bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient reported outcomes in older breast cancer survivors.
Authors: Giordano Sharon H. , Liao Kai-Ping Eric , Li Liang , Zorzi Daria , Chavez-MacGregor Mariana , Peterson Susan K. 
Published: May 2020

12072 Background: The majority of breast cancer patients are age 66 years or older at diagnosis, yet little is known about the symptom burden of older breast cancer survivors. Methods: Using the same process as for SEER-Medicare, data from the Texas Cancer Registry (TCR) and Medicare claims were linked. From this TCR-Medicare dataset, patients age 65 years and older at diagnosis, with localized or regional breast cancer, diagnosed in 2012 and 2013, and still alive in 2018 were identified. To assess long-term outcomes, a mailed survey, which included selected questions from the NCI’s PRO-CTCAE question bank, was sent to 4591 eligible patients along with a $10 gift card. Non-responders were sent a follow-up questionnaire at 4-6 weeks and 8-10 weeks after initial mailing. The percentage reporting symptoms, overall and by treatment received, are described. Results: 1594 survivors completed the questionnaire (35% response rate). Median time from diagnosis to survey completion was 67 months. 70% of responders were age 65-74, 26% age 75-84, and 3% age 85+ at diagnosis. 84% were non-Hispanic white, 6% black, and 9% Hispanic. 77% had localized stage disease and 23% had regional disease at diagnosis. 58% had lumpectomy, 36% had mastectomy, and 2% reported no surgery. 77% had ER+ breast cancer. 28% received adjuvant chemotherapy. 48% had Part D claims for adjuvant endocrine therapy. PROs are reported in Table, overall and by use of chemotherapy and endocrine therapy. Conclusions: Older breast cancer survivors, particularly those who were treated with chemotherapy, experience a high symptom burden. [Table: see text]
Financial toxicity among breast cancer survivors with health insurance.
Authors: Landier Wendy , Dai Chen , Sparks Jessica , Anthony Katie Rose , Barrett Jeffrey S. , Hageman Lindsey , Francisco Liton , Rocque Gabrielle Betty , Stringer-Reasor Erica Michelle , Nabell Lisle , Bhatia Smita 
Published: May 2020

12073 Background: Cancer treatment and its sequelae have been associated with financial toxicity in breast cancer survivors, particularly those who have no health insurance. However, the prevalence of financial toxicity in the insured survivors, and the underlying factors are not well understood. Methods: Breast cancer survivors attending a survivorship clinic (University of Alabama at Birmingham) completed a survey assessing demographics, financial toxicity (i.e., material resources; food/housing/energy insecurity), and health-related quality of life (HRQL: SF-36). Clinical characteristics were abstracted from medical records. A multivariable logistic regression model was developed to understand factors associated with financial toxicity; the model included survivor age, race, socioeconomic status, insurance type, marital status, cancer stage, time since diagnosis, current medications, and physical and mental domains of HRQL. Results: The 368 participants (1% male; 67% white, 25% African American, 8% other) were a median of 61y of age (range, 33-86y) and 4.3y post-diagnosis (1-34y) at survey completion; 90% had stage 0-II disease; 34% were single (not currently married/partnered); type of health insurance included private/military (57%), Medicare (39%), and Medicaid/self-pay (4%). Overall, 31% reported financial toxicity; 26% endorsed not being able to live at current standard of living > 2 mo. if they lost all current sources of income; 6% endorsed energy insecurity, 5% endorsed food insecurity, and 4% endorsed housing insecurity. In a multivariable model, financial toxicity was associated with age ≤60y at survey (Odds Ratio [OR] 5.1; 95% confidence interval [CI] 2.0-13.3); household income < $50K/y (OR 5.3; 95%CI 2.5-11.2); being single (OR 2.6; 95%CI 1.3-5.4); and lower physical (OR 2.6; 95%CI 1.2-5.4) and mental (OR 2.2; 95%CI 1.2-4.3) HRQL. Cancer stage, race, time from diagnosis, and insurance type were not associated with financial toxicity. The prevalence of financial toxicity among survivors who were single, ≤60y at survey, and with household income < $50k/y was 79.3%, compared with 6.7% among those who were older, married/partnered, and with higher income. Conclusions: Financial toxicity is prevalent among insured breast cancer survivors several years after cancer diagnosis, and is exacerbated among the younger survivors who are single, with low household income, and endorse poorer physical and mental quality of life. These findings inform the need to develop interventions to mitigate financial toxicity among at-risk breast cancer survivors.
Relationships between worry about dying in patients with advanced cancer and their illness understanding, treatment preferences, and advance care planning.
Authors: Rodenbach Rachel , Althouse Andrew , Smith Thomas J. , White Douglas B. , Chu Edward , Bakitas Marie , Schenker Yael , Arnold Robert M 
Published: May 2020

12080 Background: Patients with advanced cancer often worry about dying, yet little is known about the role their fears play regarding future care. We aimed to explore relationships between patients’ worry about dying and their illness understanding, treatment preference, and advance care planning. Methods: This cross-sectional study uses baseline data from a community-based, primary palliative care intervention trial. Patients had metastatic solid tumors, an Eastern Cooperative Oncology Group performance status of 0-2, and their oncologist “would not be surprised” if they died in the next year. Using patients’ response to “I worry about dying” (not at all, a little bit, somewhat, quite a bit, or very much) from the Functional Assessment of Chronic Illness - Palliative Care survey instrument, univariate and multivariate analyses assessed associations with illness understanding (report of being terminally ill or not), treatment preference (life-extending vs. symptom-focused), and advance care planning (completion of an advance directive or not). We also performed sensitivity analyses substituting “I feel scared about my future” (strongly disagree, disagree, agree, or strongly agree) from the Herth Hope Index for “I worry about dying.” Results: Of 672 patients, 54% were female, 94% white, and 69% currently receiving chemotherapy. 47% reported worrying about dying “not at all,” while 9.7% worried “quite a bit” or “very much.” In regression analysis, those who worried “quite a bit” or “very much” were more likely to describe themselves as terminally ill (adjusted odds ratio (AOR)=1.98, 95% CI=1.10-3.54, p=0.021) and more likely to prefer life-extending treatment over symptom-focused care (AOR=2.61, 95% CI=1.30-5.22, p=0.007) compared with patients who reported not worrying about dying. They also were less likely to have completed an advance directive (AOR=0.49, 95% CI=0.25-0.94, p=0.032). The same relationships were observed using patients’ response to “I feel scared about my future.” Conclusions: Patients with advanced cancer who worry more about dying can affirm they are terminally ill and are more likely to want life-extending treatment over symptom care while less likely to engage in advance care planning. Understanding these patients’ decision making is critical to ensuring that their values are known and understood near the end of life.
Results of a randomized, open-label, multicenter trial to assess the safety, dose, and schedule ofRRx-001(001) in reducing incidence, severity and duration of severe oral mucositis (SOM) inpatients receiving concomitant chemoradiation (CRT) for advanced head and neck cancer (HNC).
Authors: Bonomi Marcelo Raul , Sher David , Blakaj Dukagjin , Kabarriti Rafi , Colvett Kyle , Oronsky Bryan , Sonis Stephen T. , Bianco James A. 
Published: May 2020

12081 Background: SOM occurs in 70% of patients receiving CRT for HNC with consequent pain, treatment interruptions and increased costs of care. Supraphysiologic levels of oxidative stress are key SOM initiators. 001 activates nuclear factor erythroid related factor 2 (Nrf2) increasing expression of multiple antioxidant genes including superoxide dismutase glutathione peroxidase and glutathione S-transferase. This trial examined the effect of dose and schedule on safety and efficacy of 001. Primary efficacy endpoint was duration of SOM (WHO criteria assessed); secondary endpoints included time to onset, incidence grade 4 through 60Gy and 70Gy. Methods: Locally advanced HNC treated with definitive or postoperative CRT (cisplatin + RT) received one of 3 001 schedules: (ARM1) 2 doses/wk for 2 weeks (prior to) CRT. ARMS 2, 3: prior to + 2 doses or 6 doses with CRT respectively or standard of care (SOC). Results: 53 patients randomized, 45 evaluable. Benefit trends for endpoints were consistent across all 3 001 arms with greatest effect size in pre-treatment only, ARM1. Compared to SOC, 001 reduced duration of SOM by 45% (40 vs 22 days). Through 60Gy and 70Gy a reduction of 95% and 79% in duration SOM was also observed (17 vs 1 day, and 23 vs 5 days) respectively. No patients in ARM1 developed grade 4, (0% vs SOC 30%). Side effects were comparable to SOC. Conclusions: In this small, open label trial, 001 demonstrated a favorable risk-benefit profile supported by reductions in overall SOM duration including through 60Gy and 70Gy with no grade ARM1 was most effective suggesting short periods of Nrf2 activation before CRT oxidative stress generation may increase the threshold and buffering capacity of upregulated antioxidants. Larger, blinded trials, confirming the observed dose, schedule and treatment effects are warranted. Clinical trial information: NCT03515538 .
Assessing the impact of antiemetic guideline compliance on prevention of chemotherapy-induced nausea and vomiting (CINV): Results of the Nausea/Emesis Registry in Oncology (NERO).
Authors: Aapro Matti S. , Chrápavá Marika , Curca Razvan-Ovidiu D. , Gales Laurentia , Grigorescu Alexandru Calim , Karlínová Bára , Kellnerová Renata , Petru Edgar , Pluzanski Adam , Rubach Maryna , Steger Guenther G. , Tesarova Petra , Yordanov Nicolay , Walaszkowska-Czyz Anna 
Published: May 2020

12083 Background: Evidence-based antiemetic guidelines offer predominantly consistent recommendations for CINV prophylaxis. However, studies and surveys suggest that adherence to these recommendations is suboptimal. We explored potential inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. Methods: This was a prospective, non-interventional, observational, multicenter study designed to assess overall (0-120 h) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either 1) anthracycline/cyclosphosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK1 receptor antagonist (RA), 5-HT3RA, and dexamethasone (DEX) prior to chemotherapy or 2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HT3RA and DEX prior to chemotherapy as per MASCC 2016 guidelines. CR rates for cohorts deemed to be GCCP and GICP were compared using a chi-square test. Results: A total of 1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23% for all patients. CR rates were significantly higher in patients receiving GCCP versus GICP (Table). Conclusions: Consistent with prior studies, GCCP was very low. The primary endpoint of the study was achieved as there was a significant benefit of almost 10% improved prevention of CINV when administering GCCP. As per MASCC/ESMO guidelines such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines. [Table: see text]
Optimizing management of the oncological patient with pulmonary embolism: Validation of the epiphany index—PERSEO study.
Authors: Sánchez Cánovas Manuel , Cejuela Solís Mónica , De la Haba Vacas Irma , Gómez David , Casado Elía Diego , Fernandez Montes Ana , Morales Giménez Roberto , Biosca Mercedes , Fernández Garay David , Arrazubi Virginia , Sequero Silvia , Sánchez Cendra Cristina , Otero Candelera Remedios , Justo de la Peña Marina , Moreno Diana , De Castro Eva Martinez , Ortega Laura , Muñoz Martín Andres J. , Jiménez-Fonseca Paula , Carmona Bayonas Alberto ,   PERSEO Investigators
Published: May 2020

12085 Background: EPIPHANY is the first algorithm to predict serious complications in both suspected and unsuspected cancer-associated pulmonary embolism (PE), overcoming limitations of previous models. Methods: PERSEO is a prospective multicenter study. We recruited cancer patients with both incidental and symptomatic PE treated between Oct. 2017 and Dec. 2019. The primary aim was to determine the percentage of serious complications in patients at low predicted risk, with at least 3% accuracy. We also compared the predictive parameters of EPIPHANY with other available scores for prediction 15-day serious complications and 30-day mortality. Results: Cohort includes 831 patients (men, 58.6%; median age, 66 years). Most frequent tumors were lung (27.1%), colorectal (19%) and breast (7.8%). 78.6% had stage IV disease, and 77.6% were receiving antineoplastic treatment. EPIPHANY classified 27%, 24% and 49% of patients as low, medium and high risk, respectively. The rate of 15-day serious complications increased significantly across these prognostic categories: 2.67 (95% CI 0.6 - 4.8), 8.9% (95% CI 0.5 - 12.8), and 25.9% (95% CI 21.7 - 30.2), for low, intermediate, and high risk patients, respectively (p<0.001, linear-by-linear test). In comparison with other validated scores, EPIPHANY has a higher negative predictive value, lower negative likelihood-ratio, and comparable sensitivity (Table). Conclusions: The EPIPHANY index is able to identify a subgroup of patients with cancer-associated pulmonary embolism at very low risk of serious complications or short-term mortality, with potential implications for decision making. [Table: see text]
Phase II randomized controlled trial (RCT) of medical intensive nutrition therapy (MINT) to improve chemotherapy (CT) tolerability in malnourished patients with solid tumor malignancies.
Authors: Shusterman Michael , Brar Gagandeep , Klute Kelsey , Cooley Victoria , Rosenstock Alexandra , Hwang Eun Kyeong , Elmonshed Dina , Ruggiero Joseph T. , Ocean Allyson J. , Popa Elizabeta C. , Tagawa Scott T. , Molina Ana M. , Nanus David M. , Scheff Ronald J. , Saxena Ashish , Goncalves Marcus D. , Christos Paul J. , Shah Manish A. 
Published: May 2020

12090 Background: Malnutrition is an underrecognized predictor of inferior cancer related outcomes. Subjective global assessment (SGA), a brief validated survey for malnutrition, may predict increased CT toxicity. This phase II RCT was performed to validate SGA as a predictive tool for malnutrition and to evaluate the impact of MINT on CT associated toxicity. Methods: CT naive pts screened by SGA were assigned to well-nourished (SGA A) or malnourished (SGA B/C) cohorts. Both cohorts were followed for CT delivery, toxicity, quality of life (QOL) by FACT-G, biomarkers, radiology, and survival. SGA B/C pts, stratified by regimen/disease, were randomized 1:1 to MINT vs. usual care. The MINT cohort received weekly registered dietician counseling and symptom assessment over the 8-week study period. Percent standard and planned CT doses were calculated. Wilcoxon rank sum tests were used for differences between groups, log-rank tests for survival, and multivariable linear regression for adjusted comparisons. Results: 186 eligible pts were enrolled (94 SGA A, 92 SGA B/C). SGA A were younger (median age [range]; 63 [22, 89] vs. 70 [22, 91], p = 0.011) and more fit (ECOG 0-1; 96.8% vs. 72.8%, p < 0.001). Baseline QOL was higher for SGA A (median [range], 87 [34, 115]) vs SGA B/C (70 [31, 101], p < 0.001). SGA A was associated with higher CT delivery: median proportion of planned CT (1 [Q1 0.87, Q3 1] vs 0.94 [0.70, 1], p = 0.022) and standard CT (0.91 [0.72, 1] vs. 0.74 [0.57, 0.95] p < 0.001). Adjusted for age/ECOG, SGA A remained associated with > 80% of planned (OR 2.32, p = 0.05) and standard (OR 2.33, p = 0.04) CT. SGA B/C pts (n = 92) were randomized to MINT vs usual care: median nutrition encounters MINT 5.5 vs. usual care 0.5; we observed no differences in CT delivery: median proportion of planned CT (0.91 [0.69, 1] vs. 0.94 [0.74, 1], p = 0.84) and standard CT (0.75 [0.58, 0.96] vs 0.71 [0.52, 0.99], p = 0.59). SGA A was associated with a longer 12-month survival (77.8% [95% CI 69.6%, 86.9%]) vs. B/C (53.3% [42.8%, 66.4%], p < 0.0001; 12-month survival was similar for MINT (52.3% [38.1%, 71.9%]) vs usual care (54.4% [40.2%, 73.6%], p = 0.58). Conclusions: SGA is a validated tool to characterize malnutrition in pts receiving CT. Malnourished pts received significantly less CT, experienced worse baseline QOL, and had worse 12-month survival. Intensive medical nutrition therapy was not associated with differences in CT associated toxicity. Novel nutritional interventions are still needed to improve pt outcomes.
Depression, anxiety, and patterns of mental health care among men with prostate cancer on androgen deprivation therapy (ADT).
Authors: Tsao Phoebe A. , Ross Ryan , Bohnert Amy S. B. , Mukherjee Bhramar , Caram Megan Veresh 
Published: May 2020

12100 Background: ADT is associated with an increased risk of depression and anxiety, raising the concern that a substantial portion of men with prostate cancer need mental health care. We sought to investigate the development of depression or anxiety and subsequent patterns of mental health care in men with prostate cancer on ADT. Methods: Clinformatics DataMart, a claims database of commercially insured patients, was used to identify men with prostate cancer who received ADT between 2001-2015 and had continuous enrollment for 1 year before and 2 years after starting ADT. We determined the rate of incident diagnoses of depression or anxiety and the incident use of mental health treatments - psychotherapy and psychiatric medications (≥ 5 day supply) - after the start of ADT. Results: Among 37,388 men in the final analytic cohort, 11.3% (n=4239, 95% confidence interval (CI) 11.0-11.6%) received new diagnoses of depression or anxiety: 5.8% depression (95% CI, 5.5-6.0%), 3.7% anxiety (95% CI 3.5-3.9%), and 1.8% both (95% CI, 1.7-1.9%). Those who received a diagnosis of depression or anxiety were more likely to be white (68% v. 64%, p<0.01); no differences were noted in age, education, or household income. Among those with a new diagnosis of depression or anxiety, 0.07% received psychotherapy (95% CI, 0.02-0.23%), 34.9% a selective serotonin reuptake inhibitor (95% CI, 33.5-36.4%), 11.6% a serotonin norepinephrine reuptake inhibitor (95% CI, 10.7-12.6%), and 19.9% a benzodiazepine (95% CI, 18.7-21.1%). Conclusions: Among men with prostate cancer receiving ADT, more than 1 in 10 received a new diagnosis of depression or anxiety. Of those, 1 in 5 were introduced to a benzodiazepine, a drug class with risks of dependence, cognitive impairment, falls, and fractures, whereas receipt of psychotherapy was rare. Further investigation into how to improve the mental health care of men on ADT is needed. [Table: see text]
High-dose vitamin D supplementation for cancer-treatment-induced bone loss in 164 breast and prostate cancer patients: A pooled analysis of two randomized controlled trials (RCTs).
Authors: Peppone Luke Joseph , Kleckner Amber , Inglis Julia Ellen , Reschke Jennifer E , Belcher Elizabeth , Kleckner Ian , Xu Huiwen , Lin Po-Ju , Mustian Karen Michelle , Janelsins Michelle Christine , Culakova Eva 
Published: May 2020

12105 Background: Aromatase Inhibitor (AI) therapy and androgen deprivation therapy (ADT) significantly accelerate bone loss and increase fracture risk. Vitamin D (VITD) protects against bone loss, but it is unclear whether the recommended daily allowance (RDA; 600 IU/day for ages 51-70) of VITD is sufficient for cancer patients. Data from two RCTs were pooled to examine the safety and efficacy of high-dose VITD versus the RDA of VITD on bone mineral density (BMD). Methods: 164 breast and prostate cancer patients on AIs and ADT, respectively, with low VITD (<32 ng/ml) were randomized to either high-dose VITD (50,000 IU/week; n=99) or placebo (n=65) for 24 weeks. All subjects received 600 IU/day of VITD. Of the 99 subjects assigned to high-dose VITD, 38 breast subjects also received the Exercise for Cancer Patients (EXCAP) program combining walking and resistance training. Serum VITD and calcium were assessed at weeks 0, 6, 12, 18, and 24. BMD was assessed at the hip and spine via DXA at weeks 0 and 24. The effect of high-dose VITD was tested via ANCOVA model adjusted for cancer type, baseline BMD and VITD. Results: High-dose VITD significantly reduced the amount of hip BMD loss versus the RDA of VITD (high-dose VITD: −0.8% vs placebo: −2.6%; p<0.01) over 24 weeks. Hip BMD loss was greater for subjects on ADT (high-dose VITD: −1.5% vs placebo: −4.1%; p=0.03) than subjects on AI therapy (high-dose VITD: −0.2% vs placebo: −1.7%; p=0.02). Among the high-dose VITD group, there was no BMD difference at the total hip between those who received EXCAP exercise vs no EXCAP (p=0.96). The largest differences in BMD were for those with lower baseline VITD levels (<27 ng/ml) for both total hip (high-dose VITD: −0.6% vs placebo: −3.2%; p<0.001) and femoral neck (high-dose VITD: +0.2% vs placebo: −2.4%; p=0.03). No between-group pooled differences were noted for total spine BMD (high-dose VITD: −0.2% vs placebo: −0.1%; p=0.82). High-dose VITD increased serum VITD without negatively affecting serum calcium (Table). Conclusions: High-dose VITD was safe and effective in significantly reducing hip BMD loss, with the largest benefit in those with lower baseline VITD levels. A phase III RCT is needed to confirm these findings. NCI Funding: K07 CA168911/R21 CA175793/UG1 CA189961/T32 CA102618 Clinical trial information: NCT02064946, NCT01419730 . [Table: see text]