bluuebunny/crossref_metadata_2025_split huggingface dataset:
Axillary lymph node status in breast cancer staging: What patient and tumor factors affect the accuracy of ultrasound-guided fine needle aspiration?
Authors: Chacko Celin , Reig Beatriu , Koenigsberg Tova 
Published: March 2020

1126 Background: The purpose of the study is to evaluate the accuracy of ultrasound-guided fine needle aspiration (FNA) of axillary lymph nodes(ALNs) in patients with breast cancer and to determine factors that influence accuracy of ultrasound-guided FNA. Methods: Retrospective review of patients with breast cancer who had FNA of ALNs as well as sentinel lymph node excision or complete axillary dissection. Patients treated with neoadjuvant chemotherapy were excluded. 55 axillary FNAs in 54 patients were included in the final analysis. Pathology reports were reviewed for size of the primary tumor, FNA results, number of positive ALNs, and greatest tumor size in ALNs. FNA was performed if a suspicious lymph node was identified. Surgical sentinel lymph node biopsy or full axillary dissection were the reference standard. Micrometastases (< 0.2 mm) and isolated tumor cells in the lymph node were included in the negative group. Atypical and nondiagnostic FNA results were considered negative cytologic results. Significance was analyzed using the Mann-Whitney test. Results: Size of the primary cancer ranged from 0.3 mm to 8.5 cm. The sensitivity of FNA was 73%, with positive predictive value of 97% and negative predictive value of 52%. The NPV of FNA for primary tumors <1 cm, 1.1-2, 2.1-5 and >5 cm is 100%, 36%, 50% and 66% respectively. Correlation of primary tumor size with sensitivity of FNA was not statistically significant. The sensitivity of FNA for lymph nodes with metastatic deposit < 5mm, 6-10mm, 11-15mm, 16-20mm, and 21mm+ is 0%, 57%, 59%, 89%, and 100%, which is statistically significant (p = 0.007). The number of positive ALNs at axillary dissection is not correlated to the sensitivity of FNA. The sensitivity of FNA for 1-3, 4-9 and 10+ positive ALNs is 78%, 64% and 80%. Conclusions: Our findings indicate that FNA of suspicious axillary lymph nodes is valuable even in small tumors, which differs from the literature. The overall negative predictive value of FNA is 52%, so sentinel lymph node biopsy is essential after negative FNA. Sensitivity of FNA increases with the size of the metastatic deposit in the lymph node, but is not correlated to the number of positive ALNs found at dissection.
Breast cancer in older women.
Authors: Pearlstone David B. , Stewart Tyler , Afshari Ashkan , Nguyen Lyly , Garofalo Rosemary 
Published: March 2020

1132 Background: Recent guidelines recommend minimizing breast cancer screening for women over the age of 75. This study examines the presentation and outcome of older patients with breast cancer to determine if increasing screening among older patients may result in better outcomes. Methods: A prospective database at Hackensack University Medical Center was queried for all patients with breast cancer diagnosed between 1/1/2006 and 1/1/2011. Numerical values compared by Student’s t -test; categorical values by Fisher exact test. Median time to events determined by Kaplan-Meier; outcomes compared by log-rank test. Results: 2200 patients were identified (> 75 years, n=335, < 75 years, n=1865). Among the older cohort, mean age was 81 +/- 4 years (range: 75 – 101); mean tumor size was 2.3 +/- 0.1 cm (range: .1 – 12). Most tumors were invasive and localized (in-situ: 12.7%, localized: 57.3%, node positive: 24.0%, metastatic: 5.8%) and most commonly ductal histology (ductal: 77.0%; lobular: 16.6%, mixed:6.2%). Only 10.0% of patients with invasive disease and 29.2% with positive nodes received systemic therapy; 90.2% underwent surgical resection. Disease-free and overall 5 year survival was 54.9% and 62.9% (in-situ: 82.2%; localized: 67.1%; node positive: 57%; metastatic 22%). Older patients had larger tumors (2.30 +/- .11 v. 1.91 +/- .04 cm; p<0.001), more locally advanced (T4) disease (6.7% v. 1.7%, p<.001), more invasive disease (89% v. 84%, p<.01). Older patients had less positive family history (21.7% v. 37.3%, p<.0001). There was no difference between the groups in race, presentation with stage IV disease, tumor grade, lymphovascular invasion, histologic subtype, triple negativity, or nodal positivity. Overall and disease free five year survival were significantly worse for older patients (OS: 90.2% v. 63.9%, p< .0001; DFS: 80.9% v. 54.9%, p<.0001). Conclusions: Breast cancer among older women leads to worse outcomes compared to younger patients, regardless of histology, invasiveness of disease, hormonal status, nodal status or tumor grade. Older women present with more invasive disease, larger tumors and more locally advanced disease, despite having less family history. This implies that continued screening beyond age 75 may lead to less advanced presentation and better outcomes.
Scoring system for prediction of having three or more involved axillary nodes for breast cancer.
Authors: Ahn Soo Kyung , Kim Ji sun , You Jee Man , Shin Hee-Chul , Moon Hyeong Gon , Han Wonshik , Noh Dong Young 
Published: March 2020

1133 Background: Completion axillary lymph node dissection (ALND) is currently the standard of care in the event of a positive sentinel lymph node biopsy (SLNB). However, result from Z0011 indicate that women with a one or two involved axillary nodes and clinical T1-T2 tumors undergoing lumpectomy with radiation therapy followed by systemic therapy do not benefit from completion of ALND in terms of survival. The purpose of this study was to define possible predictors of having three or more involved axillary node to provide information for surgeons making decision about sparing intraoperative frozen section analysis of sentinel lymph node and completion ALND. Methods: We reviewed the records of 1215 patients with clinical T1-T2 invasive breast cancer. None of these patients were in situ cancer on initial gun biopsy nor received neoadjuvant chemotherapy. Factors associated with having three or more involved axillary nodes were evaluated by univariate and multivariate logistic regression analysis. Results: Among 1215 patients, 321 patients had three or more positive nodes. On a multivariate analysis, having three or more positive nodes was associated with primary tumor size by breast US, axillary LN grade according to cortical thickness by US, presence of axillary LN enlargement on chest CT and age. A scoring system to predict the probability of having three or more nodes based on patients’ data and preoperative image findings was developed from the multivariate logistic regression model. The area under the ROC curve was 0.827 (95% CI: 0.793-0.860), and negative predictive value was 90.2% for a score ≤2.7. Similar findings were observed for a validation dataset of 505 patients. Conclusions: Patients with a low probability of having three or more positive nodes can be identified from preoperative image finding. The scoring system developed will be helpful to surgeons making decision about sparing intraoperative frozen section analysis of sentinel lymph node and completion ALND.
A phase III prevention trial of low-dose tamoxifen in HRT users: The HOT trial.
Authors: Bonanni Bernardo , Maisonneuve Patrick , Serrano Davide , Varricchio Clara , Rotmensz Nicole , Cazzaniga Massimiliano , Lazzeroni Matteo , Santillo Barbara , Di Pace Raffaella , Latronico Antuono , Belloni Carlo , Rosselli Del Turco Marco , Segnan Nereo , Masullo Pietro , Andreoli Claudio , Monti Nadia , Vella Alessandro , D'Aiuto Giuseppe , Veronesi Umberto , De Censi Andrea 
Published: March 2020

1500 Background: Primary prevention trials have shown that tamoxifen (T) lowers ER+ breast cancer (BC) incidence, but adverse events are a barrier to its broad use. The Italian Tamoxifen Prevention Trial showed a positive risk/benefit ratio in the subgroup of hormone replacement therapy (HRT) users in the T arm, with fewer BC and no cardiovascular disease (CVD) excess. In a dose-ranging study, T 5 mg/day showed a favorable biomarker modulation in HRT users. We conducted a multicentre, phase III, BC prevention trial in current or de novo HRT users, randomized to either T 5 mg/day or placebo (P) for 5 yrs, with 5yrs follow-up. Methods: The study was powered to detect a 40% decrease of BC on T from an annual rate of 4/1000 on P with 20% dropout and 5y recruitment. All analyses were performed on ITT basis. The cumulative incidence of events was determined using Kaplan-Meier methods. The two treatment groups were compared by using the log-rank test. Hazard ratios (HRs) and 95% confidence intervals were obtained using Cox proportional regression model. All P values were two-sided. Results: Due to the WHI-HRT trial results, recruitment was lower than anticipated, with a total of 1884 subjects being randomized (946 P and 938 T arm, respectively). 79% were >50 years old at study entry. 66% were normal weight, 21% were hysterectomized; 80% were already on HRT at baseline, 53% were on trasdermal route and 28% had 5y-Gail risk>1.5%. At 7.7y mean follow-up, 43 BC were diagnosed, 24 (annual rate 4.1/1000) on P and 19 (3.3/1000) on T (HR 0.80, 95%CI 0.44-1.46). The efficacy of T was greater in luminal-A type (HR=0.32, 95% CI, 012-086). CVD events were rare (including 1 DVT on T), with no statistical difference between arms. A HR of 4.74 (95% CI, 1.96-11.5) was observed for benign endometrial polyps, but no increase of uterine cancers (3 on P vs 1 on T). Menopausal symptoms were more frequent on T, whereas headache was less frequent on T. Conclusions: The combination of low-dose T and HRT is safe and provides a promising way to retain the benefits while reducing the risks of either agent. While the insufficient power of our study prevents firmer conclusions, it supports further studies of low-dose T in the prevention setting.
Diabetes, related factors, and breast cancer risk.
Authors: Boyle Peter , Boniol Mathieu , Koechlin Alice , Robertson Chris , Rosenstock Julio , Bolli Geremia , Autier Philippe 
Published: March 2020

1509 Background: Diabetes and breast cancer are both common conditions in women and may share common risk factors. Methods: To shed clarification on the potential association between diabetes, related factors and breast cancer risk, a comprehensive literature review and formal meta-analysis was carried out, planned, conducted and reported following PRISMA guidelines regarding meta-analysis of observational studies. Variables studies in relation to breast cancer risk were adiposity, physical activity, glycaemic load, glycaemic index, diabetes, IGF-1, fasting glucose, fasting insulin and C-peptide, adiponectin, metformin and glargine use. The Summary Relative Risk (SRR) and the corresponding 95% Confidence Interval (CI) was calculated. Results: For breast cancer at all ages, the calculated risks were as follows: diabetes (SRR=1.23 95% CI (1.12, 1.34); physical activity (SRR=0.88, 95% CI (0.85, 0.92)); glycaemic load (SRR=1.05, 95% CI (1.00, 1.10)); glycaemic index (SRR=1.05, 95% CI (1.00, 1.09)); fasting glucose (SRR=1.14, 95% CI (0.94, 1.37)); serum insulin (SRR=1.26, 95% CI (0.86, 1.84)); c-peptide (SRR=1.29, 95% CI (0.91, 1.82)); adiponectin (SRR=1.16, 95% CI (0.93, 1.46)); metformin (SRR=0.97, 95% CI (0.82, 1.16)); and glargine (SRR=1.10, 95% CI (0.94, 1.30)). An increase of 5 units in Body Mass Index (a weight increase if 14.5 kg in a person 1.70 metres tall) was associated in post-menopausal breast cancer (SRR=1.12, 95% CI (1.08, 1.16)) but not at pre-menopausal ages (SRR=0.83, 95% CI (0.72, 0.95)). Serum insulin was associated with breast cancer at post-menopausal ages but not at pre-menopausal ages whereas with c-peptide there was a significant association at pre-menopausal ages but not post-menopausal. For IGF-1, Hodge’s Standardised Mean Difference (HSMD) was calculated and there was no significant association with breast cancer at all ages (HSMD=-0.026, 95% CI (-0.031, 0.084)), at post-menopausal ages (HSMD=0.007, 95% CI (-0.068, 0.082)) or at pre-menopausal ages (HSMD=-0.065, 95% CI (-0.009, 0.140)). Conclusions: Key risk factors for breast cancer appear to be adiposity and physical activity which are both related to the risk of developing diabetes.
Second malignant neoplasms (SMN) among 18,627 testicular cancer survivors (TCS) after chemotherapy (CHEM) or surgery (SURG).
Authors: Fung Chunkit , Fossa Sophie D. , Milano Michael T , Yu Mandi , Worman Melissa , Travis Lois B. 
Published: March 2020

1536 Background: Increased risks of SMN after radiotherapy (RT) for testicular cancer (TC) are well established. Few population-based studies, however, have focused on SMN risk among a contemporary group of TCS managed initially with non-RT approaches, including CHEM. Methods: Standardized incidence ratios (SIR) of SMN stratified by site and time since TC diagnosis were calculated for 18,627 TCS reported to the SEER program (1980-2008) who initially had CHEM (n=8,058) or SURG (n=10,569) alone without RT, with each cohort accruing 65,398 and 92,681 person-years (PY) of follow-up respectively. Results: After CHEM, significantly increased risks of solid cancers (n=154; SIR 1.3; 95% CI 1.1-1.5; absolute excess risk (AER) 5.4 per 10,000 PY) and leukemias (n=18, SIR 3.9; 95% CI 2.3-6.1; AER 2.0) were observed. Solid cancer risk remained elevated for > 20 yrs, whereas excess leukemias were concentrated within 10 years after diagnosis. SIRs for solid cancers during the <1, 1-4, 5-9, 10-14, 15-19, and 20+ yr periods were 2.0 (95% CI 1.03-3.5), 1.4 (95% CI 0.97-2.0), 0.8 (95% CI 0.5-1.2), 1.3 (95% CI 0.9-1.8), 1.6 (95% CI 1.05-2.2), and 1.5 (95% CI 0.95-2.2) respectively (P-trend 0.5) whereas SIRs for leukemia were 3.2, 9.9 (P<0.05), 2.6, and 2.3 respectively, with no cases reported in the latter 2 intervals. Median latencies to the development of solid cancers and leukemia were 12.5 yr (0.1-28) and 2.5 yr (0.1-14) respectively. Increased site-specific risks were apparent for cancers of liver (SIR 1.9; 95% CI 0.6-4.4); pancreas (SIR 2.1; 95% CI 0.8-4.6); soft tissue (SIR 4.9; 95% CI 2.1-9.7); bladder (SIR 1.9; 95% CI 1.02-3.3); kidney (SIR 2.6; 95% CI 1.4-4.3); brain/CNS (SIR 1.8; 95% CI 0.7-3.7), and thyroid (SIR 3.9; 95% CI 2.1-6.6). Secondary leukemias included 16 non-lymphocytic and 2 lymphocytic leukemias. In contrast, among TCS managed initially with SURG alone, no excess solid cancers were observed (n=198; SIR 1.0; 95% CI 0.8-1.1), albeit an increased risk of leukemia (n=15; SIR 1.9; 95% CI 1.1-3.2, AER 0.8) was seen. Conclusions: Future analytic studies should further evaluate the site-specific risks of SMN after modern CHEM for TC and the baseline risk among patients managed with non-cytotoxic approaches.
Cost sharing and hereditary cancer risk: Predictors of willingness-to-pay for genetic testing.
Authors: Matro Jennifer Madeline , Ruth Karen , Wong Yu-Ning , McCully Katen C. , Rybak Christina , Hall Michael J. 
Published: March 2020

1544 Background: The increasing availability of genetic testing (GT) in cancer (CA) care has been paralleled by increasing cost-sharing practices by payors that are intended to reduce overuse of health care services. Patients referred for hereditary CA risk assessment may be subject to financial deterrents such as high out-of-pocket (OOP) costs. Little is known about what factors may influence high-risk patients' willingness-to-pay (WTP) for GT. Methods: The Gastrointestinal (GI) Tumor Risk Assessment Registry includes individuals referred for evaluation of genetic CA risk based on personal and/or family hx. At enrollment, participants complete a survey collecting detailed demographic, CA hx, and psychosocial items related to CA risk. Baseline data on 406 participants were available; 21 who did not respond to WTP items were excluded. WTP items included intention for: GT only if paid by insurance; GT even if paid by self; and amount WTP (7 levels, $25 to $2000). Multivariable models examined predictors of WTP (self vs only if paid by insurance) (model 1, logistic), and predictors of amount WTP (model 2, ordinal logistic, 5 levels). All statistical tests are two-sided (α=0.05). Results: Most participants were women (73%), white (92%) and aged 45-64 (58%). 51% had ≥ 4 yr college degree; 22% had household income >$75,000; 42% had hx of GI CA; 56% had > 1 1st degree relative (FDR) with colorectal CA (CRC). Overall, 82 (21.3%) were willing to have GT only if paid by insurance, and 303 (78.7%) were WTP OOP. Of those WTP, 271 (89%) stated an amount. Independent predictors of WTP (model 1) were: 1) expectation of positive result, 2) confidence to control CA risk, 3) fewer perceived barriers to CRC screening and 4) benefit of guiding screening (all p<0.05). Subjects WTP a higher amount (model 2) were male, more educated, and had greater CA worry, fewer FDR with CRC (all p<0.05), and more positive attitudes toward GT (p<0.01). Conclusions: Patients who are WTP some OOP costs for GT anticipate benefits to control of CA risk afforded by GT. Women and less educated patients may face greater barriers from high co-pays. Identifying patient-level factors associated with WTP for genetic services is increasingly important as GT is integrated into routine CA care.
Profiling uptake of single site testing (SST) for familial cancer (CA) risk in an administrative genetic testing database.
Authors: Hall Michael J. , McCully Katen C. , Devarajan Karthik , Kaldate Rajesh R. , Daly Mary Beryl 
Published: March 2020

1550 Background: Among the anticipated social and cost-saving benefits to identifying a mutation in a CA predisposition gene in an individual is the subsequent opportunity to perform SST in close relatives to confirm risk status and to guide risk-reducing interventions. Despite ample research into uptake of primary genetic testing for Lynch syndrome (LS) and hereditary breast ovarian syndrome (HBOS) among moderate- and high-risk individuals, few studies have focused on the resultant cascade of SST that is predicted to follow in families. Methods: Administrative data on 2,631 consecutive single-site mutation tests performed over a 3-month interval (12/1/10-2/28/11) were obtained from a commercial genetic testing database maintained by Myriad Genetic Laboratories. 14 subjects (29 tests) were excluded due to multiple entries. Demographic, personal/family history (hx), and provider data are collected on a Test Requisition Form included in kits. All statistical tests are 2-sided (α=0.05). Results: Women had SST more often than men (HBOS 82.8%; LS 65.5%). Mean age at time of SST was 42.7 yrs, and was higher for HBOS than LS (p=0.01). Among subjects with hx of CA, mean age at CA diagnosis (dx) was similar (HBOS 48.6; LS 48.7 yrs). Subjects reported CA in >1 relatives (range 1-16) with a mean age at dx 40.1 yrs. Compared to HBOS, those tested for LS were more likely to report CA in a 1st degree relative (81.3 vs 74.4%, p=0.001) and a lower age of youngest CA dx in the family (p<0.001). Non-European ancestry was more common for HBOS SST than LS (30.0 vs 24.8%) (p=0.05). SST positive test rate was no different by syndrome or ancestry, but was higher for men (47.5 vs 42.0%, p=0.02). Conclusions: Uptake of commercial SST in high-risk families is uneven by age, sex, ancestry and CA syndrome. While between-syndrome variability in CA risks may explain some differences, more research is needed to understand barriers to uptake of SST among at-risk individuals if CA prevention goals are to be realized. [Table: see text]
A comparison of simple single-item measures and the NCI Common Toxicity Criteria version 3.0 measure of peripheral neuropathy.
Authors: Puttabasavaiah Suneetha , Liu Heshan , Qin Rui , Kottschade Lisa A. , Barton Debra L. , Loprinzi Charles L. , Grothey Axel , Soori Gamini S. , Sloan Jeff A. 
Published: March 2020

1557 Background: Peripheral neuropathy (PN), a common and intrusive side effect of chemotherapy in clinical trials, has been assessed via the clinician-rated common terminology criteria for adverse events (CTCAE) and/or patient-reported outcome (PRO) measures (Morton, ASCO, 2005). We assessed the relative sensitivity of CTCAE and PRO measures for evaluating interventions for preventing and ameliorating CIPN. Methods: Data from285 patients in two prevention trials (N05C3, N04C7) and 432 patients from three intervention trials (N00C3, N01C3, N06CA) were analyzed separately. CTCAE version 3.0 item for neuropathy was compared to 2 NCCTG numerical analogue CIPN items, 6 EORTC CIPN20 individual items, 2 McGill Pain Questionnaire items, and one Brief Pain Inventory item. The sample size provided over 80% power to detect a true Spearman rank correlation of 0.15 assessed the relationship between CTCAE and PRO measures. Results: Results from both the prevention and treatment trials were similar in terms of the relationship between the CTCAE and PRO measures. No correlation coefficients between the CTCAE and any of the PRO items at baseline were above 0.35, with the majority around 0.2. Higher scores for the numbness items were observed than for the CTCAE in 47% of the patients at baseline and 39% during treatment in the treatment trials. Many patients had severe numbness PRO scores but mild CTCAE scores (12%) at baseline and (8%) during treatment in the treatment trials. Results for the numbness and tingling PRO measures were redundant. The correlations of the CTCAE with pain were weak, all below 0.35 at baseline with differences as much as 29 points on average on a 0-100 transformed scale. Conclusions: The CTCAE and PRO measures of PN measure different constructs. The CTCAE includes both functional and ADL/motor aspects which may or may not be related to the singular constructs of pain, numbness, tingling, or adjectival characteristics of pain assessed by the PRO measures. The two measures cannot be used in place of each other.