Improving quality of care and reducing costs with angiogenesis-specific imaging tests in metastatic breast cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 150-150
Author(s):  
Carolyn Bodnar ◽  
L. Clark Paramore ◽  
Kevin B. Knopf

150 Background: Anti-angiogenesis (AA) drugs (e.g., bevacizumab) are expensive and their clinical benefit in metastatic breast cancer (MBC) has been challenged. Healthcare reform and financial pressures prioritize programs which improve patient quality of care and reduce costs of unnecessary care. Angiogenesis-specific imaging tests (A-IT) under development have potential to offer earlier, accurate determination of response. For A-IT-identified responders, AA treatment would be continued. For patients identified as non-responders, futile AA treatment and associated toxicities can be avoided and alternative therapies initiated. Methods: A decision-tree model was developed to estimate the impact of A-IT from determination of AA therapy eligibility through to disease progression. Key decision nodes were presence/absence of A-IT (assessing change in biomarker expression across 2 PET/CT scans: at AA eligibility, then after one cycle of AA), A-IT sensitivity/specificity (SE/SP) and clinician adherence to test results (tied to belief that results are valid enough to stop AA therapy). Key model inputs (and base case values): 1) median time to progression (TTP) for current MBC patients on AA therapies (9.5 months); 2) median TTP for A-IT identified responders (13 months); 3) costs of bevacizumab, one cycle ($5,200); 4) percentage of AA patients with hemorrhage (4%); 5) costs of hemorrhaging, per event ($14,694); 6) per patient costs for A-IT ($6,000); 7) estimated SE/SP of A-IT – 95%/75%; and 8) clinician adherence to test results (75%). Results: Based on a cohort of 100 MBC patients, use of A-IT results in 29 patients avoiding futile AA therapy with a saving of $460,000, versus a scenario where A-IT was not used. One-way threshold sensitivity analysis shows A-IT is cost-saving if SP >62% or when clinician adherence is ≥63%; results are not sensitive to AA hemorrhage rate. Conclusions: Use of A-IT could improve quality of care by optimizing AA therapy, i.e., by identifying responders who will experience survival benefit and non-responders who can avoid futile therapy and toxicity risks. Significant cost savings may be possible as a result of early determination of response to AA drugs.

1996 ◽  
Vol 32 (9) ◽  
pp. 1612-1615 ◽  
Author(s):  
G. Marchioro ◽  
G. Azzarello ◽  
F. Checchin ◽  
M. Perale ◽  
R. Segati ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6620-6620
Author(s):  
R. A. Miksad ◽  
S. Come ◽  
M. Weinstein

6620 Background: Osteonecrosis of the jaw (ONJ) has been linked to bisphosphonates used to prevent skeletal related events (SREs) in metastatic breast cancer (MBC). The primary aim of this decision-analysis study is to determine the preference threshold at which the quality of life (QOL) impact of ONJ may change bisphosphonate treatment decisions. Methods: We developed a Markov decision- analysis model of bisphosphonate use in MBC that includes the risk of ONJ. For the base case we estimated the QOL impact of ONJ by evaluating published ONJ reports with the Oral Health Impact Profile (OHIP). OHIP scores were transformed to EQ5D utilities and adjusted for MBC (published utility for MBC=0.63). We used published utility values for SRE: 0.46 for the month in which SRE occurs. Based on published data, we estimated that bisphosphonates reduce the incidence of SREs by 41% and that the incidence of SRE rises with increased bisphosphonate exposure: year 1=0.004/month; year 2=0.022/month; year 3=0.034/month. We inspected 2 treatment strategies: treat all patients with bisphosphonates (treat all) and treat no patient with bisphosphonates (treat none). Results: 18 published cases were adequate for evaluation. The mean OHIP score=27 (possible range 14–70), s.d.=1.8. We calculated that patients with MBC and ONJ have a utility=0.53 (s.d.=0.04) for the base-case. The model predicted a mean survival of 22 months for both strategies. In the treat all strategy each patient received a mean of 19 months of bisphosphonates and suffered 2.4 SREs. In the treat none strategy each patient suffered 4.0 SREs. In the base case, the treat all strategy maximized net quality-adjusted life, although by less than 1/2 month per patient. The treat all strategy was optimal for only 33% of patients. The treat all strategy does not maximize net quality-adjusted life if the risk of ONJ is 4.5 times higher than the base case or the ratio of the utility for ONJ to the utility for SRE is less than 0.4 (base-case ratio=1.152). Conclusions: The QOL impact of ONJ alters the decision to use bisphosphonates when 1) the incidence of ONJ is 4.5 times higher than published estimates; or 2) the long-term preference for ONJ is 60% lower than the short-term preference for SRE. Further QOL research may refine these estimates. No significant financial relationships to disclose.


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18031-e18031
Author(s):  
Ines Vaz Luis ◽  
Nancy U. Lin ◽  
Rachel A. Freedman ◽  
William Thomas Barry ◽  
Eric P. Winer ◽  
...  

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 70-70
Author(s):  
Deepa Lalla ◽  
Amye Tevaarwerk ◽  
Hans-Peter Goertz ◽  
Mary Lou Smith ◽  
Preeti S. Bajaj ◽  
...  

70 Background: Metastatic breast cancer (MBC) and its treatments can have a significant impact on patients’ health-related quality of life (HRQoL) and daily functioning. To better assess the impact of MBC on HRQoL, we conducted an online survey among women with MBC. Methods: We developed and administered a cross-sectional, web-based survey, and invited registered members of three advocacy groups currently living with MBC to participate. Respondents completed an informed consent and completed assessments on symptom burden using an overall QOL question (1 item), the MD Anderson Symptom Inventory Survey (MDASI), activities of daily living (ADLs, Rotterdam Scale), and impacts on work productivity. Results: We received 1285 complete responses to the survey. Over half the respondents were between 40-49yrs (37%) or 30-39 yrs (26%). The majority were white (87.7%), well-educated (70.7% had a bachelor’s degree or higher), and working at the time of the survey (55%), with private health insurance (63%). After diagnosis with MBC, most patients had received endocrine therapy (44.2% aromatase inhibitors, 27.3% fulvestrant). The most common chemotherapy agents received after diagnosis with MBC were capecitabine (30.1%) and docetaxel (26.9%). The overall mean HRQoL score was 74 (0-100, higher is better). Mean respondent-reported MDASI scores for symptom severity (SS) and symptom interference (SI) were 4.2 and 4.5 (0-10, higher is worse). Mean Rotterdam scale scores to assess ADLs were 23.7 (0-32, higher better). On average, working women with MBC missed 9.3 hours of work in the past 7 days due to their MBC. As symptom burden increased, respondents reported a lower ability to perform ADLs (p < 0.0001) and lower overall HRQoL (p < 0.0001). The ability to perform ADLs decreased with increase in the total number of agents received (p < 0.0001) and time since diagnosis (p < 0.0001). Conclusions: This survey provides valuable insights into health status, ability to perform ADLs, and lost productivity among patients with MBC. Future analyses will present results by tumor subtypes and drug treatments received.


2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 129-129
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma

129 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with most interventions intended to relieve disease symptoms, minimize treatment effects and prolong patient survival. The impact of disease and treatment on a patient's funcitonal abilities has led to an emphasis of incorporating quality of life (QoL) measures into clinical trials. The main objective of this study is to evaluate phase III clinical trials in MBC, and assess the inclusion of QOL as an endpoint, in addition to conventional efficacy endpoints. Methods: A structured PubMed search was conducted to identify phase III clinical trials published between Jan. 1990 and Aug. 2011, evaluating systemic treatment in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a particular focus on progression-based (PB), overall survival (OS), and QoL endpoints. Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. While the inclusion of QoL was not associated with the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as a clinical endpoint (p=0.016). When stratified by treatment arm, it was found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management and treatment decisions, only one-third of identified phase III clinical trials included an assessment of QoL. About half of these trials showed no statistically significant differences in the QoL endpoint; of not, instruments of varying validity were utilized. There needs to be a greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16547-e16547
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma

e16547 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with therapy used to relieve disease symptoms, minimize treatment effects and prolong survival. The impact of disease and treatment on patients has led to an emphasis of quality of life (QoL) measures in clinical trials. This study’s primary objective is to evaluate phase III clinical trials in MBC, and assess the inclusion of QoL as an endpoint. Methods: A PubMed search was conducted to identify phase III clinical trials published from Jan 1990 to Aug 2011, which evaluated systemic therapy in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a focus on progression-based (PB), overall survival (OS), and QoL endpoints. The instrument(s) used to evaluate QoL were also noted (if applicable). Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. 14 instruments were identified as QoL tools among the studies, with EORTC QLQ-C30 and FACT-B accounting for 54.7% of the instruments used. While the inclusion of QoL was not related to the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as an endpoint (p=0.016). Stratification by treatment arm found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management, only one-third of identified phase III clinical trials included its assessment. Half of these trials showed no statistically significant differences in QoL endpoint; of note, instruments of varying validity were utilized. There needs to be greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.


2014 ◽  
Vol 74 (S 01) ◽  
Author(s):  
M Wallwiener ◽  
AD Hartkopf ◽  
S Riethdorf ◽  
J Nees ◽  
FA Taran ◽  
...  

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