scholarly journals Defining Unmet Need Following Lenalidomide Refractoriness: Real-World Evidence of Outcomes in Patients With Multiple Myeloma

2021 ◽  
Vol 11 ◽  
Author(s):  
Catherine S. Y. Lecat ◽  
Jessica B. Taube ◽  
William Wilson ◽  
Jonathan Carmichael ◽  
Christopher Parrish ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Real World ◽  
Unmet Need ◽  
Progression Free Survival ◽  
The Real ◽  
Real World Evidence ◽  
Treatment Paradigm ◽  
History Of ◽  
Poor Outcomes

BackgroundThe treatment paradigm for multiple myeloma (MM) continues to evolve with the development of novel therapies and the earlier adoption of continuous treatments into the treatment pathway. Lenalidomide-refractory patients now represent a challenge with inferior progression free survival (PFS) reported to subsequent treatments. We therefore sought to describe the natural history of MM patients following lenalidomide in the real world.MethodsThis was a retrospective cohort review of patients with relapsed MM who received lenalidomide-based treatments in the U.K. Data were collected for demographics, subsequent therapies, treatment responses, survival outcomes and clinical trial enrollment.Results198 patients received lenalidomide-based treatments at a median of 2 prior lines of therapy at a median of 41 months (range 0.5-210) from diagnosis. 114 patients (72% of 158 evaluable) became refractory to lenalidomide. The overall survival (OS) after lenalidomide failure was 14.7 months having received between 0-6 subsequent lines of therapy. Few deep responses were observed with subsequent treatments and the PFS to each further line was < 7 months. There was a steep reduction in numbers of patients able to receive further treatment, with an associated increase in number of deaths. The OS of patients progressing on lenalidomide who did not enter a clinical trial incorporating novel agents was very poor (8.8 months versus 30 months, p 0.0002), although the trials group were a biologically fitter group.ConclusionThese data demonstrate the poor outcomes of patients failing lenalidomide-based treatments in the real world, the highlight need for more effective treatments.

scholarly journals Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting

2018 ◽  
Vol 8 (11) ◽  
Author(s):  
Paul G. Richardson ◽  
Jesus F. San Miguel ◽  
Philippe Moreau ◽  
Roman Hajek ◽  
Meletios A. Dimopoulos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Real ◽  
Real World Setting

scholarly journals Initial Experience of Atezolizumab Plus Bevacizumab for Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice

Cancers ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2786
Author(s):  
Hideki Iwamoto ◽  
Shigeo Shimose ◽  
Yu Noda ◽  
Tomotake Shirono ◽  
Takashi Niizeki ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Practice ◽  
Real World ◽  
Objective Response ◽  
Previous History ◽  
Progression Free Survival ◽  
Incidence Rates ◽  
Hepatic Disorder ◽  
The Real ◽  
History Of

Background: Atezolizumab plus bevacizumab was approved for patients with hepatocellular carcinoma (HCC). Although clinical trials have revealed its efficacy, the outcomes in the real-world clinical practice are unclear. We retrospectively evaluated the efficacy and safety of atezolizumab plus bevacizumab for HCC. Materials and Methods: This is a multicenter study conducted between November 2020 and March 2021. Among the 61 patients, 51 were assessed for progression-free survival (PFS), therapeutic response, and adverse events (AEs). Results: The median PFS was 5.4 months. The objective response rate (ORR) was 35.3%. The disease control rate (DCR) was 86.3%. The incidence rates of AEs at any grade and grade >3 were 98.0% and 29.4%, respectively. The most frequent AE at any grade and grade >3 was hepatic disorder. In patients with a previous history of molecular targeted agent (MTA) or the degree of albumin-bilirubin (ALBI) grade, there were no significant differences in the PFS, ORR, DCR, and incidence rates of AEs. Conclusion: The study demonstrated that atezolizumab plus bevacizumab was effective and safe for patients with HCC even in the real-world setting including patients with a previous MTA history or other than ALBI grade 1.

scholarly journals Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life

2021 ◽  
Vol 11 (2) ◽  
Author(s):  
Evangelos Terpos ◽  
Joseph Mikhael ◽  
Roman Hajek ◽  
Ajai Chari ◽  
Sonja Zweegman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Multiple Myeloma ◽  
Real World ◽  
Financial Burden ◽  
Phase 3 ◽  
The Real ◽  
Real World Setting ◽  
Definition Of

AbstractTreatment options in multiple myeloma (MM) are increasing with the introduction of complex multi-novel-agent-based regimens investigated in randomized clinical trials. However, application in the real-world setting, including feasibility of and adherence to these regimens, may be limited due to varying patient-, treatment-, and disease-related factors. Furthermore, approximately 40% of real-world MM patients do not meet the criteria for phase 3 studies on which approvals are based, resulting in a lack of representative phase 3 data for these patients. Therefore, treatment decisions must be tailored based on additional considerations beyond clinical trial efficacy and safety, such as treatment feasibility (including frequency of clinic/hospital attendance), tolerability, effects on quality of life (QoL), and impact of comorbidities. There are multiple factors of importance to real-world MM patients, including disease symptoms, treatment burden and toxicities, ability to participate in daily activities, financial burden, access to treatment and treatment centers, and convenience of treatment. All of these factors are drivers of QoL and treatment satisfaction/compliance. Importantly, given the heterogeneity of MM, individual patients may have different perspectives regarding the most relevant considerations and goals of their treatment. Patient perspectives/goals may also change as they move through their treatment course. Thus, the ‘efficacy’ of treatment means different things to different patients, and treatment decision-making in the context of personalized medicine must be guided by an individual’s composite definition of what constitutes the best treatment choice. This review summarizes the various factors of importance and practical issues that must be considered when determining real-world treatment choices. It assesses the current instruments, methodologies, and recent initiatives for analyzing the MM patient experience. Finally, it suggests options for enhancing data collection on patients and treatments to provide a more holistic definition of the effectiveness of a regimen in the real-world setting.

EXPLORING HEALTHCARE ARCHITECTURE THROUGH THE MEDIUM OF FILM: Motives and Techniques

2014 ◽  
Vol 8 (1) ◽  
pp. 29
Author(s):  
Stephen Verderber
Keyword(s):  
Real World ◽  
The Real ◽  
Healthcare Settings ◽  
Interdisciplinary Field ◽  
Body Of Knowledge ◽  
Behavior Setting ◽  
Physical Environments ◽  
Scant Attention ◽  
History Of

The interdisciplinary field of person-environment relations has, from its origins, addressed the transactional relationship between human behavior and the built environment. This body of knowledge has been based upon qualitative and quantitative assessment of phenomena in the “real world.” This knowledge base has been instrumental in advancing the quality of real, physical environments globally at various scales of inquiry and with myriad user/client constituencies. By contrast, scant attention has been devoted to using simulation as a means to examine and represent person-environment transactions and how what is learned can be applied. The present discussion posits that press-competency theory, with related aspects drawn from functionalist-evolutionary theory, can together function to help us learn of how the medium of film can yield further insights to person-environment (P-E) transactions in the real world. Sampling, combined with extemporary behavior setting analysis, provide the basis for this analysis of healthcare settings as expressed throughout the history of cinema. This method can be of significant aid in examining P-E transactions across diverse historical periods, building types and places, healthcare and otherwise, otherwise logistically, geographically, or temporally unattainable in real time and space.

Real-world treatment patterns in relapsed/refractory multiple myeloma: Clinical and economic outcomes in patients treated with pomalidomide or daratumumab

2021 ◽  
pp. 107815522199553
Author(s):  
Joshua Richter ◽  
Vamshi Ruthwik Anupindi ◽  
Jason Yeaw ◽  
Suneel Kudaravalli ◽  
Stojan Zavisic ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Treatment Options ◽  
Proteasome Inhibitors ◽  
Economic Outcomes ◽  
Office Visits ◽  
Refractory Multiple Myeloma ◽  
Kaplan Meier ◽  
Real World Evidence ◽  
New Treatment

Introduction Real-world evidence on later line treatment of relapsed/refractory multiple myeloma (RRMM) is sparse. We evaluated clinical outcomes among RRMM patients in the 1-year following treatment with pomalidomide or daratumumab and compared economic outcomes between RRMM patients and non-MM patients. Patient and Methods Adult patients with ≥1 claim of pomalidomide or daratumumab were identified between January 2012 and February 2018 using IQVIA PharMetrics® Plus US claims database. Patients were required to have a diagnosis or treatment for MM and a claim of any immunomodulatory drugs and proteasome inhibitors before the index date. Mean time to new therapy, overall survival (OS) using Kaplan-Meier curve and adverse events (AEs) were reported over the 1-year post-index period. RRMM patients were also matched to a non-MM comparator cohort and economic outcomes were compared between the two cohorts. Results 289 RRMM patients were matched to 1,445 patients without MM. Most prevalent hematological AE was anemia (72.0%) and non-hematological AE was infections (75.4%). Mean (SD) time to a new treatment was 4.7 (5.3) months and median OS was 14.6 months. RRMM patients had significantly higher hospitalizations and physician office visits (Both P < .0001) compared to non-MM patients. Adjusting for baseline characteristics, patients with RRMM had 4.9 times (95% CI 3.8-6.4, P < .0001) the total healthcare costs compared with patients without MM. The major driver of total costs among RRMM patients was pharmacy costs (67.3%). Conclusion RRMM patients showed a high frequency of AEs, low OS, and a substantial economic burden suggesting need for effective treatment options.

scholarly journals The Real World Effectiveness of Hematopoietic Transplant Among Elderly Individuals With Multiple Myeloma

2015 ◽  
Vol 107 (8) ◽  
Author(s):  
Aaron N. Winn ◽  
Gunjan L. Shah ◽  
Joshua T. Cohen ◽  
Pei-Jung Lin ◽  
Susan K. Parsons
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Elderly Individuals ◽  
The Real

Systematic review of the real-world evidence of adalimumab safety in psoriasis registries

2018 ◽  
Vol 32 (12) ◽  
pp. 2126-2133 ◽  
Author(s):  
B. Strober ◽  
J. Crowley ◽  
R.G. Langley ◽  
K. Gordon ◽  
A. Menter ◽  
...  
Keyword(s):  
Systematic Review ◽  
Real World ◽  
The Real ◽  
Real World Evidence
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