Aging a Decade in a Day: Age Cutoff Bias in Adjuvant Therapy Allocation for Early-Stage Breast Cancer.

PURPOSE: Physicians may expedite interpretation of data presented as a continuous variable by binning the data into "high" and "low" subgroups (cutoff heuristic). Use of this cognitive shortcut with age may lead to fewer nuanced or inappropriate decisions. We hypothesized an age cutoff heuristic may lead to non-evidence-based adjuvant treatment allocation among patients with early-stage breast cancer. METHODS AND MATERIALS: Two cohorts with strong indications for adjuvant treatment regardless of age that underwent lumpectomy for early-stage breast cancer between 2004 and 2017 were identified in the National Cancer Database. Cohort 1 had higher-risk features (estrogen receptor negative, endocrine therapy not planned, final margins positive, or size >3 cm; n = 160,990) and was appropriate for radiation. Cohort 2 had hormone receptor positivity with tumors >5 mm (n = 394,946) and was appropriate for endocrine therapy. Multivariable logistic regressions with odds ratios (ORs) and 99.8% confidence intervals (CIs) were performed to determine whether any single year-over-year age difference was independently associated with a difference in likelihood of adjuvant therapy recommendation. RESULTS: In cohort 1, radiation recommendation decreased sharply at age 70, ranging from 90% to 92% between the ages of 50 and 69 years to 81% for those aged 70 years. Multivariable logistic regressions showed year-over-year age difference was an independent predictor for adjuvant radiation recommendation at only age 70 versus 69 (OR, 0.47; CI, 0.39-0.57; P < .001). For cohort 2, endocrine therapy recommendation showed a small decline at age 70, and year-over-year age difference was a predictor of endocrine therapy recommendation at only age 70 versus 69 (OR, 0.86; CI, 0.74-0.99; P = .001). CONCLUSIONS: We observed a unique decline in appropriate adjuvant therapy recommendation between ages 69 and 70. This suggests use of an age cutoff heuristic to process patient age in this population as a categorical, binary variable. This is a previously undescribed phenomenon in early-stage breast cancer.

Associations of Early Completion of Advance Directives With Key End-of-Life Quality Measures: Analysis of an ASCO Quality Oncology Practice Initiative Patient Cohort.

PURPOSE: Despite the growing calls for early and ubiquitous completion of advance directives (ADs), studies exploring links between AD completion and their impact on outcomes of patients with cancer have mixed conclusions. We used the ASCO Quality Oncology Practice Initiative (QOPI) registry to compare end-of-life (EOL) quality measures and the effect of QOPI certification among patients with and without early AD completion, defined as completion within the first three oncology visits after cancer diagnosis. METHODS: Deidentified patient-level data were analyzed from the QOPI database from 2015 through 2017. Associations were assessed using Chi-square tests between early AD completion and patient enrollment in hospice < 7 days before death, chemotherapy receipt in the last 14 days of life, or with emergency room visits or intensive care unit admissions in the last 30 days of life. RESULTS: Data from 31,558 patients eligible for the AD question were analyzed. Patients treated at QOPI-certified practices had higher rates of early AD completion than patients at non-certified practices. Early AD completion was not associated with differences in hospice enrollment for < 7 days before death, chemotherapy receipt in the last 14 days of life, or emergency room visits or intensive care unit encounters in the last 30 days of life. CONCLUSION: The study found that QOPI certification is associated with higher rates of early AD completion. However, early AD completion was not associated with recognized EOL quality measures. Future research should focus on the timing, frequency, and content of AD conversations to demonstrate the impact on care at the EOL.

Self-Reported COVID-19 Infections and Social Mixing Behavior at Oncology Meetings.

PURPOSE: The COVID-19 pandemic largely suspended in-person scientific meetings because of risk of disease spread. In the era of vaccination and social distancing practices, meetings have begun returning to in-person formats. We surveyed attendees and potential attendees of 2 oncology meetings in the United States to identify rates of mixing behavior and the subsequent rate of self-reported COVID-19 infection. METHODS AND MATERIALS: We collected via survey reported social mixing behavior and COVID-19 positivity (within 21 days of meeting conclusion) of actual and potential in-person attendees of the American Society of Clinical Oncology (ASCO) Quality Care Symposium held September 24 to 25, 2021, and the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 24 to 27, 2021. Conference speakers and other participants were identified through publicly available meeting materials and targeted via e-mail when possible. Recruitment of additional attendees and potential attendees was also conducted through a sharable link promoted via oncology newsletters and social media. Descriptive statistics alone were performed owing to low COVID-19 event rates. RESULTS: Response rates from targeted conference participants with publicly available e-mails were 27.4% for the ASCO and 14.3% for the ASTRO meetings. The ASCO survey produced 94 responses (48 in-person attendees). The ASTRO survey produced 370 responses (267 in-person attendees). Across both meetings, 3 of 308 (1.0%) in-person attendees versus 2 of 141 (1.4%) nonattendees tested positive for COVID-19. Low COVID-19 positivity rates were reported among in-person attendees spending more (>20) versus fewer (≤20) hours attending live sessions (2.2% vs 0%) and among indoor social event participants versus nonparticipants (0.8% vs 1.9%). Attendees largely felt comfortable attending additional in-person meetings after experiencing ASCO (87.5%) or ASTRO (91.9%) and felt mask compliance was good or excellent at ASCO (100%) and ASTRO (94.6%) meetings. CONCLUSIONS: In-person meetings do not seem to be contributing to high rates of new COVID-19 infections in the setting of vaccine and social distancing mandates, supporting paths forward for at least partially in-person conferences as COVID-19 becomes endemic.

Making National Cancer Institute-Designated Comprehensive Cancer Center Knowledge Accessible to Community Oncologists via an Online Tumor Board: Longitudinal Observational Study.

BACKGROUND: Expert knowledge is often shared among multidisciplinary academic teams at tumor boards (TBs) across the country, but these conversations exist in silos and do not reach the wider oncology community. OBJECTIVE: Using an oncologist-only question and answer (Q&A) website, we sought to document expert insights from TBs at National Cancer Institute-designated Comprehensive Cancer Centers (NCI-CCCs) to provide educational benefits to the oncology community. METHODS: We designed a process with the NCI-CCCs to document and share discussions from the TBs focused on areas of practice variation on theMednet, an interactive Q&A website of over 13,000 US oncologists. The faculty translated the TB discussions into concise, non-case-based Q&As on theMednet. Answers were peer reviewed and disseminated in email newsletters to registered oncologists. Reach and engagement were measured. Following each Q&A, a survey question asked how the TB Q&As impacted the readers' practice. RESULTS: A total of 23 breast, thoracic, gastrointestinal, and genitourinary programs from 16 NCI-CCC sites participated. Between December 2016 and July 2021, the faculty highlighted 368 questions from their TBs. Q&As were viewed 147,661 times by 7381 oncologists at 3515 institutions from all 50 states. A total of 277 (75%) Q&As were viewed every month. Of the 1063 responses to a survey question on how the Q&A affected clinicians' practices, 646 (61%) reported that it confirmed their current practice, 163 (20%) indicated that a Q&A would change their future practice, and 214 (15%) reported learning something new. CONCLUSIONS: Through an online Q&A platform, academics at the NCI-CCCs share knowledge outside the walls of academia with oncologists across the United States. Access to up-to-date expert knowledge can reassure clinicians' practices, significantly impact patient care in community practices, and be a source of new knowledge and education.

Novel Tool to Monitor Adherence to Oral Oncolytics: A Pilot Study.

PURPOSE: Nonadherence is a significant issue in cancer care, especially as more oral therapies become available. Measuring and optimizing adherence to such therapies is challenging. In this study, we tested a novel technology that records real-time medication-taking behavior from a smart prescription bottle and can communicate with patients via text message to intervene in cases of nonadherence. METHODS: We conducted a 28-patient pilot study to assess the feasibility of this technology in measuring and improving adherence in patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. The study had a preintervention stage, during which patients were monitored, and an intervention stage, during which the text messaging intervention was enabled. RESULTS: During preintervention, patients had an average self-adherence of 89%, and during post intervention, they had an average adherence of 90%. We defined three categories of patients by change in adherence: category 1 (> 8%), category 2 (-8% to 8%), and category 3 (< -8%). Patients in category 1 tended to live in regions with lower average household income (mean = $58,937 in US dollars [USD]) than those in category 2 (mean = $77,482 USD) and category 3 (mean = $90,972 USD). Of poststudy survey respondents, most indicated that they would want to continue using this technology and that they would recommend it to others. CONCLUSION: This novel technology is able to monitor, measure, and intervene for patients taking capecitabine in real time. Adherence overall was high, and some patients appeared to benefit more from text-message interventions. Future work should focus on patients deemed high risk for nonadherence.

Cognitive Effects and Depression Associated With Taxane-Based Chemotherapy in Breast Cancer Survivors: A Meta-Analysis.

Purpose: This meta-analysis provides a longitudinal assessment of depression and cognitive impairment induced by taxane-based chemotherapy in women with breast cancer after 6 months of treatment. We highlighted the incidence and prevalence, the cognitive pattern in neuropsychological studies, and the relationship between chemotherapy-induced cognitive impairment and different risk factors. We estimated the effect sizes on each cognitive domain and differentiated effect sizes by each method of comparison of effects (i.e., baseline data, or control groups). Methods: The databases MEDLINE and Embase were searched for publications about taxane-related cognitive changes in patients with breast cancer published from 1980 to 2019. Cross-sectional and self-reported outcomes studies were excluded except for the depression item. Included studies were assessed for risk of bias with the Newcastle-Ottawa Scale. We estimated effect sizes for each cognitive domain and differentiated effect sizes by each method of comparison of effects. The review is reported in compliance with the PRISMA Statement; it was registered prospectively in PROSPERO as CRD42020163255. Results: Eleven studies meeting the criteria were analyzed, which resulted in a sample of 1,057 patients with breast cancer who received chemotherapy including 820 patients (77%) who received taxane-based chemotherapy. Attention and concentration, depression, and executive function domains had significant chemotherapy-induced impairment across all comparison types. Statistically significant improvement was found in language and verbal memory when comparing chemotherapy patients' test scores with baseline or matched controls. Taxane-based chemotherapy had a non-significant effect on processing speed, visual memory, visuospatial, and motor function domains. Conclusions: The occurrence of chemotherapy-induced cognitive impairment 6 months or more after the course of treatment in people with breast cancer is frequent in the domains of attention, executive function, and depression. Other domains appear stable or improve with time after treatment cessation.

Effectiveness of Eribulin in Metastatic Breast Cancer: 10 Years of Real-World Clinical Experience in the United States.

INTRODUCTION: Eribulin was approved in the United States (US) in 2010 for patients with metastatic breast cancer (MBC) who previously received at least two chemotherapeutic regimens, including anthracycline and taxane in the adjuvant or metastatic setting. With significant changes to the treatment landscape over the past decade, assessment of the real-world effectiveness of eribulin in clinical practice when used according to the approved US indication is valuable. METHODS: Patients with MBC were identified by community oncologists through a retrospective, multi-site patient chart review; de-identified data were abstracted into electronic case report forms. Eligible patients initiated eribulin consistent with approved US indication between 1 January 2011 and 31 December 2017. Clinical outcomes assessed included objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in all patients and those with triple negative breast cancer (TNBC). RESULTS: The analysis included 513 patients (median 59.0 years; 38.8% with Eastern Cooperative Oncology Group status ≥ 2). Eribulin was third-line therapy for 78.0% of patients, and fourth-line or later for the remainder. ORR was 54.4%, median PFS was 6.1 months (95% CI: 5.8, 6.6), and median OS was 10.6 months (95% CI 9.9, 11.7) in all patients. Among the 49.9% of patients with TNBC, ORR was 55.1%, median PFS was 5.8 months (95% CI 5.1, 6.4), and median OS was 9.8 months (95% CI 8.6, 11.0). CONCLUSION: The current retrospective chart review study reinforces the clinical effectiveness of eribulin in patients with MBC, including those with TNBC, when used according to the approved US indication in real-world clinical practice.

Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)-Positive Breast Cancer.

Importance: The neoadjuvant treatment options for ERBB2-positive (also known as HER2-positive) breast cancer are associated with different rates of pathologic complete response (pCR). The KATHERINE trial showed that adjuvant trastuzumab emtansine (T-DM1) can reduce recurrence in patients with residual disease compared with patients treated with trastuzumab; however, T-DM1 and other ERBB2-targeted agents are costly, and understanding the costs and health consequences of various combinations of neoadjuvant followed by adjuvant treatments in the United States is needed. Objective: To examine the costs and disease outcomes associated with selection of various neoadjuvant followed by adjuvant treatment strategies for patients with ERBB2-positive breast cancer. Design, Setting, and Participants: In this economic evaluation, a decision-analytic model was developed to evaluate various neoadjuvant followed by adjuvant treatment strategies for women with ERBB2-positive breast cancer from a health care payer perspective in the United States. The model was informed by the KATHERINE trial, other clinical trials with different regimens from the KATHERINE trial, the Flatiron Health Database, McKesson Corporation data, and other evidence in the published literature. Starting trial median age for KATHERINE patients was 49 years (range, 24-79 years in T-DM1 arm and 23-80 years in trastuzumab arm). The model simulated patients receiving 5 different neoadjuvant followed by adjuvant treatment strategies. Data analyses were performed from March 2019 to August 2020. Exposure: There were 4 neoadjuvant regimens: (1) HP: trastuzumab (H) plus pertuzumab (P), (2) THP: paclitaxel (T) plus H plus P, (3) DDAC-THP: dose-dense anthracycline/cyclophosphamide (DDAC) plus THP, (4) TCHP: docetaxel (T) plus carboplatin (C) plus HP. All patients with pCR, regardless of neoadjuvant regimen, received adjuvant H. Patients with residual disease received different adjuvant therapies depending on the neoadjuvant regimen according to the 5 following strategies: (1) neoadjuvant DDAC-THP followed by adjuvant H, (2) neoadjuvant DDAC-THP followed by adjuvant T-DM1, (3) neoadjuvant THP followed by adjuvant DDAC plus T-DM1, (4) neoadjuvant HP followed by adjuvant DDAC/THP plus T-DM1, or (5) neoadjuvant TCHP followed by adjuvant T-DM1. Main Outcomes and Measures: Lifetime costs in 2020 US dollars and quality-adjusted life-years (QALYs) were estimated for each treatment strategy, and incremental cost-effectiveness ratios were estimated. A strategy was classified as dominated if it was associated with fewer QALYs at higher costs than the alternative. Results: In the base-case analysis, costs ranged from $415 833 (strategy 3) to $518 859 (strategy 4), and QALYs ranged from 9.67 (strategy 1) to 10.73 (strategy 3). Strategy 3 was associated with the highest health benefits (10.73 QALYs) and lowest costs ($415 833) and dominated all other strategies. Probabilistic analysis confirmed that this strategy had the highest probability of cost-effectiveness (>70% at willingness-to-pay thresholds of $0-200,000/QALY) and was associated with the highest net benefit. Conclusions and Relevance: These results suggest that neoadjuvant THP followed by adjuvant H for patients with pCR or followed by adjuvant DDAC plus T-DM1 for patients with residual disease was associated with the highest health benefits and lowest costs for women with ERBB2-positive breast cancer compared with other treatment strategies considered.

Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer.

Many breast cancer patients do not complete long-term hormonal therapies. Text messaging emerged as a tool to enhance medication compliance, but a trial of twice-weekly text message reminders (published in the Journal of Clinical Oncology) failed to improve adherence. The results, however, pave the way for 2nd generation texting approaches.

Patient and Family Caregiver Considerations When Selecting Early Breast Cancer Treatment: Implications for Clinical Pathway Development.

BACKGROUND: While clinical pathways have been widely adopted to decrease variation in cancer treatment patterns, they do not always incorporate patient and family caregiver perspectives. We identified shared patient and family caregiver considerations influencing treatment preferences/decision making to inform development of a shared decision pathway. METHODS: We conducted qualitative interviews with women who completed initial definitive treatment for stage I-III breast cancer and their family caregivers. As part of a broader interview, we asked participants what they considered when choosing a treatment option for themselves/their loved one. We coded transcribed interviews, analyzed patient and family caregiver datasets separately, and compared findings. Findings Patients' (n = 22) mean age was 55.7 years, whereas family caregivers' (n = 20) mean age was 59.5 years, with most (65%) being patients' spouses/partners. Considerations reported by both groups included cancer status, treatment issues, physical/psychosocial/family consequences, and provider/health care system issues. Data revealed three key tensions that arise during treatment decision making: (1) having enough information to set expectations but not so much as to be overwhelming; (2) balancing the highest likelihood of cure with potential physical/emotional/social/financial consequences of the chosen treatment; and (3) wanting to make data-driven decisions while having a personalized treatment plan. DISCUSSION: Patients and family caregivers identified several considerations of shared relevance reflecting different perspectives. Efforts to balance considerations can produce tensions that may contribute to decision regret if unaddressed. CONCLUSION: Clinical pathways can increase exposure to decision regret if treatment options are selected without consideration of patients' priorities. A shared decision pathway that incorporates patient-centeredness could facilitate satisfactory decision making.

A clinical pathway is a tool used by doctors and nurses to help them plan how they will take care of patients. Clinical pathways do not always include what is important to patients and their families. We spoke with patients with breast cancer and their family members. We wanted to learn what is important to them when they are making decisions about how the patient will be treated for cancer. They reported thinking about the kind of cancer the patient had and about pros and cons of different treatment choices. They also thought about how much is known about different treatment choices. Other patients' stories were important. Patients and family members wanted to know how a treatment would affect their bodies, feelings, normal roles in life, and families. They also thought about their relationship with their doctors and nurses and about how they would pay for their care. It was seen as hard to balance these things when making decisions. Patients and family members wanted to make decisions they would be happy with later. We will use this information to create a new clinical pathway. This tool will help patients with breast cancer, family members, doctors, and nurses work together to make the best decisions about the patient's cancer.

"Radiotherapy for older women (ROW)": A risk calculator for women with early-stage breast cancer.

OBJECTIVE: Among older adult women with early-stage breast cancer who undergo lumpectomy, the benefits of radiotherapy vary according to tumor characteristics and life expectancy. We aimed to develop a risk calculator to predict individualized probability of long-term survival and local recurrence, accounting for these factors. METHODS: We developed a simulation model to estimate an individual patient's risk of local recurrence and all-cause mortality according to age, comorbidities, functional status, tumor characteristics, and radiotherapy status. We integrated two existing prediction models, the Early Breast Cancer Trialist's Collaborative Group prediction model for breast cancer specific outcomes and ePrognosis for life expectancy. An online risk calculator "Radiotherapy for Older Women (ROW)" was developed through an iterative multi-stage process, that included individual consultation and group meetings with an advisory committee (AC) comprised of patients, advocates, clinicians, and researchers. RESULTS: We developed the tool over 40 months and had 15 group meetings. The risk calculator developed as a simulation model with 16 factors (5 tumor-related, 3 demographic, 4 comorbidities, and 4 functional statuses). Across 56,700 simulated scenarios, the benefit of RT in terms of absolute 10-year local recurrence reduction, ranged from 0% to 34%, depending on individual characteristics. Based on feedback from the AC, overall survival and local recurrence were chosen as the output for ROW, with these outcomes displayed numerically (percentages and natural frequencies) and graphically (pictographs). CONCLUSIONS: This tool "ROW" could facilitate shared decision making regarding receipt of radiotherapy for older women with early breast cancer. Additional studies to examine usability testing are underway.

Association between perceived benefits and receipt of radiotherapy among older breast cancer patients.

While radiotherapy can be safely omitted in many older women with early-stage breast cancer after lumpectomy, approximately two-thirds of eligible women still undergo this treatment. We surveyed 63 older women with stage I (T1N0M0), estrogen-receptor-positive breast cancer who underwent lumpectomy, and were considering/receiving radiotherapy. Participants perceived that radiotherapy would reduce their 10-year risk of local recurrence by an average of 18.7%, which is significantly higher than the 8% risk reduction reported in literature. Multivariate analyses demonstrated that participants who reported a large perceived benefit were significantly more likely to undergo radiotherapy treatment (odds ratio 10.34; 95% confidence interval: 1.66-66.35).

Observational study of clinical outcomes of eribulin mesylate in metastatic breast cancer after cyclin-dependent kinase 4/6 inhibitor therapy.

Aim: To examine the effectiveness of eribulin mesylate for metastatic breast cancer post cyclin-dependent kinase inhibitor (CDKi) 4/6 therapy. Materials & methods: US community oncologists reviewed charts of patients who had received eribulin from 3 February 2015 to 31 December 2017 after prior CDKi 4/6 therapy and detailed their clinical/treatment history, clinical outcomes (lesion measurements, progression, death) and toxicity. Results: Four patient cohorts were created according to eribulin line of therapy: second line, third line, per US label and fourth line with objective response rates/clinical benefit rates of 42.2%/58.7%, 26.1%/42.3%, 26.7%/54.1% and 17.9%/46.4%, respectively. Median progression-free survival/6-month progression-free survival (79.5% of all patients censored) by cohort was: 9.7 months/77.3%, 10.3 months/71.3%, not reached/70.4% and 4.0 months/0.0%, respectively. Overall occurrence of neutropenia = 23.5%, febrile neutropenia = 1.3%, peripheral neuropathy = 10.1% and diarrhea = 11.1%. Conclusion: Clinical outcome and adverse event rates were similar to those in clinical trials and other observational studies. Longer follow-up is required to confirm these findings.

Utilization, duration, and outcomes of neoadjuvant endocrine therapy in the United States.

PURPOSE: To evaluate if real-world utilization of neoadjuvant endocrine therapy (NET) is associated with similar rates of response and breast conservation surgery (BCS) compared to neoadjuvant chemotherapy (NAC). METHODS: Our population-based assessment used the National Cancer Data Base to identify women diagnosed with stage II-III, hormone receptor (HR)-positive BC who underwent surgery and received endocrine therapy from 2004 to 2014. Women were categorized by receipt of NET, NAC or no neoadjuvant therapy. We used logistic regression to assess differences in outcomes between therapies using inverse propensity score weighting to adjust for potential selection bias. RESULTS: In our sample of 211,986 women, 6584 received NET, 52,310 received NAC, and 153,092 did not receive any neoadjuvant therapy. After adjusting for multiple relevant covariates and cofounders, there was no significant difference between NET and NAC with regard to BCS [odds ratio (OR) 0.91; 95% confidence interval (CI) (0.82-1.01)]; however, women who received NET were significantly less likely to achieve pCR [OR 0.34; 95% CI (0.23-0.51)] or a decrease in T stage [OR 0.39; CI (0.34-0.44)] compared to women treated with NAC. Patients who received NET for ≥ 3 months had higher odds of BCS (OR 1.59; 95% CI 1.46-1.73) and downstaging (OR 1.79; 95% CI 1.63-1.97) compared to patients who did not receive neoadjuvant therapy. CONCLUSIONS: Women who received NET had similar rates of BCS compared to women who received NAC. Those who received NET for longer treatment durations had increased odds of BCS and downstaging compared to women who did not receive neoadjuvant therapy.

The impact of communication style on patient satisfaction.

BACKGROUND: Communication between patients and health providers influences patient satisfaction, but it is unknown whether similarity in communication styles results in higher patient satisfaction. METHODS: This study was conducted in the Smilow Cancer Hospital Breast Center. During routine follow-up visits, patients completed a Communication Styles Assessment (CSA), health survey (SF-12), Princess Margaret Hospital Satisfaction with Doctor Questionnaire, and brief demographic form. Physicians and Advanced Practice Providers were also asked to complete the CSA. Patients and providers were blinded to each other's responses. A communication styles concordance score was calculated as the Pearson correlation between 80 binary CSA items for each provider/patient pair. Factors affecting patient satisfaction scores were assessed in mixed-effects models. RESULTS: In total, 330 patients were invited to participate; of these 289 enrolled and 245 returned surveys. One hundred seventy-four completed all survey components, and 18 providers completed the CSA. Among the factors considered, physical health score (effect size = 0.0058, 95% CI 0.00051 to 0.0011, p = 0.032) and employment status (0.12, 95% CI - 0.0094 to 0.25, p = 0.069) had the greatest impact on patient satisfaction. However, patients who were not employed and less physically healthy had significantly elevated satisfaction scores when their communication style was more similar to their provider's (1.52, 95% CI 0.66 to 2.38, p = 0.0016). CONCLUSIONS: Patients who were physically healthy and employed were generally more satisfied with their care. The similarity in communication styles of patients and providers had a greater impact on patient satisfaction for patients who were less physically healthy and not employed.

Incorporating Tumor Characteristics to Maximize 21-Gene Assay Utility: A Cost-Effectiveness Analysis.

Background: Literature suggests that Oncotype DX (ODX) is cost-effective. These studies, however, tend to ignore clinical characteristics and have not incorporated population-based data regarding the distribution of ODX results across different clinical risk groups. Accordingly, this study assessed the cost-effectiveness of ODX across strata of clinical risk groups using population-based ODX data. Methods: We created state-transition models to calculate costs and quality-adjusted life years (QALYs) gained over the lifetime for women with estrogen receptor (ER)-positive, HER2-negative, lymph node-negative breast cancer from a US payer perspective. Using the Connecticut Tumor Registry, we classified the 2,245 patients diagnosed in 2011 through 2013 into 3 clinical risk groups according to the PREDICT model, a risk calculator developed by the National Health Service in the United Kingdom. Within each risk group, we then determined the recurrence score (RS) distributions (<18, 18-30, and ≥31). Other input parameters were derived from the literature. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Results: Approximately 82.5%, 11.9%, and 5.6% of our sample were in the PREDICT low-, intermediate-, and high-risk groups, respectively. When combining these 3 groups, ODX had an incremental cost-effectiveness ratio (ICER) of $62,200 per QALY for patients aged 60 years. The ICERs, however, differed across clinical risk groups, ranging from $124,600 per QALY in the low-risk group, to $28,700 per QALY in the intermediate-risk group, to $15,700 per QALY in the high-risk group. Results were sensitive to patient age: the ICER for patients aged 45 to 75 years ranged from $77,100 to $344,600 per QALY in the PREDICT low-risk group, and was lower than $100,000 per QALY in the intermediate- and high-risk groups. Conclusions: ODX is not cost-effective for women with clinical low-risk breast cancer, which constitutes most patients with ER-positive disease.