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303 Background: ICIs are a common therapeutic option for many solid tumors. While prior studies have shown that ATB exposure may negatively impact ICI outcomes through gut microbiome changes, many were small studies with heterogeneity in ATB classes and exposure windows. Here, we performed a population level retrospective cohort study to evaluate the impact of ATB exposure prior to ICI on OS. Methods: We used administrative data to identify a cohort of cancer patients > 65 years of age receiving ICIs from June 2012 to October 2018 in Ontario, Canada and deterministically linked with databases to obtain socio-demographic and clinical co-variates and ATB prescription claims. Multivariable cox-proportional hazard models evaluated the impact of ATB exposure both within 1 year and 60 days prior to starting ICI on OS, adjusted for age, gender, body mass index, comorbidities, autoimmune history, hospitalization in the past year and treatment facility level at start of ICI therapy. Results: Among 2737 patients, median age 73; 43% received Nivolumab, 41% Pembrolizumab and 13% Ipilimumab; 53% were lung cancer, 34% melanoma. Median ATB treatment duration for patients receiving ATB within 1 year (59%) and 60 days (19%) prior to ICI were 14 days (SD = 32) and 9 days (SD = 13) respectively. Median OS estimate was 306 days. Any ATB exposure within 1 year prior to ICI was associated with worse OS (aHR = 1.12 95% CI [1.12-1.23] p = 0.03). A non significant dose effect was seen based on weeks of ATB exposure 1 year prior to ICI (aHR = 1.01 per week [1.00-1.02] p = 0.10). ATB class analysis identified fluoroquinolone exposure within 1 year (aHR = 1.26 [1.13-1.40] p < 0.001) and 60 days before ICI (aHR = 1.20 [0.99-1.45] p = 0.06) were associated with worse OS; with a dose effect based on total weeks of exposure over 1 year (aHR = 1.07 per week [1.03-1.11] p < 0.001) and 60 days (aHR = 1.12 per week [1.03-1.23] p = 0.01). Subgroup analysis showed similar results for patients receiving anti-PD1 ICIs, where patients exposed to fluoroquinolone both 1 year (aHR = 1.28 [1.15-1.44] p < 0.001) and 60 days (aHR = 1.19 [0.98-1.44] p = 0.08) before ICIs had poorer OS with dose effects observed based on weeks of fluoroquinolone exposure. Similarly, subgroup analyses based on disease site identified that lung cancer patients exposed to fluoroquinolones 1 year before starting ICIs (aHR = 1.22 [1.06-1.39] p = 0.005) and melanoma patients exposed to fluoroquinolones 60 days before starting ICIs (aHR = 1.66 [1.12-2.47] p = 0.01) had poorer OS. Conclusions: Exposure to ATBs and specifically fluoroquinolones prior to ICI therapy is associated with worse OS. Interventions aimed at altering the gut microbiome may be required to help improve outcomes for patients on ICIs with prior ATB exposure.

304 Background: ICIs are becoming a common therapeutic option for many solid tumors. Prior studies have shown that ATB exposure can negatively impact ICI outcomes through gut microbiome changes leading to poorer overall survival; however, less is known about the potential impact of ATB exposure on toxicities from ICI. We undertook a population-based retrospective cohort study in patients receiving ICIs to evaluate the impact of ATB exposure on early acute care use, defined as emergency department visit or hospitalization, within 30 days of initiation of ICI therapy. Methods: Administrative data was utilized to identify a cohort of cancer patients > 65 years of age receiving ICIs from June 2012 to October 2018 in Ontario, Canada. We linked databases deterministically to obtain socio-demographic and clinical co-variates, ATB prescription claims and acute care utilization. Patients were censored if they died within 30 days of initiating ICI therapy. The impact of ATB exposure within 60 days prior to starting ICI on early acute care use was evaluated using multi-variable logistic regression models, adjusted for age, gender, rurality, recent hospitalization within 60 days prior to starting ICI and comorbidity score. Results: Among 2737 patients (median age 73 years), 43% received Nivolumab, 41% Pembrolizumab and 13% Ipilimumab, most commonly for lung cancer (53%) or melanoma (34%). Of these patients, 19% had ATB within 60 days prior to ICI with a median ATB treatment duration of 9 days (SD = 13). 647 (25%) patients had an acute care episode within 30 days of starting ICIs; 182 (7%) patients passed away within 30 days without acute care use and were censored from further analyses. Any ATB exposure within 60 days prior to ICI was associated with greater likelihood of acute care use (aOR = 1.34 95% CI [1.07-1.67] p = 0.01). A dose effect was seen based on weeks of ATB exposure within 60 days prior to ICI (aOR = 1.12 per week [1.04-1.21] p = 0.004) and early acute care use. ATB class analysis identified that exposure to penicillins (aOR = 1.54 [1.11-2.15] p = 0.01) and fluoroquinolones (aOR = 1.55 [1.11-2.17] p = 0.01) within 60 days of starting ICIs were associated with a greater likelihood of acute care use, while there was no significant association between cephalosporin exposure and early acute care use (p > 0.05). Conclusions: Exposure to ATBs, specifically fluoroquinolones and penicillins, prior to ICI therapy is associated with greater likelihood of hospitalization or emergency room visits within 30 days after initiation of ICIs, even after adjustment for relevant co-variates including age, comorbidity score and recent hospitalization prior to ICI initiation. Further studies are required to better understand the mechanisms of recent ATB exposure on early acute care use among patients receiving ICIs.

1005 Background: Metastatic breast cancer (MBC) is generally incurable and the majority of patients with MBC will remain on treatment indefinitely. Patients usually begin each new treatment at the Recommended Starting Dose (RSD) on the FDA-approved label based on results from clinical trials. However, patients’ ability to tolerate the RSD in the real-world may differ from the clinical trial setting. While the importance of patient reported outcomes is recognized, understanding tolerability from the patient’s perspective is lacking and patients’ willingness to discuss individualized doses for MBC therapy has not been evaluated. Methods: Patient advocates from the Patient-Centered Dosing Initiative distributed a confidential online survey to patients with MBC via social media groups, organizational newsletters, and online support forums. The survey was developed by patients and medical oncologists to ascertain the prevalence and impact of patients’ treatment-related side effects, quality of patient-physician communication, management of side effects, and interest in alternative approaches to the RSD when a new treatment is initiated or adverse side effects are experienced. Results: 1,221 patients with MBC completed the survey within 15 days. The median number of lines of MBC therapy was 2.5 (range 1 - ≥5) and 46% (n = 564) of patients received their MBC diagnosis within two years of taking the survey. 86% (n = 1,051) reported experiencing at least one significant treatment-related side effect, and of these, 20% (n = 213) visited the Emergency Room/hospital and 43% (n = 454) missed at least one treatment. 98% (n = 1,026) of patients with side effects discussed them with their doctors and 82% (n = 838) were helped by their physicians. The most common (non-exclusive) mitigation strategies were dosage reductions (66%, n = 556) and prescription medications (59%, n = 494). Of the 556 patients given a dosage reduction, 83% (n = 459) reported feeling better. Notably, 92% (n = 1,127) of patients expressed willingness to discuss alternative dosing options with their physicians based upon their personal characteristics and individual preferences. Conclusions: Given that 86% of patients with MBC experienced at least one significant treatment-related side effect and 83% improved after dosage reduction, innovative dosage-related strategies are warranted to sustain Quality of Life. Patient-physician discussions in which the patient’s physical attributes and circumstances are periodically assessed may determine the right dose for the patient upon treatment initiation and afterwards, and the vast majority of patients would be receptive to such discussions.

1570 Background: Patients diagnosed with breast cancer (BC) face complex decisions about their care and many studies have shown that improved patient engagement results in increased satisfaction and better outcomes. Patient engagement includes education, treatment option selection, symptom tracking and reporting, and clinical trial opportunities. We conducted a pilot study to determine the feasibility of introducing the Outcomes4Me patient engagement app into the standard of care experience of BC patients. Methods: This was a pilot study (NCT04262518) conducted at an academic medical center. Eligible patients had any subtype of stage 1-4 BC and were on any type of chemo-, hormonal-, targeted-, or radiation-therapy for BC during the study period. Participants downloaded the app on their smartphone and their app usage was evaluated. Surveys were administered at baseline and end of study. Clinicians caring for patients using the app were surveyed at the end of the study. The primary endpoint was feasibility, defined as at least 40% of patients engaging with the app at least 3 times over the 12-week study period. Additional endpoints included usability, satisfaction, correlation of patient reported data with the EHR, clinical trial matching, and patient experience. Results: Between June 2020 and December 2020, 107 patients enrolled; results are reported for 90 patients with complete data as of 1/24/21. Baseline demographics: median age 53 (range: 27-77); 90% White, 4% Black, 3% Asian; 66% had hormone positive/HER2-, 20% HER2+, and 13% triple negative BC; 31% had stage 4 disease. At study entry, 93% had never used an app to help with their disease or treatment options. Over the 12 week study period, 58% of patients engaged with the app at least 3 times, meeting the primary feasibility endpoint. Patients engaged with the app on average 5.5 days (range: 0-40) with 20% engaging on more than 10 days during the study. The mean System Usability Score was 71 (median = 76) and was similar across age groups. The 5 app features deemed most (‘somewhat’ or ‘very’) helpful were: background about their BC (76%), information about treatment options (74%), newsfeed about their BC (70%), symptom tracking (65%), and clinical trial information (65%). 53% said that the app helped them keep track of symptoms and 33% said they are more likely to explore or enroll in a clinical trial after using the app. Conclusions: Integration of the Outcomes4Me app into the care management of BC patients is feasible with acceptable usability. Our results suggest that use of a patient smartphone app may be helpful for many aspects of patient education and engagement for patients with BC. The results also suggest that this type of intervention can help patients better track their symptoms and make them aware of clinical trials, potentially facilitating the management of side effects and accelerating clinical trials recruitment. Clinical trial information: NCT04262518.

e24108 Background: Clonal hematopoiesis of Indeterminate Potential (CHIP) is associated with adverse clinical outcomes including increased risk of hematologic malignancies and heart disease. Limited data suggest an increased prevalence of CHIP in patients treated for solid tumors, particularly after exposure to radiation and chemotherapy. CHIP testing may inform risk-reduction strategies for cancer survivors. Little is known about patient knowledge, attitudes, and preferences regarding CHIP testing. Methods: We surveyed survivors without history of recurrence participating in an ongoing prospective cohort study of young women with breast cancer (BC). The survey was sent by email and included an introduction to CHIP including risk factors and clinical associations. Respondents then reviewed a vignette and were asked about CHIP testing preferences (definitely/probably test vs. definitely/probably not test) considering sequentially: 1) population-based 10-year risk of BC recurrence, hematological malignancy and heart disease; 2) estimated increase in these risks with CHIP; 3) current CHIP management; 4) a dedicated CHIP clinic; and 5) a theoretical CHIP treatment. Changes in preferences from the prior scenario were evaluated with the McNemar's test using a type I error rate of 5%. Results: 528/642 (82.2%) eligible women responded to the survey, at a median age of 46 (range: 31-54) years (median time from diagnosis: 108 months (range: 60-168)), and 88% were white. Most had stage 1/2 BC (78.8%) and had received chemotherapy (73.1%) and/or radiation (61.9%). 93.6% had never heard of CHIP prior to survey. After initial patient vignette presentation, most women (87.1%,) recommended CHIP testing if offered. Preferences for testing decreased (p

12081 Background: Young women with breast cancer may be at increased risk for premature development of cardiovascular disease (CVD) in part due to their cancer treatment. Limited data are available on CVD risk among young breast cancer survivors. Methods: Women aged 30-40 years at diagnosis with stage 0-III breast cancer enrolled in a prospective cohort study of women diagnosed with breast cancer at ≤40 were eligible for inclusion in this analysis. Data were obtained from serial surveys and electronic medical records at breast cancer diagnosis and 5-year follow-up. We calculated “excess heart age,” which incorporates a CVD risk-based score (calculated using age, systolic blood pressure, blood pressure medication, diabetes, smoking, body mass index) to estimate the difference in years between an individual’s chronological age and their CVD-risk adjusted age. Multivariable logistic regression models (adjusting for age at diagnosis, stage, and race) were fitted to evaluate associations between treatment (radiation, endocrine therapy, anthracyclines, and trastuzumab) and having a change in excess heart age ≥2 years from baseline to 5 years. Results: Among 372 young breast cancer survivors, mean age at diagnosis was 36.6 (SD 2.89), 93% were white, and 79% were diagnosed with stage I or II breast cancer. Mean excess heart age was.32 (SD: 6.16) years at baseline, which declined to -.07 (SD 6.64) at 5-year follow-up (p=.17). At 5 years, 31% (n=114) of women experienced an increase of at least 2 years in their excess heart age since diagnosis, and their mean excess heart age was 4.34 years (range -9 to 30). In multivariable analyses, receipt of trastuzumab was associated with higher odds (OR: 1.68, 95% CI: 1.02-2.77) of experiencing an increase of ≥2 years in excess heart age between diagnosis and 5 years of follow-up. Endocrine therapy, anthracyclines, and radiation were not significantly associated with a change in excess heart age of ≥2 years at 5 years post-diagnosis. Conclusions: At 5 years post-diagnosis, approximately 1/3 of young breast cancer survivors experienced a change from baseline in their excess heart age of ≥2 years. Further research is warranted to confirm findings regarding trastuzumab and excess heart age, and potential effects on longer-term cardiac outcomes in this population. Extended follow-up of this cohort may further quantify CVD risk over time.[Table: see text]

The mission of American Society of Clinical Oncology (ASCO) is to conquer cancer through research, education, and promotion of the highest quality patient care. Toward fulfillment of this goal and at the direction of its board of directors, the ASCOValue in Cancer Care Task Force set out to develop a framework that would enable a physician and patient to assess the value of a particular cancer treatment regimen given the patient’s individual preferences and circumstances. The rationale that served as the impetus for this initiative is many faceted. Substantial progress has been made in translating our knowledge of the biologic characteristics of cancer into novel therapies. Some of these therapies have led to major improvements in outcomes for specific diseases, and others have produced only modest advances. There is now a wide array of choices for treating many cancer types, and these treatment choices often differ by only small degrees in clinical effectiveness and toxicity. Yet, there is often a wide disparity in cost to patients and payers. Because patients are often confronted with enormous expenses when receiving cancer care, the goal of describing a relationship between the cost of an agent or regimen and the clinical benefits it delivers takes on great importance. As the primary advisor to the patient, the oncologist has an important role in providing a comparative assessment of the various treatment options available; in the spirit of shared decision making, the patient should have transparent information about the clinical impact that can be expected from the different options presented and their relative financial implications. The value framework has been constructed as a conceptual model that incorporates the elements of clinical benefit, toxicity, and symptom palliation as derived from a comparative clinical trial and combines these elements into a score termed the net health benefit (NHB). Ultimately, deployment of the framework as a software application is planned, enabling a patient to modify the weight attributed to any of the elements included in the NHB depending on his or her personal preferences and circumstances. The final NHB will therefore reflect the priorities that are most important to the patient and will be arrived at through guidance from the physician. Information on the cost of the regimens will also be presented so the patient can consider the relative financial impact of his or her treatment options. Two versions of the framework have been created: one for advanced disease and the other for potentially curable (adjuvant therapy) clinical presentations. The original framework versions are shown in Appendix Tables A1 and A2 (online only). The key elements included in the framework— namely, clinical benefit and toxicity—are also those that are regularly reported in the scientific literature when discussing the outcome of a clinical trial that compares two or more therapies. The importance of relying on high-quality, quantifiable evidence cannot be overstated, and this is most often provided by a well-designed, well-conducted prospective randomized trial. The task force recognizes that a limitation of this approach is that it does not readily permit cross-trial comparisons. Such analyses are important to patients and remain a goal for future versions of the value framework. The task force is well aware that there are many elements that might be important to individual patients in assessing the relative value of their treatment options that are not taken into account in our model. These include the convenience of receiving therapy, the avoidance of interrupting the flow of activities of daily living, and the impact of a treatment on quality of life

290 Background: The high prevalence of smartphone use means that most patients can easily audio record medical consultations. Oncologists’ attitudes towards recording visits are unknown yet may impact patient care. Methods: A mail survey of oncologists practicing at 5 U.S. Alliance for Clinical Trials in Oncology sites collected information on clinicians’ beliefs, preferences, and practices regarding patient-initiated recordings, along with sociodemographic and practice characteristics. Descriptive statistics and bivariate analyses were calculated. Results: Of 523 eligible oncologists, 352 (67%) completed the survey. Median age was 47 years, 33% were female, and 86% worked in an academic setting. 53% were medical oncologists, 30% surgical oncologists, and 17% radiation oncologists. Virtually all (93%) reported experience with patients recording visits, 79% at least weekly. The majority (74%) perceived that patients record visits in order to help understand treatment choices. While 79% reported that they “always” agree to recordings, 26% reported discomfort. Nearly one-third (29%) reported concerns about liability, 26% felt recording made discussion less natural, and 18% felt recording changed the way they conveyed information. Although 86% agreed that patients have the right to record visits, nearly all felt physician permission was required and 53% reported having been previously recorded without permission. Only 51% believed recording had a positive impact on the patient-doctor relationship. One-quarter (28%) felt that recording led to a less detailed conversation and 33% felt it contributed to avoidance of difficult topics, such as prognosis. Most preferred the patient/family taking notes or having access to a written summary. Views did not vary significantly based on practice setting, specialty, or region of the country. Older age and greater years in practice were associated with both greater comfort with recording and the perception that recording has a positive impact on the patient-doctor relationship (p < 0.001). Conclusions: While most oncologists report comfort with audio recording and recognize benefits for patients, a substantial minority have reservations about its impact on clinical discussions and their liability exposure. Adopting clear institutional policies about recording could help address some concerns, such as surreptitious recording, while ensuring that patients’ interests are served.

e24098 Background: Insomnia is common among breast cancer (BC) survivors and often goes unrecognized and untreated. We sought to evaluate the association between frequent insomnia and potentially modifiable contributing factors to inform development of a comprehensive clinical program to address insomnia among patients with breast cancer. Methods: We adapted a 1-page survey from the National Comprehensive Cancer Network Guidelines for Survivorship, which was administered to BC survivors at oncology or primary care follow-up visits at our academic center and community based sites. The survey included 23 plain-language statements regarding symptoms, lifestyle concerns, and financial worries. Patients reported the frequency of concerns using a 5-point Likert scale (0 = never to 5 = always). We evaluated the frequency of insomnia and association between insomnia and 6 common concerns hypothesized to contribute among this population: emotional distress, fatigue, pain, hot flashes, fear of cancer recurrence, and healthcare-related financial stress. Prevalence of symptoms was dichotomized, grouping “very often” and “always” as “frequent”, and “sometimes,” “rarely”, and “never” as “infrequent”. Descriptive analysis was performed and associations between insomnia and other concerns were evaluated with Fisher’s exact test. Results: Among 192 patients (median age 59, range 34-92), 46 (24%) reported frequent insomnia (“I have problems falling or staying asleep”). Most patients (58%) reported experiencing insomnia at least “sometimes”, while 20% answered “rarely” and 23% “never”. Overall, 14% of survivors reported frequent anxiety/depression, 15% fatigue, 27% pain, 19% hot flashes, and 23% fear of recurrence. Only 6% of patients reported frequent financial worries due to healthcare costs. Emotional distress (p=0.016), fatigue (p≤0.001), pain (p≤0.001), hot flashes (p=0.017), and fear of recurrence (p≤0.01) were each associated with frequent insomnia. Conclusions: BC survivors who experience frequent insomnia are more likely to report emotional distress, fatigue, pain, hot flashes, and fear of recurrence, compared to those with infrequent insomnia. A clinical program designed for the management of insomnia may benefit from targeting these potentially contributing factors.

Health care costs in the United States present a major challenge to the national economic well being. The Centers for Medicare and Medicaid Services (CMS) has projected that US health care spending will reach $4.3 trillion and account for 19.3% of the national gross domestic product by 2019.1 This growth in spending—both in absolute terms and as a proportion of our gross domestic product—has not been accompanied by commensurate improvements in health outcomes, despite expenditures far exceeding those of other countries.2–4 One of the fastest growing components of US health care costs is cancer care, the cost of which is now estimated to increase from $125 billion in 2010 to $158 billion in 2020.1 Although cancer care represents a small fraction of overall health care costs, its contribution to health care cost escalation is increasing faster than those of most other areas because of several factors: the increasing prevalence of cancer due to the overall aging of the population and better control of some causes of competing mortality; the introduction of costly new drugs and techniques in radiation therapy and surgery; and the adoption of more expensive diagnostic tests. In some cases, the adoption of newer, more expensive diagnostic and therapeutic interventions may not be well supported by medical evidence, thereby raising costs without improving outcomes.5 Coupled with, or even driving, some of these rising costs are sometimes unrealistic patient and family expectations that lead clinicians to offer or recommend some of these services, despite the lack of supporting evidence of utility or benefit.6 Historically, most individuals in the United States were shielded from the acute economic impact of expensive care because they had health insurance. However, current trends suggest that patients will find themselves increasingly responsible for a greater proportion of the cost of their health care. Cost shifting or sharing can occur through the increased use of high-deductible policies and larger copayments. These increased costs are already commonplace and may not be affordable for many families. Indeed, health care expenditures are cited as a major cause of personal bankruptcy,7 and the term financial toxicity has entered the vernacular as a means of describing the financial distress that now often accompanies cancer treatment.8 Like other toxicities of cancer treatment, financial toxicity resulting from out-of-pocket treatment expenses can reduce quality of life and impede delivery of high-quality care.9,10 Patients experiencing high out-of-pocket costs have reported reducing their spending on food and clothing, reducing the frequency with which they take prescribed medications, avoiding recommended procedures, and skipping physician appointments to save money.10,11 These unintended consequences risk an increase in health disparities, which runs counter to some of the key goals of health care reform. In many communities, the high costs associated with cancer care have created a difficult situation for patients and the oncologists who care for them. Addressing this situation will require greater understanding of all the risks and benefits of various treatment options as well as the consequences of specific choices. In this regard, studies have shown that patients specifically want financial information about treatment alternatives along with information about medical effectiveness and treatment toxicity. However, they often do not receive it. Closing this knowledge gap will require educated providers who are able to sensitively initiate a dialogue about the cost of care with their patients when appropriate.12,13 Patients with cancer are often surprised by and unprepared for the high out-of-pocket costs of treatments. They also overestimate the benefits of treatments that sometimes extend life by only weeks or months or not at all. Oncologists are generally aware of this conundrum but uncertain about whether and how the cost of care should affect their recommendations.14 Although raising awareness of costs and providing tools to assess value may help to manage costs while maintaining high-quality care, some oncologists see this as being in conflict with their duty to individual patients.15 Recent American Society of Clinical Oncology Efforts Motivated by our responsibility to help oncologists deliver the highest-quality care to patients everywhere, the American Society of Clinical Oncology (ASCO) formed the Task Force on the Cost of Cancer Care in 2007. Its mission includes educating oncologists about the importance of discussing costs associated with recommended treatments, empowering patients to ask questions pertaining to the anticipated costs of their treatment options, identifying the drivers of the rising costs of cancer care, and ultimately developing policy positions that will help Americans move toward more equal access to the highest-quality care at the lowest cost.16 In 2012, through the work of the Task Force, ASCO responded to the Choosing Wisely Campaign of the American Board of Internal Medicine Foundation and identified specific instances of overuse in the delivery of cancer care. ASCO used a deliberative consensus process to identify five common clinical practices that are not supported by high-level evidence. A second list of five was developed using the same process and submitted to the Choosing Wisely Campaign in 2013. ASCO amplified the evidence basis for both top-five lists in two publications17,18 and is now developing measures to evaluate the use of these practices as part of its Quality Oncology Practice Initiative. These exercises have provided opportunities to develop a rigorous but flexible approach to assessing efficacy across diagnostic and treatment domains.

541 Background: Breast cancer therapy causes marked impairments in CV function predisposing to elevated risk of CV morbidity. We investigated the effects of two AT dosing regimens on CV function in post-treatment patients with operable breast cancer. Methods: In a three-arm, parallel-group RCT, 174 post-menopausal patients (2.8 years post primary adjuvant therapy) with impaired age/sex-matched peak oxygen consumption (VO2peak) were randomized to: (1) conventional linear AT (uniform dose-intensity / session), (2) nonlinear AT (variable dose-intensity / session), or (3) stretching (attention control). AT consisted of 64 supervised treadmill walking sessions delivered four times weekly at either ~70% VO2peak for 40 mins/session (linear) or 55% to 100% VO2peak for 20-45 mins/session (nonlinear) for 16 consecutive weeks. Stretching was matched to AT on the basis of location, frequency, duration, and treatment length. The primary end point was change in VO2peak. Secondary end points were other markers of CV risk profile (biochemical CV risk profile, cardiac function, body composition), patient-reported outcomes (PROs), tolerability (e.g., relative dose intensity), and safety. All analyses followed the intention-to-treat principle. Results: Rates of lost-to-follow were < 10% in all arms. Relative dose intensity of AT was 73% ± 27% and 80% ± 21% in linear and nonlinear arms, respectively. No serious adverse events were observed. In adjusted analysis, compared to control, VO2peak (ml O2.kg-1.min-1) increased 0.7 (± 0.3) ml O2.kg-1.min-1 (p = 0.06) and 0.8 (± 0.4) ml O2.kg-1.min-1 (p = 0.02) in linear and nonlinear AT, respectively. Rates of VO2peak improvement greater than the technical error of measurement (i.e., ≥1.32ml O2.kg-1.min-1) were 33% and 39% in linear and nonlinear AT (p = 0.03), respectively. Both AT regimens were associated with improvements in several secondary CV end points but only nonlinear AT improved PROs compared with control (all p’s < 0.05). There were no differences between the two AT regimens. Conclusion: AT significantly improves CV function and PROs in post-treatment breast cancer patients. The efficacy-tolerability ratio favors the non-linear regimen over the conventional linear prescription approach. Clinical trial information: NCT01186367.

6640 Background: Costs of cancer care may impact access to therapy, adherence, and distress among patients. However, the degree to which patients with metastatic breast cancer (MBC) wish to discuss financial issues when making treatment decisions is unknown. Methods: In a single arm feasibility trial, 40 women with newly diagnosed or progressive MBC completed a 1-page survey regarding goals and priorities for discussion with the oncology team. The survey included 17 potential priorities for discussion in the domains: treatment options, symptom management, emotional concerns, planning for the future, and lifestyle. We evaluated participants’ interest in prioritizing discussion of financial issues and sociodemographic and clinical correlates of this preference. We examined the relationship between desire to discuss financial issues and both distress on the Distress Thermometer (DT) and satisfaction with cancer care using Fisher’s exact test. Results: Among 40 participants, 11 (28%) reported interest in discussing financial issues when making treatment decisions, 29 (72%) were not interested. Average age was 57 (range 31-73), and the majority were white (85%) and college graduates (66%). Only 18% of white patients were interested in addressing cost, while 83% of non-white patients were interested (p < 0.01). Those with a college education were less likely to prioritize financial discussion compared to no college (16% vs. 47%, p = 0.04). Patients interested in discussing cost were more likely to have a household income < $50,000 (50% vs. 22% > $50,000, n.s.) and to have Medicaid (50% vs. 25% other insurance, n.s.). Additionally, patients with higher levels of distress (35% vs. 21% DT < 4, n.s.) and those on novel targeted or biologic therapy (42% vs. 21% other therapy, n.s.) were more likely to prioritize discussion of costs. Desire to discuss cost was not related to satisfaction with care. Conclusions: A substantial minority of patients with MBC, particularly those from less advantaged backgrounds, wish to discuss financial issues at time of treatment decisions. Financial toxicity research should recognize that not all patients desire this discussion and evaluate methods to screen for financial concerns and barriers to care.

11622 Background: Individualized treatment planning is a critical part of quality cancer care, but how best to achieve this for patients with metastatic breast cancer (MBC) is unclear. We evaluated the feasibility, acceptability and impact of using a simple and scalable “Individualized Goals of Care Discussion Guide” (IGCDG) to facilitate patient-provider communication at the time of treatment decisions. Methods: We developed the IGCDG based on structured interviews with MBC patients and input from experts in cancer care, decision sciences, psychology and palliative care. We then conducted a single arm feasibility trial among patients with newly diagnosed or progressive MBC. Prior to clinic, patients received the IGCDG, an 8-page MBC informational brochure and 1-page questionnaire regarding treatment preferences, personal goals and priorities for care planning. The completed questionnaire was provided to the oncology team at the patient’s visit. Pre and post assessment included the Distress Thermometer (DT), Patient Satisfaction with Cancer Care Scale and the Control Preferences Scale. Feasibility was defined as: 1) accrual of > 50%, 2) attrition rate < 32%, and 3) < 50% of patients experiencing increased distress following the intervention. Results: Among 60 eligible patients, 42 participated (70% accrual), 40 completed all surveys (2% attrition), and only 7 (18%) reported increased distress. Mean age was 57 (range 31 – 79), 85% were white, 7% black, 5% Hispanic, 66% were college graduates, and 40% reported high baseline distress (DT > 4). Patient priorities for discussion included cancer directed therapy (70%), symptom management (70%), and prognosis/planning ahead (60%). At 2-month follow-up, 53% reported decreased distress compared to baseline. Satisfaction with cancer care was high at baseline and follow-up. Most patients preferred shared decision making (77%), and 79% reported decision roles concordant with preferences. Overall, 72% of participants found the IGCDG helpful, 93% found the questionnaire easy to complete, and 44% felt it improved communication with their doctor (49% unsure). Conclusions: Administration of the Individualized Goals of Care Discussion Guide is feasible and provides patients with MBC an opportunity to define their goals of care and priorities for discussion in clinic. Clinical trial information: NCT03375827.

554 Background: HER2+ breast cancer (BC) is particularly common in young women. Genomic features of HER2+ tumors before and after H-based therapy have not been described in a population of young women and may point to clinically targetable mechanisms of resistance. Methods: From a large prospective cohort of women diagnosed with BC age ≤40 years, we identified those with HER2+ BC and tumor tissue available for sequencing before and after chemo+H. Whole exome sequencing (WES) was performed on each tumor and on germline DNA from blood. Tumor-normal pairs were analyzed for mutations and copy number (CN) changes. Evolutionary analysis was performed for patients with both pre- and post-treatment (tx) samples. Results: 22 women had successful WES samples from at least one timepoint; 13 of these had paired sequencing results both before and after chemo+H. For the majority of women, post-tx sample was following neoadjuvant chemo + H, though post-tx timepoint for other women represented locoregional or distant metastasis (Table). TP53 was the only gene that was significantly recurrently mutated in both pre- and post-tx samples. Comparison of matched pre-tx and post-tx samples demonstrated that large changes in HER2 CN over the course of tx were uncommon, only 2/13 pts had > 2-fold change in HER2 CN. Other clonal and subclonal genomic alterations were found to be acquired in the post-tx sample compared to the pre-tx sample. One patient acquired a putative activating mutation in ERBB2. Another patient acquired a clonal hotpsot mutation in TP53. MYC gene amplification was observed in 4 post-tx tumors. NOTCH2 alterations were found in post-tx biopsies from 2 different patients, and mutations in STIL were also found in post-tx biopsies from 2 patients, though the function of these mutations is not known. Conclusions: HER2+ breast tumors in young women display genomic evolution following tx with chemo+H. HER2 CN changes are uncommon, but we identified several genes that warrant exploration as potential mechanisms of resistance to therapy in this population.[Table: see text]

6575 Background: Delays in diagnosis (dx) and treatment (tx) affect breast cancer (BC) outcomes. We sought to identify factors associated with delays among young women, who do not undergo routine screening and often have pregnancy or breastfeeding-related breast changes that may mask a BC. Methods: The Young Women’s Breast Cancer Study is a multicenter, prospective cohort that enrolled 1302 women with newly dx BC age ≤40 between 2006-2016. Women reported the method and timing of cancer detection on the baseline survey. 231 were ineligible or excluded due to missing information. Among those reporting self-detected cancers, using multivariable regression we evaluated factors associated with delays ≥90 days (d) from symptom to presentation (self delay) and presentation to dx (care delay); in stage 0-III BC we evaluated delays ≥60d from dx to tx (tx delay). Results: 1071 eligible women had median age at dx of 37 yrs (17-40) and 74% reported self-detected cancers. Self delay or care delay ≥90d was reported in 17% and 13%, respectively. Factors inversely associated with self delay included pregnancy at dx (vs nulliparous, OR 0.10, CI 0.01-0.78) and perceived financial comfort (vs not, OR 0.62, CI 0.41-0.93). Women dx ≤1 year post-partum who breastfed (vs nulliparous, OR 2.60, CI 1.14-5.93) and those with a family history of breast/ovarian cancer (vs none, OR 1.79, CI 1.00-3.19) were more likely to have a care delay. Age was inversely associated with care delays (OR 0.94, CI 0.89-0.99). Tx delay was reported by 10% (105/1015), and associated with being single (vs partnered, OR 1.61, CI 1.02-2.56 ), non-white (vs white, OR 1.85, CI 1.09-3.13) and having Stage 0 BC (vs stage 1, OR: 3.08, CI 1.65-5.77); women with stage 3 BC (vs stage 1, OR 0.13, CI 0.03-0.56) were less likely to have a tx delay. Conclusions: In this cohort, most young women with BC underwent timely dx and tx initiation. Women dx ≤1 year post-partum who breastfed were more likely to experience a care delay, likely because lactational changes may mask BC signs and symptoms. The associations of perceived financial status with self delay and non-white race with tx delay underscore the need for additional support to ensure timely care for underserved populations with the goal of eliminating disparities in outcomes.

11574 Background: Weight gain after cancer diagnosis is common in cancer survivors and has been linked to increased treatment toxicity, poor quality of life, and increased risk of second cancers and overall mortality. Young breast cancer (BC) survivors may be especially susceptible to weight changes given the impact of treatments such as chemotherapy and hormonal therapy on menopausal status. Methods: We identified women with Stage 0-III breast cancer diagnosed at ≤40 years (y) between 2006-2016 from a multi-center prospective cohort study. Clinical data including self-reported pre-diagnosis and follow-up weights were obtained using baseline and follow-up patient surveys. Participants missing baseline weight, pregnant at diagnosis/within 1y of diagnosis or with BC recurrence within 1y were excluded; those pregnant or with BC recurrence between 1-3y from diagnosis were excluded from the 3y analysis. Menopausal status at baseline and treatment-related amenorrhea (TRA) in follow-up were defined by self-reported last menstrual period. Factors associated with weight gain (>5%) were evaluated using univariate two-sided Fisher's exact test. Results: At baseline, 1y and 3y post diagnosis, 956, 899 and 687 women were eligible for analysis respectively. Median age at diagnosis was 37y (17 - 40), 65% received endocrine therapy and 74% chemotherapy. Premenopausal status was verified in 94% at baseline. Mean BMI at baseline was 24.4 (SD 5.3) kg/m2; 20% (187/956) were overweight and 12% (116/956) obese. At 1y and 3y, mean BMI increased modestly to 24.7 (SD 5.6) and 24.9 (SD 5.2), respectively with weight gain (>5%) observed in 18% (164/899) and 13% (87/687) respectively. 37% (300/804) and 32% (196/615) of eligible premenopausal subjects experienced TRA at 1y and 3y, respectively. Receipt of chemotherapy, receipt of endocrine therapy and TRA were not associated with weight gain at any timepoint. Conclusions: In this large prospective cohort of young BC survivors, mean BMI increased only modestly over time. Self-reported weight gain was not associated with treatment and not exacerbated by TRA. Further analysis to understand the effects of physical activity and other predictors of weight gain in this population are ongoing.

e23075 Background: Innovation in health care delivery is needed to improve care for cancer survivors. We report a pragmatic study intended to evaluate our experience with adopting screening guidelines from the National Comprehensive Cancer Network (NCCN) to the routine care of breast cancer survivors in primary care and oncology follow up. Methods: We adapted the NCCN recommended screening questions into a plain language self-administered 1 page intake questionnaire. The tool was administered to a convenience sample of female breast cancer survivors in routine follow-up at an oncology or primary care clinic from September through December 2018. Domains included symptoms, lifestyle concerns, and financial issues. Frequency of concerns was assessed as “never”, “rarely”, “sometimes”, “very frequently” and “always”. We dichotomized results and evaluated feasibility of administration, prevalence of reported symptoms and qualitative assessment of burden as well as utility of the tool among participating clinicians. Results: 165 out of 169 patients offered the questionnaire participated (98%). Office staff provided the questionnaire at routine visits without notable impact on clinic flow. Most commonly endorsed concerns (sometimes or more) were: desire to improve fitness or nutrition (80%), worry about cancer recurrence (72%), and problems with sleep (57%). A majority also reported feeling nervous or worried (55%) and aches or pains in limbs or joints (55%). Several issues known to be underreported in clinic visits were endorsed including lack of satisfaction with sexual function (30% sometimes or more, 12% very often or always) and difficulty remembering things (47% sometimes or more, 13% very often or always). Among 7 participating clinicians, the tool was deemed useful and not burdensome. Several noted that it led to discussing issues that may not otherwise have been addressed. Suggestions included systematically identifying resources and strategies to address common issues and incorporating the tool into the electronic health record to increase utility. Conclusions: Screening for individual needs among survivors is feasible and efficient and may identify prevalent issues that otherwise can be missed in routine survivorship care.

Purpose Little is known about the effects of financial relationships between biomedical researchers and industry (financial conflicts of interest [FCOIs]) on research prominence. We examined the prevalence of FCOIs in oncology and associations between FCOIs and research prominence among abstracts presented at American Society of Clinical Oncology (ASCO) annual meetings. Methods We analyzed 20,718 abstracts presented at ASCO meetings in 2006 and 2008 to 2011. Measures included the following: financial relationships, peer review score (PRS), and meeting placement prominence (descending order of prominence: plenary session, clinical science symposium, oral presentation, poster discussion, general posters, and publish only). Results Of 20,718 abstracts, 36% reported at least one author with an FCOI. The proportion of abstracts with any FCOI increased from 33% in 2006 to 38% in 2011 (P < .001). Abstracts with FCOIs had significantly higher meeting prominence compared with publish only and general poster abstracts. The odds ratios compared with general posters were 7.3 for plenary session, 2.2 for clinical science symposium, 1.9 for oral presentation, and 1.7 for poster discussion (P < .001). Abstracts with FCOIs had significantly better PRSs compared with those without FCOIs. For all abstracts, PRS was 2.76 (95% CI, 2.75 to 2.77) with FCOIs compared with 3.01 (95% CI, 3.001 to 3.02) without FCOIs (P < .001). Omitting publish-only abstracts, PRS was 2.62 (95% CI, 2.61 to 2.63) with FCOIs compared with 2.73 without FCOIs (95% CI, 2.71 to 2.73). Conclusion Abstracts with FCOIs had more prominent meeting placement and better PRSs. FCOIs were reported more frequently by year, suggesting an increasing influence of industry on cancer research, greater disclosure, or both.

Patients with advanced incurable cancer face complex physical, psychological, social, and spiritual consequences of disease and its treatment. Care for these patients should include an individualized assessment of the patient’s needs, goals, and preferences throughout the course of illness. Consideration of disease-directed therapy, symptom management, and attention to quality of life are important aspects of quality cancer care. However, emerging evidence suggests that, too often, realistic conversations about prognosis, the potential benefits and limitations of disease-directed therapy, and the potential role of palliative care, either in conjunction with or as an alternative to disease-directed therapy, occur late in the course of illness or not at all. This article addresses the American Society of Clinical Oncology’s (ASCO’s) vision for improved communication with and decision making for patients with advanced cancer. This statement advocates an individualized approach to discussing and providing diseasedirected and supportive care options for patients with advanced cancer throughout the continuum of care. Building on ASCO’s prior statements on end-of-life care (1998) and palliative care (2009), this article reviews the evidence for improved patient care in advanced cancer when patients’ individual goals and preferences for care are discussed. It outlines the goals for individualized care, barriers that currently limit realization of this vision, and possible strategies to overcome these barriers that can improve care consistent with the goals of our patients and evidence-based medical practice. J Clin Oncol 28. © 2011 by American Society of Clinical Oncology

207 Background: Despite the recognized side effect of financial toxicity after cancer, treatment decisions for breast cancer rarely include the costs of care. We sought to determine women’s experiences with breast cancer treatment costs, and their preferences for cost transparency at diagnosis. Methods: Women ≥18 years old with a history of breast cancer completed an 88-question electronic survey based on validated or published items. Descriptive statistics and regression analysis were used. Results: In total, 607 women with stage 0-III breast cancer participated. Median age at diagnosis was 49.6 years. Median time from diagnosis was 6.7 years (range 0.1-37.1). The majority had private (70%) insurance or Medicare (25%), and reported an annual household income ≥$74,000. 43% reported considering costs in treatment decisions. Median reported out-of-pocket (OOP) costs were $3,500; 25% reported OOP costs ≥$8,000, 10% reported OOP costs ≥$18,000 and 5% reported OOP costs ≥$30,000. 15.5% reported significant to catastrophic financial burden. Bilateral mastectomy +/- reconstruction vs lumpectomy (OR 1.9, p 0.03), greater stage at diagnosis (stage 3 vs 0, OR 3.9, p < 0.01), and discussion of costs during the clinical encounter (OR 2.3, p < 0.01) were associated with a higher risk of financial harm. Women who reported discussing costs were more likely to be stage 2 or 3 (56% vs 40%, p = 0.02), less likely to be depressed (24% vs 30%, p = 0.03), and had less insurance coverage (trend p = 0.02) compared to those who did not. Older age (OR 0.95, p < 0.01), increasing household income (overall p < 0.001), better insurance coverage (OR 0.5, p < 0.001), and longer time since diagnosis (OR 0.65, p < 0.001) was associated with a decreased risk of financial harm. 78% of participants never discussed costs with their cancer team. 79% preferred cost transparency prior to embarking on care, and 40% preferred that doctors consider costs when making recommendations. Conclusions: Many women with breast cancer reported significant financial burden related to their care, and the vast majority preferred knowing costs at diagnosis. Cost transparency may improve the quality of preference-sensitive treatment decisions and reduce the risk of financial harm.

533Background: The Oncotype Dx Recurrence Score (RS) predicts distant recurrence risk and benefit from chemotherapy for women with early-stage estrogen receptor (ER) positive (+)/human epidermal gr...

e18612Background: Novel cancer research frequently involves storage of biospecimens for future use. However, ethical questions related to collection, control, and use of stored tissue persist. We s...

e18905Background: In the context of financial burdens that can impact distress and adherence, there is a movement to promote high value care and discussions of value and cost with patients in clini...

62 Background: In efforts to inform clinical screening and development of survivorship care services, we sought to characterize patterns of healthcare needs among cancer survivors by 1) identifying and characterizing subgroups of survivors based on self reported health care needs, and 2) assessing socio-demographic, clinical and psychosocial factors associated with these subgroups. Methods: We conducted a cross-sectional self administered survey among patients presenting for routine follow-up care for early stage cancer (breast, gynecologic, neuro, gastro-intestinal, genito-urinary, thoracic, head and neck, melanoma, sarcoma and hematologic) at our academic medical center. Latent class cluster analysis was used to identify clusters of survivors based on survivorship care needs within 7 domains (side-effects, lifestyle/self-care, emotional coping, social support, sexual health, complementary services and practical support). Multiple logistic regression analyses were used to assess factors associated with these clusters. Results: Among 292 respondents, the highest unmet needs were related to information regarding side effects (53%), lifestyle/self-care (51%) and emotional coping (43%) domains. Our analysis identified 4 clusters of survivors: 1) low needs (N = 123, 42%), 2) mainly physical needs (N = 46, 16%), 3) mainly psychological needs (N = 57, 20%) and 4) both physical and psychological needs (N = 66, 23%). Compared to cluster 1, those in clusters 2, 3, and 4 were younger (P < 0.03); those in clusters 3 and 4 had higher levels of fear of recurrence, anxiety, depression and insomnia (P < 0.05); and those in clusters 2 and 4 reported higher levels of fatigue (P < 0.05). Conclusions: Unmet needs among cancer survivors are prevalent and must be addressed, however a substantial group of survivors report low or no healthcare needs. The wide variation in healthcare needs among cancer survivors suggests a need for screening all patients, followed by tailored interventions in clinical care delivery and research to improve outcomes.

63 Background: More than a decade after the widespread recommendation of survivorship care plans (SCPs), evidence-based content and processes for providing survivorship care planning in gynecologic oncology remain undefined. This qualitative study sought to characterize the challenges experienced in care after treatment of gynecological cancer and preferences for survivorship care planning among patients, their caregivers and health care providers. Methods: Between July and August 2017, in-depth semi-structured interviews were conducted at a large academic hospital in the United States among patients that recently ended treatment ( < 12 months) of a gynecological cancer (ovarian, endometrial, cervical and vulvar), their caregivers, and health care providers (oncologists, nurses and fellows). Main themes were identified using descriptive content analysis. Results: A total of 30 individuals participated in this study (13 patients, 9 caregivers, 8 health care providers). The vast majority of patients and caregivers (91%) expressed satisfaction for survivorship care, although all reported that remaining needs and ongoing issues remained unaddressed (i.e. distressing symptoms and mood). Almost all (95%) reported a desire for more information on how to address these needs, including issues related to side effects (59%), follow-up planning (32%), and psychological assistance (23%). Preferences for survivorship care planning differed across individuals, with respect to content, timing, and mode of delivery. Some patients did not want a SCP at all (14%). Health care providers expressed that they 1) experience challenges in communicating with patients about survivorship, 2) want to shift the focus to improving quality of life as opposed to focusing on likely disease recurrence, 3) do not currently provide formal SCPs, 4) want disease specific and tailored SCPs to support their survivorship care. Conclusions: Patients, caregivers and health care providers express a need for resources to support survivorship care in gynecologic oncology. The variation of disease types and patient and caregiver needs in this field requires multi-faceted, tailored survivorship care planning.

200 Background: Despite the recognized need for high quality survivorship care, barriers to identifying and addressing patients’ needs still remain. We sought to evaluate cancer survivor care priorities, awareness of available services, and factors associated with care and informational needs. Methods: A needs assessment survey was distributed to patients presenting for routine follow-up care in adult oncology clinics at the MGH Cancer Center between February and August of 2016. The survey assessed sociodemographic characteristics, and preferences for care and communication. Care priorities were selected from a list of options including open ended response. Discussion of supportive care services was assessed by the item “have any of your providers informed you about the types of supportive care services that are available to cancer patients" with response options of “yes,” “no” or “don’t know.” Results: Among 637 total respondents, 339 patients with early stage cancer completed the survey. The majority of participants were between 50-69 years old (54%), white (89%), female (64%), and college educated (80%). Breast (32%) and hematological malignancies (21%) were the most prevalent diagnoses. Commonly endorsed priorities for care included: emotional concerns related to cancer (40%), strategies to increase self-care (33%), and management of physical cancer symptoms (30%). Demographic and clinical factors associated with endorsing emotional concerns as a care priority included female gender, and moderate or greater levels of fatigue, depression, or anxiety (all p< 0.01). Factors associated with endorsing management of physical cancer symptoms as a care priority included younger age, and moderate or greater levels of fatigue or depression (all p≤0.01). Despite these priorities for care, only 41% of patients reported receiving information from providers about available supportive care services. Conclusions: Cancer survivors’ preferences for emotional support and symptom management are strongly associated with self-reported depression and fatigue. Routine screening for these issues and improvement in communication regarding available services should be prioritized in survivorship care.

Purpose Investigational cancer therapies being tested in clinical trials may be available outside of trials, or off-protocol (OPRx). We evaluated the practices and attitudes among US oncologists with regard to this controversial practice. Methods We mailed an anonymous survey to a random sample of US medical oncologists evaluating frequency and prevalence of OPRx and evaluated the correlation between demographic factors, attitudes, and practice. Results One hundred forty-six (31%) of 471 oncologists responded. Ninety-three percent reported ever discussing and 81% ever prescribing OPRx. Academic oncologists were more likely than community oncologists to have ever provided OPRx (89% v 75%; P = .06), to discuss OPRx at least once/month (41% v 19%; P = .0004), and to deny requests for OPRx at least once/month (16% v 2%; P = .004). While 61% of oncologists believed that patients should be discouraged from OPRx, only 31% felt it should not be available. With regard to trial recruitment, 53% felt that informed consent requires discussion of OPRx, 34% disagree, and 26% feel that patients should be provided OPRx on request, while 56% disagree. There was lack of consensus on access to OPRx in scenarios based on open trials at the time of the survey, such as adjuvant trastuzumab, which 41% would provide, 59% would not. Conclusion US oncologists report common discussion and use of OPRx, but attitudes and practices may vary substantially. There is need for greater debate regarding OPRx in oncology, further definition of the ethical and clinical issues at stake, and development of guidelines in this area.

Some challenges inherent in cancer care are obvious. We are acutely aware of the limitations of our interventions in many settings. What is less often considered is the adequacy of our care delivery, and the degree to which serious errors in care or communication may contribute to harm and suffering among our patients. In this issue, Mazor et al suggest that from the patient’s perspective such problems may be “relatively common, physically and emotionally harmful, and frequently unreported.“ Should the oncology community now sound the alarm? What can and should we learn about challenges in cancer care delivery and the patients’ experience from this study? In responding, we must first ask: Is this accurate? What types of problems are reported? What, if any, further research is needed, and how can we move forward to improve care? Mazor et al sought to assess the prevalence of serious problems in cancer care by identifying and interviewing patients within HMO networks in Georgia, Massachusetts, and Washington who had recently completed initial therapy for operable breast or colon cancer. They report that among 416 patients screened, 93 (22%), met eligibility criteria for the perception of a serious preventable error in care or communication. However, as the authors acknowledge, only 12 patients with colorectal cancer were recruited. This is essentially a study of problems experienced by insured patients with early-stage breast cancer. In general, these patients can expect a high cure rate, (80% or greater), they receive highly multidisciplinary care, and they face multiple difficult treatment decisions (including type of surgery and choice of adjuvant therapy). These data may not be generalizable to patients with advanced solid tumors, hematologic malignancies, or even other early-stage solid tumors. Restricting analysis to breast cancer, and including patients who declined participation or were unable to be contacted in the denominator, we find that among 539 patients identified with operable breast cancer, 81 (15%) reported experiencing major problems in care, communication, or both. At first glance, this suggests that serious problems in breast cancer care may be common and urgent efforts to improve safety are required. However, if we consider analysis at the level of the individual encounter or intervention a slightly different impression of the problem emerges. Perhaps serious errors are infrequent, but occur sufficiently in the course of multiple clinical encounters and interventions that at least one error is eventually experienced by a substantial percentage of patients. Part of the challenge then may lie in identification and response to these rare events when they occur. Most patients with breast cancer experience a complex course of care in the first year after diagnosis. A patient may first interact one or more times with their primary care provider in the process of initial screening, work-up, and referral to oncology specialists. They might have one or more procedures for diagnosis, multiple surgical consultations, one or more surgeries (including reconstruction), and multiple surgical follow-up visits. Most patients will consult radiation oncology and may undergo up to 6 weeks of daily radiation. Virtually all patients will discuss adjuvant (or neoadjuvant) systemic therapy with a medical oncologist. Those undergoing chemotherapy will be treated with four to 16 chemotherapy infusions depending on the regimen (perhaps as many as 30 for patients with human epidermal growth factor receptor 2–positive breast cancer). The majority will also be treated with endocrine therapy and have several follow-up visits within the first year. In addition, patients may undergo several imaging studies, physical therapy, genetics consultation, nutritional consultation, and counseling with a social worker. Although the exact mix of multidisciplinary care varies among patients, assuming, conservatively, 20 medical encounters per patient and 539 patients, we might estimate that there were 81 reported problems among 10,780 encounters, or 0.8%. This figure includes diverse problems with different implications for prevention, impact, and response. Nearly 25% related to concerns over late diagnosis, presumably before the patient had entered the cancer care system. An additional 50% were issues of communication, such as failure to adequately prepare patients for adverse effects of chemotherapy. While it is helpful to understand the cumulative impact of these problems on our patients, it is important to recognize that the incidence of any specific problem in care delivery may be low. The reported rate of serious problems should be considered within the context of known complications from breast cancer therapy reported in the medical literature. For example, infection rates following mastectomy may range from 4% to 12%. Radiation pneumonitis has been reported in up to 3% of patients with breast cancer. Chemotherapy can cause severe nausea and vomiting, mouth sores, or infection in up to 3% of patients. It is possible that rare but predictable complications (of which those listed here are but a small sample) may contribute to patients experience of major problems in care, particularly if they are not discussed in advance or addressed adequately when they occur. In the communication arena, an extensive body of literature supports the notion that we have substantial room for improvement. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 30 NUMBER 15 MAY 2

10053 Background: Fear of cancer recurrence (FoCR) following definitive cancer therapy is often reported by patients, but little is known about who is most likely to be impacted, how FoCR influences emotional distress, and what interventions may mitigate patients’ FoCR. We sought to determine the prevalence of FoCR among cancer survivors and to evaluate potential predictors of FoCR in this population. Methods: As part of a comprehensive supportive care needs assessment, we evaluated the prevalence of FoCR among patients receiving follow-up cancer care at our institution as well as factors associated with FoCR. Elevated FoCR was measured with a single item: “I worry about my cancer coming back” rated on a 4-point Likert scale (1 = “not at all” to 4 = ”very much”); responses of 3 or 4 were considered positive for FoCR. Descriptive statistics were used to characterize patterns of FoCR. Chi-square and Fisher’s exact tests compared differences in emotional, clinical, and demographic characteristics between participants with and without FoCR, as well as interest in and knowledge of survivorship services. Results: Of 636 patients who completed the survey, 318/636 (50.0%) patients had curable cancer and had either completed cancer therapy or were completing maintenance treatment. On inquiry, 167/318 (53%) reported FoCR. Those with FoCR were more likely to be female (p < 0.002) and under the age of 70 (p < 0.003). They were also more likely to be sad (25% vs. 14%, p < 0.015), anxious (40% vs. 21% p < 0.0005), feel uncertain about the future (30% vs. 14%, p < 0.0005), have problems managing stress (26% vs. 13%, p < 0.003), and were more likely to worry about dying (55% vs. 8%, p < 0.0001) and to fear another cancer (74% vs. 8% p < 0.0001). Education level, cancer type, knowledge of and interest in support services, and survivorship care plan receipt were not associated with FoCR. Conclusions: Patient FoCR is prevalent among more than half of survivors of cancer and is associated with emotional distress that is insufficiently addressed by survivor care planning and supportive services. Clinicians can and should screen for and address this issue. Future research is needed to develop and test interventions, beyond care plans, to address FoCR in both low risk and high risk patient populations.

10065 Background: Prospective data regarding fertility and pregnancy after breast cancer are limited. Many young survivors are interested future fertility, but pregnancy rates among women attempting and not attempting pregnancy have not been studied prospectively. Methods: As part of a multicenter cohort study, women diagnosed age ≤40 with stage 0-3 breast cancer are surveyed at baseline then annually regarding fertility interest, attempts, and pregnancies. Chi-square tests were used to compare proportions attempting and achieving pregnancy. Results: At least once in the 5 years (yrs) after Dx, 334/959 (35%) women reported interest in future biologic children. The percent interested was stable in the first 3 yrs then declined: 256 (27%, baseline), 244 (27%, 1 year), 209 (25%, 2 yrs), 176 (25%, 3 yrs), 106 (18%, 4 yrs), and 72 (16%, 5 yrs). Pregnancy was attempted by 104/334 (31%) of women who reported interest and 4/625 (1%) who did not. Pregnancy occurred in 118 women (12%), including 76/108 (70%) who attempted and 42/851 (5%) who did not. Attempts and achieving pregnancy were associated with younger age, partnered status, and not having children prior to Dx (table). Lower stage was associated with attempting pregnancy and ER negative disease with achieving pregnancy. Conclusions: A substantial number of young women become pregnant in the 5 years after a breast cancer diagnosis. Given that over 1/3 of pregnancies were among women who did not report attempting, additional attention to contraception counseling should be considered. Further evaluation of assisted reproductive technology use, pregnancy and disease outcomes in this cohort, and the POSITIVE Trial (NCT02308085) will shed light on the feasibility and safety of pregnancy after breast cancer. [Table: see text]

e21601 Background: Exercise can improve outcomes and quality of life following cancer diagnosis. The American College of Sports Medicine (ACSM) recommends 150 minutes of moderate aerobic activity for patients with cancer. We sought to evaluate exercise patterns and barriers to exercise among patients presenting for follow-up care. Methods: Patients were recruited from the outpatient cancer clinic and completed a self-administered survey focused on symptoms, lifestyle and needs. Participants reported height, weight, weekly time performing moderate-to-vigorous aerobic activity, time spent strength training and perceived barriers to exercise. Descriptive statistics characterized the sample and patterns of exercise. An independent-samples t-test examined differences in strength training between patients currently on and off treatment; Chi-square examined differences among those meeting or not meeting ACSM activity guidelines. Results: Of 637 patients surveyed, 590 (93%) completed exercise questions (55% female; median age 60-69). The most common cancer diagnoses were breast (26%), hematologic (18%) and gastrointestinal (12%). Over half (57%; n = 352) were overweight (BMI ≥ 25) and 26% (n = 161) were obese (BMI ≥ 30). Patients engaged in moderate-to-vigorous aerobic exercise an average of 110 min/week and in strength training for 30 min/week. 71% did not meet ACSM aerobic exercise guidelines; 62% reported no strength training and 29% reported no exercise. 76% of respondents reported at least one barrier to exercise. Common barriers included other illness (35%), lack of free time (21%), fatigue (8%) and boredom with exercise (8%). Most participants (60%; n = 351) decreased exercise after cancer diagnosis. Participants currently on therapy were significantly less likely to meet ACSM aerobic activity guidelines (p = 0.04) and reported doing less strength training (p < 0.001) than those not on therapy. Over half of participants (53%) expressed interest in receiving more information about exercise and physical activity services. Conclusions: There is potential to improve activity, fitness and cancer outcomes through increasing exercise among patients with cancer. Accessible, engaging exercise interventions are needed.

e21603 Background: Insomnia is prevalent among cancer survivors. However, screening and treatment is inconsistent across U.S. cancer centers. We sought to identify factors associated with moderate to severe insomnia (MSI) to inform the development of a screening and treatment program for survivors. Methods: As part of a comprehensive supportive care needs assessment, we evaluated the prevalence and correlates of insomnia among patients receiving follow-up cancer care. Patients reported on a 5 point Likert scale (0 = never to 5 = always) how often they have “problems falling or staying asleep”. MSI was defined as those who endorsed “4 = very often” or “5 = always,” and remaining responses were characterized as “No Insomnia” (NI). Descriptive statistics summarized patterns of insomnia and sleep hygiene. Chi-square and Fisher’s exact tests compared differences in sleep hygiene, fatigue, anxiety, depression, and other clinical and demographic characteristics between patients with and without insomnia. Results: Among 312 respondents, 83 (27%) endorsed MSI. Women were more likely to endorse MSI compared to men (32% vs. 19%, p = 0.02). Age was not associated with MSI. MSI was most common among patients with hematologic malignancy (36%), breast cancer (32%), gynecologic cancer (31%), and melanoma (29%). Regarding sleep hygiene: Most reported frequent exposure to bright light before sleep (89% MSI vs. 85% NI). Patients with MSI, compared to NI, were more likely to report watching the clock (86% vs. 75%, p = 0.04) and an irregular sleep schedule (47% vs. 32%, p = 0.02). Patients with MSI were also less likely to meet exercise guidelines (31% vs. 45% NI, p = 0.03) and more likely to report fatigue (29% vs. 14%, p = 0.004). Further, those with MSI were more likely to report anxiety (40% vs. 8%), fear of recurrence (74% vs. 46%), and financial concerns (35% vs. 15%) (all p < 0.001). 67% of patients with MSI were interested in supportive care to address insomnia. Conclusions: A simple one-item screener identified survivors susceptible to moderate to severe insomnia. Interventions beyond attention to sleep hygiene are needed to improve insomnia and its impact on fatigue and emotional distress. The relationships between insomnia, fitness, anxiety and distress merit further evaluation.

9 Background: Optimal follow up care for the 3.1 million breast cancer (BC) survivors in the United States has not been definitively determined. ASCO and NCCN recommend that early stage BC patients have a history and physical by their oncology or primary care provider every 3 to 6 months in the first three years post treatment. Additional visits have not been shown to improve outcomes. However, many patients are seen more frequently, leading to increased healthcare costs. In this context, we developed and implemented a BC care redesign algorithm (BCCRA) to reduce redundant follow up. Methods: The BCCRA multidisciplinary team recommended BC survivors be seen by an oncology provider every 6 months for the first five years post treatment and annually thereafter. Retrospective chart review was conducted to evaluate BCCRA adherence from November 2014 to November of 2015. Patients were deemed ineligible if there was a medically necessary reason for visits outside of the BCCRA such as reconstruction, ongoing treatment or clinical trial participation. Eligible charts were analyzed for adherence. For survivors who did not adhere, charts were analyzed for outcome of additional visits. Results: 116 patient charts reviewed and 72 (62.1%) were deemed ineligible. Of the remaining 44 survivors, 26 (59.1 %) adhered and 18 (40.91%) did not adhere. Of the 18 survivors who did not adhere, six had visits due to clinical concern and 12 had visits due to patient or provider preference. Of the 6 patients who had visits for clinical concern, 4 resulted in a change in the patient’s medical management (CMM). Of the 12 patients who had visits due to patient/provider preference, 2 resulted in a CMM. Conclusions: Despite buy-in from a motivated multidisciplinary team, there were challenges to implementing the BCCRA. 62.1% of patients were ineligible and there was a significant proportion of patients/providers who chose more frequent visit schedules. However, the BCCRA had 59.1% adherence which could result in cost reduction and increased flexibility in oncologists’ schedules. Further evaluation of the model is needed to validate these claims.

It has long been observed that young women with breast cancer are more likely to suffer from recurrence and death than older women after diagnosis. In this issue, Anders et al explore the potential biologic basis for differences in outcomes and argue that breast cancer in younger women is a unique biologic entity. Their study confirms prior work demonstrating that breast cancers in young women are characterized by lower levels of estrogen receptor (ER) expression and higher grade. In addition, through analysis of both immunohistochemistry (IHC) and mean mRNA levels, they found that breast cancers in younger women, defined in this study as age 45 years, have higher levels of human epidermal growth factor receptor 2 (HER-2) expression compared with women age 65 years, a correlation not found consistently in prior population-based studies. Although this work confirms that the distribution of breast cancer characteristics varies based on age at presentation, to this point, there would be little basis to claim that breast cancer in younger women is a separate disease. However, in addition to exploring differences among these wellcharacterized features of breast cancer, these investigators also explored differences in gene expression for thousands of genes that might distinguish one tumor from another in this combined data set. Using single-gene analysis and focusing on the 50 genes with greatest differences among tumor samples, they were unable to identify additional features that consistently distinguished tumors from younger versus older women. However, Anders et al also used gene set enrichment analysis, which is a technique specifically designed to evaluate groups of genes with common function or from common pathways to identify similarities that may not emerge with single-gene analysis. Using this forest versus trees approach, Anders et al found overexpression of multiple gene sets involved in immune function, cell signaling, survival, and several other pathways of interest that could reliably differentiate tumors in younger women at the molecular level from tumors of older women. On the basis of these admittedly exploratory findings, the authors contend that breast cancer in young women has unique biologic features and, by extension, deserves consideration as a distinct form of breast cancer. This research joins a rapidly expanding body of literature revealing the heterogeneity of breast cancer at the molecular level. Although there are many possible explanations for differences in outcomes among patients, it is clear that underlying differences in tumor biology play a large role. The question then becomes how we can best use this information to characterize the disease in individual patients to inform prognosis and choice of therapy, as well as to focus future research. This also raises more general questions confronting breast cancer clinicians and researchers regarding how many discrete forms of breast cancer exist and consideration of the value and potential costs in distinguishing them. It is important to note that initial progress in development of medical therapy arose from the recognition of discrete diseases that were fundamentally similar from patient to patient, allowing meaningful comparisons of outcomes and, later, development of clinical trials. The conceptual shift in viewing disease as a specific entity comparable across patients, rather than a personal state of underlying imbalance in humors or other elements varying from patient to patient, coupled with the rise of hospitals where similar patients were clustered and development of biostatistics, which provided the tools for comparison, was fundamental to what historian Charles Rosenberg has termed the Therapeutic Revolution. The pioneering work of Pierre Louis in 1836 in recognizing that blood letting was no more effective than diet and rest for treatment of pneumonia could not occur until pneumonia was recognized as sufficiently similar from one patient to the next to justify comparing outcomes. It should also be noted that much of the initial benefit from this conceptual advance was not in developing new therapies but, instead, in abandoning those that did not work. It was during this period of first evaluating established interventions in newly defined diseases that Oliver Wendell Holmes famously remarked to his students at Harvard that “if the whole materia medica [standard medical therapies] could be sunk to the bottom of the sea, it would be all the better for mankind and all the worse for the fishes.” Although recognition of discrete subtypes of breast cancer need not induce a similar state of therapeutic nihilism, it is important to consider how and when we know we are dealing with a distinct disease and what the consequences of this for both current practice and research may be. Until relatively recently, breast cancer was viewed as one disease, albeit with variable features that could affect prognosis and treatment options. Differences between ER-positive disease and ER-negative disease in terms of both natural history and response to therapy have been well documented, but studies demonstrating the potential for changes in receptor expression over time contributed to the notion that there was one underlying condition. Even when the importance of HER-2 overexpression leading to inferior outcomes in a subset of breast cancers was first recognized in 1987, this was essentially considered a poor-prognosis feature of the disease, rather than a discrete entity. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 26 NUMBER 20 JULY 1

Costs of cancer care in the United States are projected to rise from $124.6 billion in 2010 to approximately $174 billion in 2020, contributing to an emerging consensus that health care spending is on an unsustainable trajectory. With the annual cost of novel therapies often exceeding twice the US median household income of $50,000, access to quality care for individual patients is threatened. Costs of care can lead to financial distress and even bankruptcy. For the health system as a whole, health care spending consumes a growing proportion of federal and state budgets. Rising costs threaten the viability of public health insurance programs, including Medicare and Medicaid, as well as spending on other social priorities, including cancer research. Controlling costs while improving access to quality care and continuing to support innovation thus poses a critical challenge. In considering this problem, it is important to recognize that concerns over cost and access to health care are not new. These concerns were behind efforts at reform under Presidents Nixon in the 1970s and Clinton in the 1990s. Previous reform efforts have been subject to labels of socialized medicine and branded anti-American. Recent efforts to expand access and control costs under the Affordable Care Act have met the same discord and demagoguery. The US public has long endorsed the concept of health care reform, but it has been divided over the nature of reform and how it should be achieved. Writing in 1984 about the “schizophrenia” of the nation over health care costs, and summarizing multiple public opinion polls from that time, Blendon and Altman explained that although controlling costs was viewed as the number one health care priority for the nation, it was not viewed as a top national priority, compared with unemployment, government spending, defense, and other areas. Furthermore, they found that although Americans were deeply concerned with the rising costs of health care for themselves as individual patients, they were not particularly troubled by rising societal spending on health care, and some favored greater national spending on health. We hope to control costs along with improving access and quality; however, it is not clear that cost control can be achieved without facing hard choices. The proportion of the US gross domestic product spent on health care costs has been steadily rising since the enactment of Medicare in 1965. This rise has been driven by multiple factors, including the growth and development of new technologies, an aging population, increased use of tests and scans, and reimbursement policies for physicians, hospitals, and other providers that incentivize delivery of more services. Although many countries struggle with high costs of health care, the United States is somewhat unique in that we prohibit consideration of cost effectiveness in our public health insurance system. At its inception, Medicare was established with a statutory obligation to cover any care deemed reasonable and necessary, but precisely how this should be defined is the subject of ongoing political debate. In this context, Gogineni et al sought to understand current concerns over health care costs among physicians, patients with cancer, and members of the general public, with a focus on Medicare and potential methods to control Medicare spending. They achieved response rates consistent with expectations in similar populations (at roughly three quarters of eligible patients and 50% of selected oncologists and members of public). Some response bias must be considered when interpreting results, with 50% of patients and oncologists self-identifying as Democrats versus roughly one third identifying as Republicans. Approximately three quarters of respondents agreed that Medicare spending was a substantial national problem, and roughly two thirds thought Medicare spending could be reduced without harming health outcomes. The vast majority of each group felt that both pharmaceutical industry and private health insurance company behaviors contributed to high costs. Roughly 80% of the public and approximately 70% of patients and oncologists also believed that unnecessary treatments contributed to high costs. Not surprisingly, larger differences emerged over the question of excessive physician charges, with approximately 80% of the public, 67% of patients with cancer, and only 19% of oncologists viewing this as an important factor. These data highlight the extent to which multiple stakeholders are concerned about costs of care and suggest that there is consensus on potential to reduce unnecessary health care spending without restricting high-value care. Indeed, this is the premise behind the American Board of Internal Medicine Choosing Wisely campaign, through which the American Society of Clinical Oncology and other specialty organizations have identified practices that should be eliminated to lower costs with no adverse impact on quality (and, in some cases, improvement). The challenge of drawing firm policy conclusions from survey work becomes apparent when considering the question of Medicare adopting reference pricing for cancer drugs. Gogineni et al found that 75% of respondents agreed that Medicare should not pay for more expensive treatments when equally effective alternatives were available. They then argue that this indicates widespread support for reference pricing, in which reimbursement for an intervention is set at the rate of the lowest cost equivalent. One might question why 100% JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 33 NUMBER 8 MARCH 1

6542Background: Mammography screening reduces breast cancer mortality, but there is ongoing controversy over optimal target population and interval. We sought to explore the association between scr...

e18269Background: Limited transparency exists regarding eligibility and benefits for PAPs. Little is known about the extent of financial assistance provided by PAPs to reduce costs for prescription...

9557 Background: Patients undergoinghematopoietic stem cell transplantation (HCT) experience a steep deterioration in quality of life (QOL) and mood during hospitalization for HCT. The impact of this deterioration on patients’ long-term QOL and post-traumatic stress disorder (PTSD) symptoms is unknown. Methods: We conducted a prospective longitudinal study of patients hospitalized for HCT. At baseline (day-6), day+1, day+8, and 6 months post-HCT, we assessed QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplantation [FACT-BMT]) and mood (Hospital Anxiety and Depression Scale [HADS]). We used the PTSD Checklist to assess for PTSD symptoms at 6 months. We used multivariable linear regression models to identify predictors of QOL and PTSD symptoms at 6 months post-HCT. Results: We enrolled 97% (90/93) of consecutively eligible patients undergoing autologous (n = 30), myeloablative allogeneic (n = 30), or reduced intensity allogeneic (n = 30) HCT. Overall, patients’ QOL at 6 months (mean FACT-BMT...

e20645 Background: Adjuvant endocrine therapy (ET) plays an important role in reducing risk of recurrence among women with hormone receptor positive breast cancer. Although the literature suggests ...

161 Background: Growing evidence suggests that financial distress is a side effect of cancer care needing attention. Little is known about how patients cope with treatment-related financial distress. This study describes how patients with cancer cope with treatment-related costs and identifies those at greatest risk for using potentially harmful cost-coping strategies. Methods: Eligible patients for this cross-sectional, survey study were adults being treated for solid malignancies enrolled June 2010 to May 2011 in a national copay assistance program. Coping strategies were grouped as lifestyle-altering or care-altering. Descriptive statistics and analysis of variance assessed coping strategies and relationships between covariates. Results: Among 174 participants, 89% used at least one lifestyle-altering strategy to cope with costs, while 39% used a care-altering strategy. Most common care-altering coping strategies included: not filling a prescription (28%); and taking less medication than prescribed (23%). Lifestyle-altering strategies included: spending less on leisure activities (77%); spending less on basics (57%); borrowing money (54%); and spending savings (50%). The mean number of coping strategies was higher for patients < 65 than for those ≥ 65 (Table). Lower-income patients used more care-altering strategies than higher-income patients. Patients with more education and shorter duration of chemotherapy adopted more lifestyle-altering strategies than their counterparts. Conclusions: Patients were generally more likely to use lifestyle-altering approaches to cope with treatment-related financial burden, but more than one-third adopted care-altering strategies. Younger patients and those with lower incomes were more likely to alter their care. Screening for and anticipating potentially harmful cost-coping behavior in the oncology clinic is important to reduce patient distress and promote optimal care. [Table: see text]

To date, the terms of the debate, occurring within scientific meetings and the literature, have focused on the presumed scientific necessity for mandatory research biopsies versus the rights of prospective trial participants to freely consider consent to a research biopsy separately from consent to a clinical trial. Proponents argue that some important scientific questions can only be addressed by evaluation of tumor tissue from all trial participants. They claim that in the era of molecular medicine, clinical researchers frequently need to understand not just who benefits or fails to benefit from a drug, but why benefit has occurred as assessed by whether the drug reached its intended target, and whether there are molecular factors that can predict response or guide further therapy. They assume that clinical samples will be unavailable or inappropriate to address some questions, that participation rates in optional research biopsies will be inadequate, and that biopsies can be conducted safely, with informed consent, and yield meaningful knowledge to advance the field. Opponents of mandatory research biopsies do not dispute the need for research biopsies in some settings. However, they argue that linking consent to a biopsy to trial participation is at minimum unfair, and at worst coercive. Access to promising, if unproven, experimental therapy within a trial is viewed by many as an important component of quality cancer care. It is clear that patients in some settings feel that they will be harmed, through loss of access to the experimental intervention, if they fail to pursue trial care. This arguably creates a sense of coercion that violates the principle of voluntarily informed consent to the research biopsy. Further, some trial participants mistakenly assume that all aspects of trial care and procedures are intended to provide direct clinical benefit. This therapeutic misconception complicates achieving informed consent in this setting. In addition, some argue that technical limitations in our ability to conduct meaningful correlative science make requirements for universal biopsies within a trial inappropriate at this time. Achievement of evaluable molecular analysis on all patients is rareevenwhenallarerequiredtoparticipate,andevaluationofasubsetof participants can be achieved through optional biopsies. The science, according to this view, should be improved before mandatory research biopsies are considered. It should be noted that no one supports asking trial participants to undergo a biopsy for research purposes in the absence of a strong scientific rationale, meaningful informed consent, and a low to minimal risk of expected complications. In addition, there is very little, if any, debate over trials that require a biopsy to guide management within the study, such as dose of a drug or choice of intervention, termed “integral biomarker” trials. Concerns arise when the purpose of the mandatory research biopsy is correlative science, or, most controversially, when a research biopsy is planned for purely exploratory purposes or for collection for future unspecified research. Acknowledged in most of the policy statements and position papers on this subject is a relative lack of data to inform discussions of the strength of the scientific rationale used to justify inclusion of mandatory research biopsies in a protocol, the quality of informed consent, participation rates and efficiency of accrual, safety, and outcomes of the procedures. Into this relative void, and a debate that at times brings more heat than light, step Overman et al, with a welcome report on the experience with mandatory research biopsies at a single institution over a recent 5-year period. The authors conducted a retrospective analysis of clinical trials contained in the MD Anderson interventional radiology database. They identified 19 clinical trials involving mandatory research biopsies conducted for purely correlative or exploratory purposes. For these trials, they reviewed the protocol, the informed consent document, and the medical record. Overman et al found that in the trial protocols the rationale for the biopsy was inconsistently explained and a statistical plan justifying the collectionofmandatorybiopsieswasfoundinonly30%oftrials involving correlativescience.Consentdocumentswerealsoproblematic.Only40% of informed consent documents for studies using mandatory research biopsies for correlative purposes explained the research nature of the biopsy, 70% explained the scientific rationale for the biopsy, and 30% addressed biopsy safety. With regard to safety, in analysis that included trials with optional biopsies and integral biomarker studies, the investigators reported an overall complication rate of 5.2% and a major complication rate (indicating need for hospitalization or surgery) of 0.8%. When considering intrathoracic and abdominal biopsies alone the overall complication rate rose to 9.8% with a major complication rate of 1.5%. They reported no biopsy-related deaths. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 31 NUMBER 1 JANUARY 1 2013

6559 Background: Patients with cancer are at risk for experiencing financial distress. Prior studies have indicated that objective financial burden follows trends associated with treatment course. However, little is known about whether patients’ subjective financial distress follows similar trends during the course of their treatment. The ability to predict risk of financial distress in relation to time on treatment may facilitate timing of interventions to alleviate financial distress. Methods: This was a cross-sectional study of insured adults with solid tumors on anticancer therapy for ≥1 month. Consecutive patients were surveyed, in person, at a referral center and 3 rural oncology clinics. Participants were asked about financial distress (via a validated measure) and out-of-pocket costs. Medical records were reviewed for disease and treatment data. We used the Spearman Rank Correlation Coefficient test and multivariable logistic regression to assess the correlation between months on treatment and fin...

QUESTION ASKED: Because the cost of oncologic care is perpetually rising, we wanted to know how often physicians who treat cancer discuss the cost of care (both out-of-pocket and societal) with their patients, what the nature of those discussions is, and whether such discussions affect treatment decisions. SUMMARY ANSWER: Sixty percent of responding physicians reported addressing costs frequently or always in clinic, 40% addressed costs rarely or never, and 36% did not believe it is the doctor’s responsibility to explain costs of care to patients. Additional responses are listed in Table 3 . The majority of physicians feel their patients are not well informed about costs. “I don’t know enough/lack of resources” is the largest reported barrier to cost discussions, and those who reported frequent discussions were significantly more likely to explain costs and to prioritize treatments in terms of cost. [Table: see text] METHODS: A 15-question, study-specific, self-administered anonymous survey was sent electronically to a randomly selected sample of 2,290 ASCO physician members. BIAS, CONFOUNDING FACTOR(S), DRAWBACKS: Our overall response rate was somewhat low at 15%, with an adjusted response rate of 25% after adjusting for nonpracticing physician ASCO members. This increased the potential for selection bias, by which the respondents to this survey may not represent the true beliefs and practices of medical, radiation, and surgical oncologists. REAL-LIFE IMPLICATIONS: Our study offers a current snapshot of the frequency, nature, and attitudes toward cost discussions among medical, radiation, and surgical oncologists and their patients. Although the majority of responding physicians seem to agree that such discussions are legitimate—and arguably necessary—components of quality cancer care, there remains a substantial proportion who do not discuss costs nor feel it is their duty. Few believe they have adequate resources to discuss costs, suggesting that greater cost transparency, education concerning costs of care, tools to facilitate discussions, and validated interventions are needed.

1502 Background: The 2009 US Preventative Services Task Force (USPSTF) guidelines for breast cancer screening have proven controversial. Previously, annual screening was recommended for women over ...

6615 Background: Assuring treatment-related decision-making aligns with patients’ preferences is a critical component of quality care. Yet often patients’ preferred and actual treatment-related dec...

561 Background: Tamoxifen treated breast cancer patients with diminished CYP2D6 activity have lower endoxifen exposure, which may lead to inferior treatment outcomes. Increasing the daily tamoxifen...

2 Background: Little is known about the association between patient-oncologist discussion of cancer treatment out-of-pocket (OOP) cost and medication adherence, a critical component of quality cancer care. Methods: We conducted a cross-sectional survey of insured adults receiving anti-cancer therapy. Patients were asked if they had discussed OOP cost with their oncologist. Medication non-adherence was defined as skipping doses to make prescriptions last longer, taking less medication than prescribed to make prescriptions last longer, or not filling prescriptions due to cost. Multivariable analysis assessed the association between cost discussions with an oncologist and non-adherence. Results: Among 300 respondents (84% response), 77% (n=230) were white and 53% (n=158) were men. 17% (n=52) reported “high” or “overwhelming” financial distress. 19% (n=56) had talked to their oncologist about cost. 27% (n=81) reported medication non-adherence. 14% (n=43) skipped medication doses to make the prescription last longer; 7% (n=3) of these had skipped chemotherapy. 11% (n=34) took less medication than prescribed to make the prescription last longer; 15% (n=5) of these took less chemotherapy. 22% (n=67) did not fill a prescription because of cost; 15% (n=10) of these did not fill a chemotherapy prescription. In adjusted analyses, cost discussion (OR 2.56, 95% CI 1.15-5.68; p=0.02), financial distress (OR 1.57, 95% CI 1.33-1.85, P

13 Background: Screening mammography leads to early detection of breast cancer and improved survival. We conducted a survey of predominantly rural U.S. women who receive health insurance through the National Rural Electric Cooperative Association (NRECA) to evaluate the prevalence of annual and biennial screening and to identify potential disparities and barriers to breast cancer screening. Methods: We conducted a national cross-sectional survey of women between ages 40 and 65 who are insured by the NRECA regarding their utilization of mammography screening and barriers to screening. A study specific survey was mailed to 2,000 randomly selected eligible women without prior diagnosis of breast cancer. We assessed demographics and receipt of mammography within past 12 months (all women) and number of screening mammograms within the past 4 years (among women age 44 and older) to identify consistent annual screening and biennial screening patterns. Results: 1,204 women responded to the survey (response rate 60.2%). 74% live in rural areas, 18% suburban, 8% urban. 73% report less than 4 years college education and 19% have family incomes < $50,000/year. Overall, 72% reported screening mammography within 12 months, 59% reported consistent annual screening and 84% reported at least biennial screening. Rural women were less likely to undergo consistent annual (56% vs. 66%, p = 0.003) or biennial screening (82% vs. 89%, p = 0.01) compared to women in non-rural areas. Women under 50 were less likely to report screening within 12 months (67% vs. 77%, p = 0.0002), consistent annual (49% vs. 63%, p < 0.0001) or biennial screening (79% vs. 86%, p = 0.002). Significantly more rural women cited cost and distance as barriers, while busy schedule, fear of diagnosis, and fear of discomfort were important barriers among all demographic groups. Fear of the test was a greater barrier among younger vs. older women (p < 0.02). In univariate analysis; household income did not correlate with screening, and education was only a factor among younger women. Conclusions: A substantial percentage of rural U.S. women fail to undergo screening mammography. Potentially modifiable barriers include out of pocket expenses, convenience of screening, and fear of diagnosis and the test itself.

110 Background: The optimal method for delivery of care to over 2 million breast cancer survivors in the U.S. remains unclear, with multiple models currently in practice. This study involved a patient-centered investigation of experiences and preferences for breast cancer survivorship care. Methods: We conducted a single-institution, cross-sectional, self-administered survey of needs, experiences, and interests following initial breast cancer care at an academic multidisciplinary breast clinic. For 4 weeks, all patients presenting for routine oncology care were provided a survey at appointment check-in. Analysis is descriptive, with chi square testing used to evaluate demographic correlates of response. Results: 612 surveys were distributed, with a response rate of 66.8%. Median age of respondents was 56 (range 26-93); 71% were white, and 18% identified themselves as black. Over 55% had a college degree. Regarding ongoing care, 63% preferred to see a cancer specialist at least annually, and 30% wanted access to a cancer specialist as needed. Less than 15% preferred referral to a local practice, and less than 15% favored follow-up care from a specialized cancer survivorship clinic. Regarding visit content, over 90% felt assessment for disease recurrence was a priority on follow-up. A majority were interested in emotional and psychological support (52%). Nearly 40% of patients felt that assistance with non-cancer related health issues was very important in oncology clinic follow-up, but only 25% wanted a cancer specialist to provide general medical care. 42% reported receiving a summary of their cancer treatment. 37% reported receiving awritten plan or list of recommendations regarding care needed as a cancer survivor. White patients were less likely than non-white patients to receive a treatment summary (p < 0.02) or a care plan (p

1076 Background: The FN rate for the approved regimen of TC is 5% in pivotal studies. Other small retrospective reports have reported FN rates as high as 20-35%. We report the incidence of FN from a large retrospective series of breast cancer patients receiving TC with or without pegfilgrastim (PF) for adjuvant therapy. Methods: We reviewed records of 240 sequential patients who had received adjuvant TC (75 and 600 mg/m2) between Mar ’07 and Nov ’12 for FN, upfront PF use, and adverse events by treatment cohort. FN was defined as T> 100.4°F and ANC stcycle of TC administration. Comparisons between two proportions used exact binomial methods; effect of PF on FN after adjusting for baseline characteristics was tested using multivariate logistic regression. Results: 153 (63.7%) patients received upfront PF, while 87 (36.3%) did not (Table). Patients receiving upfront PF were older (57 vs. 52 yrs, p=0.02). Other baseline characteristics (size of primary tumor, hormone receptor status, and nodal status) were no different between groups. FN, fever, antibiotic use, hospitalization, and dose delay were significantly higher when upfront PF was not used (Table). The average length of hospital stay was 2.9 days for TC + PF, and 3.8 days for TC pts. 31/87 (35.6%) of patients without upfront PF went on to receive PF after the 1st cycle. Conclusions: FN for adjuvant TC meets clinical practice threshold and ASCO guidelines for upfront use of PF. FN-related outcomes such as fever, antibiotic use, dose delays, and number of hospitalizations, and were significantly increased without upfront PF. The cost-effectiveness of these findings will be presented and have major clinical implications for routine care. [Table: see text]