bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of breast cancer diagnosis and treatment on sexual dysfunction.
Authors: Assad Hadeel , Badhwar Gauri , Bhama Sameeksha , Vakhariya Cynthia , Goodman Judie R. 
Published: February 2017

125 Background: Sexual dysfunction is a common and under acknowledged disorder in women with breast cancer. Sexual dysfunction in this scenario may be related to multiple factors: psychological distress due to diagnosis, physical decline due to treatment, change in hormonal milieu and/or poor body image. Methods: We assessed the changes in sexual activity after breast cancer diagnosis and treatment in 45 women using an anonymous questionnaire. Data was analyzed via descriptive statistics and paired sample t-test. Results: The age of women in our study ranged between 33-73 years with an average age of 51.6 years. Most of the subjects (89%) had completed chemotherapy and/or radiation therapy however 52% were still on hormonal treatment. Women who were more sexually active prior to breast cancer diagnosis were more likely to experience sexual dysfunction (p = 0.001). Overall, 45% of the women with breast cancer experienced a decline in their sexual health. A greater decline occurred after breast cancer treatment (chemotherapy and/or hormonal therapy) than after diagnosis (p < 0.05). Fifty percent had a decrease in libido and sexual arousal, 40.5% had difficulty in reaching sexual orgasm, and 29% had dyspareunia. Sexual difficulties were addressed by the treating oncologist in 3 out of the 45 women. Conclusions: The data reveals that sexual dysfunction is prevalent in breast cancer survivors. Its onset in concomitance with the diagnosis of breast cancer reflects the psychosocial impact of such a diagnosis. The further decline in sexual health after treatment emphasizes the important adverse effects of chemotherapy and hormone therapy in terms of vaginal dryness, dysparunia and sexual well-being. Despite its prevalence, sexual dysfunction is not commonly addressed in women with breast cancer. [Table: see text]
Ph IB study of LEE011 and BYL719 in combination with letrozole in ER+, HER2- breast cancer.
Authors: Munster Pamela N. , Hamilton Erika Paige , Estevez Laura G. , De Boer Richard H. , Mayer Ingrid A. , Campone Mario , Asano Shizuka , Bhansali Suraj , Zhang Vickie , Hewes Becker , Juric Dejan 
Published: February 2017

143 Background: Activation of the PI3K/AKT/mTOR and cyclin D–CDK4/6–INK4–Rb pathways has been implicated in endocrine therapy resistance in pts with advanced HR+ breast cancer (BC). BYL719 (BYL), an α-isoform selective PI3K inhibitor and LEE011 (LEE), a CDK4/6 inhibitor have demonstrated clinical activity in pts with advanced HR+ BC and advanced solid tumors, respectively. In preclinical HR+ BC models, the combination of LEE, BYL, and letrozole (LET) had enhanced antitumor activity vs either agent alone. Here we report results from Arm (A)1 (LEE + LET) and A2 (BYL + LET) of the Ph Ib part of a Ph Ib/II, 3-arm study of LEE, BYL, and LET in pts with advanced ER+ BC (CLEE011X2107/NCT01872260). Methods: Postmenopausal women with advanced ER+, HER2− BC receive daily oral doses of LEE (3-wks on/1-wk off; A1) or BYL (continuous; A2), plus fixed, daily LET (2.5 mg, continuous), as part of a 28-day cycle. Primary objective: determine the MTD and/or RP2D of A1 and A2. Dose escalation is guided by a Bayesian Logistic Regression Model using the escalation with overdose control principle and real-time PK. Safety and preliminary efficacy are also assessed. Results: As of March 28, 2014, 10 pts have been treated with 600 mg LEE + LET (A1), and 7 pts with 300 mg BYL + LET (A2). One DLT was observed (A1: Grade [G]4 neutropenia; data cut-off: May 15). Common (all grade >30%) study drug-related AEs (all grade/G3–4) were: A1: neutropenia (90%/50%) and nausea (40%/0%); A2: hyperglycemia (57%/14%), decreased appetite, diarrhea, and nausea (43%/0% each). PK for LEE and BYL on Days 1 and 21, and LET on Day 1, are comparable to historic single-agent data. PK of LET at steady state is being evaluated. In A1, 6 pts had known responses: 1 PR, 2 SD, 1 NCRNPD, and 2 PD. In A2 5 pts had known responses: 2 SD, and 3 NCRNPD. Conclusions: LET plus LEE or BYL had an acceptable safety profile and preliminary signs of clinical activity have been observed. Upon determination of the MTD/RP2D in A1 and A2, enrollment into A3 (LEE + BYL + LET) will commence. The randomized Ph II part of the trial will compare LET + LEE or BYL with LET + LEE + BYL. MONALEESA-2 (CLEE011A2301/NCT01958021), a Ph III, randomized, double-blind, placebo-controlled study of LEE + LET in untreated advanced HR+ BC is currently recruiting pts. Clinical trial information: NCT01872260.
Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.
Authors: Bartley Karen , Wildiers Hans , Kim Sung-Bae , Krop Ian E. , Kang Jennifer , Yu Ron , Leung Abraham C. F. , Trudeau Caroline , Gonzalez-Martin Antonio 
Published: February 2017

153 Background: Progression-free survival and objective response rate were significantly improved with T-DM1 vs TPC in TH3RESA. The impact of treatment on quality of life is a key aspect in determining treatment value. Here we present the PRO results from the TH3RESA study. Methods: Patients were randomized 2:1 to T-DM1 (3.6 mg/kg every 21 days) or TPC. Patients were asked to complete the EORTC QLQ-C30 (a 30-item questionnaire assessing symptom bother, functioning and health status) and the EORTC QLQ-BM22 (a 22-item survey evaluating pain from bone metastases) at the start of each cycle. Data from patients with a baseline and ≥1 post-baseline assessment were included; a clinically meaningful difference was defined as ≥10 points. Time to pain progression (TPP) was assessed using the Kaplan-Meier method and Cox proportional-hazards models. Results: A greater proportion of patients in the T-DM1 arm (n=297) vs. the TPC arm (n=117) experienced a clinically meaningful improvement in global health status (57.8% [95% CI; 52.0–63.3] vs. 47.1% [95% CI; 38.4–56.4]). The most bothersome symptoms in the T-DM1 arm as measured by the EORTC QLQ-C30 were fatigue and pain. Over the first 10 T-DM1 treatment cycles, 19–30% of patients reported being impacted “quite a bit” or “very much” by fatigue, and 16–25% by pain. Nausea/vomiting and diarrhea were perceived as more tolerable, with 1–5% and 1–4% of patients reporting “quite a bit” or “very much” impact, respectively. TTP was 2.9 months in the T-DM1 arm vs 3.6 months in the TPC arm, but was not significantly different (HR 1.12 [95% CI; 0.82–1.52], p = 0.495). Mean baseline EORTC QLQ-BM22 pain scores were similar in the T-DM1 (n = 306) and TPC arms (n = 130); (25.4 ± 23.8 [SD]) and (27.3 ± 24.4), respectively. There were no clinically meaningful changes in pain levels from baseline over time in either arm. Conclusions: For patients on T-DM1, the most impactful symptoms were fatigue and pain, while the least bothersome were diarrhea and nausea/vomiting; distribution of severity of impact was relatively stable over the first 10 cycles of treatment. TPP was similar between the T-DM1 and TPC arms. Clinical trial information: NCT01419197.
Qatar experience of standard risk breast cancer screening program (BCSP).
Authors: Bujassoum Salha M. , Alassam Reena , Bugrein Hekmat 
Published: February 2017

18 Background: Qatar has one of the highest age-adjusted breast cancer incidences in the Arab world. Although this is much lower than the incidence in the West. Breast-cancer incidence in Qatar was 45 per 100,000 in 2003 to 2007.These higher incidence rates in Qatar are mainly due to the growing population. The prevalent age group, for Qatari and non-Qatari patients, was age 40 to 50. This suggests that the age-specific incidence of breast cancer in Qatari women is unlike the pattern usually seen in Western nations where median age at diagnosis is 61 years, moreover the diagnosis is often at advanced stages of breast cancer. These factors led to establishment the first hospital based (BCSP) in Qatar. It uses a distributed model of mammography service. The program launched 2008, accepts eligible asymptomatic women at ages 40 to 69. Methods: Retrospective study was done during the period from April 2008 to December 2013. Our aim is to describe our experience of (BCSP) in Qatar and to monitor performance indicators. Our (BCSP) includes an office call and recall as well as triple assessment. We also discuss positive cases in multidisciplinary meeting. Results: Total number of screened women was 4,264 with an increasing participation, year by year. Out of these, Qatari patient’s accounts for 1,145, and non Qatari for 3,119. The age group of cases was (43 to 51). Total breast biopsies were 82, of which 45 were positive of breast carcinomas, (37) invasive ductal carcinoma, (8) noninvasive ductal carcinoma. The invasive cancer detection rate was 8.2 %. The positive predictive value (PPV) was 46%. Sensitivity value has improved from 51% in 2008 to 70% in 2012 as well as specificity value that has increased from 77% in 2008 to 83% in 2012. Conclusions: Public acceptance of (BCSP) in Qatar gradually increased and detection rates are higher than western countries. We’re detecting biologically aggressive tumors at younger age groups. We’ve a unique population and we need to utilize our data and evidence based medicine to guide policy makers and women to make the correct decision towards (BCSP).
A program evaluation of best practice methods to assess integrated health needs for breast cancer survivors.
Authors: Gilmore Katherine Ramsey , Damani Shamsha , King Rachel M , Nelson Bonnie , Austin Allica , Scroggs Sally , Bevers Therese Bartholomew , Zandstra Frances Ann 
Published: February 2017

111 Background: A fundamental tenet of survivorship care is to identify and deliver a wide range of supportive care services. Survivors rely on clinicians to provide integrated care personalized to their own supportive care needs. Yet there is lack of evidence demonstrating which method is “best practice” when assessing survivor’s needs. The aim of our Plan-Do-Study-Act quality improvement project was to determine the best method to identify survivors’ supportive care needs and coordinate services. Methods: We used the appointment list of the Breast Survivorship Clinic to identify 114 adult survivors seen for their initial survivorship visit between January-March 2014. Survivors were asked to complete a questionnaire assessing their needs related to: 1) energy-balance, 2) complementary medicine, 3) lymphedema, 4) psychosocial concerns, 5) sexual health, and 6) tobacco use. Survivors were randomly assigned into 3 groups to identify the best method to assess their health care needs: 1) Mail, 2) Secure Electronic Messaging, and 3) Navigation Visit with Health Educator (HE). Questionnaires for the mail and electronic messaging groups were distributed before being seen in the clinic. Navigation participants completed the questionnaire during the visit with HE. Descriptive statistics were used to describe and compare group characteristics. Results: A total of 114 patients were randomized to complete the assessment by either mail (N=28), secured electronic message (N=50), or during the navigation visit (N=36). The in-person, navigation visit had the highest completion rate (78%) compared to secured message (22%), and mail (7%). An overwhelming majority of survivors’ in the navigation group (93%) indicated they had needs in in at least one of the 6 domains. The top two needs across all groups were nutrition and physical activity. Conclusions: This evaluation suggests the use of a health navigator to guide the survivor through the needs assessment was the most successful way to assess needs of long-term breast cancer survivors. Enhanced navigation during a cancer survivor’s visit can be used to tailor integrative health services, which can improve their well-being and mental health outcomes.
Multidisciplinary breast clinic: Impact on patient satisfaction, timeliness, and guideline concordant care.
Authors: Gomez Caitlin Laurel , Dawson Nicole Ann , Dvorak Robyn Lynn , Foster Nova , Hoyt Anne , Hurvitz Sara A. , Kusske Amy , Tseng Charles Y. , McCloskey Susan Ann 
Published: February 2017

124 Background: After recent implementation of a multidisciplinary breast clinic (MDC) for newly diagnosed women at our institution, we sought to examine the impact of MDC on patient satisfaction, timeliness and guideline concordant care. Methods: Women with newly diagnosed breast cancer at our institution are referred to MDC where they are seen by a team of breast specialists for initial consultation. The MDC model is further facilitated by a patient navigator/coordinator who serves as a single point of contact across disciplines and through the continuum of care. We deployed patient satisfaction surveys querying helpfulness of the care coordinator and satisfaction with seeing breast cancer specialty physicians together in one visit. We further retrospectively analyzed timeliness of care and guideline concordant care since MDC implementation. Results: Patient satisfaction survey response rate was 42% (n=133).On a scale of 1 (very poor) – 5 (excellent), 93% of respondents rated helpfulness of care coordinator as excellent and seeing specialty physicians together in one visit as excellent. 99% of respondents rated these factors as either excellent (5) or good (4). Regarding timeliness, among 202 women with newly diagnosed, non-metastatic breast cancer seen in MDC between June 2012 and April 2014, mean time from neoadjuvant chemotherapy to surgery was 43.1 days (range 26-78 days), from surgery to adjuvant radiation was 39.2 days (range 22-79 days), from surgery to adjuvant chemotherapy was 40.6 days (range 19-89 days), and from adjuvant chemotherapy to radiation was 34.9 days (range 13-67 days). All timeliness metrics well exceeded established national standards of 60-90 days. Regarding guideline concordant care, 94% and 90% respectively received indicated radiation therapy and chemotherapy in accordance with National Comprehensive Cancer Network (NCCN) Guidelines. Those not receiving guideline concordant care either declined, were of advanced age, or had prohibitive co-morbidities. Conclusions: The MDC model, which emphasizes care coordination via a team approach and patient navigation, is associated with excellent patient satisfaction and timely, guideline concordant breast cancer care.
Individual attributions of living longer with HER2+ metastatic breast cancer: Findings from a community web-based survey.
Authors: Mayer Musa , Sussman Matthew , Masaquel Anthony , Kamath Tripthi , Lai Catherine , Tripathy Debu , Hurvitz Sara A. , Menzin Joseph 
Published: February 2017

197 Background: Advances in targeted therapy have led to an increase in the median overall survival in patients with HER2+ metastatic breast cancer (MBC). However, patient attributions related to living longer have not been studied. Methods: A one-time, web-based survey was administered through multiple US-based breast cancer organizations. The inclusion criteria were being female, age 18+, having HER2+ MBC, and living in the US. The surveys included health related quality of life (HRQL), symptom burden, activities of daily living, satisfaction with medical care, work productivity, and attributes of living longer. To assess beliefs about length of survival with HER2+ MBC, participants were asked to rate the importance of 16 items. Descriptive results were stratified by time since metastatic diagnosis and HRQL. Results: Of 560 attempted surveys, 365 (65%) participants met inclusion criteria. Mean (SD) age was 53.6 (10.5) years, 93% were white, and 27% reported having participated in a clinical trial. 59% of respondents reported living ≥4 years since HER2+ MBC diagnosis. Common reasons patients gave for living longer included: choosing the right doctor/medical team (91%), having a positive outlook on life (79%), and learning about the disease or treatments (79%). Women with <4 years since HER2+ MBC diagnosis were more likely to report having a positive outlook on life (85% vs 76%), using complementary and alternative medicine (45% vs 36%) and exercising regularly (74% vs 66%) compared with those having ≥4 years since diagnosis. Women reporting a better compared with a poorer HRQL reported more frequent regular exercise (73% vs 49%) and more often had a positive outlook on life (86% vs 64%). Conclusions: To our knowledge, this is the first study of women with HER2+ MBC and their attributions about length of survival. Having the right medical team, remaining positive, and being educated about the disease and its treatments were most important to participants. Women reporting better quality of life were more likely to report multiple attributions of living longer. HRQL and patient perceptions about their survival are important factors that should be considered in providing patient-centered care.
Daily rounds on inpatient oncology floor by inpatient hospitalist oncologist and reduced length of stay.
Authors: Mekan Sabeen Fatima , Loen Dan , Raptis George , Budman Daniel R. 
Published: February 2017

228 Background: Hospitalist services have expanded recently resulting in improved patient care and reduced length of stay compared with traditional inpatient services. Methods: We implemented an inpatient oncology hospitalist service with consistent daily rounding by the same team on all patients on the oncology floor in July 2012 and compared the impact on inpatient length of stay (LOS), inpatient mortality, cost saving, 30 day readmission rate and patient satisfaction scores before and after. Data was collected from hospital administration from patient medical and billing records. Results: The changes had an immediate effect on LOS which reduced from 7.30 days to 6.38 days over the next 6 months and further trended down to 6.20 over the next 11 months. Total number of discharges increased from 839 from Jan-Jun 2012 to 947 in Jan-Jun 2013. Decrease in LOS occurred in almost all groups including patients with and without cancer. However, the greatest reduction occurred in patients who were admitted with primary diagnosis related to complications of their cancer from 11.2 days to 9.0 days from Jan-Jun 2012 to Jan-Jun 2013. Inpatient mortality decreased from 37 to 30 from Jan-Jun 2012 to Jan-Jun 2013 and discharges to hospice increased from 42 to 65 patients. The 30 day readmission rate increased slightly from 196 to 222 patients. The most common admission diagnoses remained relatively constant. The payer mix of the patients, administrative structure and staffing on the floor remained unchanged during this time period. Patient satisfaction measured by the overall Press-Ganey scores remained unchanged. Conclusions: Daily consistent rounding of inpatient hospitalist service had a significant positive impact on all patients especially patients admitted with oncologic diagnoses. It also resulted in decrease in inpatient mortality and increased the number of discharges to hospice without significant increase in readmission rate.
Patient-reported outcomes (PROs) from the systemic therapies for HER2-positive metastatic breast cancer (MBC) registry study (SystHERs): Eliciting the patient experience.
Authors: Hurvitz Sara A. , Jahanzeb Mohammad , Kaufman Peter , Mason Ginny , Mayer Musa , Rugo Hope S. , Tripathy Debu , Ogale Sarika , Masaquel Anthony , Yoo Bongin , Beattie Mary , Cobleigh Melody A. 
Published: February 2017

286 Background: Patients with HER2-positive MBC are, on average, living longer. Data are limited on patient-reported quality of life (QoL) and economic burden during these extended survival periods. In accordance with guidelines for comparative effectiveness research in oncology (Basch et al, 2012), SystHERs, initiated in 2012, includes PROs to capture the patient experience. Here we report baseline (at enrollment) PRO results from SystHERs. Methods: SystHERs is a US-based prospective observational cohort study that aims to enroll 1000 patients with HER2-positive MBC within 6 months of metastatic diagnosis. Patients will be followed for 5–8 years.PROs, including QoL, economic burden, and symptoms related to neuropathy, alopecia, and cognition, are collected at baseline and ~90-day intervals during clinic visits, including after disease progression. Results: As of Feb 17, 2014, 319 patients were enrolled, and baseline data from 306 eligible patients are reported. Median time to enrollment since MBC diagnosis was 2.4 months. At least 1 PRO item was completed by 90% of eligible patients. Scale reference ranges (higher scores indicate better status) and median scores at baseline were: overall HRQoL (0–100)=80.0; FACT-B Trial Outcome Index (0–96)=58.0, and the Rotterdam Activities of Daily Living Scale (0–100)=85.7. One hundred patients (40.3%) were employed. These patients reported on average 36% work time missed (absenteeism) and 30% decreased on-the-job effectiveness (presenteeism) due to MBC. Patients reported a median out-of-pocket MBC-related expenditure of $735 in the past 3 months (range $0–11,700). Of this, the median deductible and copay-related cost was $350. Conclusions: To our knowledge, this is the only HER2-positive MBC patient registry that includes comprehensive PROs to supplement clinical data. To date, participation in PROs is high at baseline (90%).QoL and economic burden were consistent with other studies (Cortés et al, 2013; Zafar et al, 2013). Baseline results for ~500 patients are expected by the time of the congress presentation and will include data on symptoms related to neuropathy, alopecia, and cognition. Clinical trial information: NCT01615068.