bluuebunny/crossref_metadata_2025_split huggingface dataset:
Retrospective analysis of patients with sentinel lymph node (SLN) positive melanoma (MEL) who received adjuvant nivolumab (NIVO) without completion lymph node dissection (CLND).
Authors: Eroglu Zeynep , Babacan Nalan , Grossmann Kenneth F. , Markowitz Joseph , Brohl Andrew Scott , Cisneros Jennifer , Cruse Wayne , Harrington Michael , Gonzalez Ricardo Jorge , Sarnaik Amod , Zager Jonathan S. , Sondak Vernon K. , Khushalani Nikhil I. 
Published: May 2019

9590 Background: Until recently, most patients (pts) with SLN+ MEL underwent CLND, a procedure mandated in published trials of adjuvant anti-PD-1 therapy to date. Following MSLT-II, this practice has dramatically changed with most pts now undergoing surveillance or adjuvant therapy without CLND. In addition, pts with in-transit/satellite MEL were excluded or not reported in these prior adjuvant studies. Our aim was to explore real-world outcomes of adjuvant NIVO in these pts. Methods: We carried out a single center retrospective analysis of stage 3 MEL pts who received adjuvant NIVO. Results: 32 pts with SLN+ MEL who did not undergo a CLND and started adjuvant NIVO within 3 months of surgery were included. Median age was 60 (26-77); per AJCC v7, 12 pts had Stage 3A, 11 stage 3B, and 9 pts had Stage 3C MEL. One was acral MEL; 18 had an ulcerated primary. 6 pts had BRAF-mutant MEL, 20 had BRAF-WT, and 6 unknown. NIVO treatment was 240 mg Q2wks or 480 mg Q4wks, up to one year. 21 pts developed grade 1/2 immune-related adverse events (irAEs), and 1 pt stopped NIVO due to toxicity (fatigue). With median follow-up of 7 months, only 1 pt had a recurrence, which was in the in SLN+ nodal basin; pt was rendered disease-free with surgery. The relapse-free rate (RFS) rate at 1 year was 95% (95% CI, 71-100). Of 21 pts with in-transit/satellite recurrent MEL (median age 68 [29-84]) who started adjuvant NIVO (no prior drug treatment), 5 had BRAF-mutant MEL, 14 BRAF-WT, 2 unknown; two were acral-lentiginous. 3 pts had recurrences: 2 regional and 1 distant mets, treated with surgery, TVEC, or BRAF-targeted therapy. Median follow-up was 8 months from NIVO start; 1-year RFS was 72% (95% CI 32-91). 15 pts developed irAEs; in 12, these were grade 1-2 and in 3, were grade 3 that led to discontinuation. Conclusions: While preliminary, these findings suggest that adjuvant anti-PD-1 therapy may be effective in SLN+ pts who forego CLND prior to adjuvant treatment, as 1-year RFS rate appears similar to rates in the published adjuvant anti-PD-1 trials that mandated CLND. This therapy may be similarly effective in pts with resected in-transit/satellite stage 3 melanoma. Further follow-up will be presented.
The CYP2C19 rs4917623 single nucleotide polymorphism to predict tamoxifen efficacy in estrogen receptor-positive breast cancer patients.
Authors: Yoshimoto Nobuyasu , Naito Akihiro , Kawaguchi Nobuko , Kato Miwa , Kondo Naoto , Wanifuchi-Endo Yumi , Toyama Tatsuya 
Published: May 2019

e12001 Background: Tamoxifen is a selective estrogen receptor modulator that is widely used to treat estrogen receptor (ER)-positive breast cancer. However, not all patients benefit from the incorporation of tamoxifen into an adjuvant therapy. This is also the case when tamoxifen is used in chemoprevention, since only half of participants benefit from the drug. In order to improve treatment response, we attempted to identify single nucleotide polymorphisms (SNPs) that correlated with tamoxifen efficacy. Methods: ER-positive breast cancer patients at our hospital were enrolled on this study between January 2007 and September 2010. The primary endpoint was ER-positive breast cancer-free survival. We examined 17 SNPs in these patients. The survival benefit associated with each genotype was determined with a log-rank test, and the hazard ratio was analyzed using a Cox proportional-hazards model. Results: The median follow-up time of the 320 patients enrolled on the study was 3298 days. Of 240 patients who received any endocrine therapy, ER-positive breast cancer-free survival in patients with the 2q35 rs13387042 AA genotype was significantly shorter than in those who had the AG or GG genotype (p < 0.0001), and the hazard ratio was significantly higher (HR 8.83; 95% CI 2.09–25.53, p = 0.0064). Of the 145 patients who received tamoxifen therapy, there was a trend among ER-positive breast cancer patients with the CYP2C19 rs4917623 TT genotype to have a shorter disease-free period (p = 0.0635) when compared to patients with TC or CC genotypes. Similarly, there was a trend for the TT genotype patients to exhibit a higher hazard ratio (HR 2.62; 95% CI 0.86–7.55, p = 0.0861). Conclusions: The rs4917623 SNP in the CYP2C19 gene, which encodes a metabolic enzyme, predicts tamoxifen efficacy. This finding will facilitate selection of ER-positive breast cancer patients for tamoxifen treatment; it may also be useful for selection of patients most likely to benefit from tamoxifen-dependent chemoprevention.
Clinical practice patterns on the use of adjuvant bisphosphonate for early breast cancer: A Canadian perspective.
Authors: Zibdawi Lara , Simos Demetrios , Kassam Shaqil , Rana Amira , Kassam Farrah , Rahim Yasmin 
Published: May 2019

e12002 Background: Adjuvant bisphosphonates (ABPs) in menopausal women with early breast cancer (EBC) decrease the risk of BC relapse and modestly improve overall survival (OS). In the era of personalized medicine, a one size fits all approach is not ideal–it is important to identify the subgroup of patients who may not derive a clinically meaningful benefit to avoid over treatment, unnecessary toxicity, and optimize resource utilization. Objectives: To better characterize how Canadian medical oncologists (MOs) use ABPs and whether practice patterns are concordant with the CCO/ASCO guideline. Methods: A brief survey was circulated by e-mail to 618 Canadian MOs between Nov 2017 - May 2018. Questions were designed to gather data on demographics, patient selection, choice of bisphosphonate, schedule/duration of treatment and barriers to use. No incentive was provided. Results: Sixty-eight MOs from 8 Canadian provinces completed the survey (response rate 11.0%). Most practiced in Ontario (65.7%) and just over half (51.5%) were community oncologists. MOs offered ABPs to 52.2% of menopausal women with EBC. Use was higher in the community compared to the academic setting (p=0.049). Most used zoledronic acid (85.3%) every 6 months (95.6%) for 3 years (69.1%) and started treatment within 3 months of completing adjuvant chemotherapy/radiation (67.7%). Factors associated with use of ABPs were: high Oncotype Dx score (89.1%), high tumor grade (72.1%), triple negative disease (63.6%), osteoporosis (87.7%)/osteopenia (83.9%) and use of aromatase Inhibitor (75.0%). The most common factor precluding use of ABPs was presence of comorbidities (89.7%). About 1/3rd indicated they would offer ABPs to women with stage I HR positive/Her2 negative EBC. Conclusions: Canadian MOs have added intravenous ABPs to their armamentarium of therapies in keeping with the spirit of the recent guideline. High-risk disease features and low bone density appear to be influencing the decision-making process. Further work aimed at identifying those patients who are unlikely to benefit from treatment is needed.
Use of treatment pathways reduce cost and decrease ED utilization and unplanned hospital admissions in patients (pts) with stage II breast cancer.
Authors: Weese James L. , Shamah Corey J. , Sanchez Federico Augusto , Perez Moreno Ana Cristina , Mitchell Dorry , Sessa Thomas , Gutantes Jean , Huibregtse Carol , Clement Kevin , Barry-Weers Anne Marie , Amy Bock , Bjegovich-Weidman Marija 
Published: May 2019

e12012 Background: VIA Oncology evidence-based pathways have been integrated into our medical oncology workflows since November 2014. Within 3 months, compliance was high for our 42 medical oncologists at 19 sites working with a common EHR with over 85% of pts treated on pathway. The aim of this study was to determine if there was a significant difference in the overall cost of treatment between pts treated on pathway versus off pathway, and whether on pathway pts had a lower rate of ED use and unplanned admissions within 30 days of chemotherapy as required in the new CMS directives. Methods: Newly diagnosed stage 2 breast cancer pts diagnosed between January 1, 2016 to December 31, 2017 were identified from the tumor registry for the system. The VIA database was queried to separate these pts into two groups–those pts who were treated on pathway, and those who were off pathway. The data warehouse was utilized to determine the total charges of adjuvant medical oncology treatment for these pts. In addition, data was extracted for the same groups to determine those pts who sought ED evaluation and or hospital admission within 30 days of chemotherapy treatment. Statistical analysis was performed utilizing Fisher’s exact test to compare proportions and t-test to compare treatment costs and ED/hospitalizations between the on and off pathway groups. Results: During the 2 years, 412 (93%) Stage 2 breast cancer pts were treated on pathway (including clinical trials); 32 (7%) were off pathway. 81% of the on-pathway group were + for ER and/or PR and 17% were HER-2 +; 78% of the off-pathway group were + for ER and/or PR and 38% were HER-2 +. Mean cost for treating the on-pathway group was $111,067 compared to $200,717 for the off-pathway pts (p=0.01). 18.8% of the off-pathway pts were seen in the ED / unplanned admissions and had more multiple visits compared to 12.1% of on-pathway pts within 30 days of chemotherapy (p=0.026). Conclusions: Standardized usage of evidence based pathways can be used successfully across a large number of providers over wide geography. Adherence to pathways results in significant cost savings for each patient, and significant reduction in ED/hospital utilization for on pathway patients.
Weight change after (neo)adjuvant chemotherapy in a cohort of breast cancer survivors: Trends by race, hormone positivity, and chemotherapy regimen.
Authors: Colton Bradley S , Kareff Samuel , Li Shaw , Alintah Princess , Dash Chiranjeev , Dilawari Asma Ali 
Published: May 2019

e12018 Background: It is estimated that over 50% of breast cancer survivors gain weight during treatment; patients receiving chemotherapy are at higher risk for weight gain. Previous studies have reported limited information about weight gain with current chemotherapy regimens. Methods: Individual data were collected from a cohort of 98 breast cancer patients treated with neoadjuvant or adjuvant chemotherapy between 2015 and 2017 at Lombardi Comprehensive Cancer Center. Weight was recorded from baseline visits and ≥ 1 visit following completion of chemotherapy. Regimens were grouped into anthracycline- (AC) and non-anthracycline-based (NAC) chemotherapy. Results: Overall, 49% ( n = 48) of patients gained weight after chemotherapy, though African-American patients demonstrated higher baseline BMI. Patients with ER-positive cancers displayed greater weight gain than hormone-negative counterparts ( p = 0.04); PR- or HER2-status was not associated statistically significant changes in weight ( p = 0.12 and 0.82, respectively). Among patients who did gain weight, NAC was associated with greater weight gain (4.47kg) than AC-based regimens (2.54kg) ( p = 0.03). Conclusions: ER positivity and NAC may serve as independent predictors of weight gain during chemotherapy. Further studies might consider further analyzing these trends to demonstrate additional long-term patterns. Baseline and After Chemotherapy BMI (kg/m2) and Weight Change (kilograms and percentage change) (P* derived from ANOVA). [Table: see text]
Impact of treatment on patient-reported pain and fatigue in early breast cancer patients receiving adjuvant radiotherapy.
Authors: Wan Bo Angela , Pidduck William , Zhang Liying , Yee Caitlin , Wang Katie , Chow Selina , Chan Stephanie , Drost Leah , Soliman Hany , Leung Eric , Sousa Philomena , Lewis Donna , DeAngelis Carlo , Taylor Prince , Chow Edward 
Published: May 2019

e12019 Background: Patients who receive radiotherapy (RT) for breast cancer often report pain and fatigue which contribute negatively to quality of life (QoL). We aim to identify demographic, treatment, and disease characteristics associated with pain and fatigue using the Edmonton Symptom Assessment Scale (ESAS). Methods: We identified all patients diagnosed with non-metastatic breast cancer from 2011 Jan-2017 Jun at the Odette Cancer Centre with at least one ESAS completed pre- and post-RT. Data on systemic treatment, RT, demographics, and disease stage were extracted. To identify factors associated with pain and fatigue pre- and post-RT and their changes, univariate and multivariable linear regression analysis was conducted. p < 0.05 was considered statistically significant. Results: This study included 1222 female patients (mean age 59 years old) who completed ESAS on average 28- and 142-days pre-RT (baseline) and post-RT respectively. In multivariable analysis, higher baseline pain scores associated with adjuvant chemotherapy (p < 0.001) and eventual receipt of locoregional (p = 0.026) or chest wall RT (p = 0.003), whereas higher baseline fatigue scores associated with higher disease stages (p = 0.001) and locoregional RT (p < 0.001). Post-RT symptom severity correlated only with locoregional RT (higher pain scores, p < 0.001). Reductions in pain was associated with adjuvant chemotherapy (p = 0.002) and chest wall RT (p = 0.031). Reduction in fatigue was associated with adjuvant chemotherapy (p = 0.011) and locoregional RT (p = 0.007) although both had higher pre-RT scores in univariate analysis. Conclusions: Patients at higher disease stages or who received chemotherapy or chest wall RT tended to experience more severe short-term morbidity. However, patients who received locoregional RT tended to have greater pain that persisted after RT completion compared to those who did not.
Relation between dexamethasone (DEX) usage, preventive trimetprim/sulfametoxazole (ST), and pneumocystis pneumonia (PCP) for patients with breast cancer receiving dose-dense AC followed by dose-dense paclitaxel (ddAC-ddP): Preplanned analysis of WJOG9016B.
Authors: Matsumoto Koji , Nishimura Meiko , Ozaki Yukinori , Futamura Manabu , Miyaki Toshikio , Tsurutani Junji , Imoto Shigeru , Doi Mihoko , Tokunaga Shinya , Aogi Kenjiro , Yoshimura Kenichi , Okada Hideaki , Sagara Yasuaki , Baba Motoi , Nagai Shigenori E. , Takano Toshimi ,   West Japan Oncology Group
Published: May 2019

e12022 Background: PCP is rare complication of ddAC-ddP. DEX is plausible risk factor for PCP. Dose and duration of DEX against CINV is changing over time as other anti-emetic drugs (5HT3 RA, NK1 RA, and olanzapin) became available. Then DEX usage varies widely in each hospitals. ASCO/IDSA guideline recommends preventive ST for patients receiving 20 mg or more predonisone equivalents daily for more than one month, although evidence is lacking in patients receiving ddAC-ddP. This study is to investigate relation between DEX usage, preventive ST, and risk of PCP for patients receiving ddAC-ddP. Methods: This study is preplanned analysis of WJOG9016B (UMIN000024992) which investigated relative dose intensity of ddAC-ddP supported by 3.6 mg (approved dose in Japan) of pegfilgrastim. Eligible pts were HER2 negative PBC with stage I to IIIc, going to start ddAC-ddP and younger than 65 y.o.. DEX usage and preventive ST usage were discrete to treating physicians. Results: From Jan. 2017 to Jan. 2018, 92 pts were registered and 91 pts were in the FAS set, because one patients turned out be ineligible after registration. All patients received DEX for prevention of delayed CINV. Median total dose of DEX during ddAC was 112 mg (range; 80 to 212 mg), which was equal to 13.3 mg (9.52 mg–24.76 mg) predonisone equivalents daily. Only five of them (5.4%) received more than 20 mg predonisone equivalents daily. Twenty patients received preventive ST. Three patients developed PCP. None of them with preventive ST developed PCP (0%), whereas three of patients without ST developed PCP (4.2%). These three patients received total DEX dose during ddAC at 80 mg, 112 mg, and 112 mg, respectively. Conclusions: ST was highly effective for PCP prevention for patients receiving ddAC-ddP, if DEX used against delayed CINV. Without ST prevention, the risk of PCP was 4.2 %, which was higher than threshold (3.5%) proposed in ASCO/ IDSA guidelines. The threshold of steroid dose leading to the risk of PCP might be lower than 20 mg or more predonisone equivalents daily in patients receiving ddAC-ddP. Clinical trial information: UMIN000024992.
Evaluation of androgen receptor expression in core needle biopsies and clinico-pathological factors in primary breast cancer.
Authors: Arima Nobuyuki , Nishimura Reiki , Osako Tomofumi , Okumura Yasuhiro , Nakano Masahiro , Fujisue Mamiko 
Published: May 2019

e12023 Background: Immunohistochemistry (IHC) is used to determine breast cancer subtypes and to evaluate the ER, PgR, and HER2 expressions and the Ki-67 index value. The androgen receptor (AR) is frequently expressed in breast cancer but has not been standardized. IHC is recommended when using preoperative biopsy specimens to determine biomarker expressions. In this study, the differences in AR expression between core needle biopsy and matched surgical samples were investigated. The AR expression was evaluated as a predictor for neoadjuvant chemotherapy and grade of malignancy. Methods: Primary breast cancer patients (n = 363) who underwent surgery between March 2017 and December 2018 were divided into 3 groups; the core needle biopsy and matched surgical comparison group (n = 167), the neoadjuvant chemotherapy group (n = 54), and the without neoadjuvant chemotherapy group (n = 309). The AR expression was evaluated using IHC and the expression was divided into the negative, low ( < 10%) and high (≥10%) groups. Breast cancer subtypes were categorized using the IHC data derived from ER/PgR, HER2 and Ki-67 (cutoff 20%) values. Results: 1. There was no difference between the ER, PgR and HER2 expressions in the comparison group. AR was significantly lower in the surgical specimens. 2. The pCR rate was significantly higher in the ER and PgR negative cases. AR and the Ki-67 value did not correlate with pCR. 3. The AR positive rate was 61.2% in invasive carcinoma cases. Apocrine carcinoma showed a 100% positive rate. 4. AR expression significantly correlated with positive ER and PgR, a lower Ki-67 value, negative p53, and a lower nuclear grade. Luminal A type showed a higher AR rate (78.2%) than the TN and HER2 types. The AR rate was significantly lower (17.1%) in the TN type cases. Conclusions: discordance in the AR expression between the core needle biopsies and matched surgical specimens was found. AR expression using IHC should be evaluated in core needle biopsies.
Assessing adherence to hormone therapy (HT) in breast cancer (BC) patients receiving care at BC unit in a Uruguayan university of Hospital de Clínicas.
Authors: Castillo Cecilia , Camejo Natalia , Artagaveytia Nora , Hernandez Ana laura , Apud Patricia , Melo Florencia , Delgado Lucia Beatriz 
Published: May 2019

e12026 Background: Adjuvant HT in Hormone Receptors (HR) + BC increases overall survival (OS). Adherence to therapy is a complex and multifaceted issue that can alter outcomes; however, not much of it is known abouth this in routine clinical practice. Methods: This was a retrospective study that enrolled patients treated with HT because of HR+ BC (stages I-III) at the BC unit in the 2002-2012 period. Methods: The proportion remaining on endocrine therapy was analysed by Kaplan-Meier curve. Univariate analysis (log rank test) was used to identify the factors that might independently impact on such discontinuation. The study was approved by the Ethics Committee of the Hospital de Clínicas. Results: 139 (73.1%) of the 190 patients enrolled were postmenopausal; their median age being 61 years. Most patients were single or divorced or widowed (121, 63.7%) and resided in the capital (125, 65.7%). Most tumors (166, 87.3%) were ductal carcinomas and most presented at a low histological grade: HG 2-3: 112 (58.9%). The distribution by stage was: SI: 63 (33.1%); SII: 82 (43.1%); SIII 39 (20.5%); S0 6 (3.1%). At the end of their first, second, third, fourth and fifth years of treatment; 95.3%, 87.9%, 80.6%, 76.4% and 69.5% of the patients still adhered, respectively. Adherence was not associated with either age (p = 0.687), menopausal status (p = 0.449), marital status (p = 0.221), origin (p = 0.5640), or stage (p = 0.168). The patients who received combined HT (tamoxifen followed by AI) adhered better than those who received one drug alone (p = 0.017). Conclusions: we assessed the adherence to HT in real life and found that it was reduced by 30.5% in 5 years, despite patients were well informed about the well-known benefit in terms of OS, of being a well-tolerated treatment and of being provided for free. These results are similar to or even better than those reported in several international studies. Further investigation is needed to understand why patients interrupt HT. We need to work harder to increase compliance, given the potential impact this may have on the patients’ OS.
Vitamin D insufficiency and risk of paclitaxel-induced peripheral neuropathy.
Authors: Jennaro Theodore Salvatore , Smith Ellen M. Lavoie , Vangipuram Kiran , Kidwell Kelley M. , Burness Monika Leigh , Griggs Jennifer J. , Van Poznak Catherine H. , Hayes Daniel F. , Henry Norah Lynn , Hertz Daniel Louis 
Published: May 2019

e12027 Background: Peripheral neuropathy (PN) is a severe, dose-limiting toxicity of paclitaxel that occurs in up to 25% of patients and can lead to permanent loss of balance and manual dexterity. Due to the lack of effective strategies for PN prevention or treatment, there is a critical need to identify predictive risk factors for paclitaxel-induced PN. Vitamin insufficiencies are known risk factors for PN in other disease states. However, the effect of vitamin insufficiency on paclitaxel-induced PN has not been adequately investigated. Methods: Baseline levels of vitamin D and other nutrients (vitamin B, homocysteine, folate) were measured, and PN was assessed weekly in an observational trial of patients receiving paclitaxel 80 mg/m2 for 12 weeks for non-metastatic breast cancer (NCT0233811). Nutrient levels were measured by Michigan Medicine and insufficiency defined by institutional standards (vitamin D insufficiency < 20 ng/mL). In the primary analysis, the maximum increase from baseline in the 8-item sensory subscale (ΔCIPN8) of the EORTC CIPN20, a validated patient-reported PN assessment tool, was compared in nutrient insufficient and sufficient patients. The effect of vitamin insufficiencies on PN-induced treatment disruptions (dose decrease, delay, or discontinuation) was conducted as a secondary analysis. Results: Only vitamin D insufficiency was identified in enough patients for analysis (15/37 = 41%). Vitamin D insufficient patients reported a greater mean (+/- SD) ΔCIPN8 (36.39 ±22.8) than vitamin D sufficient patients (16.29 ±16.3) (p = 0.003). However, the increase in treatment disruption for vitamin D insufficient patients was not significant (OR = 2.98, 95% CI [0.72, 12.34], p = 0.16). Conclusions: Paclitaxel-treated patients who were vitamin D insufficient at baseline had greater increases in patient-reported PN. If validated in larger studies, vitamin D insufficiency may be a clinically translatable, modifiable risk factor that can be used to prevent paclitaxel-induced PN in patients with non-metastatic breast cancer.