Does Knowledge of Treatment Assignment Affect Patient Report Of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials

2021 ◽  
Author(s):  
Jessica K. Roydhouse ◽  
Pallavi S. Mishra-Kalyani ◽  
Vishal Bhatnagar ◽  
Roee Gutman ◽  
Bellinda L. King-Kallimanis ◽  
...  
2020 ◽  
Vol 42 (2) ◽  
pp. 166-172
Author(s):  
Édila Figuerêdo Feitosa ◽  
Roberto José Pessoa Magalhães ◽  
Carlos Augusto de Melo Barbosa ◽  
Fabio Ribeiro Guedes ◽  
Angelo Maiolino ◽  
...  

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2348-2348 ◽  
Author(s):  
Bita Fakhri ◽  
Mark A Fiala ◽  
Sascha Tuchman ◽  
Tanya M Wildes

Abstract Background. With the expanding armamentarium of therapeutic agents for multiple myeloma (MM), it is important to identify any untreated or undertreated patient populations. MM is a disease of older adults, with a median age at diagnosis of 66 years. We hypothesized that older patients and those with poorer overall health are less likely to receive treatment. To test this, we performed a retrospective analysis of MM patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. Methods. We extracted all MM (ICD-9 code 203.0) cases in the SEER-Medicare database from 2007-2011. Patients were included in this study if they had been continuously enrolled in Medicare Part A, B, and D starting the year prior to diagnosis. The ICD-9 code 203.0 (MM and immunoproliferative neoplasms) captures both active MM and smoldering/asymptomatic myeloma, the former warrants treatment and the latter does not. To identify the population of patients with active MM, we created an algorithm based on ICD-9 codes for different variants of MM defining clinical features, referred to as CRAB criteria [elevated calcium, renal failure, anemia, and bony lytic lesions]. We defined symptomatic MM as either meeting CRAB criteria or receiving chemotherapy within 1 year of diagnosis. The diagnosis and procedure codes for the administration of MM agents were used to differentiate patients who received treatment versus those who did not. Multivariate logistic regression was performed to determine the variables that were independently associated with receipt of treatment. All statistical analyses were performed using SAS Enterprise Guide 5.1. A p value of <.05 was considered statistically significant. Results.Of the initial 2,871 patients included in the study, 132 patients did not meet CRAB criteria and did not receive any treatment. These 132 patients were considered to have a diagnosis of smoldering/asymptomatic MM, and were excluded from the analyses. Another 89 were excluded due to missing data, leaving 2,650 patients in the final analysis. The median age of the cohort at the time of diagnosis was 75 years old (range 26-99). 52% of patients were female, 77% were Caucasian, 17% African-American, and 7% belonged to other races. 20% of all patients were found to have at least one poor performance indicator; 55% of the cohort at least had one comorbidity based on the Charlson Comorbidity Index (CCI), and 33% were enrolled in Medicaid in addition to Medicare. Among the 2,650 patients with active MM, 839 (32%) did not receive any systemic treatment. Older age, poor performance indicators, comorbidities, African-American background, and a lower socioeconomic status (SES) were statistically significant factors associated with receipt of no systemic treatment. The risk of not receiving treatment was increased by 4% per year of age (OR 1.04, 95% CI 1.03-1.05), was 29% higher in the presence of poor performance indicators (OR 1.29, 95% CI 1.03-1.60), 17% higher per CCI score increase (OR 1.17, 95% CI 1.11-1.24), 28% higher for patients of African-American descent (OR 1.28, 95% CI 1.01-1.63), and was reduced by 4% per every $10,000 increase in median household income of home census tract (OR 0.96, 95% CI 0.92-0.99). Conclusions.In this retrospective study of the SEER database, we found that age, health status, race, and SES were predictive of receiving treatment for MM. These factors have previously been linked to reduced utilization of specific treatments for MM, such as stem cell transplants. But, to our knowledge, this is the first study to show their association with the receipt of any MM therapy. Given the advances in MM treatment in the past 2 decades, many with a more favorable toxicity profile compared to conventional chemotherapy, it is critical to investigate and address the barriers to treatment in patients who are less likely to receive the life-prolonging drugs. Disclosures Wildes: Carevive Systems: Consultancy.


Cancers ◽  
2021 ◽  
Vol 13 (17) ◽  
pp. 4320
Author(s):  
Laura Gengenbach ◽  
Giulia Graziani ◽  
Heike Reinhardt ◽  
Amelie Rösner ◽  
Magdalena Braun ◽  
...  

Treatment of relapsed/refractory multiple myeloma (RRMM) is more complex today due to the availability of novel therapeutic options, mostly applied as combination regimens. immunotherapy options have especially increased substantially, likewise the understanding that patient-, disease- and treatment-related factors should be considered at all stages of the disease. RRMM is based on definitions of the international myeloma working group (IMWG) and includes biochemical progression, such as paraprotein increase, or symptomatic relapse with CRAB criteria (hypercalcemia, renal impairment, anemia, bone lesions). When choosing RRMM-treatment, the biochemical markers for progression and severity of the disease, dynamic of disease relapse, type and number of prior therapy lines, including toxicity and underlying health status, need to be considered, and shared decision making should be pursued. Objectively characterizing health status via geriatric assessment (GA) at each multiple myeloma (MM) treatment decision point has been shown to be a better estimate than via age and comorbidities alone. The well-established national comprehensive cancer network, IMWG, European myeloma network and other national treatment algorithms consider these issues. Ideally, GA-based clinical trials should be supported in the future to choose wisely and efficaciously from available intervention and treatment options in often-older MM adults in order to further improve morbidity and mortality.


2019 ◽  
Vol 29 (1) ◽  
pp. 69-79 ◽  
Author(s):  
Katja Weisel ◽  
Heinz Ludwig ◽  
Achim Rieth ◽  
Andrea Lebioda ◽  
Hartmut Goldschmidt

Abstract Background Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. Methods We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based therapies (ASPIRE, ENDEAVOR) and two of daratumumab-based therapies (POLLUX, CASTOR) to conduct a descriptive assessment of health-related quality of life (HRQoL). HRQoL was assessed using the European Organisation for Research and Treatment of Cancer 30-item HRQoL Questionnaire, with hazard ratios calculated for carfilzomib- and daratumumab-based therapy versus comparators for time to HRQoL deterioration of ≥ 10 points. Analyses were also conducted on data from the EORTC 20-item myeloma-specific questionnaire, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, and the visual analog scale of the EuroQoL 5-dimension, 5-level questionnaire, where results for these instruments were available. As the designs and patient population of the four trials were similar but not identical, the analysis included only indirect, descriptive comparisons. Results Compared with lenalidomide/dexamethasone, median time to deterioration in global health status/QoL was longer for carfilzomib-based therapy versus control, but similar for daratumumab-based therapy and control. Compared with bortezomib/dexamethasone, time to deterioration was significantly longer for carfilzomib-based therapy versus control for global health status/QoL and numerous functional and symptom subscales. HRQoL measurement is feasible in large RRMM populations. Conclusion Descriptive assessment of HRQoL data suggests potential benefits for carfilzomib-based over daratumumab-based therapy.


2005 ◽  
Vol 41 ◽  
pp. 205-218
Author(s):  
Constantine S. Mitsiades ◽  
Nicholas Mitsiades ◽  
Teru Hideshima ◽  
Paul G. Richardson ◽  
Kenneth C. Anderson

The ubiquitin–proteasome pathway is a principle intracellular mechanism for controlled protein degradation and has recently emerged as an attractive target for anticancer therapies, because of the pleiotropic cell-cycle regulators and modulators of apoptosis that are controlled by proteasome function. In this chapter, we review the current state of the field of proteasome inhibitors and their prototypic member, bortezomib, which was recently approved by the U.S. Food and Drug Administration for the treatment of advanced multiple myeloma. Particular emphasis is placed on the pre-clinical research data that became the basis for eventual clinical applications of proteasome inhibitors, an overview of the clinical development of this exciting drug class in multiple myeloma, and a appraisal of possible uses in other haematological malignancies, such non-Hodgkin's lymphomas.


2000 ◽  
Vol 111 (4) ◽  
pp. 1118-1121 ◽  
Author(s):  
A. Bellahcene ◽  
I. Van Riet ◽  
C. de Greef ◽  
N. Antoine ◽  
M. F. Young ◽  
...  

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