bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of cytopathological and histological results in 1,053 fine-needle aspiration cytology of breast lesions performed in a one-stop clinic
Authors: Borget I. , Caramella C. , Balleyguier C. , Suciu V. , Uzan C. , Domont J. , Mathieu M. , Dromain C. , Delaloge S. , Vielh P. 
Published: August 2020

635 Background: Fine-needle aspiration cytology (FNAC) has been used extensively in the diagnosis of breast lesions, but false-negative rates are a matter of concern. However, immediate onsite evaluation of breast lesions, combining FNAC results with clinical and radiological data allows to improve its diagnostic accuracy. The objective of this study was to evaluate the concordance between cytopathological and histological results in a large series of FNAC performed during the first 3-yr period of the dedicated one-stop clinic set up in our institution since 2004. Methods: We reviewed data of all patients (pts) seen in the one stop clinic between May 2004 and March 2007 who had a lesion diagnosed by FNAC and verified by histology. For benign lesions, histological verification of the lesion was mandatory each time there was no perfect concordance between clinico-radiologic features and FNAC results (such as benign FNAC but BI-RAD 5). Pts characteristics, radiological findings, cytopathological and histological (by per-cutaneous biopsy or surgery) results were extracted from the hospital computerized prospectively registered medical records. Results: A total of 1053 nodular breast lesions (mean size: 24±23 mm, BI-RAD ACR 1/2/3/4/5: 2/10/68/283/684) in 1015 pts (mean age: 59±13 years) were studied. FNAC was US-guided in 521 lesions (49.4%). FNAC classified lesions as malignant in 741 (70.4%), benign in 127 (12.0%), suspicious in 143 (13.6%), and unsatisfactory in 42 (4.0%) cases. Among definitive benign or malignant diagnosis, FNAC and histological results showed concordance in 840/868 (96.7%) cases (738 malignant and 102 benign cases). The numbers of false-negative and false-positive lesions were respectively 25/127 (19%) and 3/741 (0.4%). Among the 143 suspicious and 42 unsatisfactory specimens, 114 and 20 were malignant, respectively. Conclusions: FNAC performed in a one-stop clinic allows obtaining an immediate on-site diagnosis of breast cancer with a good concordance with histological results and low rate of unsatisfactory specimens. However, affirming benign lesion requires a multi-disciplinary team: whenever clinico-radiologic features and FNAC results are non concordant, histologic assessment is mandatory. No significant financial relationships to disclose.
Identifying high-priority quality measures for breast cancer quality improvement using data from a nationally representative sample
Authors: Hassett M. J. , Weeks J. C. 
Published: August 2020

6507 Background: We previously developed a simple, data-based strategy for selecting high-priority quality measures, and applied it to practice performance data from eight National Comprehensive Cancer Network (NCCN) centers to identify high-priority measures for breast cancer care. We now seek to evaluate the generalizability of these results by identifying which measures rank highly when practice performance data from a nationally representative sample, rather than a select group of cancer centers, are used. Methods: Using SEER-Medicare data, we assessed practice performance for 9933 women 65–70 years old diagnosed 1998–2002 with non-metastatic invasive breast cancer. For each quality measure, we determined the number of eligible patients, the number who did not receive recommended therapy, and the overall and target (goal) concordance values. We entered these data into a previously described algorithm to derive a numerical prioritization score for each measure. Spearman correlations were used to analyze comparisons between datasets. Results: We were able to evaluate practice performance relative to most (18/30; 60%) of the measures included in our original NCCN analysis. The absence of oral hormone therapy and DCIS pathology data in SEER-Medicare precluded assessments of quality relative to the remaining measures. The highest-ranking measures recommended chemotherapy for hormone-receptor positive tumors >1 cm, axillary node surgery and radiation after lumpectomy for stage I-II cancer, and no radiation after mastectomy for node-negative cancer <5 cm. Excluding hormone therapy and DCIS measures, the 6 highest-ranking measures in the SEER-Medicare and NCCN analyses were identical. Correlation between the prioritization scores for the 18 measures common to both datasets was 0.74. Conclusions: While SEER-Medicare data only include patients >65 and NCCN data only represent select institutions, information from both can be used to identify high-priority quality measures. That the same measures rank highly in both analyses suggests these are comprehensive, generalizable, policy ready national standards, and that this is a valid method for identifying high-priority quality measures. No significant financial relationships to disclose.
Excessive false-positive errors in single-arm phase II trials: A simulation-based analysis
Authors: Tang H. , Foster N. R. , Grothey A. , Ansell S. M. , Sargent D. J. 
Published: August 2020

6512 Background: The use of randomized phase II designs with an experimental arm and a standard-treatment control arm (R2PII) instead of a conventional single-arm design is clearly increasing in oncology. In practice, sample size, related cost issues, the belief that historical controls are adequate, and the use of a standard-treatment control arm in a phase II setting are frequently raised objections to R2PII trials. As the expense and complexity of definitive phase III trials increase, the ability of phase II trials to provide reliable and accurate results is critical. Methods: We investigated the ability of single arm vs R2PII trials to provide accurate conclusions by modeling variability in historical controls, patient outcome drifts independent of the tested therapy, and patient selection effects. Simulations compared R2PII and single-arm designs with binary endpoints under realistic parameters (e.g. alpha = beta = 0.10, historical control success rate = 20%, target success rate = 40%). Results: In the absence of variability in historical controls, estimated false positive and negative rates in both designs mirror the designated specifications. However, even in the presence of a modest drift effect in the population (mean 5% absolute shift in true control success rate), the false positive rate in single-arm designs is inflated two to three fold (to 20%-30%), while the R2PII retains the desired error rates. Greater confidence in historical controls in the single-arm design corrects only a small portion of the deviations. Increasing the sample size in each trial inflates the false positive error rate further to as much as 50%. Varying several sets of parameters gave similar results. Conclusions: In the presence of variability in historical controls, patient drift and/or selection effects, the false positive error rate of a single arm design is unacceptably high. In contrast, the R2PII design is reliable and robust despite the complexities in patient outcome drift and selection effects, and variability in historical control success rates. Given the rapid improvements in outcomes of many tumor types, the R2PII design should be the preferred method to evaluate novel agents in oncology in spite of the associated costs and the use of a reference control arm. No significant financial relationships to disclose.
The effect of pretreatment patient characteristics on the allocation of treatment for advanced epithelial ovarian cancer
Authors: Chase D. M. , Fedewa S. , Chen A. , Ward E. , Brewster W. R. 
Published: August 2020

6514 Background: While the standard treatment of advanced ovarian cancer is maximum cytoreductive surgery followed by adjuvant platinum-based chemotherapy, some patients are treated with neoadjuvant chemotherapy (NCT) with or without surgery and others receive no therapy. The primary objective of this study was to identify pre-treatment characteristics associated with receipt of non-standard treatment. Methods: 11,155 patients with clinical stage recorded were selected from 25,784 patients diagnosed between 2003 and 2005 from the National Cancer Database, a registry sponsored by the American Cancer Society and the American College of Surgeons. Among the 11,155 patients, 9,015 were stage IIIC or IV. 383 (4.25%) were excluded due to missing treatment information leaving 8,632 patients for the analysis. Evaluable variables included demographics, health insurance, Charlson co-morbidity score, area-level income and facility characteristics. Multivariate logistic regression analyses were performed to assess factors associated standard care versus suboptimal care. Results: In this cohort, 5,517 (63.91%) of patients received optimal treatment. In multivariate analyses, Uninsured and Medicaid-insured patients were less like likely to receive optimal treatment as compared to privately insured patients (OR = 0.58, 95% CI 0.46–0.73; OR = 0.61, 95% CI = 0.49–0.76, respectively). Blacks and Hispanics were also less likely receive optimal treatment (OR = 0.60, 95% CI 0.50–0.72, OR = 0.72, 95% CI 0.57–0.90, respectively) compared to whites. Patients with a Charlson comorbidity score of 1, 2, or 3 were also less likely to receive optimal care (OR = 0.84 95% CI 0.74–0.96; OR = 0.46 95% CI 0.34–0.62; OR = 0.27 95% CI 0.13–0.55, respectively). Treatment in a comprehensive cancer facility or teaching hospital compared to community cancer hospitals was associated with optimal treatment (OR = 1.28 95% CI 1.10–1.48; OR = 1.66 95% CI 1.43–1.93). Conclusions: In this large retrospective multi-institutional cohort, approximately one-third of patients with clinical stage III and IV ovarian cancer did not receive optimal treatment. Pretreatment patient characteristics, such as race, insurance status, age, medical cormorbidities, and facility-type, were strongly associated with suboptimal treatment. No significant financial relationships to disclose.
Personalized end-of-life care: Associations between patient preferences and treatment intensity near death
Authors: Wright A. A. , Mack J. W. , Trice E. D. , Balboni T. A. , Block S. D. , Prigerson H. G. 
Published: August 2020

6516 Background: Medical treatment at the end-of-life (EOL) should be responsive to patient values, but research shows it may instead reflect the regional supply of health services and/or physician practice patterns. We sought to determine whether patients' preferences are associated with EOL medical care and place of death. Methods: Coping with Cancer is an NCI/NIMH-funded, multi-site prospective, longitudinal cohort study of patients with advanced cancer, conducted from September 2002-February 2008. Analyses were based upon 317 deceased patients interviewed at baseline and followed until death, a median of 4.4 months later. EOL care was obtained from chart review, and regressed on patients' baseline preferences for life-extending therapy. Analyses were adjusted for significant confounds; i.e., socio-demographics, cancer type, patient denial, EOL discussion, do-not resuscitate (DNR) order, and treatment center. A sub-analysis examined EOL care within three different medical centers to determine whether patients' preferences and treatment intensity varied by region/practice type. Results: 90 of 317 patients (28.4%) reported a desire to receive life-extending therapy at baseline. Patients' preferences did not differ by proximity to death or performance status, but patients who preferred life-extending therapy had higher rates of denial (75.0% vs. 55.6%, p = 0.002) and were less likely to report having an EOL conversation (24.4% vs. 48.9%, p = 0.0002) or a DNR order (24.4% vs. 48.9%, p < 0.0001). These patients were more likely to undergo ICU admission (AOR 4.6, 95% CI 1.9–11.1) and ventilation (AOR 3.0, 95% CI 1.2–7.3), and die in an ICU (AOR 6.7, 95% CI 2.4–18.7) instead of at home (AOR 0.6, 95% CI 0.3–0.9). A sub-analysis of patients treated at Yale, Parkland, and New Hampshire Oncology-Hematology confirmed that patients' preference for life-extending treatment was associated with higher rates of ICU admission in all three centers. Conclusions: Advanced cancer patients' treatment preferences may play a more important role in determining the intensity of medical care at the EOL than previously recognized. Future research should determine whether these preferences are informed and thus reflect patients' true values for EOL care. No significant financial relationships to disclose.
Association between lung cancer survival and pessimistic explanatory style
Authors: Novotny P. J. , Colligan R. , Szydlo D. , Clark M. , Rausch S. , Wampfler J. , Sloan J. A. , Yang P. 
Published: August 2020

6518 Background: Several studies have demonstrated the importance of pessimism in cardiovascular disease. However, this construct has not been well explored in oncology. Methods: This study examined the survival time of 534 adult who were diagnosed with lung cancer. These patients had completed the Minnesota Multiphasic Personality Inventory (MMPI) approximately 18.2 years prior to their lung cancer diagnosis. MMPI Optimism-Pessimism (PSM) scores were divided into high (60 or more) and low scores (less than 60), and log-rank tests and Kaplan-Meier curves were used to determine survival differences. Multivariate Cox models were used for assessing prognostic values of pessimism along with other known predictors for survival outcome. Results: At the time of diagnosis, patients were on average 67 years old, 48% were female, 85% had non-small cell lung cancer (NSCLC), 15% had small cell lung cancer (SCLC), 30% were stage I, 4% were stage II, 31% were stage III/Limited, and 35% were stage IV/Extensive. Patients who exhibited a non-pessimistic explanatory style survived approximately six months longer than patients classified as pessimists. Pessimists have significantly worse survival rates even after adjusting for other known prognostic variables. Conclusions: Among lung cancer patients, having a pessimistic explanatory style was related to surviving on average six months less compared to patients with a non-pessimistic explanatory style. [Table: see text] No significant financial relationships to disclose.
Quality of life (QOL) with sunitinib versus interferon-alfa (IFN-α) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): Final results
Authors: Cella D. , Michaelson M. D. , Cappelleri J. C. , Bushmakin A. G. , Charbonneau C. , Kim S. T. , Li J. Z. , Motzer R. J. 
Published: August 2020

6529 Background: In an international, randomized phase 3 trial (Figlin et al, ASCO. 2008), sunitinib showed superior progression-free survival (the primary endpoint) and objective response rate over IFN-α (11 vs. 5 mo and 47% vs. 12%, respectively; p < 0.000001) as first-line mRCC therapy, with a median overall survival of more than 2 years. Here, we report the final health-related QOL results from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib 50 mg orally once-daily in recurring cycles of 4 weeks on drug and 2 weeks off or IFN-α 9 MU subcutaneously thrice-weekly. QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G), which has 4 subscales, the FACT-Kidney Symptom Index-15 item (FKSI-15), which includes a Disease-Related Symptoms (FKSI-DRS) subscale, and the EQ-5D questionnaire's utility index (EQ-5D Index) and visual analog scale (EQ-VAS). The primary QOL endpoint was FKSI-DRS. Higher scores indicated better outcomes. Patients completed questionnaires on days 1 and 28 of each cycle. Data were analyzed for the intent-to-treat population using mixed-effects models (MM), supplemented with pattern-mixture models (PMM). We also compared QOL of patients in the United States (US) with patients in the European Union (EU; France, Germany, Italy, Poland, Spain and United Kingdom). Results: Patients on sunitinib reported better FKSI-15 and FKSI-DRS scores than those on IFN-α, with a significant difference in the overall means across cycles (4.06 and 2.36, respectively; p < 0.0001; MM). Similarly, differences in means for FACT-G (and all subscales), EQ-5D Index, and EQ-VAS all significantly favored sunitinib (p < 0.05). Based on pre-set, required minimum score differences, between-treatment differences in the mean scores were clinically meaningful for FKSI-15, FKSI-DRS, FACT-G, and the FACT-G functional well-being subscale. Between-treatment differences were similar for both the US and EU populations. Across all analyses, results from PMM were similar to those from MM. Conclusions: Sunitinib provides superior QOL over IFN-α, in addition to superior efficacy, as first-line mRCC therapy. [Table: see text]
Comorbidities in Medicare patients with and without breast cancer
Authors: Danese M. , O'Malley C. , Kim D. , Lindquist K. , Gleeson M. , Griffiths R. , Wyszynski D. 
Published: August 2020

6533 Background: Patients with comorbidities may be at increased risk for adverse effects from treatment. We used the SEER-Medicare linked dataset to see if patients with breast cancer had a higher prevalence and subsequent incidence (after diagnosis) of comorbid conditions compared to patients without breast cancer. Methods: We selected all women with breast cancer across all stages, diagnosed from 1998–2002 with follow up through 2005. Patients were at least 66 years old with at least 12 months of non-HMO Medicare coverage prior to diagnosis. One non-cancer patient was matched to each breast cancer patient on sex and county of residence, and was assigned the cancer diagnosis date of her matched subject. Comorbidities were identified through groups of comorbidity-specific International Classification of Diseases, 9th revision (ICD-9) codes used in Medicare claims. Claims only for diagnostic testing were excluded, and outpatient-based diagnosis codes were required to be present at least twice with at least 30 days in between to be included. Prevalence at baseline (%) and incidence rates (per 1,000 person-years) and their 95% confidence intervals were calculated for each comorbidity. Rates in the non-cancer group were standardized to the age and race distribution of the breast cancer group to control for potential confounding. Results: 52,977 cancer patients met the inclusion criteria. See table for prevalence and incidence estimates. Conclusions: Physicians should be aware that patients with breast cancer have higher prevalence and subsequent incidence of these comorbidities compared to non-cancer subjects. These differences may be related to the diagnostic process, as well as to therapies used in cancer treatment. [Table: see text] [Table: see text]
Preliminary evaluation of quality of psychosocial care indicators: Results from the Quality Oncology Practice Initiative (QOPI)
Authors: Jacobsen P. B. , Kadlubek P. , Neuss M. N. 
Published: August 2020

6534 Background: To gauge the opportunity for improvements in psychosocial care, ASCO's QOPI program tested two new quality indicators in 2008. Similar to other QOPI indicators, these were presented as questions to be answered (yes/no) based on review of patient records: 1) was current emotional well-being assessed within one month of a first visit with a medical oncologist; and 2) was action taken for a patient identified as having a problem with emotional well-being. In addition to examining variability on these indicators, performance of assessments of pain (another QOPI indicator) and emotional well-being were directly compared. Methods: Practices participating in the Spring 2008 QOPI data collection round were included if they reported results for psychosocial care indicators with at least 40 patients. This criterion was met by 96 practices, which provided information on 9,045 patient records. Results: Across practices, rates of assessment of emotional well-being ranged from 0–100% (Mdn = 78%), with 27% of practices achieving rates < 50%. In contrast, rates of assessment of pain ranged from 12–100% (Mdn = 88%), with 9% of practices achieving rates < 50%. Mean rates of assessment of pain (83%) and emotional well-being (70%) differed significantly across practices (t = 4.61, p < 0.001). Problems in emotional well-being were documented in 10% of records. Among these records, rates of documentation of action taken ranged from 0–100% (Mdn = 73%, M = 72%), with 26% of practices achieving rates < 50%. Conclusions: Wide variability in the documentation of psychosocial care was evident among the practices surveyed, with at least 26% showing substantial opportunity for improvement (i.e., performance < 50%). Additional findings suggest that, to date, efforts to promote routine symptom assessment have been more successful for pain than for emotional well being. No significant financial relationships to disclose.
Hospital characteristics associated with surgery for non-small cell lung cancer
Authors: Virgo K. S. , Fedewa S. A. , Chen A. Y. , Stewart A. K. , Flanders W. D. , Ward E. M. 
Published: August 2020

6543 Background: Previous research suggests that black patients are less likely to undergo curative-intent surgery for early stage non-small cell lung cancer (NSCLC) compared to whites, holding all else constant. Among Medicare beneficiaries 65 and older, the likelihood of patients undergoing surgery is significantly reduced in hospitals with racial compositions of > 30% black patients after controlling for hospital and patient characteristics. This study analyzes whether hospital racial composition is associated with curative-intent surgery among early stage NSCLC patients of all ages. Methods: All adult patients ages 19–104 diagnosed with an invasive initial primary early stage (TNM I-II) NSCLC during 2003–2005 were selected from the National Cancer Data Base (NCDB). Facility characteristics were extracted from the NCDB and American College of Surgeons (ACoS) Commission on Cancer (CoC) Facility Information Profile System (FIPS). Hospital racial composition of lung cancer patients, operationalized as percent black, was initially divided into tertiles; sensitivity analyses used dichotomous definitions. Generalized estimating equations with a logistic model were used to control for clustering by facility. Results: Of 52,853 evaluable patients seen at CoC-approved hospitals, blacks were primarily (74%) seen at hospitals with a racial composition of > 11% black patients. Hispanics (72%), non-Hispanic whites (69%), and Asians or other (72%) were primarily seen at hospitals with < 11% black patients. In sensitivity analyses, irrespective of the cutpoint used to classify hospitals by racial composition of black patients (10, 20, or 30%), black patients seen at hospitals with a high black racial composition were significantly less likely to undergo curative-intent surgery than black patients seen at hospitals with a lower black racial composition. After controlling for patient characteristics in multivariate models, however, high black racial composition at the facility level was no longer significant. Conclusions: Hospital racial composition (% black) was not predictive of reduced likelihood of curative-intent surgery among patients > 18 years of age with NSCLC. Patient-level predictors accounted for the majority of the variation in likelihood of curative-intent surgery. No significant financial relationships to disclose.