scholarly journals Managing Multiple Myeloma in Older Adults Using Real World Evidence and Clinical Integration of a Geriatric Assessment Tool in Clinical Practice

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5019-5019
Author(s):  
Smith Giri ◽  
D'Ambra Dent ◽  
Kelly N. Godby ◽  
Luciano J. Costa ◽  
Susan Bal ◽  
...  

Abstract Background: Over two thirds of patients with Multiple Myeloma (MM) are ≥ 65 years old at the time of diagnosis. Older adults are at greater risk for treatment related toxicity and inferior survival; such risks are inadequately explained by chronologic age and performance status. In 2015, the International Myeloma Working Group (IMWG) proposed a geriatric assessment (GA) based frailty index to identify older adults with MM at greatest risk of toxicities. Yet, routine implementation of GA in busy oncology practice remains challenging. We have previously shown the feasibility of a tablet-based modified Geriatric Assessment (mGA), capturing the Charlson Comorbidity Index (CCI), Katz Activity of Daily Living (ADL) Score, and Lawton Instrumental Activity of Daily Living (IADL) score, and its impact on clinical decision-making and treatment outcomes (Nathwani, et al. JOP. 2020). In the prior study, physicians recommended integration of the mGA into the electronic medical record (EMR) to improve usefulness at the clinic. Methods: We conducted a single institution pilot study to test the feasibility of integrating an electronic care planning system within the EMR such that with a single sign on, the dashboard showing results of the mGA was visualized within the EMR. Eligible patients had symptomatic MM, > 60 years old, and seeing their oncology providers to make a decision about treatment. After completing informed consent, patients completed a tablet-based mGA in clinic just prior to seeing the physician. Survey results were compiled and were immediately available for evaluation on a dashboard within the EMR. Providers reviewed the mGA results before meeting with the patient and completed a short survey after the visit regarding their own subjective impression of frailty and how the mGA influenced their treatment decision making. Agreement between provider's subjective vs mGA based frailty categorization was measured using Cohen's Kappa statistic. We measured relevant toxicity outcomes at 3 months post treatment initiation. Results: 25 patients were enrolled, with a median age of 68 (range=61-82), 52% (n=13) female, and 68% (n= 17) white. One patient did not complete the mGA survey and was not included in the analysis. The remaining patients completed the mGA successfully without interrupting clinic flow and mGA was immediately available for providers to review during the clinic visit. The average time providers spent reviewing results was of 5 (range 1-10) minutes. Providers subjectively categorized patients as 42% (n=10) fit, 58% (n=14) intermediate fit, and 0% (n=0) frail. According to the mGA, patients were 50% (n=12) fit, 29% (n=7) intermediate fit, and 21% (n=5) frail. There was an overall 46% (n=11) concordance between physician and mGA result. The most agreement was in fit status (58%, n=7) and least was frail (0%, n=0). There was 33% (n=4) agreement on intermediate fit status. The unweighted Cohen's kappa statistic was 0.09 indicating only slight agreement between the two methods. Providers reported mGA influenced their treatment decision in 33% (n=8), with the decision being either chemotherapy modification (n=6) or reduced dose transplant (n=2). One patient, who was frail and received induction treatment, died during the 3-month study period. The remaining patients (n=23) received treatment as planned. Discussion: In this study, we report the feasibility of an EMR integrated mGA tool completed by the patient prior to meeting with the physician. Patients completed the survey with assistance and without disrupting the clinic workflow. The mGA results were reviewed by providers in real time and influenced treatment decisions one third of the time. Nearly all patients (96%, n=24) completed therapy as planned. Providers tended to view the patients as more fit than the mGA result, suggesting that the mGA uncovers additional information related to the patient's ability to tolerate therapy. Toxicity follow up is ongoing and will be updated at the time of presentation. Disclosures Giri: CareVive: Honoraria, Research Funding; PackHealth: Research Funding. Costa: BMS: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Karyopharm: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Speakers Bureau.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21703-e21703 ◽  
Author(s):  
Nitya Nathwani ◽  
Supriya Gupta Mohile ◽  
Brea Lipe ◽  
Karen Carig ◽  
Laura DiGiovanni ◽  
...  

e21703 Background: Multiple myeloma (MM) is a disease of older adults (OAs) with > 60% of diagnoses and nearly 75% of deaths occurring in patients > 65 years old (YO). Geriatric Assessment (GA) is associated with toxicity and survival in OAs with MM, but not routinely used in practice. This project pilot tests a tablet-based modified Geriatric Assessment (mGA) that presents compiled GA results, including (the Palumbo) frailty score, to clinicians at a treatment decision-making visit in a single screen dashboard. Methods: In this multisite ongoing study, 210 patients with MM ≥65 YO facing a decision point for care will complete a mGA that includes the Charlson Comorbidity Index (CCI), Katz Activity of Daily Living (ADL) Score, and Lawton Instrumental Activity of Daily Living (IADL) Score prior to meeting with a physician. mGA results, including composite frailty score, are provided to physicians at the start of a visit. Results: Thirty-six patients have been enrolled to date; enrollment continues. Participants are 69% (n = 25) white, 64% (n = 23) male, and mean age of 72 YO (range 65-87). Most (74%, n = 20) currently receive ≥1 therapy and have few co-morbidities (CCI median 1, SD 1.95, range 0-8); 57% require assistance with IADLs and 37% require assistance with ADLs. Based on Palumbo score, 36% of participants were frail (n = 13), 33% intermediate (n = 12), and 31% fit (n = 11). Providers report mGA results influenced treatment decision (54%, n = 28) and frailty score was the most frequently cited result to impact treatment decision-making (61%, n = 39). The most common way the mCGA influenced decision-making was to reduce dose/dose intensity (25%, N = 8). Clinicians on average spent 5 minutesreviewing the mGA results. Patients reported an average of 7 minutes to complete the survey, most independently (83%, n = 30), and were satisfied with the electronic program overall (80%, n = 29), including how easy it was to use (88%, n = 32). Conclusions: Preliminary data support feasibility, usability, and acceptability of the tablet-based mGA and that frailty score influences provider decision-making ≥50% of the time. Future analyses will explore the relationship of the mGA with toxicity, dose modification and/or treatment discontinuation in OAs with MM.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2373-2373 ◽  
Author(s):  
Tanya M Wildes ◽  
Carrie T. Stricker ◽  
William Dudley ◽  
Diana Harris ◽  
Nitya Nathwani ◽  
...  

Abstract Background: More than 60% of multiple myeloma (MM) diagnoses and nearly 75% of deaths occur in patients over 65 years old. Because older adults (OAs) experience more treatment-related toxicities, treatment disruptions or dose reductions may be based on age and performance status alone, despite their poor predictive value for patient outcomes. Comprehensive Geriatric Assessment (CGA), including frailty indices, has shown predictive validity for toxicity and survival in OAs with MM, but is not routinely used in practice due to time and complexity, a lack of clarity about optimal tools and technologies to implement them, and clinician knowledge gaps on how to incorporate CGA into decision-making and care. Purpose: This project aims to address these gaps by pilot testing a tablet-based modified (m)CGA in 120 patients that presents compiled CGA results, including a frailty score, back to clinicians interacting with patients at the time of a treatment decision. Outcomes include feasibility, usability, utility, and impact on treatment decision-making, from both patient and provider perspectives. Pre-study implementation processes and milestones, including development of the mCGA, clinical workflow planning processes, training and other site-initiation activities are presented herein. Methods: The mCGA was developed using an iterative and dynamic consensus-driven process that included: 1) literature review and expert input to identify CGA domains for potential inclusion and 2) consensus building within a multi-disciplinary panel of gero-oncology experts, nurse scientists, and psychometricians. Domains and measures were selected based on predictive ability, length, and ability to administer via patient self-report so as to reduce clinician assessment burden. Study training and implementation procedures were developed using the same approach, as well as through workflow analysis and clinical team consensus building at the participating sites. Results: The Palumbo frailty index (FI) was chosen as the core of the mCGA tool given correlation with clinical outcomes specifically in OAs with MM. In addition to the 4 mGA measures comprising the Palumbo FI (age, comorbidity, ADL, and IADL), other GA variables were also chosen based on their strong predictive ability, clinical feasibility, and relevance to the MM population. This summary of results is displayed for ease of provider use within the Carevive dashboard (see Figure 1). Given prevalent knowledge gaps in use of CGA for MM treatment decision-making and care, a certified medical education self-study course was developed for training prior to the study intervention. Four geographically-dispersed academic and community hospitals who treat high volumes of diverse MM patients are participating to date. All 4 sites developed a process for ensuring treating providers would have easy access to the platform. Conclusions: Real-world, comprehensive and innovative solutions, combining education, geriatric assessment (GA) tools to determine a patient's fit/frailty status, realistic clinical work flow processes, and technology tools are needed to support and enhance treatment-decision making for patients with MM as well as their providers. Figure 1 Screenshot: Touch-screen based dashboard results display example Figure 1. Screenshot: Touch-screen based dashboard results display example Disclosures Wildes: Carevive Systems: Consultancy. Stricker:Carevive Systems, Inc.: Employment, Equity Ownership. Dudley:Carevive Systems, Inc.: Consultancy. Harris:Carevive Systems, Inc.: Consultancy. Nathwani:Carevive Systems, Inc.: Research Funding. Brant:Carevive Systems, Inc.: Research Funding. Kurtin:Carevive Systems, Inc.: Research Funding. Hurria:Boehringer Ingelheim Pharmaceuticals: Consultancy; GTx, Inc: Consultancy; Carevive: Consultancy; Celgene: Other: Research; Optum Health Care SOlutions: Consultancy, Other: Conference panel, research; Sanofi: Consultancy; Novartis: Other: Research.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3292-3292
Author(s):  
Paolo Milani ◽  
Morie A. Gertz ◽  
Giampaolo Merlini ◽  
Giovanni Palladini ◽  
Martha Q. Lacy ◽  
...  

Abstract Background: Both MM specific and patient specific parameters place patients at risk for death. Patient frailty has been delineated primarily by age and ECOG performance score (PS) and secondarily with creatinine, eGFR, and the International Staging System (ISS), which reflect both renal function and disease burden. In an attempt to improve upon these commonly used measures, a frailty score for elderly patients that combines functional status [Activity of Daily Living (ADL) and Instrumental Activity of Daily living scores], comorbidities [Charlson comorbidity index (CCI)] and age has been developed by the IMWG. Incorporation of these tools into a busy clinical practice is challenging due to time constraints. Therefore, the identification of frail patients with an easily applicable, rapid and objective tool remains a challenge and an unmet need. A reliable, non-invasively assessable, biochemical marker of frailty would be an ideal tool to identify patients at higher risk of death. It was our goal to determine the role of NT-proBNP, a well-established cardiovascular risk biomarker, as a marker of frailty in patients with MM and in predicting overall survival (OS). Methods: Patients were elegible for this retrospective study if they were seen at the Mayo Clinic, Rochester, MN within 30 days of their myeloma diagnosis during the interval between 1/1/2007 and 12/31/2011. As part of the Mayo Clinic registration, all patients complete forms containing their past medical history, symptoms, and ADLs. Data from that first visit was abstracted and used to calculate a CCI. We excluded all patients with a concomitant diagnosis of light-chain AL amyloidosis. NT-proBNP concentration was measured in frozen sera collected within 30 days of diagnosis. NT-proBNP assay was run on the E170 Modular analyzer (Roche Diagnostics, Penzberg, Germany). We evaluated the prognostic role of NT-proBNP and these indices on OS using the Kaplan-Meier method. Results: Among the 351 consecutive patients satisfying entry criteria, median age was 65 years (range 22-95), 33% were ≥70 years, and 56% were male. Twenty-eight percent were ISS stage III, 13% had a creatinine ≥2 mg/dL, 19% had PS ≥2, and 11% had ADL score ≥2, and 30% CCI ≥2. The median value of NT-proBNP was 109 ng/L (interquartile range: 30-375 ng/L). NT-proBNP concentrations differed in the three ISS stages (median: 122 ng/L stage I, 190 ng/L stage II and 1822 ng/L stage III, P<0.0001). Median OS was 5.6 years. The best cutoff of NT-proBNP predicting OS at one year was 301 ng/L (sensitivity: 57.88%, specificity: 74.29%; AUC=0.668) and distinguished two groups with different OS (median not reached vs. 35 months, P<0.0001). Variables predictive for OS are shown in the Table and included PS, age, CCI, ISS, NT-proBNP. On multivariate analysis, ISS and NT-proBNP were independent of each other as long as age, PS and/or CCI were excluded from the model. NT-proBNP withstood these clinical variables better than did ISS (data not shown). We built two different models (table). In model 1, NT-proBNP >301 ng/L was an independent predictor of survival while age ≥70 and PS ≥2 and CCI were not significant. However, if we considered ISS stage instead of NT-proBNP in the same model, ISS stage was not significant. Conclusions: In this unselected cohort of patients with newly diagnosed multiple myeloma, NT-proBNP was a useful predictor of survival independent of age and PS. The threshold of 301 ng/L is remarkably similar to the well-established cutoff for heart failure of 300 ng/L. NT-proBNP outperformed the CCI and the ISS as risk factors. NT-proBNP is a widely available biomarker that could be added to the panel of laboratory tests of newly diagnosed MM patients and serve as a simple means of determining patient frailty in a busy clinical practice. Table. Results of univariate and multivariate analysis of various prognostic factors (NS, not significant; NI, not included). Univariate Multivariate Multivariate RR (95% CI) P Model 1 P Model 2 P PS ≥2 3.4 (2.4-4.8) <0.0001 2.5 (1.7-3.6) <0.0001 2.8 (1.9-4.0) <0.0001 Age ≥70 2.7 (1.9-3.6) <0.0001 2.1 (1.5-2.9) <0.0001 1.9 (1.3-2.7) 0.0003 CCI >=2 1.9 (1.4-2.6) <0.0001 NS NS 1.5 (1.0-2.0) 0.03 ISS stage 1.1 (1.1-1.8) 0.0004 NI NI NS NS NT-proBNP >301 ng/L 2.3 (1.7-3.2) <0.0001 1.6 (1.1-2.2) 0.007 NI NI Disclosures Merlini: Janssen-Cilag: Honoraria; Prothena: Honoraria; Millennium-Takeda: Honoraria; Pfizer: Honoraria. Kumar:Janssen: Research Funding; Celgene: Research Funding; Sanofi: Research Funding; Millenium/Takeda: Research Funding; AbbVie: Research Funding; Onyx: Research Funding; Celgene, Millenium, Sanofi, Skyline, BMS, Onyx, Noxxon,: Other: Consultant, no compensation,; Skyline, Noxxon: Honoraria.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 23-23
Author(s):  
Alessandra Brescianini ◽  
Renaud Desgraz ◽  
Ananda Plate ◽  
Kathryn E. Morgan ◽  
Ana Vallejo ◽  
...  

Background: Patient (pt) involvement in treatment decisions or 'shared decision making' has been associated with increased pt satisfaction, increased compliance to advice from health professionals, enhanced treatment adherence and overall improved treatment outcomes. Methods: A multinational non-interventional cross-sectional survey was designed and aimed to enrol approximately 1,000 adult pts with multiple myeloma (MM) through Myeloma Patients Europe's (MPE) member network across 12 participating countries: France, Israel, Netherlands, United Kingdom (UK), Sweden, Germany, Hungary, Austria, Finland, Switzerland, Poland and Romania. Patient advocacy organizations were asked to disseminate a URL link for the survey to pts by posting the link on their website, e-mailing the link to pt members on their mailing list or through social media. The primary survey objective was to describe pt confidence in making an informed treatment decision. Main secondary objectives were to describe how pt confidence in making an informed treatment decision was associated with types of information, importance of information and sources of information. Pts fulfilling the following criteria were included: adults who had started MM treatment and received at least one dose, who were able to self-report diagnosis of MM and recall the decision-making process at the start of their most recent line of treatment, and who were able and willing to complete an online questionnaire lasting approximately 30 minutes. Results: Out of 4325 pts who accessed the online survey link, 1559 pts fulfilled eligibility criteria and were included in the primary analysis, of which 1081 provided fully completed surveys. France, Israel, Netherlands, and UK were the largest recruiters with over 200 pts each. Median age of respondents was 54-64 years. Time since diagnosis was 0-4 years for over half of pts (53.1%), and ≥16 years since diagnosis for 4.8% of pts. The majority of pts had received 1 line (40.1%, n=592) of anti-MM treatment, 20.5% (n=303) of pts had received 2 lines, 16.0% (n=236) of pts had received 3 lines, and 19.9% (n=294) reported having received 4 or more lines of treatment. Last treatment decision was taken &lt;3 months before the survey for 26.1% of respondents, and &gt;2 years ago for another 25.5% of respondents. Of the 1112 pts who responded to the question for the primary objective, half of pts (54.4%, n=605) reported being very confident in their most recent treatment decision, and 37.2% (n=414) of pts reported being somewhat confident. Similarly, over half of pts (56.8%, n=634/1116) felt that they were 'very involved' in their last treatment decision, 28.4% (n=317/1116) reported being 'somewhat involved'. Confidence in making an informed treatment decision did not appear to differ by lines of therapy, primary treating physician, type of clinic primarily treated at, or whether help from a carer was received. In terms of types of information received, pts most commonly received information on location of treatment (84.5%, n=1037), mode of administration (83.0%, n=1019), frequency of treatment (77.7%, n=953) and common side effects (72.2%, n=886), and least commonly received information on overall survival (OS) benefit (38.4%, n=471) and how long until MM returns (30.9%,n=379) or healthcare provider costs (20.0%, n=245). Information relating to treatment effectiveness (OS benefit, likelihood treatment would work, how long until MM returns) were reported as the most important types of information amongst those who received them, followed by types relating to treatment tolerability (how safe the treatment is). Operational aspects of treatment (mode of administration, location of treatment and healthcare provider costs) were considered the least important type of information. Receiving the types of information perceived as most important by pts was significantly associated with increased pt confidence in making an informed treatment decision. Conclusion: The most important types of information to pts with MM are related to treatment effectiveness and tolerability. However, effectiveness seems to be communicated to pts less frequently than tolerability and this may be due to the uncertainty surrounding this type of information. However, the survey results suggest some elements on effectiveness should be considered to be shared with pts to increase their confidence in making an informed treatment decision. Disclosures Brescianini: Amgen: Current Employment, Current equity holder in publicly-traded company. Desgraz:Amgen: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Plate:Pfizer: Research Funding, Speakers Bureau; Roche: Research Funding, Speakers Bureau; Sanofi: Research Funding, Speakers Bureau; Takeda: Research Funding, Speakers Bureau; ASCO: Membership on an entity's Board of Directors or advisory committees; ESMO: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding, Speakers Bureau; Amgen: Research Funding, Speakers Bureau; Myeloma Patients Europe: Current Employment; Novartis: Research Funding, Speakers Bureau; Mundipharma: Research Funding, Speakers Bureau; Karyopharm: Research Funding, Speakers Bureau; Janssen: Research Funding, Speakers Bureau; GSK: Research Funding, Speakers Bureau; Oncopeptides: Research Funding, Speakers Bureau. Morgan:Amgen, BMS, GSK, Janssen, Karyopharm, MundiPharma, Novartis, Oncopeptides, Pfizer, Roche, Sanofi, Takeda: Research Funding, Speakers Bureau; Myeloma Patients Europe: Current Employment. Vallejo:Amgen, BMS, GSK, Janssen, Karyopharm, MundiPharma, Novartis, Oncopeptides, Pfizer, Roche, Sanofi, Takeda: Research Funding; Myeloma Patients Europe: Current Employment. Wetten:Amgen: Current Employment, Current equity holder in publicly-traded company. DeCosta:Amgen Ltd: Current Employment, Current equity holder in publicly-traded company. Suzan:Amgen: Current Employment, Current equity holder in publicly-traded company.


2003 ◽  
Vol 43 (4) ◽  
pp. 493-502 ◽  
Author(s):  
N. E. Schoenberg ◽  
C. H. Amey ◽  
E. P. Stoller ◽  
S. B. Muldoon

2021 ◽  
Vol 11 ◽  
Author(s):  
Sarah A. Wall ◽  
Ying Huang ◽  
Ashleigh Keiter ◽  
Allesia Funderburg ◽  
Colin Kloock ◽  
...  

The incidence of hematologic malignancies (HMs) is highest in the seventh decade of life and coincides with increasing occult, age-related vulnerabilities. Identification of frailty is useful in prognostication and treatment decision-making for older adults with HMs. This real-world analysis describes 311 older adults with HMs evaluated in a multidisciplinary oncogeriatric clinic. The accumulation of geriatric conditions [1-unit increase, hazards ratio (HR) = 1.13, 95% CI 1.00–1.27, p = 0.04] and frailty assessed by the Rockwood Clinical Frailty Scale (CFS, mild/moderate/severe frailty vs. very fit/well, HR = 2.59, 95% CI 1.41–4.78, p = 0.002) were predictive of worse overall survival. In multivariate analysis, HM type [acute leukemia, HR = 3.84, 95% CI 1.60–9.22, p = 0.003; myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN)/bone marrow failure, HR = 2.65, 95% CI 1.10–6.35, p = 0.03], age (per 5-year increase, HR = 1.46, 95% CI 1.21–1.76, p &lt; 0.001), hemoglobin (per 1 g/dl decrease, HR = 1.21, 95% CI 1.05–1.40, p = 0.009), deficit in activities of daily living (HR = 2.20, 95% CI 1.11–4.34, p = 0.02), and Mini Nutrition Assessment score (at-risk of malnutrition vs. normal, HR = 2.00, 95% CI 1.07–3.73, p = 0.03) were independently associated with risk of death. The most commonly prescribed geriatric interventions were in the domains of audiology (56%) and pharmacy (54%). The Rockwood CFS correlated with prescribed interventions in nutrition (p = 0.01) and physical function (p &lt; 0.001) domains. Geriatric assessment with geriatric intervention can be practically integrated into the routine care of older adults with HMs.


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