bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient-reported use of marijuana and cannabinoid (CBD) oil in patients with renal cell carcinoma undergoing systemic therapy.
Authors: Battle Dena , Bergerot Cristiane Decat , Msaouel Pavlos , Zhang Tian , George Daniel J. , Staehler Michael D. 
Published: May 2020

5084 Background: The use of cannabis and cannabinoid related products has become increasingly common among cancer patients. We sought to gather independent data from online kidney cancer patient communities to assess frequency of use of marijuana and CBD-oil and estimate influence on treatment duration and side-effects. Methods: The KCCure online survey was performed between August 1, and September 30, 2019. Descriptive statistics were used to characterize patients who self-report using marijuana, their systemic treatments, and interactions with their oncologists. Results: Out of 1,136 patients responding, 411 patients were on systemic therapy with a median age of 57 years (28-86). Of the 441 patients with systemic therapy, 223 patients (54%) were male. There was no difference in gender distribution or race among patients who reported using or not using marijuana and or CBD oil. 93 patients (21%) reported using marijuana or CBD oil and 35 patients (8.5%) reported using both. Patients using marijuana and/or CBD oil had a median age of 55.7 +/- 1.1 years compared with patients not using (65.1 +/- 6.9 years). The median treatment duration was 23.9+/-2.4 months for patients using marijuana and/or CBD oil versus 26.4+/- 1.9 months for patients not using these supplements (p=0.437). Patients using marijuana and/or CBD oil were more likely to have bothersome side effects from therapy (p=0.001) and were less likely to talk to their doctor about their situation (p=0.044). The median NCCN distress score in patients using marijuana and/or CBD oil was 49.5+/-25.7 versus 51.4+/-24.0 (p n.s.). No correlation was seen with the use of steroids, anti-diarrhea drugs, anti-nausea-drugs, hormone substitution or other drugs used to manage side effects. Conclusions: Marijuana and/or CBD oil are used by a significant number of patients. No benefit/harm on treatment duration and use of concomitant drugs to control side effects and severity was seen. Patients using marijuana and/or CBD oil were more likely to report bothersome treatment related side effects and were more willing to report their side effects to their provider. As cannabinoids become more mainstream and legal in a number of states, more research is needed to better understand the impact these supplements may have on patients.
Defining the mutational landscape of 3,217 primary breast cancer transcriptomes through large-scale RNA-seq within the Sweden Cancerome Analysis Network: Breast Project (SCAN-B; NCT03430492).
Authors: Brueffer Christian , Gladchuk Sergii , Winter Christof , Vallon-Christersson Johan , Hegardt Cecilia , Häkkinen Jari , George Anthony M , Chen Yilun , Ehinger Anna , Larsson Christer , Loman Niklas , Malmberg Martin , Rydén Lisa , Borg Åke , Saal Lao H. 
Published: May 2020

518 Background: Breast cancer is a disease of genomic alterations, of which the complete panorama of somatic mutations and how these relate to molecular subtypes and therapy response is incompletely understood. The Sweden Cancerome Analysis Network-Breast project (SCAN-B; ClinicalTrials.gov NCT02306096) is a multi-center population-based ongoing prospective observational study elucidating the global transcriptomic profiles for thousands of patients and tumors using RNA sequencing. Since September 2010, over 15,000 patients with breast cancer have been enrolled at 9 hospitals across a wide geography of Sweden, comprising greater than 90% of all eligible patients in the catchment area. Methods: Within SCAN-B, we developed an optimized bioinformatics pipeline for detection of single nucleotide variants and small insertions and deletions from RNA-seq data. From this, we describe the mutational landscape of 3,217 primary breast cancer transcriptomes, and relate it to patient overall survival in a real-world setting (median follow-up 75 months, range 2-105 months). Results: We demonstrate that RNA-seq can be used to call mutations in important breast cancer genes such as PIK3CA, TP53, ESR1, and ERBB2, as well as mutation status of key molecular pathways and tumor mutational burden, identify mutations in one or more potentially druggable genes in 85.3% percent of cases, and reveal significant relationships to patient outcome within specific treatment groups. To make this rich and growing mutational portraiture of breast cancer available for the wider research community, we developed an open source interactive web application, SCAN-B MutationExplorer, publicly accessible at http://oncogenomics.bmc.lu.se/MutationExplorer . Conclusions: These results add another dimension to the use of RNA-seq as a potential clinical tool, where both gene expression-based signatures and gene mutation-based biomarkers can be interrogated simultaneously and in real-time within one week of tumor sampling.
Does chemotherapy affect survival of breast cancer (BC) patients with recurrence score 26-30?
Authors: Goranta Sowmya , Drizik Eduard , Omaduvie UyoyoTonte , Haykal Tarek , Bala Areeg , Gorle Swathi , Sidahmed Shima , Pandit Trailokya Nath , Kanugula Ashok Kumar , Bachuwa Ghassan , Katato Khalil 
Published: May 2020

523 Background: The Oncotype-DX recurrence score (RS) allows providers to identify hormone receptor positive and HER2-negative breast cancer (BC) patients that may benefit from adjuvant chemotherapy (AC). The TAILORx Trial showed no benefit of AC among patients with RS of 11-25, except for patients younger than 50 years. There are, however, limited studies examining any benefit of AC among those with RS of 26-30. We sought to examine the effect of AC on BC-specific survival among these patients utilizing a national database. Methods: We queried the Surveillance, Epidemiology, and End Results database for newly diagnosed female BC patients between 2010-2015. We included patients with T1-T3, hormone receptor positive, HER2-negative, and lymph node-negative BC with RS of 26-30. Patients with tumors 5 mm or less and with incomplete records were excluded. Cox Proportional-Hazards Model was done to examine the effect of AC on BC-specific survival. A sub-group analysis was performed for patients younger than 50 years to examine the effect of AC on BC-specific survival. Results: We included 2,982 patients, of whom 1,686 (56.5%) received AC. Administration of AC was associated with lower age (56.5 [9.2] vs 61.8 [9.7], p < 0.001), Grade III&IV (39.7% vs 30.2%, p < 0.001), married or patients with partners (66.5% vs 61.5%, p < 0.001), and T stage > 1 (31.3% vs 26.8%, p = 0.03). AC was not associated with insurance status, race, and histology. Overall 5-year BC-specific survival was 97.3% (96.2-98.3%). After adjustment through cox regression, AC was found to not have an effect on survival (HR: 0.54 [0.27-1.10], p = 0.09). There were 579 (19.4%) patients that were younger than 50 years, and AC did not have an effect on survival among these patients (HR: 0.44 [0.08-2.44], p = 0.35). Similarly, among the 2,403 (80.6%) patients aged 50 or older, AC did not have an effect on survival (HR: 0.49 [0.22-1.11], p = 0.09). Conclusions: In this retrospective analysis, administration of AC was associated with lower age, higher grade, marital status, and T stage. AC did not affect BC-specific survival among patients with a RS of 26-30. Subgroup analysis did not show any benefit of AC among patients younger than 50 years or among those 50 or older. Further prospective randomized trials are warranted to identify sub-groups that may potentially benefit from AC.
CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC).
Authors: Boni Valentina , Burris III Howard A. , Liu Joyce F. , Spira Alexander I. , Arkenau Hendrik-Tobias , Fidler Mary J. , Rosen Lee S. , Sweis Randy F. , Uboha Nataliya Volodymyrivna , Sanborn Rachel E. , O'Neil Bert , Harding James J. , LoRusso Patricia , Weise Amy M. , Garcia-Corbacho Javier , Victoria Iván , Frye John W. , Li Rachel , Stroh Mark , Meric-Bernstam Funda 
Published: May 2020

526 Background: CX-2009 is a PROBODY drug conjugate (PDC) directed against CD166 (ALCAM) and conjugated to DM4, a potent microtubule inhibitor (MTI). CD166 is overexpressed in carcinomas but is also ubiquitously expressed in normal epithelium and thus has not been previously considered a viable target for a traditional antibody drug conjugate. PDCs have a peptide mask that blocks normal tissue binding and can be removed by tumor-associated proteases, thereby limiting off-tumor/on-target binding. CX-2009 demonstrated preclinical activity in multiple solid tumor models. Here we report results of the first in human study in patients with advanced cancer. Methods: In this phase I multi-part dose-escalation study, pts with advanced solid tumors received CX-2009 0.25–10 mpk IV every 14 or 21 days (Q2W or Q3W). Tumor types were selected based on expected high CD166 expression and MTI sensitivity. Results: The dose-escalation phase of the trial enrolled 43 pts; 49 additional pts were subsequently enrolled between 4–10 mpk to collect biomarker data and define the recommended phase II dose (RP2D), for a total of 92 pts as of 30 Nov 2019 (39 pts with breast cancer [BC], 22 ovarian [OC], 12 non-small cell lung [NSCLC], 9 head/neck squamous cell [HNSCC], 10 other) with a median of 6 (range 1–19) prior therapies. Median number of CX-2009 doses was 2 (range, 1–15). For Q3W dosing, one dose limiting toxicity (DLT; grade 3 vomiting) was observed at 8 mpk; MTD was not reached up to 10 mpk. The RP2D for Q3W schedule was 7 mpk based on safety, dose-response, and population pharmacokinetic simulations. Q2W dosing continues; DLTs were observed at 6 mpk. Common treatment-related adverse events (TRAEs) at 7 mpk (n=9) were nausea (44%), fatigue, infusion-related reactions (both 33%), vomiting and arthralgias (both 22%). Grade 3 TRAEs occurred in 2 pts (nausea/vomiting; peripheral neuropathy). No pts discontinued at 7 mpk due to TRAEs. Ocular toxicity was dose dependent; mild to moderate reversible keratitis/blurred vision was seen in 3 pts at 7 mpk and mitigated by ocular prophylaxis. Partial responses were seen in 8 pts (2 confirmed, both HR+/HER2- BC) treated between 4–10 mpk, including BC (n=5), OC (n=2), and HNSCC (n=1). SD (≥1 on-study scan) was observed in 21 pts, 5 had SD ≥3 mos. Conclusions: CX-2009 at 7 mpk is the RP2D on Q3W schedule. Phase II expansion has begun in pts with HR+/HER2- BC. The Q2W schedule will continue to enroll pts to define the RP2D. CX-2009 will also be studied in combination with CX-072, a PD-L1 PROBODY therapeutic ( NCT03149549 ) Clinical trial information: NCT03149549 .
Adherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers.
Authors: Foldi Julia , Schnabel Catherine A. , Salganik Max , Pusztai Lajos , Sanft Tara B. 
Published: May 2020

527 Background: Evidence suggests continuing endocrine therapy (ET) beyond 5 years (yr) may reduce breast cancer recurrence in early stage HR+ breast cancers. Given the modest benefit and potentially serious adverse effects of extended ET (EET), improved approaches to identify patients who are at increased risk of late distant recurrence and who derive benefit from EET are critical. Guidelines recommend shared decision-making between oncologists and patients. The adherence rate to EET by 5 yr is only 50-60%. BCI is a gene-expression assay used to predict late distant recurrence and is predictive of benefit from EET. We assessed adherence to EET in women who had BCI testing. Methods: Women with stage I-III HR+ breast cancer s/p 3.5 yr of adjuvant ET and had BCI testing at our institution (8/2013-7/2015) were included. Pts who had < 4 yr of follow-up since BCI testing were excluded. Information including demographics, tumor characteristics, treatment history, number DXA scans, history of osteopenia/osteoporosis were collected. Data on medication adherence was based on prescriptions in the electronic health record. Results: 102 pts were included in our analysis. The median age was 61yr (46-89 yr). The majority of pts had stage I (63%), N0 (77%) and HER2- (90%) disease. 50 pts (46%) received chemotherapy. 44 (43%) received tamoxifen and 79 (77%) had an aromatase inhibitor. BCI categorized 61 (60%) pts as low risk, 26 (25%) as intermediate, and 15 (15%) as high risk for late distant recurrence. 61 (60%) and 41 (40%) pts were predicted to have low and high likelihood of benefit from EET, respectively. All 15 (100%) pts categorized as high risk for late recurrence were predicted to have a high likelihood to benefit from EET; all were recommended to continue EET by their oncologist and all 15 elected EET. 11 (73%) completed 10 yr or were on EET at last follow-up. Of the 4 (27%) pts who stopped before 10 yr, 1 pt had metastatic recurrence and 3 had intolerable side effects. Pts on EET underwent an avg of 1.91 DXA scans, compared with 1.23 for those who stopped ET at 5 yr (p = 0.003). At a median follow-up of 10 yr from diagnosis, there were 2 metastatic (1/15 in the high risk and 1/26 in the intermediate risk group) and 1 local recurrence (1/61 in the low risk group). Conclusions: In pts who continued ET beyond 5 years based on BCI testing and discussion with their oncologist, the rates of adherence and persistence to EET were higher than those previously published. EET may increase the number of DXA scans performed.
Factors associated with adjuvant endocrine therapy adherence in non-metastatic breast cancer.
Authors: Neuner Joan Marie , Winn Aaron N , Pezzin Liliana E , Laud Purushottam W. , Nattinger Ann B , Fergestrom Nicole 
Published: May 2020

533 Background: Over 50% of breast cancer patients prescribed adjuvant endocrine therapy (ET) are nonadherent during the recommended 5-year course of therapy. We investigated the role of cancer medication delivery on adherence, including mail order pharmacy use, number of pharmacies and copays. Methods: We conducted a retrospective cohort study of 15,769 commercially insured breast cancer patients age 18-64 with newly diagnosed breast cancer in 2007-2015 that initiated ET. Incident breast cancer was identified by a validated algorithm which identifies mainly non-metastatic breast cancer. We examined the association between 12-month AET adherence (proportion of days covered by fills ≥0.80) and mail order pharmacy use, number of pharmacies, and AET copays. We used Poisson regression to estimate nonadherence risk ratios and adjusted for demographics (age, income, race, urbanicity), comorbidities, total medications, primary cancer treatments (surgery, radiation, chemo, and ET initiated), and generic AI availability. Sensitivity analyses were conducted using alternate specifications for independent variables. To test whether any observed differences were due to self-selection, we also conducted a negative control analysis. Results: Most patients were white (74.4%) and age 55-64 (43.3%). Only 16% of patients used a mail order pharmacy for ET fills, most patients only used one pharmacy (58.8%) and 25.2% had a co-pay of $20 or more. In the primary analysis, mail order patients were more likely to be adherent to their ET (aRR 1.21; 95% CI 1.18-1.24), patients using one pharmacy were more likely to be adherent (1 vs 3+: aRR 1.09; 95% CI 1.06-1.13), and patients with lower copays were more likely to be adherent (quartile 1 vs 4: aRR 1.04; 95% CI 1.01-1.08). Results were consistent across sensitivity analyses, and there was no association between mail order and copays and the negative control outcome of any pneumonia diagnoses. Conclusions: Medication delivery factors are associated with adherence to breast cancer AET. Future work should investigate whether interventions to streamline medication delivery could improve adherence for this population.
Real-world patterns of treatment and recurrence by frailty status among older women with HR-positive, HER2-negative early breast cancer.
Authors: Calip Gregory Sampang , Hubbard Colin , Nabulsi Nadia Azmi , Asfaw Alemseged Ayele , Lee Inyoung , Zhou Jifang , Cueto Jenilee , Mitra Debanjali , Law Ernest H 
Published: May 2020

535 Background: Frail health status impacts clinical decision making for older cancer patients and their families, and frailty is independently associated with increased risks of mortality. Our objective was to describe differences in treatment and rates of recurrence by frailty status among older women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Methods: We performed a large, population-based retrospective cohort study of women aged 65 years and older diagnosed with first primary stage I-III HR+/HER2-breast cancer using the Surveillance, Epidemiology, and End Results Medicare-linked database between 2007 and 2015. Using administrative health claims, we ascertained information on breast cancer treatment and utilized validated claims-based algorithms to determine frailty status (robust, pre-frail, and frail) and identify subsequent invasive breast cancer recurrences. Relative hazards of recurrence were determined using Fine and Gray competing risks regression models with estimated subdistribution hazard ratios (SHR) and robust 95% confidence intervals (CI). Results: From an overall cohort of 46,027 women, most women (56%) were classified as robust at breast cancer diagnosis, whereas 37% and 7% were identified as pre-frail and frail, respectively. Compared to robust patients, frail patients were more likely to have stage III disease (10% vs. 7%) and receive mastectomy (27% vs. 18%), and less likely to receive radiation (35% vs. 57%) or chemotherapy (5% vs. 9%). Five-year cumulative incidences of recurrence were 15%, 18% and 22% among robust, pre-frail, and frail women, respectively. In multivariable competing risks models adjusted for age, race, stage, and treatment, frail (SHR 1.28, 95%CI 1.17-1.41) and pre-frail (SHR 1.15, 95%CI 1.09-1.21) women had a significantly increased risk of breast cancer recurrence. Conclusions: Independent of differences in treatment, frailty was associated with increased breast cancer recurrence risk in this population-based cohort of older women. However, the vast majority of older women living with HR+/HER2- early breast cancer were not identified as frail. These study results suggest that age alone is not an adequate indicator of physical resilience and underscores the need to consider additional factors when assessing the benefits and risks of treatments for the prevention of recurrence among HR+/HER2- early breast cancer patients.
Trends in utilization of hypofractionated whole breast radiation in breast cancer: An analysis of the National Cancer Database.
Authors: Woodward Steven Gerard , George Brandon , Varshney Karan , Willis Alliric Isaac 
Published: May 2020

536 Background: Utilization of hypofractionated radiation (HR) as a component of breast conserving treatment (BCT) in breast cancer is lacking in the U.S. despite studies demonstrating its efficacy and guidelines supporting its use from the American Society for Radiation Oncology (ASTRO) in 2011 and 2018. Little is known regarding national trends in uptake and factors associated with uptake of HR in the U.S. since the 2011 ASTRO guidelines. Methods: We performed a retrospective review of the National Cancer Data Base (2012-2016) on patients undergoing BCT. Logistic regression modeling was used to identify relationships between patient, hospital, and tumor factors with the use of HR or traditional radiation (TR). Results: A total of 360,834 cases of BCT were identified with 65% (n=235,783) undergoing TR and 35% (n=125,051) undergoing HR. The odds of utilization of HR increased with year of diagnosis, patient age, higher median income, private insurance, treatment at an academic center, travel distance to treatment >20 miles, smaller tumors, lymph node negative disease, and without use of chemotherapy (p-values <0.0001, Table). Conclusions: Despite studies demonstrating the efficacy of its use and the support of ASTRO, HR utilization in the U.S. is still lacking. By understanding which patient populations are still not receiving the benefit of this therapy we can improve our utilization of HR in the U.S. leading to reduced healthcare costs and patient satisfaction. [Table: see text]
Expanding criteria for prognostic stage IA disease in HR+ breast cancer.
Authors: Kantor Olga , King Tari A. , Shak Steven , Russell Christy Ann , Giuliano Armando E. , Hortobagyi Gabriel N. , Burstein Harold J. , Winer Eric P. , Sparano Joseph A. , Mittendorf Elizabeth A. 
Published: May 2020

550 Background: The 8th ed AJCC staging system incorporated grade, receptor status and the Oncotype DX Recurrence Score (RS) result into staging. Based on TAILORx trial data and evidence of utility for RS results in node positive disease, this study was undertaken to determine if staging should incorporate expanded RS criteria. Methods: Patients (pts) with T1-3N0-3 HR+HER2- disease undergoing surgery 2010-15 were identified in the SEER database. 5yr DSS was estimated based on T and N category, grade and RS result; differences were compared between pts with path prognostic stage IA disease and all other groups. Results: 154,054 pts were identified; median follow up was 49 mo (range 0-83). RS results were obtained in 60,886 (39.5%); RS <11 in 13,570 (22.3%) and RS 11-25 in 39,240 (64.5%). The table details 5yr DSS rates. 5yr DSS for path prognostic stage IA pts (n=114,675, 73.4%) was 98.2%. Among all pts with RS <11, 5yr DSS was excellent and not significantly different than for path prognostic stage IA pts. For those with RS 11-25 not receiving chemo, 5yr DSS was inferior to path prognostic stage IA disease for T1-2N1 pts and for those with T2-3N0 disease although among N0 pts the differences were numerically small (1.4%-2.5% vs overall path prognostic stage IA). Conclusions: Pts with Recurrence Score <11 have excellent 5yr DSS regardless of T and N category or grade suggesting further modification of the AJCC staging system using this cutoff. Additional study is required to optimize staging for patients with Recurrence Score 11-25. [Table: see text]