bluuebunny/crossref_metadata_2025_split huggingface dataset:
Elevated pretreatment serum activin A and progression-free and overall survival in trastuzumab-treated metastatic breast cancer.
Authors: Lipton Allan , Zubritsky Lindsey , Leitzel Kim , Ali Suhail M. , Koestler Wolfgang , Fuchs Eva-Maria , Costa Luis , Knight Robert D. , Laadem Abderrahmane , Sherman Matthew L. 
Published: March 2020

607 Background: About half of HER2-positive metastatic breast cancer patients will respond tofirst-line trastuzumab-containing therapy, but most will progress within a year. Trastuzumab resistance remains a vexing clinical problem, and better predictive and prognostic biomarkers are needed. Activin A is a TGF-B superfamily member and regulates cell proliferation, apoptosis, differentiation, and immune response. Methods: Serum activin A was measured using ELISA (R&D Systems, Minneapolis, MN) in 60 metastatic breast cancer patients before starting first-line trastuzumab-containing therapy. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox modeling with both continuous and dichotomous (median) serum activin A analyses. Results: Pretreatment serum activin A levels averaged 2376 pg/ml, and had a median of 629 pg/ml and 25th and 75th quartile values of 406 and 1791 pg/ml, respectively. Patients who were hormone receptor negative had significantly higher activin A levels (median 1287 vs 450 pg/ml, p=0.002). Higher serum activin A was significant on a continuous basis for predicting reduced PFS to first-line trastuzumab-containing therapy (p<0.003), and for predicting shorter OS (p<0.0001). When analyzed using a dichotomous (median) cutpoint, the elevated serum activin A cohort had a significantly reduced PFS (HR 2.79, p <0. 002) (median 6.6 mo vs. 31.1 mo) and OS (HR 5.24, p <0.0001) (median 19.6 mo vs. median not reached). In multivariate analysis for PFS with other covariates (age, line of therapy, CA 15-3, and hormone receptor status), activin A was the only significant covariate (p=0.021). In multivariate analysis for OS, activin A (p=0.002) and CA 15-3 (p=0.03) remained significant as prognostic factors. Conclusions: Elevated pretreatment serum activin A predicts reduced PFS and overall survival in metastatic breast cancer patients treated with first-line trastuzumab-containing therapy. Activin A deserves further study as an adverse biomarker, and to select patients most likely to respond to activin A-targeted therapy.
Disparities in the treatment and outcomes of lung cancer among HIV-infected people in Texas.
Authors: Suneja Gita , Shiels Meredith S. , Melville Sharon K. , Williams Melanie A. , Rengan Ramesh , Engels Eric A. 
Published: March 2020

6070 Background: HIV-infected (HIV+) people are at elevated risk for lung cancer and have higher mortality following lung cancer diagnosis than uninfected (HIV-) individuals. The disparity in survival is partly due to advanced stage at diagnosis, but it is unclear whether HIV+ people with lung cancer are less likely to receive cancer treatment, which could worsen survival. Methods: We included adults ≥ 18 years of age with lung cancer reported to the Texas cancer registry (N=156,930). HIV status was determined by linkage with the enhanced Texas HIV/AIDS Reporting System. We compared HIV+ and HIV- lung cancer cases with respect to demographic and clinical characteristics. For non-small cell lung cancer (NSCLC) cases, we identified predictors of cancer treatment (surgery, radiation, and chemotherapy) using logistic regression. We used Cox regression to evaluate the effects of HIV and treatment on lung cancer-specific mortality. Results: Compared with HIV- lung cancer cases (N=156,593), HIV+ lung cancer cases (N=337) were more likely to be young, non-Hispanic black, male, and to have distant stage disease (53.7% vs. 44.4%). HIV+ cases were less likely to receive cancer treatment than HIV- cases (60.3% vs. 77.5%; odds ratio 0.39, 95%CI 0.30-0.52 after adjustment for diagnosis year, age, sex, race, stage, and histologic subtype). In Cox models adjusted for these variables, both HIV infection (hazard ratio [HR] 1.34, 95%CI 1.15-1.56) and lack of cancer treatment (HR 1.69, 95%CI 1.66-1.72) were associated with higher lung cancer-specific mortality. After adjustment for cancer treatment, the association between HIV and lung cancer mortality was attenuated (HR 1.25, 95%CI 1.06-1.47). The association between HIV and lung cancer-specific mortality was stronger among untreated lung cancer cases (HR 1.32, 95%CI 1.01-1.72) than treated cases (adjusted HR 1.16, 95%CI 0.94-1.43; p-interaction=0.34). Conclusions: In this population-based study, HIV+ people with NSCLC were less likely to be treated for lung cancer than their HIV- counterparts. This lack of treatment may be partly responsible for higher cancer-related mortality in HIV+ cases. Further investigation is needed to understand disparities in cancer treatment for HIV+ people.
Beyond the performance rate: Understanding differences in treatment status using the Rapid Quality Reporting System (RQRS).
Authors: McNamara Erica J. , Stewart Andrew , Gay E. Greer , Banasiak James , Eremin Dmitry , Harman Dennis , Flores Rafael , Edge Stephen B. 
Published: March 2020

6088 Background: RQRS is a cancer registry based tool for rapid case ascertainment and real-time care tracking using 5 National Quality Forum approved quality measures for breast (BC) and colon cancer (CC) and 1 American Society of Clinical Oncology, National Comprehensive Cancer Network and Commission on Cancer (CoC) endorsed rectal cancer (RC) measure. RQRS was introduced in 2009 for testing at selected CoC accredited programs. The purpose of this study was to evaluate the proportion of cases with treatment administered for 4 measures where care is concordant with treatment either “administered” or “considered but not administered” (CNA). Methods: Case information on 19,631 breast, colon and rectal cancer patients diagnosed from 2009 – 2010 submitted by 64 RQRS participating sites were reviewed for 4 measures: (1) hormone therapy within 1 year of diagnosis (dx) for AJCC T1c, N0M0, or stage II or II; hormone receptor positive BC (HT), (2) multi-agent chemotherapy within 4 months of dx; age < 70; hormone receptor negative BC (MAC), (3) adjuvant chemotherapy within 4 months of dx; age <80; AJCC Stage III CC (ACT), and (4) radiation therapy within 6 months of dx; age <80; AJCC T4N0M0 or stage III patients receiving surgical resection for RC (AdjRT). Treatment status was defined as concordant (administered or CNA) or non-concordant (NC – not part of planned first course therapy or received after required time frame). Patient demographics and Charlson-Deyo (CD) co-morbidity scores were compared by concordance status using Chi-square tests. Results: The aggregate concordance rate was 83.3%. Among these 889 (5.4%) were CNA. Co-morbidity score was > 0 for 15% of cases. Patients age > 70, with Medicare insurance, CD score > 0 were significantly more likely to be CNA compared to completed or NC. Patient choice was the most common reason for CNA (64%). Conclusions: Among patients treated at RQRS test sites for which RQRS measures applied and care was concordant, only 5% were CNA. Patients over age 70 or with CD > 0 were more likely to have treatment CNA. Inclusion of CNA as concordant care has a minor impact on concordance rates and provides cancer programs with important information for targeting care review and quality improvement programs.
Health-related quality of life assessment in EORTC cancer clinical trials.
Authors: Zikos Efstathios , Coens Corneel , Ediebah Divine Ewane , Quinten Chantal , Greimel Eva , Flechtner Henning , Taphoorn Martin J. B. , Reijneveld Jaap , Koller Michael , Bottomley Andrew 
Published: March 2020

6090 Background: Over the last three decades health-related quality of life (HRQOL) has become an important part of the randomised controlled trials (RCTs) conducted by the European Organisation for Research and Treatment of Cancer (EORTC). This review aims to undertake a descriptive database evaluation of all the HRQOL studies conducted in EORTC since 1980. Methods: The EORTC protocol database (n=785) was reviewed, restricting the search to between 1980 and 2011 (n=735). We investigated the number of HRQOL studies conducted in EORTC trials, the RCTs’ status and the use of HRQOL tools since 1980. Results: 157 protocols with HRQOL assessment were identified involving 70,903 patients. 73 studies ended as defined in the protocol; 27 studies closed early due to poor accrual; 17 are at the final analysis of the primary end point stage; 14 studies are still open to recruitment; 11 are closed to patient entry; and 15 new RCTs are pending activation with HRQOL. The majority of phase III (n=135) and phase II/III (n=9) RCTs have HRQOL as secondary endpoint. EORTC also conducted a number of large scale field studies (n=11), where HRQOL was the primary endpoint. During the early period of 1980 to 1989 HRQOL was assessed in 12 EORTC RCTs by using a small number of HRQOL items, but from 1990 to 2000, HRQOL was assessed in 97 RCTs using more comprehensive HRQOL tools. Between 2001 and 2011 the number of RCTs with HRQOL was 48. The EORTC clinical groups with the most RCTs containing HRQOL were Radiation Oncology (n=22), Genito-Urinary (n=20), Gynaecological (n=16), Breast Cancer (n=16), Lung (n=13), Gastrointestinal, (n=13) and Brain (n=10). The EORTC HRQOL tools were used in 90% of the trials, with other validated tools being used when required. Conclusions: Our review of EORTC RCTs has shown how patient perspective has been constantly considered of major importance in oncology during the last three decades. The inclusion of patient perspective in drug development shows that a more comprehensive HRQOL assessment has taken place over time as better instruments have become available. As the positive value of patient perspective grows to clinicians, regulatory bodies and industry, we expect that EORTC will continue its support by including HRQOL endpoints where appropriate.
Relationship between Oncotype DX testing and the use of chemotherapy in high-risk patients (pts).
Authors: Wong Winston , Cooper Joseph , Richardson Steve , Feinberg Bruce A. 
Published: March 2020

6098 Background: CareFirst BlueCross BlueShield (CFBCBS) insurance network partnered with Cardinal Health Specialty Solutions (CHSS) to develop a cancer care pathway for network physicians in 2008. The program included a recommendation for molecular diagnostic testing with the Oncotype DX assay for pts with early-stage estrogen receptor-positive breast cancer. Based on NCCN guidelines, the pathway suggested adjuvant chemotherapy for all pts with Oncotype DX Recurrence Scores (RS) in the high-risk category. We aimed to determine the RS risk distribution among pts who received Oncotype DX testing and assess the patterns of care that followed. Methods: Using data from CFBCBS, CHSS proprietary claims software, and Genomic Health, we retrospectively identified a cohort of women with breast cancer who were treated on the CFBCBS clinical care pathways program from 8/2008 to 6/2011 and received Oncotype DX testing. We determined the number of pts with a RS value in the low- (RS <18), intermediate- (RS 18-30), and high-risk (RS ≥31) groups along with the number of pts who subsequently received chemotherapy in each category. Results: Of 1174 women who received Oncotype DX testing, 53% of pts were in the low-, 35% in intermediate-, and 12% in the high-risk groups. Five percent of low-, 41% of intermediate-, and 74% percent of pts in the high-risk category were treated with chemotherapy. Twenty-six percent of pts in the high-risk group did not receive chemotherapy. Conclusions: The proportionate use of chemotherapy in the low and intermediate risk groups was as expected based on adjuvant chemotherapy guidelines; however, the underuse of chemotherapy in 26% of high-risk pts was an unexpected finding. Further study is needed to determine: (1) why physicians avoided chemotherapy in 26% of high-risk pts; (2) the overall number of appropriate pts who underwent Oncotype DX testing; and, (3) the tumor characteristics that may have driven the underutilization of chemotherapy in the high-risk population.
Long-term central venous catheter use among cancer patients in administrative claims data.
Authors: Lipitz Snyderman Allison Nicole , Sepkowitz Kent , Elkin Elena B. , Pinheiro Laura C , Son Crystal , Bach Peter 
Published: March 2020

6101 Background: This study’s objective was to examine administrative claims data’s capacity to serve as a surveillance tool for long-term catheter use and related bloodstream infections among cancer patients. Population-based estimates and efforts to track catheter use and infections for this group are limited. As such, we sought to explore catheter use documentation using a cohort of colorectal cancer patients. Methods: We performed a retrospective analysis using the population-based SEER-Medicare dataset for patients 66 years or older diagnosed with colorectal cancer in 2005-2007 (n = 54,870). Insertions and removals of long-term central venous catheters (i.e., tunneled, ports/pumps, peripherally inserted central catheter [PICCs]) were identified by billing codes within 2 years of diagnosis. Factors associated with catheter use were identified in multivariable logistic regression analysis. Results: Findings were consistent with clinical expectations. A total of 11,775 patients (21%) had at least one documented long-term catheter insertion within 2 years of diagnosis, 19% within 6 months. Of those with catheters, approximately 25% had more than one insertion. Sixty-eight percent had at least one port/pump, 8% at least one tunneled catheter, and 33% at least one PICC. Seventy-four percent of catheterized patients had IV chemotherapy. Of patients stages I, II, III, and IV, 10%, 18%, 37%, and 39% had catheters, respectively. Adjusted for other factors, patients with catheters were significantly more likely to be younger, female, black (vs. white), and have comorbidities (vs. none documented in year prior to diagnosis), compared to patients without catheters. By the end of the study, 34% of patients with ports/pumps had documented removal and 42% died (for patients with tunneled catheters, 28% and 52%, respectively). Conclusions: Findings support the use of claims data to capture long-term catheter use in cancer patients, providing a foundation for exploration of its capacity to capture infections. Given extensive documented catheter use (21%), infections may be a significant problem. Claims data may offer a low-burden method for surveillance and study, aiding the development of targeted initiatives.
Assessing the clinical significance of real-time quality of life data in cancer patients treated with radiation therapy.
Authors: Halyard Michele Y. , Tan Angelina D. , Atherton Pamela J. , Wong William , Schild Steven E. , Vora Sujay A. , Ashman Jonathon , Callister Matthew , Ciafone Denise , Zimmerman Pamela , Phillips Paula , Mortarotti Joan , Kruse Janice , Luna Hermenigilda , Olson Jillian , Burris Patricia , Young Brian , Dueck Amylou C. , Sloan Jeff A. 
Published: March 2020

6108 Background: This pilot study evaluated whether providing clinicians with patient(pt) QOL results and symptom management pathways linked to QOL domains at the time of clinical appointment would result in improvement in QOL and treatment (tx) satisfaction. The objective was to obtain preliminary effect size estimates and logistical evidence for design of a larger, definitive trial. Methods: Oncology pts receiving 5-7 weeks of radiotherapy (RT) electronically completed QOL assessments (LASA) at baseline and biweekly prior to seeing clinicians. Was It Worth It (WIWI) and Interpersonal Patient-Provider Relationship (IPPRS) were measured at tx end. Pt endpoints (pro-rated primary endpoint LASA area under the curve (AUC), LASA changes from baseline, and WIWI responses) and clinician endpoints (IPPRS) were compared between the control group (Phase 1: no QOL feedback) and the intervention group (Phase 2: QOL feedback) via Wilcoxon, Chi-square and Fisher Exact tests. There was 80% power to detect a 10 point difference in average AUC. Results: 148 pts enrolled (79 Phase 1, 69 Phase 2) from 11/28/2008 to 09/20/2011 (sites GI (27%), Lung (22%) and Head and Neck (52%)). 68% received RT and chemo. There were consistently moderate effect sizes observed but no statistically significant differences in any AUC nor end of tx change from baseline scores. 20% fewer pts in phase 2 reported clinical deficits in overall QOL (pain). In pts receiving 7 weeks of RT, end of tx average overall QOL, mental well-being (WB), physical WB and pain severity were significantly better in Phase 2 pts. WIWI results showed 76% found participation worthwhile, 95% would participate again, and 92% would recommend the study to others. No differences between groups were found in communication between clinicians and pts (IPPRS). Conclusions: Preliminary estimates indicate potentially clinically significant improvements of moderate effect size in mental and physical WB and pain severity when clinicians received QOL real time with symptom management pathways. Further study is warranted in larger trial setting.
Implications of smoking for quality of life and illness perceptions of lung cancer patients.
Authors: Danson Sarah , Rowland Christine , Eiser Christine , Rowe Richard , Ellis Sue , Crabtree Carol , Horsman Janet M , Wadsley Jonathan , Hatton Matthew , Woll Penella 
Published: March 2020

6113 Background: Adverse publicity about smoking may lead to feelings of guilt among lung cancer patients or pessimism about their future, potentially compromising health-related quality of life (QoL) and adherence with medical advice. QoL is an important outcome in clinical trials, particularly where survival rates are low. We aim to compare QoL and illness perceptions of lung cancer patients depending on smoking history. Methods: Clinical data, measures of QoL (EORTC-QLQ-C30+LC13) and illness perceptions (Brief IPQ – includes items to assess perceived severity, causality, timeline, understanding, emotional impact, and control over illness) were completed by 190 newly diagnosed lung cancer patients (Non-small cell: 75%; Mean age: 68 years, range: 48-85 years; 58% males). Of these, 24% were current smokers, 69% former smokers, and 7% never smoked. Results: Although overall QoL was similar between the three smoker groups, there was a significant effect of smoking status on QoL subscale emotional function (EF)(F(2,168)=4.08,p=.019). Those who never smoked had significantly higher EF than current smokers (p=.03). There was also a significant effect of smoking history on cough (F(2,166);=5.40 ,p=.005) with smokers reporting significantly greater levels than former smokers (p=.004). Smokers were more likely than former smokers (p=.015) to attribute their lung cancer to smoking (F(2,161)=16.49,p<.000). Furthermore, there was a significant effect of smoking on the perceived timeline of illness (F(2,144)=3.33,p=.039), with smokers being more pessimistic about this than former smokers (p=.043). Conclusions: These findings have implications for planning the care of lung cancer patients. In addition to the different treatment needs of smokers and former smokers, smokers may need greater support to cope with the emotional effects of their illness. Our findings suggest that smokers blame their illness on their own behaviour, and have a more pessimistic view of likely survival time, so they may need more encouragement to accept life-prolonging treatments. These results may also inform tailored smoking-cessation advice.
Impact of oncology drug shortages on patient treatment.
Authors: Becker Daniel Jacob , Talwar Sumit , Levy Benjamin , Thorn Molly , Roitman Janna , Blum Ronald H. , Harrison Louis Benjamin , Grossbard Michael L. 
Published: March 2020

6114 Background: Cancer drug shortages increased considerably over the past 5 years, but quantitative analyses of the scope and effects are limited. We assessed the effects of drug shortages on outpatient medication use in a single New York City university hospital. Methods: We examined pharmacy records for drug shortages, defined by the ASHP as supply issues that affect “how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.” We examined outpatient records for all cancer patients treated with infusional antineoplastic and/or supportive medications from 4/2010-9/2010 and from 4/2011-9/2011, and performed subgroup analysis on Aug/Sept 2011, the peak of medication availability problems at our hospital. We compared proportions of patients treated with specific medications in 2010 and 2011 with Pearson’s chi-square test. Results: Twelve medications were in shortage during the study period in 2010 and 22 in 2011. Between 4/1/10 and 9/30/10, 335 cancer patients were treated, and 379 patients were treated between 4/1/11 and 9/30/11. Median patient age was 60 years. Cancer site of origin was comparable between years: breast (40%), GI (15%), lymphoma (10%), GU (8%), and lung (7%). Drugs considered in shortage were used for 170 (50.8%) patients in 2010 and 241 (63.6%) patients in 2011 (p=0.0005). Of 235 patients treated in Aug/Sept 2011, there were 23 (9.8%) documented therapy changes due to shortages, compared with 0 changes among 211 patients treated in Aug/Sept 2010 (p<0.0001). Among patients treated in Aug/Sept 2010 24 (11.4%) patients received paclitaxel and 19 (9.0%) received docetaxel. Among patients treated in Aug/Sept 2011, 11 (4.7%) received paclitaxel and 38 received docetaxel (16.2%), a 69% decrease for paclitaxel and 80% increase for docetaxel from 1 year prior (p=0.009, and p=0.024, respectively). The estimated cost of a single treatment with paclitaxel for 1 patient with BSA 1.75 was $47.59 versus $858.39 for docetaxel, a 1704% increase. Conclusions: Oncology drug shortages affected the majority of patients in our center and increased at an alarming rate. Drug shortages have substantial economic costs and mandate treatment changes that may affect efficacy and toxicity.