Effectiveness of Maintenance Treatment in Newly Diagnosed Multiple Myeloma (NDMM): Results of an SLR to Inform Clinical Decision-Making in the US

2019 ◽  
Vol 19 (10) ◽  
pp. e296-e297
Author(s):  
Anna Forsythe ◽  
Ed Kim ◽  
Kejal Parikh ◽  
Ronda Copher
Author(s):  
Cian Tan ◽  
Mohammed Idhrees ◽  
Mohamad Bashir

ABSTRACT The involvement of Medical Technology (MedTech) corporations in the provision of surgical care remains a topic of debate. This relationship is especially relevant in cardiac and aortic surgery as the use of grafts, stents, prostheses, and other devices is an integral component of most procedures. Many argue that the involvement of device representatives in cardiac surgical cases is valuable – they are often experts on their product and are able to contribute their expertise in challenging cases. Yet, the potential for MedTech corporations to influence surgeons’ clinical decision-making introduces a conflict-of-interest and calls into question what the ‘best practice’ for sales reps should be. The influence of MedTech corporations over policymaking bodies in the US, UK, and Europe also represents a major issue for transparency and is equally deserving of evaluation.


2021 ◽  
Author(s):  
Junping Liu ◽  
Xin Liu ◽  
Zhengying Guo ◽  
Xiaojuan Lv ◽  
Weimin Mao ◽  
...  

Abstract Objective: To investigate whether ultrasound guided fine-needle aspiration cytology(US-FNAC) is an effective technique for diagnosing para-aortic lymph nodes(PALNs) metastasis in uterine cervical cancer and access the impact on clinical therapeutic decision. Methods: We retrospectively reviewed the clinical data of 92 patients with PALN enlargement in cervical cancer between 2010 and 2018. The US-FNAC cytological results were classified by the same experienced cellular pathologists. The diagnostic indicators were calculated according to biopsy , imaging and clinical follow-up results. Univariate and multivariate analysis was used to analyze the differences of influencing factors. The effect of US-FNAC on clinical decision making was evaluated. Results: The results of cytological diagnosis by US-FNAC were categorized as malignancy(n=62;67.4%), suspicious malignancy(n=11;12.0%), undetermined(n=5;5.4%), benign (n=10;10.9%), and inadequacy(n=4;4.3%). The satisfactory biopsy samples were obtained from 95.7% of PLANs (88/92). The sensitivity, specificity, PPV, NPV and accuracy of FNAC in distinguishing benign from malignant were 90.1%(95%CI:0.809-0.953), 100%(95%CI:0.561-1), 100%(95%CI:0.938-1), 46.7%(95%CI:0.223-0.726) and 90.9%(95%CI:0.848-0.970) respectively. Univariate analysis indicated that experience of the puncture physicians(radiologists) was significant differences between the correct diagnosis group and wrong diagnosis group (P<0.05); the experience was confirmed as independent predictor of diagnostic accuracy by multivariate analysis (p=0.031,OR=0.077,95%CI:0.354-0.919). All patients tolerated the US-FNAC procedure well and only nine patients presented slight abdominal discomfort. Through US-FNAC technique, the therapeutic methods of 74 patients (80.4%) were subjected to affect.Conclusions: US-FNAC is a relatively safe and effective examination technique for enlarged para-aortic lymph nodes, which can be considered as a routine examination before treatment of cervical cancer to guide clinical decision-making.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8026-8026
Author(s):  
Joaquin Martinez-Lopez ◽  
Sandy Wai Kuan Wong ◽  
Nina Shah ◽  
Natasha Bahri ◽  
Kaili Zhou ◽  
...  

8026 Background: MRD assessment is a known surrogate marker for survival in multiple myeloma (MM). Most data come from patients enrolled in clinical trials. We present a single institution’s experience assessing MRD in patients receiving frontline therapy and therapy for relapsed disease. We describe the impact of depth, duration, and direction of response on prognosis. Methods: 181 MM patients at University of California, San Francisco (UCSF) from 2008 to 2016. 126 were newly diagnosed and 55 in ≥ 2nd line. MRD was assessed in patients achieving VGPR or better by IMWG criteria. MRD assessment was performed by NGS (Adaptive Biotechnologies, Seattle, WA). PFS curves were plotted by the Kaplan-Meier method, and the log-rank test was used to estimate statistical significance. Results: 398 MRD samples were analyzed. MRD was available at 3 time points for 59 patients and 2 time points for 36 patients. Median follow up was 26m. Overall, 66 of 181 patients (36%)achieved MRD- ( < 10-6) on one or more samples. In the newly diagnosed group, 43 of 126 (34%), achieved MRD- at least once. These patients had a prolonged PFS versus patients who were persistently MRD+ (NR vs 49m, p = 0.006). Of the 55 patients who received therapy for relapsed disease, 21 achieved MRD- (38%) and PFS was also prolonged versus patients who remained MRD+ (53m vs 23m, p = 0.03). We analyzed the effects of depth of response. Patients who were MRD- or who were MRD+, at a very low level (between 10-5and 10-6), had a better prognosis than those with higher disease burdens ( > 10-5) (p = 0.001). Finally, we analyzed the effect of repeated MRD monitoring on PFS. Three categories were identified in newly diagnosed patients: (A) patients with ≥3 MRD- samples, (B) patients with continuously declining detectable clones, and (C) patients with a stable number of clones. Groups A and B had a more prolonged PFS than group C (NR vs 31m, p < 0.0001). Conclusions: MRD assessment in a real-world setting has the same predictive power as that seen in clinical trials. MRD dynamics can accurately predict disease evolution and drive clinical decision-making. This study lends support to the concept of MRD-driven decision-making and helps validate the relevance of MRD.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3570-3570
Author(s):  
Patricia Repetto ◽  
Noopur S. Raje ◽  
Sara R Fagerlie

Abstract Introduction/Background: Recent advances in the understanding and treatment of multiple myeloma (MM) have led to improvements in patient management, including stratifying patients according to disease- and patient-specific risk factors, identifying appropriate patients for autologous stem cell transplantation, selecting treatment and incorporating new therapies into practice, and managing adverse effects. Materials and Methods: An online educational program using clinical problem-based instruction methodology was developed for hematologists and posted November 30, 2015 (http://www.medscape.org/viewarticle/853712). Each patient case included interactivity in the form of clinical decision questions and knowledge assessmentquestions. Tailored feedback and potential consequences in response to clinical decision questions was provided to each learner. Learners who answered a question incorrectly on the first attempt were provided feedback without revealing the correct answer and given the opportunity to answer the question again (second attempt) [Figure 1]. To determine measurable improvements in competence and clinical decision making, first and second attempt answer choices were evaluated for the clinical decision questions. Overall effect size was calculated using Cohen's d to show the magnitude and strength of the consequence-based feedback learning method. Data were collected through February 17, 2016. Results: A total of 404 hematologists participated in the activity during the study period, and responses from 129 (those who completed all clinical decision questions) were assessed. Responses to the 6 clinical decision questions show that a range of 28% to 67% of learners answered a question correctly on the first attempt. After receiving feedback specific to each incorrect answer, there was an overall 71% relative improvement in hematologists/oncologists who answered a question correctly on the second attempt [Figure 2]. The consequence-based feedback had a large impact on hematologists' ability to make clinical decisions correctly as demonstrated by the overall effect size of d=.94. Conclusions: This study demonstrated the success of a web-based CME activity with tailored feedback to learners' responses. Participation in this activity led to large improvements in clinician knowledge and the ability to select appropriate evidence- based practice choices, which may ultimately improve outcomes of patients being treated for multiple myeloma. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3489-3489
Author(s):  
Lauren Willis ◽  
Pan Chen ◽  
Katie S Lucero

Introduction: Two surveys were conducted to understand the rationale for hematologists/oncologists (hem/oncs) to seek continuing medical education (CME) as well as how the information is applied to clinical practice. Additionally, we studied the clinical decision making of hem/oncs who treat patients with multiple myeloma (MM) in order to understand the areas to focus for future CME activities. Methods: We conducted two incentivized surveys where only hem/oncs in the US who treat patients were eligible: 1) MM decision-making survey (MM survey) in November 2018 where they were asked case-based questions to assess practice patterns and they were asked to rate their level of confidence in their decisions for the cases; and 2) Information seeking behaviors and preferences survey (behavior survey) in May and June 2019 where they responded to questions about what information informs practice and how often they need new information. Physicians were paid for their participation in the surveys. Results: 93 hem/oncs participated in the behavior survey with 56% from the community setting and 44% practicing exclusively in an academic setting. Community hem/oncs visit online CME more frequently than academic hem/oncs (daily or at least once a week: 67 vs 51%, respectively). The primary factors driving hem/oncs to access online CME include the need to learn about the latest developments (45%) and looking for an answer to a specific question (25%). Community hem/oncs are 2x more likely than academic hem/oncs to access online CME in order to earn credits. All of the hem/oncs surveyed have modified or implemented a new clinical practice in the last year, with the majority of the modified or new practices related to treatment (69%). Community hem/oncs are 174% more likely than academic hem/oncs to use CME as the source of the information leading to modified/new practice (27% vs 10%). The influence of CME on clinical practices is especially striking among hem/oncs practicing in a community vs academic setting on both gaining more confidence in their current practices (71% vs 59%) and modifying treatment practices (64% vs 54%). There were 101 hem/oncs who participated in the MM survey with 51% practicing in the community setting and 55% seeing between 1 to 10 patients with MM per month, whereas 22% saw more than 20 patients with MM per month. Case 1 highlights the lack of confidence among hem/oncs in making treatment decisions for patients with relapsed/refractory MM, with the majority, between 55% to 72%, only somewhat or not confident in their clinical decision. Although various options would be acceptable and not harmful, ideally treatment decisions would be made with a sense of confidence. In case 2, a striking 48% of hem/oncs would use a bortezomib-based regimen in a patient who has severe peripheral neuropathy, despite bortezomib's known side effect of peripheral neuropathy. For those who would use carfilzomib (52%) or a non-bortezomib regimen (13%), less than half (42% and 46%, respectively) were confident in their decision. Case 3 highlights the complexity of tailoring therapy for patients with MM as any of the answers could be appropriate, but between 37% and 67% of hem/oncs were only somewhat or not confident in their choices, indicating a need for additional education. Conclusions: Large Impact of CME on Community Hem/Oncs: A majority of hem/oncs access online CME at least once a week in order to learn about the latest developments and to find answers to specific questions, with the need for CME credits being a minor driver of CME consumption. The data show that CME has a high impact on clinical practices as the majority of hem/oncs surveyed modified or implemented new clinical practices in the last year as a result of what was learned in CME activities. The impact of CME on clinical practices is particularly striking among hem/oncs who practice in community-based settings. Additional Multiple Myeloma-Focused CME is Needed:The treatment paradigm for MM is rapidly evolving and this analysis shows that in order to improve the skills of hem/oncs as well as their confidence in their clinical decision making, additional CME is needed in the areas of (1) individualizing treatment for R/R MM, (2) managing adverse events, and (3) selecting maintenance therapy for high-risk MM. Table Disclosures No relevant conflicts of interest to declare.


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