useful context for existing and future drug approvals in RRMM.

Mixed-Methods Study on the Responsiveness of the Comprehensive Score for Financial Toxicity Among People With Multiple Myeloma.

PURPOSE: Financial toxicity is a contributor to the psychosocial burden of cancer care. There is no consensus measure of financial toxicity; however, recent studies have adopted the Comprehensive Score for Financial Toxicity (COST). Despite its growing popularity, data on the responsiveness to change of the COST instrument are lacking. To address this gap in the literature, we performed a sequential mixed-methods study of people with multiple myeloma. MATERIALS AND METHODS: In the quantitative phase of the study, we collected COST scores at two time points approximately 8 weeks apart from 72 patients. In the qualitative phase, we conducted semistructured interviews with a subset of 12 patients who reported the largest changes in scores. The qualitative data were analyzed using a deductive coding scheme developed using the Framework Method in the context of a commonly cited conceptual model of financial toxicity. RESULTS: The median absolute change in COST scores was four points (IQR, 2-6). Only 13% of the sample had the same COST scores at both assessments; 38% had an improved score and 50% had a worsened score. Only, seven of the 12 patients (58%) interviewed reported changes to one or more of the constructs in the conceptual model of financial toxicity. Most commonly, changes to out-of-pocket medical costs were reported (5/12). Changes to nonmedical expenses (n = 2) and subjective financial distress without changes to objective financial burden (n = 2) were also reported. CONCLUSION: Additional research is needed to explicate changes in COST scores over time.

Functional Status Associations With Treatment Receipt and Outcomes Among Older Adults Newly Diagnosed With Multiple Myeloma.

PURPOSE: Multiple myeloma (MM) is a prevalent hematologic malignancy in older adults, who often experience physical disability, increased health care usage, and reduced treatment tolerance. Home health (HH) services are frequently used by this group, but the relationship between disability, HH use, and MM treatment receipt is unclear. This study examines the connections between disability, treatment receipt, and survival outcomes in older adults with newly diagnosed MM using a nationwide data set. METHODS: The SEER-Medicare data set was used to identify adults aged 66 years and older diagnosed with MM from 2010 to 2017, who used HH services the year before diagnosis. Disability was assessed with the Outcome and Assessment Information Set, using a composite score derived from items related to ability to complete activities of daily living. Mortality, therapy receipt, and health care utilization patterns were evaluated. RESULTS: Of 37,280 older adults with MM, 6,850 (18.2%) used HH services before diagnosis. Moderate disability at HH assessment resulted in similar MM-directed therapy receipt as mild disability, with comparable health care usage after diagnosis to severe disability. HH users had a higher comorbidity burden and higher mortality (adjusted risk ratio for 3-year mortality: 1.59 [95% CI, 1.55 to 1.64]). Severe functional disability before diagnosis was strongly related to postdiagnosis mortality. CONCLUSION: Among older adults with MM receiving HH services, disability is a predictor of early mortality. Moderately disabled individuals undergo similar therapy intensity as the mildly disabled but experience increased acute care utilization. Previous HH use could identify patients with MM requiring intensive support during therapy initiation.

Simulating the population impact of interventions to reduce racial gaps in breast cancer treatment.

BACKGROUND: Inequities in guideline-concordant treatment receipt contribute to worse survival in Black breast cancer (BCa) patients. Inequity-reduction interventions (eg, navigation, bias training, tracking dashboards) can close such treatment gaps. We simulated the population-level impact of statewide implementation of inequity-reduction interventions on racial BCa inequities in North Carolina. METHODS: Using registry-linked multi-payer claims data, we calculated Black/White inequities in endocrine (ET; n = 12,033) and chemotherapy (CTx; n = 1,819) receipt. We then built cohort- (ET and CTx), and race-stratified Markov models to simulate the potential increase in the proportion of patients receiving ET or CTx and subsequent improvements in BCa outcomes if inequity-reducing intervention were implemented statewide. We report uncertainty bounds representing 95% of simulation results. RESULTS: 75.6% and 72.1% of Black patients received ET and CTx over the 2006-2015 and 2004-2015 periods (vs 79.3 and 78.9% of White patients, respectively). Inequity-reduction interventions could increase ET and CTx receipt among Black patients to 89.9% (85.3, 94.6%) and 85.7% (80.7, 90.9%). Such interventions could also decrease 5-and 10-year BCa mortality gaps from 3.4 to 3.2 (3.0, 3.3) and from 6.7 to 6.1 (5.9, 6.4) percentage points in the ET cohorts and from 8.6 to 8.1 (7.7, 8.4) and from 8.2 to 7.8 (7.3, 8.1) percentage points in the CTx cohorts. CONCLUSIONS: Inequity-focused interventions could improve cancer outcomes for Black patients. However, they would not fully close the racial BCa mortality gap. Addressing other inequities along cancer continuum (eg, screening, pre-and post-diagnosis risk factors) is required to achieve full equity in BCa outcomes.

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

BACKGROUND: Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. OBJECTIVE: Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. METHODS: We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. RESULTS: Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. CONCLUSIONS: The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

Race, geography, and risk of breast cancer treatment delays: A population-based study 2004-2015.

BACKGROUND: Treatment delays affect breast cancer survival and constitute poor-quality care. Black patients experience more treatment delay, but the relationship of geography to these disparities is poorly understood. METHODS: We studied a population-based, retrospective, observational cohort of patients with breast cancer in North Carolina between 2004 and 2017 from the Cancer Information and Population Health Resource, which links cancer registry and sociodemographic data to multipayer insurance claims. We included patients >18 years with Stage I-III breast cancer who received surgery or chemotherapy as their first treatment. Delay was defined as >60 days from diagnosis to first treatment. Counties were aggregated into nine Area Health Education Center regions. Race was dichotomized as Black versus non-Black. RESULTS: Among 32,626 patients, 6190 (19.0%) were Black. Black patients were more likely to experience treatment delay >60 days (15.0% of Black vs. 8.0% of non-Black). Using race-stratified modified Poisson regression, age-adjusted relative risk of delay in the highest risk region was approximately twice that in the lowest risk region among Black (relative risk, 2.1; 95% CI, 1.6-2.6) and non-Black patients (relative risk, 1.9; 95% CI, 1.5-2.3). Adjustment for clinical and sociodemographic features only slightly attenuated interregion differences. The magnitude of the racial gap in treatment delay varied by region, from 0.0% to 9.4%. CONCLUSIONS: Geographic region was significantly associated with risk of treatment delays for both Black and non-Black patients. The magnitude of racial disparities in treatment delay varied markedly between regions. Future studies should consider both high-risk geographic regions and high-risk patient groups for intervention to prevent delays.

Physical Function, Psychosocial Status, and Symptom Burden Among Adults with Plasma Cell Disorders and Associations with Quality of Life.

BACKGROUND: The plasma cell disorders (PCDs), multiple myeloma (MM), and light-chain amyloidosis (AL) are disproportionately diseases of older adults, whose care may be complicated by frailty associated with advancing age. We sought to evaluate the prevalence of functional deficits and symptoms in a cohort of persons with PCDs and associations of demographic, disease-related, functional, and psychosocial measures with quality of life (QoL). PATIENTS AND METHODS: Adults with PCDs were recruited into an observational registry in 2018-2020. Patients completed a functional assessment and European Organization for Research and Treatment of Cancer QoL questionnaire (QLQ-C30). Associations of covariates of interest with QoL were evaluated via univariate linear regression. RESULTS: Among 121 adults, the mean age was 68.6. Diagnoses were 74% MM, 14% AL, 7% both MM and AL, and 5% other PCDs. The median time from diagnosis was 34.9 months. Median lines of therapy were 2, with 11% having received ≥4th-line therapy.Patients with functional deficits had lower mean QoL scores: dependence in IADLs (66.3 vs. 79.9, P = .001) and recent falls (56.7 vs. 76.8, P = .001). Patients ≤6 months from diagnosis had lower QoL (66.7) than those ≥2 years from diagnosis (77.3, P = .03). However, patients on later lines of therapy (≥4th-line) had lower QoL (62.2) than those on 1st-line treatment (76.0, P = .04). CONCLUSIONS: Patients with physical impairments and more advanced PCDs had lower QoL than those without deficits or earlier in their disease course. Early identification of physical impairments may facilitate interventions that mitigate these deficits and thereby improve QoL for patients with PCDs.

A cross-sectional observational study of health-related quality of life in adults with multiple myeloma.

BACKGROUND: The purpose of this manuscript is to describe health-related quality of life (HRQoL) outcomes in a United States (US)-based sample of multiple myeloma (MM) patients and identify characteristics associated with poor HRQoL. PATIENTS AND METHODS: MM patients identified through the Tumor Registry of a Southeastern US medical center were mailed surveys assessing patient characteristics and HRQoL outcomes. HRQoL outcomes were measured using PROMIS short form instruments which included measures of global health (global physical health and global mental health), physical function, and ability to participate in social roles and activities (social function). HRQoL domain scores were summarized, and best subset linear regression was used to identify predictors of HRQoL. RESULTS: A total of 690 patients completed and returned surveys for a response rate of 64.7%. Respondents reported global physical health (44.9), global mental health (47.5), and physical function (44.1) significantly worse than the general population mean of 50 (p < .0001). Social function (49.5) did not differ significantly (p = .09). Worse socioeconomic status, higher comorbidities, not being in remission, and past receipt of radiation therapy were significantly associated with worse HRQoL. Treatment status and time since diagnosis were not associated with HRQoL outcomes. CONCLUSIONS: Patients with MM have significantly worse HRQoL than the general population. These findings warrant increased attention from clinicians and researchers. More research is needed to better describe the relationship between treatment patterns and HRQoL in patients with MM, and to identify effective interventions.

Persistent fatigue among long-term non-Hodgkin lymphoma survivors.

This study describes the prevalence and persistence of fatigue among a cohort of long-term non-Hodgkin lymphoma (NHL) survivors. Mailed surveys assessed quality-of-life including fatigue (SF-36) at baseline and five years. Logistic regression was used to identify factors associated with prevalence of fatigue at baseline and persistence of fatigue across timepoints. More than one-quarter (27.7%) of the 555 NHL survivors reported clinically meaningful fatigue at baseline and 18.7% reported persistent fatigue at five years. One-third (34.4%) reported clinically meaningful worsening of fatigue over time. Independent associations with persistent fatigue included female gender, less education, past chemotherapy, increased comorbidities, and posttraumatic stress symptoms (P <.05). Our findings suggest that one in three NHL survivors experience clinically meaningful fatigue long after their diagnosis and initial treatment. Furthermore, we found that fatigue worsens or persists for many, highlighting the need for vigilance in assessing and treating fatigue in this population.

A Qualitative Study of the Experiences of Living With Multiple Myeloma.

PURPOSE: To explore the ways in which multiple myeloma affects an individual's life in the modern treatment era. PARTICIPANTS & SETTING: 15 individuals with multiple myeloma and 10 clinicians were recruited from two academic medical centers in the southeastern United States. METHODOLOGIC APPROACH: Semistructured interviews were conducted with individuals with multiple myeloma and clinicians to explore the effect of a multiple myeloma diagnosis and treatment on individuals' lives. Transcribed interviews were analyzed using conventional content analysis. FINDINGS: The following four themes emerged from the analysis. IMPLICATIONS FOR NURSING: The treatment journey for those with multiple myeloma can be lifelong and may require frequent visits to an oncologist and, potentially, many successive lines of therapy. Life effects are far-reaching and long-term. Nurses should be aware of the interprofessional resources to help meet these individuals' needs. With thorough assessment, care planning, and education, nurses can play a key role in mitigating the negative effects of multiple myeloma and its treatment.

How are patient-reported outcomes and symptoms being measured in adults with relapsed/refractory multiple myeloma? A systematic review.

PURPOSE: Patients with relapsed and/or refractory multiple myeloma (RRMM) are living longer due in part to changing treatment patterns. It is important to understand how changing treatment patterns affect patients' lives beyond extending survival. Research suggests that direct patient report is the best way to capture information on how patients feel and function in response to their disease and its treatment. Therefore, the purpose of this review is to summarize evidence of patients' experience collected through patient-reported outcomes (PRO) in RRMM patients, and to explore PRO reporting quality. METHODS: We conducted a systematic search to identify manuscripts reporting PROs in RRMM and summarized available evidence. We assessed PRO reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) PRO Extension checklist. RESULTS: Our search resulted in 30 manuscripts. Thirteen unique PRO measures were used to assess 18 distinct PRO domains. Pain, fatigue, and emotional function were commonly assessed domains though reporting formats limited our ability to understand prevalence and severity of PRO challenges in RRMM. Evaluation of PRO reporting quality revealed significant reporting deficiencies. Several reporting criteria were included in less than 25% of manuscripts. CONCLUSIONS: Existing evidence provides a limited window for understanding the patient experience of RRMM and is further limited by suboptimal reporting quality. Observational studies are needed to describe prevalence, severity and patterns of PROs in RRMM overtime. Future studies that incorporate PROs would benefit from following existing guidelines to ensure that study evidence and conclusions can be fully assessed by readers, clinicians and policy makers.

Oncology nurses need to get serious about cancer rehabilitation
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Patients with cancer suffer greatly. Rehabilitation helps them suffer less, and yet very few patients with cancer get rehabilitation services of any kind. Oncology nurses are well positioned to see the toll that cancer and its treatment take on patients and to facilitate appropriate supportive care, including rehabilitation.
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