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Sociodemographic and healthcare factors in relation to recruitment sites of patients with cancer (N=154)

Cancer treatment can trigger or exacerbate health-related socioeconomic risks (HRSR; food/housing insecurity, transportation/utilities difficulties, and interpersonal violence). The American Cancer Society and National Cancer Institute recommend HRSR screening and referral, but little research has examined the perceptions of patients with cancer on the appropriateness of HRSR screening in healthcare settings. We examined whether HRSR status, desire for assistance with HRSRs, and sociodemographic and health care–related factors were associated with perceived appropriateness of HRSR screening in health care settings and comfort with HRSR documentation in electronic health records (EHR). A convenience sample of adult patients with cancer at two outpatient clinics completed self-administered surveys. We used χ2 and Fisher exact tests to test for significant associations. The sample included 154 patients (72% female, 90% ages 45 years or older). Thirty-six percent reported ≥1 HRSRs and 27% desired assistance with HRSRs. Overall, 80% thought it was appropriate to assess for HRSRs in health care settings. The distributions of HRSR status and sociodemographic characteristics were similar among people who perceived screening to be appropriate and those who did not. Participants who perceived screening as appropriate were three times as likely to report prior experience with HRSR screening (31% vs. 10%, P = 0.01). Moreover, 60% felt comfortable having HRSRs documented in the EHR. Comfort with EHR documentation of HRSRs was significantly higher among patients desiring assistance with HRSRs (78%) compared with those who did not (53%, P < 0.01). While initiatives for HRSR screening are likely to be seen by patients with cancer as appropriate, concerns may remain over electronic documentation of HRSRs.Significance:National organizations recommend addressing HRSRs such as food/housing insecurity, transportation/utilities difficulties, and interpersonal violence among patients with cancer. In our study, most patients with cancer perceived screening for HRSRs in clinical settings as appropriate. Meanwhile, concerns may remain over the documentation of HRSRs in EHRs.

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Sociodemographic and healthcare factors in relation to comfort with EHR documentation (N=154)

Background: We previously reported on the decreased survival in cancer patients associated with alternative medicine (AM). There is limited information on incidence and stage-specific survival outcomes of breast cancer patients who receive AM compared to those who receive conventional cancer treatment (CCT). Methods: Patients diagnosed with breast cancer in 2004-2016 were identified using the National Cancer Database. Patients were excluded if they had multiple malignant primaries, had radiation to a site other than breast, had unknown treatment status, received palliative care, or had missing death, estrogen receptor (ER), progesterone receptor (PR), and/or clinical stage information. Those who received an unproven cancer treatment and did not receive any CCT, defined as surgery, radiotherapy, chemotherapy, and/or hormone therapy, were classified within the AM group. Annual cumulative incidence of AM was assessed and differences by year were analyzed by the Cochran-Armitage test. Treatment selection was evaluated by the chi-square test, t-test, and logistic regression. Following 2:1 matching on age, clinical group stage, Charlson-Deyo comorbidity score (CDCS), insurance type, race, and year of diagnosis, overall and stage-specific survival were analyzed using the Kaplan-Meier method, log-rank test, and Cox proportional hazards regression for early stage (clinical stages I and II), locally advanced stage (clinical stage III), and metastatic disease (clinical stage IV).Variables with a p-value of ≤ 0.1 on univariate analyses were selected for entry into multivariable Cox proportional hazards survival modeling. Results: We identified 139 patients with breast cancer who received AM. The annual cumulative incidence of AM varied widely by year with increasing use from 10.8/100,000 in 2012 to 20.5/100,000 in 2015. Use of AM from 2004 to 2015 did not significantly increase. On multivariable analysis, when controlling for demographic and clinical factors, those residing in a non-metropolitan county compared to a metropolitan country (Odds Ratio [OR] = .42, 95% Confidence Interval [CI] = .17 to .99) and those with a CDCS of 1 compared to 0 (OR = .33, 95% CI = .12 to .91) were less likely to receive AM; those receiving care in a Pacific location compared to a Northeast location (OR = 5.57, 95% CI = 2.61 to 11.88) and those with a clinical stage of 4 compared to 1 (OR = 6.53, 95% CI = 3.30 to 12.94) were more likely to receive AM. Following matching, there were no significant differences between matched characteristics (all p>0.9). On matched univariate survival analysis, AM was associated with worse 5-year survival compared to CCT in the overall group (54% vs 82%, p Citation Format: Huaqi Li, James B Yu, Cary P Gross, Henry S Park, Skyler B Johnson. Stage-specific survival of breast cancer patients receiving alternative medicine for treatment of cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-14-03.

Introduction: An emphasis on patient-centered care has led to a growing interest in collecting PROs in cancer care. Our prior work has demonstrated substantial variation in what types of PROs patients deem most important; although physical symptoms are common, a substantial minority of patients report concerns in non-physical symptom (non-PSx) domains, such as emotional or social health, practical or financial problems, and daily functional activity. Here we report initial findings from a pilot study of a secure web-based tool, called My PROfile, which addresses not only individual symptoms but also non-PSx domains. Methods: We enrolled women who had started a treatment regimen for MBC within the past 6 weeks at Smilow Cancer Hospital of Yale New Haven Hospital or an affiliated care center. Using My PROfile, participants responded to validated surveys and provided PROs addressing physical symptoms as well as non-PSx domains including practical problems, social well-being, emotional well-being, spiritual or religious concerns, alcohol and drug use, daily activities and any other areas of difficulties experienced within the past week. Patients also ranked their top 3 concerns at the time of My PROfile completion. Patients were followed prospectively for 6 months and asked to complete My PROfile as often as desired during that time frame, but at least once prior to each visit with their provider. This information was compiled into a report that was shared with their medical oncology provider prior to the clinic visit. For this analysis, we analyzed the frequency of reporting individual symptoms and domains by patient. Results: A total of 28 patients consented to participate. At the time of data analysis, 9 patients had completed all six months of the pilot. Across the different PRO domains, the majority of patients reported difficulties with physical symptoms (68%) or emotional well-being (50%). Overall, 21% of patients reported physical symptoms only, and 46% of patients reported difficulties with both physical symptoms and non-PSx domains; however, 32% of patients reported difficulties from non-PSx domains only. Approximately 29% of patients reported practical problems (including 21% who noted the impact of treatment on diet/activity and 14% who had concerns about monitoring diet and activity in general). Difficulties with daily activities were reported in 29% of patients (with 18% reporting housework and walking specifically). Difficulties in social well-being were reported by 18% of patients, including 11% who specifically reported concerns with family health. The PRO domain reported by the fewest number of patients (n=1) was alcohol and drug use. The three most common individual symptoms reported were fatigue (57% of patients), pain (54% of patients), and worry (36% of patients). Nearly half (47%) of our respondents (13 out of 28) used My PROfile at least 3 times during follow-up. Among these patients, all but 1 patient reported difficulties with physical symptoms at least twice. Additionally, 23% of these patients reported the non-PSx domains of practical concerns and daily activity concerns more than once during the follow-up period. Conclusion: Although physical and mental health symptoms are commonly reported among patients undergoing systemic treatment for metastatic breast cancer, a substantial minority of patients report non-physical symptom concerns including practical and daily activity-based challenges. Because the specific concerns of interest vary substantially across patients, tools to collect PROs should include additional domains that can significantly affect quality of life in women with MBC. Citation Format: Sarah Mougalian, Maureen Canavan, Renee Capasso, Jenerius Aminawung, Carolyn J. Presley, Cary P Gross. My PROfile: A web-based tool to assess patient reported outcomes (PROs) in women with metastatic breast cancer (MBC): Preliminary results [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-12-09.

Background: The bone modifying agents (BMAs), bisphosphonates, reduce risk of cancer recurrence after diagnosis of early-stage breast cancer (EBC), particularly in postmenopausal women, while another BMA, denosumab, has not been shown to improve EBC outcomes. The 2017 American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO) clinical guidelines recommended consideration of adjuvant bisphosphonates for postmenopausal women with EBC who are candidates for adjuvant systemic therapy. Despite this, small survey-based studies suggest that their prescribing is variable. The goal of this study was to evaluate prescribing of adjuvant BMAs in the United States before and after publication of the 2017 ASCO/CCO guidelines (ACGD). Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database and included 11,740 patients diagnosed with stage I-III breast cancer from 2012 to 2019. We analyzed data on use of BMAs (bisphosphonates or denosumab) in the adjuvant setting, defined as receiving first dose of BMA within 24 months of breast cancer diagnosis and before diagnosis of metastatic disease. Any episodes of BMA use after a metastatic recurrence were excluded. We used Chi-squared test to compare the proportion of patients receiving adjuvant BMAs pre- and post-ACGD. We used univariable and multivariable logistic regression analyses with list-wise missing value deletions to identify predictors of adjuvant BMA prescribing. Results: Of 11,740 patients, 7,391 were diagnosed pre-ACGD and 4,349 post-ACGD. Of the pre-ACGD patients, 545 (7.4%) patients received adjuvant BMAs, and of the post-ACGD patients, 390 (9.0%) patients received adjuvant BMAs. Patients diagnosed post-ACGD were more likely to receive adjuvant BMAs compared with patients diagnosed pre-ACGD (OR 1.23; 95% confidence interval (CI) 1.08-1.42; p=0.002). Of patients age ≥ 50 (n=9,654), 522 of 6,027 (8.7%) and 360 of 3,627 (9.9%) received adjuvant BMAs pre- and post-ACGD, respectively (OR 1.146; 95% CI 0.996-1.319; p=0.0572). In multivariable analysis, age ≥ 50 years at diagnosis, post-menopausal status, having T2 or higher stage at diagnosis, adjuvant endocrine therapy, and coexisting bone loss diagnosis were significantly associated with receipt of adjuvant BMAs (Table 1). Of the 935 patients who received adjuvant BMAs, 615 (65.8%) had denosumab only, 305 (32.6%) had a bisphosphonate only, and 13 (1.4%) received both a bisphosphonate and denosumab during the course of adjuvant treatment. Two patients received an adjuvant BMA as part of a clinical trial. Conclusions: Adjuvant BMA prescribing in our cohort was overall low; there was a modest increase in uptake in patients with EBC diagnosed after the publication of the 2017 ACGD. Older age, higher T stage, endocrine therapy, and coexisting bone loss diagnoses were significantly associated with receipt of adjuvant BMAs. Despite the recommendations for bisphosphonates in the adjuvant setting in EBC, the majority of patients received denosumab only. Considering these findings, further research is required to determine barriers to BMA prescribing and factors that influence physician and patient decisions. There continues to be a need for improved implementation and dissemination of recent guidelines, including the updated 2021 ASCO/CCO recommendations which continue to endorse bisphosphonate use in the adjuvant setting. Table 1: Univariable and multivariable logistic regression analyses to identify predictors of receiving adjuvant BMAs sabs Citation Format: Nicole Odzer, Rachel Jaber Chehayeb, Maryam Lustberg, Cary P. Gross, Julia Foldi. Patterns of adjuvant bone modifying agent use in patients with early-stage breast cancer in the United States [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-02-05.

BACKGROUND: For many older women with early-stage breast cancer, radiotherapy (RT) reduces local recurrence but does not improve overall survival. Risk calculators provide individualized risk estimation; however, there is a paucity of risk calculators specific to the elderly, in whom competing mortality is an important consideration. This study aimed to develop and validate a risk calculator to provide older patients with accurate, personalized risk estimates for local recurrence and mortality. METHODS: We used two existing prediction models, the Early Breast Cancer Trialist Collaboration Group prediction model for breast cancer specific outcomes and ePrognosis for life expectancy, to construct a simulation model to predict individual patient risk. This new model was used to create the “Radiotherapy for Older Women (ROW)” risk calculator. ROW predicts 5-year and 10-year risks of local recurrence and mortality, according to age, comorbidities, functional status, tumor characteristics, and RT receipt. To validate the risk calculator, we collected clinical data from all women older than 65, with newly diagnosed stage I/II breast cancer between 2001 and 2010 at our institution. Discrimination was assessed using c-statistics. Calibration was examined graphically by plotting observed versus predicted probabilities and Hosmer-Lemeshow tests (H-L tests; a p-value RESULTS: Based on our simulation, the 5-year all-cause mortality estimated by ROW ranged from 2% to 79%. ROW also projected the 5-year local recurrence, from 1% to 57% for patients not undergoing RT, and from 0% to 26% for patients undergoing RT. Among the 487 patients we identified in the validation study, the predicted 5-year mortality was 20%, compared to observed 5-year mortality of 16%. The predicted 5-year local recurrence rate was 3.9%, compared to observed 5-year local recurrence rate of 3.1%. The c-statistics were 0.761 for 5-year mortality and 0.775 for 5-year local recurrence. The calibration plot for 5-year local recurrence reflected good agreement between the observed outcomes and predictions; however, the model seemed to over-estimate 5-year all cause-mortality (H-L test; p=0.01). The performance for 10-year outcomes was similar (Table). A beta-version of this risk calculator can be accessed online at https://rtbreastcancer.org. CONCLUSIONS: Based on simulation modeling without cohort data collection, the authors developed an online individualized risk calculator. The outcome estimates projected by the tool were compatible with the observed estimates from real-world data. Such individualized risk provision could facilitate shared decision-making between provider and patient. Future research collecting prospective data to validate our estimates is needed. MortalityLocal recurrencec-statistics95% CIc-statistics95% CI5-year0.761(0.700, 0.822)0.775(0.664, 0.887)10-year0.769(0.722, 0.817)0.721(0.594, 0.849)CI: Confidence interval Citation Format: Shi-Yi Wang, Sarah Mougalian, Brigid Killelea, Jeph Herrin, Liana Fraenkel, Cary Gross, Suzanne Evans. Development and validation of the “radiotherapy for older women” risk calculator [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-07-08.

Hazard Ratios (95% CI) of Overall Mortality by Comparing Early-onset and Later-onset CRCAgeUnadjustedAdjusted for Stage OnlyFully Adjusted except StageFully Adjusted Despite significantly reduced colorectal cancer (CRC) incidence in Americans aged 50 and older since 2000, the incidence of CRC among those Citation Format: En Cheng, Holly N. Blackburn, Kimmie Ng, Donna Spiegelman, Melinda L. Irwin, Xiaomei Ma, Cary P. Gross, Fred K. Tabung, Edward L. Giovannucci, Pamela L. Kunz, Xavier Llor, Kevin Billingsley, Jeffrey A. Meyerhardt, Nita Ahuja, Charles S. Fuchs. Survival for patients with early-onset colorectal cancer - An overall survival analysis from the National Cancer Database, 2004-2015 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 898.

Introduction Although needle biopsy (NB) is recommended prior to breast cancer surgery, the use of NB has been shown to vary according to patient socioeconomic status (SES), operating surgeon, and geographic region. We hypothesized that surgeons who work in the same peer referral network (defined by patient sharing) might have similar practice patterns with regard to NB, and that the magnitude of SES disparities might vary across networks. We therefore examined: 1) SES disparities in the receipt of NB, 2) variation in NB across networks, and 3) whether the association between SES and NB varied across networks. Methods We used the SEER database and 5% Medicare sample to examine all patients with a new diagnosis of breast cancer from 2004 through 2006. We used Medicare claims to construct peer groups of physicians based on patient-sharing ties. Patients were assigned to peer groups based on the surgeon who performed their definitive surgery. We defined a patient as having low SES if she was in the lowest quintile of area-level income. We used hierarchical generalized linear models (HGLM) to assess the association between low SES and receipt of NB, including random effects for the surgeon, peer group, and Hospital Referral Region (HRR). We then allowed the low SES effect to vary across peer groups in order to determine whether the association between SES and NB varied across groups. Results In the full sample of 14,552 patients, 9,498 (65%) received needle biopsy. In bivariable analysis, patients in the lowest income quintile were less likely to receive NB compared to all other patients (59% vs 67%, p Conclusions Patients with low SES are significantly less likely to receive NB prior to breast cancer surgery, and moreover the magnitude of this SES-related disparity varies significantly according to which referral networks are providing care. Future policies to increase NB rates and standardize care for all breast cancer patients may consider the implications of how care for patients with low SES varies across surgical provider networks.Introduction Although needle biopsy (NB) is recommended prior to breast cancer surgery, the use of NB has been shown to vary according to patient socioeconomic status (SES), operating surgeon, and geographic region. We hypothesized that surgeons who work in the same peer referral network (defined by patient sharing) might have similar practice patterns with regard to NB, and that the magnitude of SES disparities might vary across networks. We therefore examined: 1) SES disparities in the receipt of NB, 2) variation in NB across networks, and 3) whether the association between SES and NB varied across networks. Methods We used the SEER database and 5% Medicare sample to examine all patients with a new diagnosis of breast cancer from 2004 through 2006. We used Medicare claims to construct peer groups of physicians based on patient-sharing ties. Patients were assigned to peer groups based on the surgeon who performed their definitive surgery. We defined a patient as having low SES if she was in the lowest quintile of area-level income. We used hierarchical generalized linear models (HGLM) to assess the association between low SES and receipt of NB, including random effects for the surgeon, peer group, and Hospital Referral Region (HRR). We then allowed the low SES effect to vary across peer groups in order to determine whether the association between SES and NB varied across groups. Results In the full sample of 14,552 patients, 9,498 (65%) received needle biopsy. In bivariable analysis, patients in the lowest income quintile were less likely to receive NB compared to all other patients (59% vs 67%, p Conclusions Patients with low SES are significantly less likely to receive NB prior to breast cancer surgery, and moreover the magnitude of this SES-related disparity varies significantly according to which referral networks are providing care. Future policies to increase NB rates and standardize care for all breast cancer patients may consider the implications of how care for patients with low SES varies across surgical provider networks. Citation Format: Killelea BK, Herrin J, Soulos PR, Pollack CE, Forman HP, Yu J, Xu X, Tannenbaum S, Wang S, Gross CP. Socioeconomic disparities in needle biopsy prior to breast cancer surgery across physician referral networks [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-03.

Background: Physical resilience, the ability to resist decline and maintain functional status despite a stressor such as chemotherapy, is a central aspect of successful aging. Understanding clinical and biological factors associated with resilience in older women receiving chemotherapy for early breast cancer may facilitate the development of targeted interventions to maintain an individual’s robustness.Methods: Women age ≥65 (N=406) with Stage I-III breast cancer who were part of a clinical study of neo/adjuvant chemotherapy in older women were recruited from 16 sites (NCT01472094, R01AG037037). The Deficit Accumulation Index (DAI), a continuous score (0-1) calculated based on 51-items from geriatric assessment data (Cohen et al Cancer 2017), was measured before and after receipt of chemotherapy. DAI was categorized as robust (0.0 12 weeks, and 74% received primary prophylaxis with WBC growth factors. Among these 324 robust older women, 253 (78%) remained robust (resilient) at the end of chemotherapy, 63 (19%) became prefrail, and 8 (3%) became frail. In univariate analyses, patients treated with anthracycline (OR=0.63, p=0.09), planned duration of treatment > 12 weeks (OR=0.56, p=0.04), elevated IL-6 ≥2.7 pg/ml (OR=0.59, p=0.05), elevated CRP ≥4.3 μg/ml (OR=0.57, p=0.04), elevated D-dimer ≥0.7 μg/ml (OR=0.61, p=0.07), or at least one elevated biomarker (OR=0.18, p Conclusions: In this cohort of older women with early breast cancer who were robust prior to initiation of chemotherapy, 22% became prefrail or frail at end of treatment. Resilience to chemotherapy was related to inflammatory and coagulation biomarkers. Further research is needed to examine the mechanism underlying why some older women are resilient and retain their robustness after receiving treatment, whereas others experience decline, and further explore the role of inflammation/coagulation in this phenomenon. Table 1. Multivariable associations between baseline blood biomarkers and resilienceResilient (n=253) No. %Non-resilient (n=71) No. %Multivariable OR (95%CI)P value# of elevated biomarkers*064 (25)4 (6)1.00190 (36)29 (41)0.16 (0.05-0.55)0.004255 (22)22 (31)0.14 (0.04-0.49)0.002344 (17)16 (23)0.14 (0.04-0.51)0.003No elevated biomarker64 (25)4 (6)1.00At least one elevated189 (75)67 (94)0.15 (0.04-0.49)0.002*Biomarkers were defined as elevated using the entire cohort median value as cut off points (IL-6 ≥2.7 pg/ml, CRP ≥4.3 μg/ml, and D-dimer ≥0.7 μg/ml). Combined effects of biomarkers were examined by creating a four-level categorical combination variable: 0=all three biomarkers are Citation Format: Mina S Sedrak, Canlan Sun, Hyman Muss, Rachel A. Freedman, Allison Magnuson, Cary P. Gross, William P. Tew, Heidi D. Klepin, Tanya M. Wildes, Efrat Dotan, Tracey O'Connor, Mary Ann Fenton, Ruby Sharma, Andrew Chapman, Cynthia Owusu, Selina Chow, Heeyoung Kim, Vani Katheria, Mark LaBarge, William Dale, Saro Armenian, Susan Neuhausen, Harvey J. Cohen. Inflammation and coagulation biomarkers associated with physical resilience in older women receiving chemotherapy for early breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS8-03.

Background: It is unclear if all breast cancer (BC) patients require baseline left ventricular function (LVEF) assessment prior to anthracycline based chemotherapy (ABC), and the approach is variable in clinical practice. Our objective is to determine the cost effectiveness of obtaining a baseline LVEF assessment prior to (neo) adjuvant ABC in clinical practice. Methods: We performed a retrospective analysis of the Yale Equilibrium Radionuclide Angiography (ERNA) database for 701 breast cancer patients who had a baseline ERNA scan prior to systemic therapy for an initial diagnosis of stages I-IV BC between July 2003 and May 2013. We found that 14 of 701 (2%) patients had a baseline LVEF < 50%. Age, pre-existing cardiac risk factors and coronary artery disease did not predict an abnormal baseline LVEF Results: Assuming that 20% of the unscreened patients with a LVEF < 50% will develop CHF if treated with ABC regimen without management of baseline cardiac dysfunction, the base case incremental cost effectiveness ratio (ICER) was determined to be 18,520 $USD/QALY. Sensitivity analysis suggested that the cost-effectiveness of baseline LVEF assessment is primarily driven by the prevalence of patients with LVEF < 50%, the incidence of CHF in this high-risk patient group if treated with ABC regimen, and time to CHF development. While our analysis did not reveal risk factors predictive of low baseline LVEF, our model's dependence on prevalence of LVEF < 50% demonstrates the importance of risk factor stratification. A hypothetical predictive marker which enriches the prevalence of an abnormal baseline LVEF 5-fold to 10% would result in a cost-effectiveness of 10,990 $USD/QALY. The model is less sensitive to the cost of baseline echocardiogram testing. Conclusion: Baseline LVEF assessment was found to be cost-effective under a willingness-to-pay threshold of $50,000/QALY. Our sensitivity analysis suggests that risk factor-guided LVEF baseline LVEF screening may increase the number of high-risk patients in the treatment population, thus further increasing the cost-effectiveness of baseline LVEF assessment. Citation Format: Safonov A, Hatzis C, Stratton J, Gross CP, Russell R, Pusztai L, Abu-Khalaf MM. A cost effectiveness analysis of baseline left ventricular function assessment for breast cancer patients undergoing anthracycline chemotherapy. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P6-11-03.

Introduction: Approximately 75% of stage I-III breast cancers are hormone receptor (HR) positive for which the standard of care is 5-10 years of adjuvant endocrine therapy, which has been shown to reduce recurrences and improve survival. Unfortunately, up to 40% of patients may not take the prescribed medication daily or may discontinue it early. Mobile health technology provides an opportunity to develop new innovative tools to identify women who are not taking medication as prescribed, to understand their barriers for adherence and to facilitate communication with providers to improve adherence. Methods: The objective of the BETA study was to develop a new bi-directional text messaging application that simultaneously assesses patient adherence to endocrine therapy and provides direct communication to the provider team. Our primary endpoint was to assess feasibility of the application and the secondary endpoints included adherence, side effects and their severity, and quality of life (QOL). The intervention consisted of 3 types of text messages to which patients responded: 1) daily, evaluating adherence, 2) weekly, evaluating medication-related side effects and their severity, and 3) monthly, evaluating barriers to taking the medication. After 3 months of participation, patients completed surveys assessing the tolerability and financial burden of the intervention and adherence to medication. Patients were eligible if they had stage I-III, HR-positive breast cancer, owned a cell phone, and were initiating endocrine therapy. Target enrollment is 100 patients. For comparison, 100 consecutive patients meeting the above criteria were identified retrospectively as historical controls; adherence was assessed via chart review. Results: Between November 2014 and May 2015, 62 patients (mean age 53.5 years) were enrolled and 25 had completed the study. Of those approached, 66% participated. Of those who completed the study, the application was found to be helpful by 63%; specifically, 76% felt the intervention was a reminder to take the medication, 96% felt it was easy to use, and 71% wanted to continue receiving text messages after the study ended. On average, patients spent 12 minutes with the application per week, 0% felt it took up too much time, and only 1 patient incurred text messaging fees. No patients withdrew from the study and only 1 patient did not adhere to treatment (as defined by ≥ 80% adherence). None of the enrolled patients discontinued endocrine therapy, compared to 9% of historical controls. Side effects were common: hot flashes/night sweats (61% of patients), joint aches/pains (56%), and vaginal symptoms (29%) were reported. Severe side effects (reported by 29% of patients) prompted a return phone call to the patient. The study is ongoing and final results will be available by December 2015. Conclusion: We developed a new bi-directional text messaging intervention to assess adherence to endocrine therapy that provides real-time feedback to providers. Patients found the application helpful, easy to use, and not time consuming. Our tool is scalable for large population-based trials. Citation Format: Epstein LN, Jhaveri AP, Han G, Abu-Khalaf MM, Hofstatter EW, Sanft TB, DiGiovanna MP, Silber AL, Adelson KB, Chung GG, Pusztai L, Gross CP, Mougalian SS. Development of an interactive text messaging tool to improve adherence with adjuvant endocrine therapy: Breast cancer endocrine therapy adherence (BETA) pilot study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-11-03.

Background: Older adults with breast cancer receiving neo/adjuvant chemotherapy are at increased risk for toxicity and dose reductions, often leading to decreased relative dose intensity (dRDI < 85%) and potentially compromised chemotherapy benefits. Identifying which older patients are projected to have dRDI with standard regimens could help to optimize systemic treatment delivery and completion. Methods: We prospectively enrolled patients aged ≥ 65 who were starting neo/adjuvant chemotherapy for HER2-negative, stage I-III breast cancer. Geriatric assessment and clinical variables were captured at baseline. Chemotherapy regimen, dosing, and treatment-related modifications (reductions, delays, discontinuation) were also captured. RDI was calculated as the ratio of actual dose delivered to intended dose. Our primary outcome was dRDI, which we defined as RDI < 85% (associated with poorer survival, Bonadonna et al. NEJM 1995). Bivariate logistic regression for dRDI was performed to elucidate the relationship with baseline factors. Stepwise regression was used to identify the significant factors that are independently associated with dRDI. Results: Of 323 patients (median age 69, range 65-86), 216 had HR+/HER2- breast cancer and 107 had triple negative breast cancer (TNBC). Patients were treated with taxotere and cyclophosphamide [TC] (47%), anthracycline-based regimens (46%), and cyclophosphamide, methotrexate, and 5-fluorouracil [CMF] (7%). Overall, the mean RDI was 90.1% (median 100%, range 16.7%-100%), and 69 patients (21%) had dRDI (i.e. RDI 70, higher stage (II/III), use of non-TC regimens (anthracycline-based or CMF), abnormal liver function, KPS < 90, poor physical function, lack of social support, and cardiac conditions were associated with reduced RDI. Multivariate stepwise regression identified that anthracycline-based or CMF regimens (28% dRDI, OR=3.34, 95% CI 1.77-6.29), age >70 (27% dRDI, OR = 2.01, 95% CI 1.11-3.63), abnormal liver function (41% dRDI, OR = 2.50, 95% CI 1.10-5.66), and KPS < 90 (48% dRDI, OR = 4.31, 95% CI 2.06-9.03) were significantly associated with dRDI. dRDI was significantly associated with grade 3 or higher toxicities, hospitalization, dose reduction, dose delay, and early discontinuation of chemotherapy (all p < 0.001). Conclusion: Among older patients receiving neo/adjuvant chemotherapy for HER2-negative early-stage breast cancer, those aged > 70, treated with anthracycline or CMF regimens, with abnormal liver functions, and KPS < 90 were at substantially higher risk for reduced RDI (actual/planned dose) likely due to increased rates of toxicities, hospitalizations, dose modifications, and/or early treatment discontinuation. Future targeted supportive care interventions and/or alternative treatment regimens are needed to improve the delivery of chemotherapy in older patients who are predicted to have dRDI and better understand whether dRDI impacts outcomes in this population. Citation Format: Mina S Sedrak, Can-Lan Sun, Allison Magnuson, Hyman Muss, Rachel Freedman, Cary P Gross, William P Tew, Heidi Klepin, Tanya M Wildes, Efrat Dotan, Tracey O'Connor, Harvey J Cohen, Heeyoung Kim, Vani Katheria, Reena Jayani, Anait Arsenyan, Abrahm Levi, Kemeberly Charles, Arti Hurria, William Dale. Factors associated with decreased relative dose intensity in older adults with early-stage breast cancer receiving chemotherapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD10-10.

Background: Breast cancer care imposes a significant financial burden to U.S. healthcare systems and has become a key focus in the health care debate. Therapies for breast cancer are expensive, and the economic burden of these therapies may be rising due to the rapid introduction of pricey new drugs and techniques. There are limited data on the health care costs of individuals with breast cancer after initial diagnosis and how these costs have changed over time. Methods: We conducted a retrospective analysis of commercially insured adult women with newly diagnosed non-metastatic breast cancer (identified via previously published claims-based algorithms) using 2007-2016 data from a large US health plan available in OptumLabs® Data Warehouse. We included patients with continuous health plan coverage for at least 2 years after initial diagnosis 2007-2014 and assessed how total health care spending and out-of-pocket costs (paid amounts) changed over this time. Costs were adjusted to 2016 US dollars using the general Consumer Price Index. Inpatient, outpatient, and outpatient pharmacy costs were evaluated. A multivariable logistic regression model was used to examine predictors of above average cost (cost > mean for that year of diagnosis). Results: A total of 12,446 newly diagnosed breast cancer patients were identified (mean age, 51.6 years). Forty percent had undergone mastectomy, 38% chemotherapy, and 63% radiation. After adjustment for inflation, total healthcare costs increased 29.7% from 2007 to 2014 (Table 1), with increases primarily observed during the first year after diagnosis. Out-of-pocket costs remained relatively stable, and accounted for 5.3% of the total spending. Approximately 80% of the total costs were related to care received in the outpatient setting. Factors independently associated with above average spending included treatment with mastectomy [OR 1.78 (95% CI 1.5-2.1)], reconstruction [OR 3.0 (95% CI 2.6-3.5)], radiation [OR 4.0 (95% CI 3.4-4.7)] and chemotherapy [OR 18.4 (95% CI 16.6-20.3]. Table 1.Average healthcare spending over time Mean cost during first year after diagnosisMean cost during second year after diagnosisYear of diagnosistotalout-of-pockettotalout-of-pocket2007$80,296.17$4,271.25$16,559.21$1,907.012008$84,126.70$4,445.78$16,785.43$2,205.982009$88,331.45$4,728.42$17,005.68$2,214.932010$91,502.58$5,067.78$17,243.91$2,126.192011$93,826.40$5,089.45$16,862.45$2,027.962012$96,690.06$5,449.91$17,814.09$2,179.262013$104,064.93$5,678.19$17,087.47$2,115.972014$104,169.74$5,620.51$16,714.12$1,590.67 Conclusions: Breast cancer care is increasingly expensive during the first year after diagnosis, and costs are greatest for the recipients of more aggressive treatments. Costs during the second year after diagnosis have remained relatively stable. Citation Format: Ruddy KJ, Sangaralingham LR, Freedman RA, Jemal A, Mougalian SS, Keegan T, Loprinzi CL, Gross CP, Henk HJ, Shah N. Trends in the cost of care for breast cancer among women with commercial insurance [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr PD6-07.

Purpose Hypofractionated whole breast radiation therapy (hypofractionation) for early-stage breast cancer is a treatment innovation that is both supported by high quality randomized trial evidence and clinical guidelines, and is more cost effective and convenient than conventional fractionation. However, whether hypofractionation has been adopted nationally, and what factors are related to its adoption, are unknown. Methods We performed a retrospective study of breast cancer patients in the National Cancer Data Base from 2004-2011 who were treated with radiation therapy and met eligibility criteria for hypofractionation. We used logistic regression to identify factors associated with receipt of hypofractionation (vs. conventional fractionation). Results We identified 13,271 (11.7%) and 99,996 (88.3%) women with early-stage breast cancer who were treated with hypofractionation and conventional fractionation, respectively. The use of hypofractionation increased significantly, with 5.4% of patients receiving it in 2004 compared with 22.8% in 2011 (P50 miles from the cancer reporting facility had increased odds of receiving hypofractionation (OR 1.57 [95% CI 1.44-1.72], p Adoption of hypofractionation was associated with treatment at an academic center (p Adjusted odds ratios for receipt of conventional fractionation vs hypofractionationFeature (Reference)OR (95% CI)p-valueFacility Type (Academic)Community0.38 (0.35-0.42)=803.12 (2.88-3.38)= 46 0001.25 (1.16-1.35)=50 miles1.57 (1.44-1.72)=50 mm0.94 (0.67-1.32)0.76Unknown0.63 (0.42-0.95)0.03 Conclusions The use of hypofractionation is rising and is associated with increased travel distance and treatment at an academic center. Further adoption of hypofractionation may be tempered by both clinical and non-clinical concerns. Citation Format: Elyn H Wang, Sarah S Mougalian, Pamela R Soulos, Charles E Rutter, Suzanne B Evans, Bruce G Haffty, Cary P Gross, James B Yu. The adoption of hypofractionated whole breast irradiation for early-stage breast cancer: A national cancer data base analysis [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-15-04.

Background: Older pts with BC receiving adjuvant tx are at increased risk of chemo tox; however, no BC-specific tool exists to quantify this risk. The Cancer and Aging Research Group (CARG) developed/validated a chemo tox score for older pts with all stages of solid tumor. The goals of this study were to: 1) build upon the CARG score by developing/validating CARG-BC (a BC specific adjuvant chemo tox score for older pts) and 2) evaluate its association with dose modifications, reduced relative dose intensity (RDI) and hospitalizations. Methods: 501 pts age ≥65 with stage I-III BC from 16 sites were accrued (300 development; 201 validation cohort). A pre-chemo assessment captured: CARG chemo tox score, BC tumor/tx variables, and additional geriatric assessment (GA) items. Grade 3-5 chemo tox by NCI CTCAE v 4.0 was captured. Univariate analysis identified chemo tox risk factors (p Results: Among 501 pts, 28 received non-standard regimens and were excluded, leaving 473 evaluable pts: 283 development and 190 validation cohort. The development cohort (median age 70; range 65-85) had Stage I (39%), II (41%), & III (20%) BC with 65% hormone positive, 24% triple negative, 27% Her2 positive; and 37% received an anthracycline. Grade 3-5 tox occurred in 46% (36% grade 3, 10% grade 4, 0.4% grade 5). The CARG score was significantly associated with grade 3-5 tox (p Conclusions: We developed and validated a risk score (CARG-BC) which identifies an older pt's risk for adjuvant BC chemo tox and is associated with dose reduction, delay, reduced RDI, and hospitalization. This tool could be considered as a part of adjuvant tx decision-making. Chemo Tox Risk Score for BC (CARG-BC) Grade 3-5 Tox (%)ScoreCARG-Score: age, # of chemo drugs, dose, hemoglobin, creatinine clearance, hearing, falls, ability to walk 1 block and take meds, decreased social activitiesLow360Middle573High613StageI330II/III552Planned Tx Duration≤ 3 mo.330> 3 mo.584AnthracyclineNo380Yes591Liver FunctionNormal450Abnormal623Ability to Walk a MileNot limited370Limited613Someone to Provide AdviceMost of Time440None to Some of Time613 CARG-BC Risk ScoreLow210-5Middle456-9High7910+ Citation Format: Hurria A, Magnuson A, Gross CP, Tew WP, Klepin HD, Wildes TM, Muss HB, Dotan E, Freedman R, O'Connor T, Dale W, Cohen HJ, Katheria V, Arsenyan A, Levi A, Kim H, Sun C-L. Development and validation of a chemotherapy toxicity (Chemo Tox) risk score for older patients (Pts) with breast cancer (BC) receiving adjuvant/neoadjuvant treatment (Adjuvant Tx): A R01 and BCRF funded prospective multicenter study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr GS6-04.

Objective: Oncotype DxTM (ODx) is a gene expression profile test that is rapidly gaining popularity for its ability to stratify breast cancer patients according to risk of distant recurrence and suggest the potential benefit of adjuvant chemotherapy (CTx). Presently, National Comprehensive Cancer Network (NCCN) guidelines suggest use of ODx for all patients with node negative (or micrometastatic node positive disease), hormone receptor positive breast cancer with a primary tumor measuring over 5mm. However, if risk factors predictive of a high recurrence score (RS) were defined, clinicians would be better able to tailor use of ODx. This study was undertaken to identify standard clinicopathologic factors that correlate with a high RS by ODx, and to determine whether these factors or RS most influenced receipt of CTx. We also measured compliance with NCCN guidelines regarding ODx utilization. Methods and Materials: We performed an IRB approved retrospective review of women with invasive breast cancer treated at Yale Cancer Center from 2008-2012 to identify patients that received ODx testing, and abstracted clinical and tumor characteristics including: age, tumor size, grade, histology, lymphovascular invasion (LVI), number of involved nodes, size of nodal metastasis, presence of extracapsular extension, hormone receptor status (including percent positive), HER2 status (by FISH), RS, and receipt of CTx. The RS was categorized into low (30). We assessed the association between these characteristics and both high RS as well as CTx receipt using Chi squared tests and Wilcoxon ranked test as appropriate. Characteristics with a p-value Results: We identified 432 women with a median age of 58 years. RS was low, intermediate, and high in 56%, 37%, and 7%, respectively. Median tumor size was 1.6cm (range 0.1-13.2). Differentiation was rated as well, moderate, or poor in 32%, 60%, and 8%, respectively. Tumors were hormone receptor positive in 99%. ODx was used outside of NCCN guidelines in 12%. CTx was given to 30% of patients. Younger age, HER2-positivity, LVI, poor differentiation, progesterone receptor positivity (PR+) 50% or less, and RS were associated with receipt of CTx (p< = 0.01) in bivariate analyses. High RS remained independently associated with CTx receipt in multivariate analysis. Poor differentiation, PR+ 50% or less, and HER2-positivity were significantly associated with a high RS (p Conclusions: High RS independently influences recommendations for chemotherapy. Poor differentiation, PR+ 50% or less, and HER2-positivity were associated with a high RS. In the absence of any of these three factors, the likelihood of a high RS is minimal. Noncompliance with NCCN guidelines was observed. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-11-22.

Objectives: To characterize variation in Medicare expenditures on initial breast cancer care across hospital referral regions (HRRs) and to examine the relative contribution of patient characteristics and treatment factors to such variation. Methods: This was a retrospective cohort study using the 2003-2007 Surveillance, Epidemiology and End Results (SEER)-Medicare linked database and the Medicare 5% random sample of non-cancer beneficiaries. Each woman with localized (stage I-III) breast cancer (“case”) was matched to a woman without cancer (“control”) based on HRR, age, comorbidity and Medicare expenditure in the year prior to cancer diagnosis. We defined initial phase of care as the period from two months prior to breast cancer diagnosis (for cases) or index date (for controls) through 12 months after the diagnosis or index date. For each HRR, we calculated the risk-standardized cancer-related Medicare expenditure as the difference in total expenditure between cases and controls, using hierarchical generalized linear models to control for clustering by HRR and adjust for patient characteristics (age, race, comorbidity, and tumor characteristics) and treatment factors. Treatment factors were first assessed by whether different treatments were used (surgery, radiation therapy, chemotherapy, growth factors, and imaging services), and then assessed by specific treatment modalities (breast conserving surgery, radical mastectomy, intensity modulated radiation therapy, external beam radiation therapy, brachytherapy, traditional chemotherapy, biological therapy, growth factors, and imaging). All estimates were reported in 2009 U.S. dollars. Results: There were 35,055 patients with breast cancer and an equal number of controls in our cohort. After excluding HRRs with fewer than 25 cases, there were 78 HRRs in our final analysis. Unadjusted Medicare expenditure on breast cancer-related care averaged $19,207 per patient. HRRs in the highest quintile had an average expenditure of $23,522 per patient, which was $8,032 higher than HRRs in the lowest quintile (mean expenditure = $15,490). Patient characteristics explained only 18.5% of the difference in total cancer-related expenditure between the highest and lowest-expenditure quintiles. Treatment factors explained more variation across the HRRs. Adjustment for whether different treatments were used (e.g., chemotherapy: yes/no; radiation: yes/no) explained an additional 26.0% of the difference between the highest and lowest-expenditure HRR quintiles. In contrast, adjustment for specific treatment modalities (e.g., specific type of radiation) explained 36.4% of the variation. Variation in expenditures on radiation therapy contributed the most to the difference in total cancer-related expenditure between the highest and lowest-expenditure HRR quintiles. Conclusions: There is large regional variation in Medicare expenditures on initial breast cancer care, even after accounting for patient characteristics. Treatment factors (whether cancer therapies were used at all and the specific modality of therapy used) were important contributors to such regional variation. Future work exploring the relation between cancer treatment intensity, costs, and outcomes is warranted. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-07-05.

PURPOSE: Arthralgias occur in up to 50% of women with breast cancer treated with adjuvant aromatase inhibitors (AIs), and are one of the most common reasons for poor adherence to therapy. We examined whether a year-long exercise program improves arthralgias in breast cancer survivors taking AIs. METHODS: Postmenopausal women diagnosed with hormone receptor-positive breast cancer were identified via the Connecticut Tumor Registry. Women who were taking an AI for at least 6-months and reported ≥ 3 out of 10 on the worst joint pain item of the Brief Pain Inventory-Short Form (BPI) were eligible and randomized to either exercise (150 min/wk of moderate-intensity aerobic exercise and twice-weekly supervised resistance exercise sessions) or usual care. The BPI questionnaire was completed at baseline, 6- and 12-months. VO2 max testing and Dual Energy X-ray Absorptiometry (DEXA) scans were also collected at baseline, 6- and 12-months. The primary outcome was change in BPI worst joint pain score between 0 and 12 months. We performed intent-to-treat statistical analyses including analysis of covariance, where each participant's change in outcome was modeled as a function of randomization group RESULTS: Out of 728 women screened that were taking an AI, we randomized 121 women, with 61 women randomized to exercise and 60 women randomized to usual care. Baseline characteristics were comparable between the two groups. Over 12 months, women randomized to exercise attended, on average, 80% ± 14% of the twice-weekly supervised resistance training exercise sessions and participated in an average 146 ± 75 min/wk of at least moderate-intensity aerobic exercise. Worst joint pain scores decreased by 20% at 12 months among women randomized to exercise vs. a 3% decrease among women randomized to usual care (p = .017). Joint pain severity also decreased significantly in exercise vs. usual care groups (p = 0.025), as well as joint pain-related interference (p = 0.005). The exercise intervention also favorably impacted body weight (p = 0.0057) and cardiorespiratory fitness (p = 0.024). Baseline to 12 month changes in BPI joint pain scores (mean (SD)) Baseline Values Change from baseline to 12 months BPI ItemExercisersUsual Carep-valueExercisersUsual Carep-valueWorst Pain5.5 (1.9)5.9 (1.9)0.29-1.1 (2.5)-0.2 (1.6)0.017Pain Severity3.9 (1.6)4.3 (1.8)0.27-0.8 (2.1)0.0 (1.5)0.025Pain Interference2.8 (2.1)2.9 (2.3)0.81-0.8 (2.0)0.2 (1.9)0.005Body weight (kg)80.9 (16.8)74.6 (14.5)0.11-3.5 (6.0)0.1 (3.7)0.0057VO2max (ml/kg/min)23.5 (4.8)23.1 (4.3)0.751.9 (1.9)0.4 (2.7)0.024 CONCLUSION: We found that participating in an exercise intervention led to clinically meaningful improvements in AI-induced arthralgias in breast cancer survivors experiencing moderate joint pain. The intervention also induced favorable changes in body weight and cardiorespiratory fitness, factors that may be linked to incidence and severity of AI-induced arthralgias. Further work is needed to determine whether exercise leads to increased AI adherence and possibly better outcomes in women with breast cancer. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S3-03.

Background: It is unclear if all breast cancer patients require baseline left ventricular function (LVEF) assessment prior to anthracycline chemotherapy, and the approach is variable in clinical practice. While some oncologist do not obtain baseline LVEF assessment in breast cancer patients under the age of 65 without known cardiac risk factors, others continue to perform baseline LVEF assessment in all breast cancer patients who will be receiving adjuvant anthracycline chemotherapy. We sought to determine the prevalence of left ventricular dysfunction in breast cancer patients prior to anthracycline and /or trastuzumab therapy, and to identify the cardiac risk factors associated with a low LVEF. Methods: We performed a retrospective analysis of the Yale Equilibrium Radionuclide Angiography (ERNA) database, which also included self-reported cardiac risk factors. We identified 702 patients who had a baseline ERNA scan prior to anthracycline and/or trastuzumab therapy for an initial diagnosis of stages I-IV BC between July 2003 and May 2013. Our objective was to determine the prevalence rate of an abnormal baseline LVEF defined as Results: Median age was 51(range 26-86); 637 (91%) patients were 65 years of age or younger. BMI Conclusion: The prevalence of abnormal baseline LVEF in patients being considered for anthracycline and/or trastuzumab therapy is small. Age, BMI, pre-existing cardiac risk factors and coronary artery disease were not associated with LVEF Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-09.