Pathways clinical decision support for appropriate use of key biomarker.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 172-172
Author(s):  
Peter G. Ellis ◽  
Kathleen Lokay

172 Background: UPMC CancerCenter (UPMC) has utilized clinical pathways for almost ten years in an effort to ensure standardization to the evidence based care for its patients. UPMC oncologists participate in the various pathways disease committees that develop and maintain the pathways content and utilize the pathways through a web-based portal in their daily decision making and documentation. The pathways cover not only treatment recommendations but also guidance for work up such as recurrence risk tools (OncoType Dx) for node negative, HER2 negative, ER positive breast cancer who are candidates for chemotherapy. For patients with a low recurrence risk score, the pathways recommends hormonal therapy only, saving the patient both toxicities and costs of chemotherapy where appropriate. Methods: UPMC analyzed its use of chemotherapy in patients with a recurrence risk score of less than 19 through a retrospective review of physician-input data in its Via Pathways Portal for the twelve months ended May 31, 2014. During this time period, the Via Pathways recommended the recurrence risk test for node negative, HER2 negative, ER positive patients. For patients with a low risk score (less than 19), the Via Pathways recommended hormonal therapy only. For those low risk score patients receiving chemotherapy, the physician would document that an Off Pathway decision was being made, indicate the reason for going Off Pathway, and document the actual therapy delivered. Results: For the twelve months ended May 31, 2014, UPMC physicians documented 288 decisions for patient presentation of node negative, HER2 negative, ER positive patients with a recurrence risk score of less than 19. Of these decisions, 99% (n=284) were On Pathway for hormonal therapy. Of the remaining 1%, three (3) were for accrual to a clinical trial and one (1) was Off Pathway for chemotherapy. Conclusions: Pathways are a tool for promoting adherence to evidence based care by oncologists through the use of a point of care decision support system. Pathways have the potential to reduce costs and toxicities of treatment through the evidence based guidance developed by the pathways disease committees and the adherence to such guidance by oncologists utilizing the pathways decision support tool.

2021 ◽  
Author(s):  
Takeo Fujii ◽  
Hiroko Masuda ◽  
Yee Chung Cheng ◽  
Fei Yang ◽  
Aysegul A. Sahin ◽  
...  

Abstract Purpose A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk.Methods Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11-25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. Results Two hundred six patients had RS of 11-25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81-19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows.Conclusions The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11-25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively-accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11067-11067 ◽  
Author(s):  
H. Patel ◽  
K. Hook ◽  
C. Kaplan ◽  
R. Davidson ◽  
A. DeMichele ◽  
...  

11067 Background: The 21 gene RT-PCR assay Oncotype DX (Genomic Health, CA) stratifies patients into low, intermediate and high risk for systemic recurrence. The objective of this study was to examine the patterns of use of Oncotype DX in a single institution. Methods: All patients who had ODX testing requested by the University of Pennsylvania were identified and recurrence scores (RS) obtained. Patient and tumor characteristics, as well as treatment administered, were obtained by chart review for analysis. Results: 100 ODX tests were ordered between 1/1/05–11/30/06. RS results classified 51% of breast cancers as low risk, 38% intermediate risk, and 11% high risk. Characteristics of the tumors of the overall population and by RS group are shown in Table . 99% of patients received hormonal therapy. Of the low risk patients, only one patient was treated with chemotherapy (2%) while 34% of the intermediate risk group and 80% of the high risk group received chemotherapy. Notably, only 4/100 patients with ODX were under age 35 and 17/100 had tumors over 2cm. Conclusions: In this series, ODX use is accelerating. The results of the ODX tests appear to be used clinically as demonstrated by the very low use of chemotherapy in the low risk group. Comparison to the overall population of ER positive, node negative patients seen at this institution is underway. [Table: see text] No significant financial relationships to disclose.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2379-2379 ◽  
Author(s):  
Chris Wynick ◽  
Joanne Britto ◽  
Daniel Sawler ◽  
Arabesque Parker ◽  
Mohammad Karkhaneh ◽  
...  

Thrombotic thrombocytopenic purpura (TTP) is a life-threatening thrombotic microangiopathy (TMA), characterized by widespread intravascular thrombosis. Diagnosis of TTP is confirmed by a deficiency in ADAMTS13. However, given the urgency of prompt diagnosis and delayed turnaround time of ADAMTS13 assay in most labs, initial diagnosis is based on clinical acumen. Suspected TTP is empirically treated with plasma exchange (PLEX), which, while beneficial in TTP, may delay appropriate treatment for similar disorders. The PLASMIC score was developed by Bendapudi et al. (Lancet Hematology 2017) to utilize clinical signs and investigations to predict which patients had an ADAMTS13 score < 10%, and therefore TTP, who require PLEX. Validation studies have shown a very high sensitivity (90-98%) and high specificity (46-92%), although these studies included an enriched population with available ADAMTS13 assay results (Jajosky et al. Transfusion and Apheresis Science, 2017, Li et al. Journal of Thrombosis and Hemostasis 2018). The purpose of this study is to validate the PLASMIC score using a Canadian population of suspected TTP regardless if ADAMTS13 was ordered, and compare it to clinical gestalt. This is a retrospective cohort study of all adults aged 18 years or older who presented or were transferred to any of the two apheresis centres in Alberta, Canada with a suspected diagnosis of TTP from January 1, 2008 - December 31, 2018. A confirmed diagnosis of TTP was defined as an ADAMTS13 level prior to PLEX < 10%, or ADAMTS13 level between 10-20% if drawn after plasma infusion or PLEX. ADAMTS13 testing was done in accordance with the procedures at these institutions. The PLASMIC score was used to stratify patients into low (0-4), intermediate (5) and high (6-7) risk of TTP (Table 1). Descriptive analyses was performed to examine the proportion of patients with low-, intermediate-, and high-risk PLASMIC score who had ADAMTS13 testing done and who received PLEX. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PLASMIC score were calculated. Two PLASMIC score cutoffs were used for the analysis, 1) high risk vs low to intermediate risk, and 2) intermediate to high risk vs low risk. Receiver operator curve (ROC) analysis was used to test the association between severe ADAMTS13 deficiency and the PLASMIC score. PLASMIC scores were also compared to clinical gestalt, defined as initiation of PLEX within 48 hours of presentation. The C statistic was calculated from the area under the ROC and compared using the Z-test. As some patients who may have died from TTP did not have ADAMTS13 level sent, sensitivity analysis was performed to assess the ROC curve for the PLASMIC score in detecting both definite and probable TTP. A P-value of <0.05 was considered statistically significant. Of the 162 cases of suspected TTP, 61 (38%) had severe ADAMTS13 <10%. ADAMTS13 was sent prior to plasma exchange in 103 (64%) cases and shortly after PLEX initiation in 15 (9%). Using a high-risk PLASMIC score cut-off (6-7) vs low to intermediate-risk score (0-5), the sensitivity was 83.6%, specificity 67.3%, PPV 60.7% and NPV 87.2%. In contrast, using a cut-off of medium to high-risk PLASMIC score (5-7) vs low-risk score (0-4), the sensitivity improved to 96.7%, whereas the specificity was reduced to 30.7% (PPV 45.7% and NPV 93.9%). The C-statistics were 0.75 (95% CI 0.69-0.82) and 0.64 (95% CI 0.59-0.69) using the high PLASMIC score and medium-high PLASMIC score cut-offs, respectively (Figure 1). In contrast to PLASMIC score-based risk stratification, clinical gestalt has a comparable sensitivity of 83.6%, but a much lower specificity of 38.9%. There was very low correlation between PLASMIC score and clinical gestalt (kappa 0.0883 (95% CI -0.03-0.21). In our cohort, a high-risk PLASMIC score successfully predicted patients with severe ADAMTS13 deficiency in a Canadian TMA population, with similar sensitivity and improved specificity compared to clinical gestalt. Integration of this scoring system into institutional clinical pathways should be considered to supplement clinician judgment and reduce costs. Disclosures No relevant conflicts of interest to declare.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 512-512 ◽  
Author(s):  
R. A. Bender ◽  
M. Knauer ◽  
E. J. Rutgers ◽  
A. M. Glas ◽  
F. A. de Snoo ◽  
...  

512 Background: The 70-gene expression profile (MammaPrint) is validated as an independent prognostic indicator for breast cancer patients with T1–2 node-negative and positive disease regardless of estrogen receptor status. Here we present the relationship between MammaPrint outcome and chemotherapy benefit in the adjuvant setting. Methods: We performed a pooled analysis of 1,637 patients with MammaPrint outcomes (T1–2, node-negative and positive invasive breast cancer and median FU 7.1 yrs) to determine the chemotherapy benefit of patients treated with adjuvant chemotherapy in addition to endocrine therapy. Patients were collected from 7 large datasets at multiple institutions across Europe. Results: In this meta-analysis, MammaPrint assigned 772 patients (47%) to “low risk” and 865 (53%) to “high risk”. In total 349 patients were treated with endocrine therapy alone, whereas 226 were treated with both chemo- and endocrine therapy. Patients with poor prognosis MammaPrint profile had a substantial benefit from chemotherapy: At 5 years, distant disease-free survival was improved from 69% to 88% (HR 0.28 (95% CI 0.14–0.56, p<0.001) when chemotherapy was added to hormonal therapy. The results remained significant in multivariate analysis including stratification by standard clinico-pathologic prognostic factors. Patients classified by MammaPrint as good prognosis (“low risk”) had no significant benefit from chemotherapy (p=0.962). Conclusions: The 70-gene MammaPrint profile is not only a strong and independent prognostic indicator for patients with early stage breast cancer, but it may also be predictive for the benefit of chemotherapy. While MammaPrint “high risk” classified patients demonstrate a clear benefit from adjuvant chemotherapy added to hormonal therapy, patients classified by MammaPrint as “low risk” for recurrence do not appear to benefit from the addition of chemotherapy to hormonal treatment alone. [Table: see text]


2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 94-94
Author(s):  
Adam Harris ◽  
Sarah A. McLaughlin ◽  
Cameron Adkisson ◽  
Sanjay Prakash Bagaria ◽  
Tammeza Gibson ◽  
...  

94 Background: Octogenarian breast cancer (BrCa) patients accept less aggressive BrCa treatment due to decreased life expectancy, increased comorbidities, and high likelihood of death from other causes. Unfortunately little data exist stratifying octogenarian outcomes by disease risk. We sought to characterize treatment and recurrence patterns in patients >80yo. Methods: Retrospective review identified 432 women >80yo treated surgically for stage 0-3 BrCa between 11/99-8/11. We gathered clinicopathologic data and classified patients by disease risk as DCIS only, low risk (<2cm and ER positive and node negative), or high risk (>2cm or ER negative or node positive). We compared recurrence rates and estimated survival by Kaplan-Meier curves. Results: Among the 432 women, disease was found by mammogram in 86%, treated with BCT in 64%, and predominantly ER-positive (87%). We classified patients as having DCIS only (N=61), low risk (N=205), or high risk (N=166) disease. We identified the following deviations from standard treatment guidelines: 68% DCIS BCT and 38% high risk BCT patients did not have radiation therapy, 25% low risk BCT patients had surgery only, 51% low risk patients did not take adjuvant hormonal therapy, and 40% high risk patients had no adjuvant chemo/hormonal therapy. At 5 and 10 years the overall estimated survival was 63% and 31%, respectively. Overall, 19/432 (5%) patients developed recurrence (table 1). Patients needing mastectomy for high risk disease had significantly higher risk of recurrence than high or low risk BCT patients (p=0.02). Of the 19 recurrence patients, 7/19 (37%; 1 DCIS, 1 low risk, 5 high risk) occurred despite standard multimodality treatment, while12 (63%; 3 low risk, 9 high risk) had the initial tumor treated less aggressively due to patient choice (n=9) or medical co-morbidities (n=3). Conclusions: Significant deviations from treatment guidelines occur in women >80yo. Those with high risk disease should be counseled accordingly and encouraged to receive adjuvant treatment as two thirds of women >80yo will live at least 5 years. [Table: see text]


2006 ◽  
Vol 24 (6) ◽  
pp. 872-877 ◽  
Author(s):  
Linda C. Harlan ◽  
Limin X. Clegg ◽  
Jeffrey Abrams ◽  
Jennifer L. Stevens ◽  
Rachel Ballard-Barbash

Purpose We describe trends in the use of chemotherapy and hormonal therapy by nodal and estrogen receptor (ER) status in women with early-stage breast cancer. Methods Cases were randomly sampled from the population-based Surveillance, Epidemiology and End Results (SEER) program and physician verified treatment was examined. A total of 9,481 women, aged 20 years and older, diagnosed with early-stage breast cancer in 1987 to 1991, 1995, and 2000 were included in the study. Results The use of chemotherapy plus tamoxifen increased between 1995 and 2000 for women with node-negative, ER-positive breast cancer ≥ 1 cm (8% to 21%). Nearly 23% of women with node-negative and ER-positive tumors ≥ 1 cm received no adjuvant therapy. The use of chemotherapy alone increased to nearly 60% in women with node-negative, ER-negative tumors ≥ 1 cm (48% to 59%). However, in 2000, 16% of women with node-positive and ER-negative tumors received no adjuvant therapy and an additional 6% received tamoxifen alone. The influence of age can clearly be seen. Chemotherapy is given much less often in women 70 years or older. Conclusion The results from SEER areas across the United States suggest that physicians quickly responded to publications and guidelines regarding breast cancer therapy. The lack of definitive findings from clinical trials on the use of adjuvant therapy in women 70 years and older may explain the lower use in this group of women.


Sign in / Sign up

Export Citation Format

Share Document