tbuckley/cabot-search huggingface dataset:
Abstract P161: Accelerometer-Measured Physical Activity and Heart Failure Incidence in Women Ages 63-99 Years: The OPACH Study
Authors: Michael J LaMonte, John Bellettiere, Charles B Eaton, Marcia L Stefanick, Andrea Z LaCroix
Journal: Circulation (2019)

Background: The burden of heart failure (HF) is increasing in older adults, yet optimal treatment options are not available. Therefore, prevention efforts are paramount to population HF control. Physical activity (PA) has been associated with lower HF incidence, however few studies have evaluated older women and none have measured PA using accelerometry. We prospectively examined 6,173 multiethnic (White, 49%; Black, 34%; Hispanic, 17%) women ages 63-99 (mean 78.6) without known HF at baseline in the Objective Physical Activity and Cardiovascular Health Study. Methods: Vector magnitude counts/15-sec epoch from hip worn Actigraph GT3X+ triaxial accelerometers (required ≥4 of 7 days with ≥10 hr/day wear time) were used to define time spent in light (LPA; 19-518 counts/15-sec), moderate-to-vigorous (MVPA; ≥519), and total (average VM counts across wear days) PA. Count cutpoints were determined from a calibration study among similarly aged women. Incident HF cases were ascertained by self-report annually and were adjudicated by medical record review. Cases of hospitalized acute decompensated HF were included here. Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for these associations. Results: There were 213 (3.5%) incident HF cases identified during a mean 4.5 year follow-up. Crude HF rates (per 1000 person-years) across PA tertiles were 13.2, 5.7, and 4.9 for total PA; 12.3, 5.4, and 5.8 for light PA; and 14.8, 6.1, and 3.3 for MVPA. After adjusting for awake wear time, age, race, ethnicity, smoking, comorbidities including CHD, diabetes and hypertension, and self-rated health, the HR comparing the highest to lowest tertile was 0.61 (0.42, 0.89) for total PA, 0.69 (0.48, 0.98) for light PA, and 0.39 (0.25, 0.59) for MVPA. After adjusting for these covariates and for PA intensity, among all women the HR for a 30-min/day increment in light PA was 0.93 (0.88, 0.99) and in MVPA was 0.73 (0.59, 0.88). Similar magnitudes of inverse associations with HF risk for light PA and MVPA were seen in women &lt;80 and ≥80 years of age, and in women with low physical function (SF36 score &lt;60) and with higher function (≥60). Inverse associations with HF for light PA and MVPA also were seen in white (HR = 0.94 and 0.78), black (HR = 0.92 and 0.58) and Hispanic (HR = 0.97 and 0.65) women, and in those who were obese (BMI ≥30; HR = 0.93 and 0.81) and not obese (HR = 0.93 and 0.54), although HRs across these stratum were more variable. Results among all women were materially the same after discarding HF cases occurring during the first year of follow-up. Conclusions: Greater levels of accelerometer-measured total, light intensity and moderate-to-vigorous intensity PA were associated with lower incidence of HF in older community-living women. These findings underscore the potential public health relevance of being physically active in later life for primary HF prevention.
Abstract P159: Relationships Between Objectively Measured Physical Activity, Exercise Performance, and Quality of Life in Older Obese HFpEF Patients
Authors: Charles A German, Peter H Brubaker, Benjamin Nelson, Dalane W Kitzman
Journal: Circulation (2019)

Introduction: Heart failure with preserved ejection fraction (HFpEF) is the most rapidly increasing type of heart failure. Markedly reduced exercise capacity (peak VO 2 ) is the primary manifestation of chronic HFpEF and impacts quality of life (QOL); however, its relationship to objectively measured physical activity (PA) levels is unknown. Accordingly, we prospectively measured PA, exercise performance, and QOL in older patients with chronic obese HFpEF. Hypothesis: PA levels would be low in obese HFpEF patients and would be strongly correlated with reduced exercise performance and QOL. Methods: Obese HFpEF patients ≥60 years old (N=58) wore Kenz Lifecorder EX accelerometers to obtain light PA (LPA), moderate-vigorous PA (MVPA), PA energy expenditure (PAEE), and steps. Peak VO 2 and ventilatory anaerobic threshold (VAT) were assessed by cardiopulmonary exercise testing, and six-minute walk distance (6MWD) was assessed using the Guyatt method. QOL was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), Minnesota Living with Heart Failure Questionnaire (MLHF), and Short Form 36 (SF-36). Pearson correlations were performed to examine relationships between PA, exercise performance, and QOL. Results: Patients were 68.0±5.7 years old, 78% (45 of 58) female, 59% (34 of 58) white, obese (BMI 39.1±6.1 kg/m 2 ), and had predominantly NYHA class II symptoms (62%, 36 of 58). Patients had low PA levels with 33.4±12.6 min/day of LPA, 10.4±6.7 min/day of MVPA, 3785±1436 steps/day, and a PAEE of 147±57 kcal/day. Patients also had low exercise performance with peak VO 2 of 14.4±2.7 ml/kg/min, VAT of 9.7±1.9 ml/kg/min, and 6MWD of 410±75 meters. LPA (r=0.32, p=0.014) and steps/day (r =0.30, p=0.022) were modestly correlated with peak VO 2 , but MVPA and PAEE were not. All PA measures were moderately correlated with 6MWD (r=0.41-0.49, all p&lt;0.002). None of the PA measures were correlated with any of the QOL assessments (KCCQ r=0.00-0.15, p=0.25-0.99; MLHF r=-0.13-0.00, p=0.33-0.99; SF-36 r=0.05-0.11, p=0.41-0.70). Conclusion: Obese HFpEF patients had low levels of objectively measured daily PA and low exercise performance. Contrary to our hypothesis, PA levels were only modestly correlated with exercise performance including peak VO 2 and 6MWD. PA was not correlated with any assessment of QOL. This indicates that measures of PA, exercise capacity, and QOL assess different aspects of the patient experience in obese HFpEF and are largely independent of each other. While each remains a valid potential target for intervention, they should not be considered interchangeable.
Single institution experience with neoadjuvant chemotherapy in stage IB2 cervical cancer in Peru.
Authors: Luis Alberto Mas Lopez
Journal: Journal of Clinical Oncology (2015)

e16505 Background: Cervical cancer is the most common malignancy among women in Peru. Neoadjuvant chemotherapy followed by radical surgery could represent an alternative to concurrent chemoradiation in stage IB2 cervical cancer; however, its role is still unclear. Methods: We retrospectively analyzed the clinical records of stage IB2 cervical cancer patients who received neoadjuvant chemotherapy. All patients were diagnosed and treated at the National Cancer Institute in Peru (Instituto Nacional de Enfermedades Neoplásicas) between 2001 and 2013. The main objective was to determine the response to the neoadjuvant treatment in terms of achieving resectability. Additionally, we assessed clinical downstaging and pathological response. Results: Forty-three cases were found. Median age at diagnosis was 38 years old (range 26-58), 31 patients (91%) had begun sexual intercourse at age 19 or younger, 42 patients (97.7%) had tumors greater than 4cm. Cisplatin based chemotherapy was used in all the patients and Cisplatin 100mg/m2 with Paclitaxel 175mg/m2 every three weeks was the regimen most commonly administered (83,7%). Thirty-four patients (81%) received an average of three cycles of treatment. Clinical response was observed in 30 patients (70%). Thirty-one patients (72.1%) underwent surgery; radical hysterectomy was performed in 29 patients (67.4%), systematic pelvic lymphadenectomy was done in all patients and 2 (4.7%) had a conservative surgical procedures. Examination of pathological specimens revealed complete pathological response in 5 cases (9.6%), and only microinvasive disease in 11 patients (25.5%). Conclusions: Neoadjuvant chemotherapy in stage IB2 cervical cancer achieves important response rates and improves resectability. If this intervention translates in an OS benefit remains to be clarified.
Questioning the status quo: Should Gleason 3+3=6 PCa be considered a “negative core” for pre-RP risk nomograms?
Authors: Joon Yau Leong, Thenappan Chandrasekar, Elwin Tham, Seth Teplitsky, Edouard John Trabulsi, Leonard G. Gomella, Costas D. Lallas
Journal: Journal of Clinical Oncology (2019)

31 Background: Current pre-radical prostatectomy (RP) nomograms predicting RP pathology do not differentiate between Gleason 6 prostate cancer (Gl6 PCa) and clinically significant Gleason 7-10 PCa. As such, use of these nomograms can be problematic. We assess the impact of excluding Gl6 PCa on nomogram and RP outcomes. Methods: Utilizing a prospectively maintained database, all men who underwent prostate biopsy (PBx) prior to RP were identified. Each patient was assessed using the MSKCC Kattan and Briganti nomogram using the following iterations: 1) “Original” [ORIG] (all available core data) and 2) "Selective” [SEL] (only cores Gleason score ≥7). Nomogram outcomes (risk of LNI, ECE, SVI, and OCD), were compared across iterations and stratified based on pre-RP risk classification (3+3 [low], 3+4, 4+3, 8-10 [high]). Clinically significant impact on management [CSIM] was defined as a change in risk of LNI above or below 2% (Δ2) or 5% (Δ5), based on current guidelines recommendations for PLND. Nomogram outcomes were validated using RP pathology. Results: 1118 men met inclusion criteria. Using the Kattan nomogram, when compared to actual RP pathology, the SEL iteration was a better predictor of LNI, ECE and OCD than the ORIG iteration, but not SVI. Using the Briganti nomogram, the SEL iteration was a better predictor of LNI. As for CSIM, the greatest impact was on men with Gl7 PCa. In the 359 Gl 3+4 patients, Δ2 was 3.9-28.13% and Δ5 was 12.81-17.27%. In the 184 Gl 4+3 patients, Δ2 was 0% and Δ5 was 7.61-11.41%. In all cases, the change favored decreased need for PLND. Conclusions: As Gleason 3+3=6 PCa is increasingly being considered an insignificant prostate cancer, its inclusion in established pre-RP nomograms becomes problematic. We find that excluding Gl6 PCa cores from these nomograms can reduce the need to complete a PLND at the time of RP, and more importantly, may better reflect the true extent of cancer. [Table: see text]
Value of serum neuroendocrine markers in evaluation of neuroendocrine prostate cancer: A validation study using metastatic biopsies.
Authors: Panagiotis J. Vlachostergios, Nicolas Peruzzo, Jones Nauseef, Clara Oromendia, Jyothi Manohar, Ana M. Molina, David M. Nanus, Himisha Beltran, Scott T. Tagawa
Journal: Journal of Clinical Oncology (2019)

278 Background: NEPC, de novo or treatment-related in late stage CRPC, is a distinct entity with poor prognosis. Developing non-invasive methods for detection of NEPC is important for clinical practice and trial enrollment. We previously reported on the clinical and genomic characterization of NEPC (Conteduca et al ESMO 2018). A separate study (Aggarwal et al JCO 2018) suggested that low levels of NSE and CgA were associated with a strong NPV for NEPC on biopsy (bx). This study aimed to validate the utility of NSE and CgA in evaluation of NEPC by comparison with met bx. Methods: Our IRB-approved NEPC database was screened for pts who underwent met bx and had concurrent serum NSE, CgA. Clinical data, serum PSA, LDH, ALP, Hb were recorded at time of bx. Comparison of continuous variables between CRPC adeno and NEPC was assessed by nonparametric Kruskal-Wallis test. ROC curve analysis was performed for evaluation of predictive models with serum NE markers. Results: 152 men were identified, median age 71 yrs (49-97). 35 pts had pure/mixed NEPC, while the rest (N=117) had typical adenoca on bx. Half of pts (80/152, 52.6%) received abiraterone or/and enzalutamide. Liver mets were more common in NEPC pts (P=0.001). Median serum NSE (11.2 vs 8.6 ng/mL, P=0.008) and CgA (211 vs 135 ng/mL, P=0.035) were higher in pts with NEPC vs CRPC adeno (Table). Using ROC curve analysis for NSE (normal 3.7-8.9 ng/mL) and CgA (normal 0-95 ng/mL) as independent diagnostic tests, the following cut-offs were identified: NSE 30.1 (Sn: 37%, Sp: 94%, PPV: 34%, NPV: 82%), CgA 170 (Sn: 63%, Sp: 59%, PPV: 23%, NPV: 83%). Conclusions: Our study confirms the potential utility of serum NSE and CgA in excluding a morphological dx of NEPC when below certain thresholds. However, our findings cannot support deferring a met bx in such cases. Larger studies are needed to evaluate for a more robust predictive ability of serum NE markers. [Table: see text]
Patient-reported care coordination and outcomes of colorectal cancer surgery.
Authors: Sarah T. Hawley, Scott E. Regenbogen, Christine Marie Veenstra, Arden M. Morris
Journal: Journal of Clinical Oncology (2015)

6516 Background: Care coordination is an essential component of effective, patient-centered cancer care. Yet little is known about the impact of patient reported care coordination on clinical outcomes, such as postoperative complications following high risk colorectal cancer surgery. Methods: In 2011-13, we surveyed Stage III colorectal cancer patients from Detroit and Georgia SEER registries 4-12 months after diagnosis. The primary outcome was self-report of a postoperative complication. We adapted a validated 6-item scale to assess perceived coordination across the overall continuum of cancer care (range 6-30). We used a separate 7-item scale to assess perceived care coordination specifically pre- and postoperatively (range 7-35). We compared the association between postoperative complications and overall and pre- /postoperative care coordination with chi-square tests. We assessed associations between complications and coordination in each phase of care in separate models, using logistic regression to control for age, race, education and insurance. Results: Among 1465 patients who returned surveys (RR = 66%), 23.1% reported a postoperative complication. Most respondents perceived their care coordination to be good overall (mean: 25.9, SD: 3.7), as well as pre- (mean: 29.5, SD 4.6) and postoperatively (mean: 30, SD 4.3). Older, minority and those with more comorbidities significantly more often perceived poor care coordination (P < 0.001). In adjusted analyses, postoperative complications were inversely associated with perceptions of good care coordination overall (OR: 0.72, 95% CI: 0.59-0.97) and with better pre- and post-operative coordination (OR = 0.96, 95% CI = 0.93-.98; OR = 0.93, 95% CI = 0.91-0.97, respectively). Conclusions: Similar to other large studies, complications in this sample were common after colorectal cancer surgery. Reported care coordination was good for most patients, but less so for certain vulnerable subgroups. Better care coordination was associated with lower rates of surgical complications. Such findings indicate that better care coordination may lead to better clinical outcomes, however further work to confirm and expand these results is needed.
Yield of adequate tissue on research biopsies with pathologic review.
Authors: Elizabeth Eden, Shalu Pahuja, Julia Manzo, Jing Yu, Shannon Puhalla
Journal: Journal of Clinical Oncology (2015)

e17626 Background: Clinical trials are increasingly requiring tissue biopsies in order to further our understanding of tumor biology and mechanisms of drug sensitivity and resistance. Several studies confirm that obtaining tissue for research biopsies is equally as successful as that of diagnostic biopsies, however little is known about the adequacy of this tissue for evaluation. Methods: We reviewed the medical records for 37 patients (pts) enrolled in two phase I trials that mandated paired biopsies. Trial one (single agent veliparib) required collection of at least two core biopsies, while trial 2 (veliparib with carboplatin and paclitaxel) required a minimum of three cores all no less than 18 gauge diameter and 1 cm in length. At least one core was sent for pathologic review to assess for biopsy adequacy. On-site touch prep was also performed in the majority of cases and all pts were assessed by interventional radiology for biopsy feasibility as an eligibility requirement for study entry. Results: Initial biopsy was attempted in 36/37 pts and subsequent paired biopsy in 25/36, most ultrasound-guided by interventional radiology. Most common reason for aborted biopsy attempt on the subsequent biopsy was suspected poor yield, due to response to treatment. Of the 61 biopsies performed, 75% were deemed adequate for evaluation by pathology. Pre-treatment biopsy yield was 80.5% compared to 68% for that of subsequent biopsies. Low quantity/quality and paucity of tumor cells were the most commonly cited reasons for tissue insufficiency. Overall, only 15/37 pts (40%) achieved two adequate paired biopsies. The sites most biopsied were superficial lymph nodes (27%) and liver (23%). Sites of highest and lowest yield overall were the skin (85%) and omentum (62%) respectively. Conclusions: Despite having on site touch prep, interventional radiology review and real time pathologic tissue adequacy assessment, less than half of pts had adequate paired biopsies. We suspect the actual specimen adequacy in research biopsies may be sub-optimal overall and recommend real time pathologic review for adequacy. Additionally, these data suggest that trials may benefit from increasing study enrollment to ensure appropriate power in studies with mandatory research biopsies.
Outcomes analysis for patients taking oral chemotherapy through specialty and retail pharmacy.
Authors: Lukas Halim, Irwin W. Tischler, Thomas Stambaugh, Aran Canes, Saad Aslam
Journal: Journal of Clinical Oncology (2015)

e17772 Background: Specialty pharmacy programs are increasingly used to better manage healthcare outcomes of patient therapy with targeted oral oncology medications. A large US health plan provides a comprehensive array of care delivery services that are closely aligned with its in-house specialty pharmacy. We evaluated whether, compared with retail services, the use of particular specialty pharmacy services is associated with improved oncology medication use and reduced overall healthcare costs. Methods: The study is a retrospective analysis of a health plan–sponsored specialty pharmacy program. A matched sample of patients using specialty pharmacy services and those using retail pharmacies for targeted oral cancer therapies were compared. Patients were identified based on their oral oncology claims experience in 2012 and followed for one year. Primary outcomes were financial, including overall healthcare costs, outpatient costs, medical costs, and pharmacy costs. Engagement with coaching programs was also evaluated. Specialty pharmacy users and retail pharmacy controls were compared with t-tests for continuous variables, chi-square tests for nominal variables, and logistic regression for matching. Propensity scores were used to adjust for confounding in the groups. Results: The final analysis included 260 patients per cohort. The mean medical cost per patient was 13% lower in the specialty pharmacy group ($65,390 v $76,649; difference = $-11,259; P = 0.04) in the follow-up period. The mean inpatient hospital costs ($11,168 v $16,265, difference = $-5,097; P < 0.01) were lower in the specialty group by 45%. Patients in the specialty pharmacy group were more adherent to therapy, 62.6% v 71.9% had a PDC > 80%, (P < 0.01). Further, the specialty pharmacy group was more likely to engage with a specialty management program, 1.1% vs 4.6% (P = .03). Conclusions: Specialty pharmacies appear to improve oral oncology medication adherence and decrease overall healthcare costs, mainly by affecting inpatient hospital utilization.
Abstract P167: Exergaming Experience: Perspectives of Patients With Heart Failure
Authors: Marysol C Cacciata, Lorraine Evangelista
Journal: Circulation (2019)

Background: Heart failure (HF) is a chronic illness that affects the physical and psychosocial well being of individuals afflicted with this debilitating disease. Physical activity in patients with HF is known to have positive outcomes. Exergaming is a new form of physical activity that has gained popularity among older adults and with older individuals with chronic illnesses. This home-based exercise platform has the potential to improve the physical activity in patients with HF. Aims: To explore HF patients perceived facilitators, attitudes and experiences when using an exergame platform at home utilizing the Nintendo Wii sports. This qualitative study was conducted as part of a larger study to determine feasibility and usability of using a home-based exercise program to improve the physical and psychosocial well-being in patients with HF. Methods: Semi-structured face to face interviews were conducted in 13 participants diagnosed with HF (5 women, age range between 35 and 67 years old). The participants were recruited at a university hospital HF clinic in Southern California. Participants were asked about their experience with exergames. Exergaming devices were installed in participants’ homes and they were given advice to use the devices a minimum of 30 minutes a day. The interviews evolved around themes such as acceptance of exergame, usefulness and engagement. Transcribed interviews were analyzed with content analysis. Results: The exergame device was easy to use. The virtual reality environment appeared real. However, participants verbalized challenges with hand-eye coordination in playing some of the games. Not all participants felt improvement in their physical activity. Participants reported eagerness and fun with exergaming but engagement diminished overtime. Greater variation of exergames were identified to reduce monotony. Conclusion: This study provided insight on the value of home-based exercise platform using technology in improving the physical activity of participants with HF. Participants’ perceptions of usefulness, acceptability and engagement are warranted to ensure that exergaming will achieve the intended aim of improving physical activity and ultimately improve the overall well being and health care delivery in this patient population.