bluuebunny/crossref_metadata_2025 huggingface dataset:
Reasons for discordance in treatment approaches between oncology practice and clinical decision support in China.
Authors: Liang Jun , Li Tianle , Zhang Shan-shan , Chen Cheng , VanHouten Courtney , Preininger Anita , Dankwa-Mullan Irene , Jackson Gretchen Purcell
Published: May 2019

6555

Background: Therapeutic clinical decision-support systems (CDSS) are often evaluated by comparisons between CDSS options and actual practice decisions or expert opinions. Few such studies have carefully examined reasons for discordance. Methods: We reviewed 11 concordance studies from different hospitals across 8 provinces in China, published between 2017 and 2018. The studies compared IBM Watson for Oncology (WfO) therapeutic options to treatments selected by oncologists or a tumor board involved in review of cases for lung, colon, rectal, breast, gastric, and gynecological cancers. We identified given reasons for discordance and summarized themes across studies. Results: Of the 11 studies, 9 provided 1 or more reasons for discordance which could be analyzed. We found three major themes related to discordance: formulary restrictions, treatment-protocol differences, and physician or patient preferences (Table). Formulary differences between WfO and regional practices included off-label drug uses or unavailable therapies. Treatment-protocol differences included variations in regimens, such as simultaneous versus sequential treatments. Physician or patient preferences included factors such as the cost of treatment and logistics associated with various treatments. Conclusions: This study identified multiple reasons for discordance between an oncology CDSS option and oncologists’ treatment choices in China. Treatment differences arose from local formulary or protocol differences as well as provider and patient preferences. Future studies of CDSS should include reasons for discordance when assessing system performance in this manner. [Table: see text]
Accelerating advanced precision medicine through a harmonized data exchange platform and research consortium (PMEC).
Authors: Sohal Davendra , Doudement Julien , George Ben , Alexander Brian Michael , Grant Stefan C. , Kim William Y. , Gutierrez Martin , Kelly William Kevin , Knudsen Karen E. , McPherson John , Hoimes Christopher J. , Davis Elizabeth J. , Singal Gaurav , Webster Jennifer , Chan Lindsay , Cristofanilli Massimo , Miller Vincent A.
Published: May 2019

6557

Background: Clinico-genomic data sharing is consistently identified by the global oncology community as a critical requirement to accelerate the discovery and development of new targeted therapies. However, lack of effective collaborative models, fragmented and lengthy legal contracting processes, paucity of funding, and inadequate technological platforms have historically been obstacles for effective data sharing. Methods: In 2015, 10 US academic medical centers (AMC) and Foundation Medicine Inc. (FMI) formed PMEC. Feasibility assessments included creation of a master agreement across sites and willingness to use a central IRB. Oversight and research steering committees were created within the consortium. Through a centralized, secure web-based platform, FoundationInsight, we combined and shared de-identified, harmonized comprehensive FoundationOne genomic profiling data. Research proposals mining this data warehouse are invited quarterly from participant AMCs and peer-reviewed; approved studies are executed at all sites. Results: All 10 AMCs collaborated to execute a master registry participation agreement, followed by a master IRB protocol (New England IRB # 120180008), subsequently approved by individual site IRBs. Since its launch, the PMEC database has grown, on average, 60% per year, to now house over 14,000 cases. The shared dataset covers all tumor types (most commonly lung [17.2%], gastrointestinal [13.8%] and breast [9.2%]), encompasses genomic alterations in >300 genes, and reports relevant supplementary data such as tumor mutation burden and microsatellite instability status. To date, 15 studies have been proposed and evaluated using this platform, with 2 projects currently approved and in progress. Conclusions: We demonstrated the feasibility of creating a collaborative academic consortium that facilitates data sharing and potential discovery efforts in oncology. Technology solutions can accelerate the ability of AMCs, in partnership with central labs, to share and harmonize data to advance precision medicine. This approach lays the groundwork for conducting prospective, biomarker-enriched clinical trials among participating AMCs.
Patient reported outcomes and predictors of distress.
Authors: Meadors Patrick Leland , Trufan Sally J , Walsh Kendall , Walsh Declan
Published: May 2019

6559

Background: ASCO/NCCN guidelines recommend screening for multifactorial distress in cancer patients. Understanding predictors of cancer related distress can lead to early intervention and improve clinical outcomes, symptom management, and operational efficiency. Through electronic distress screening (EDS), patient reported outcomes (PRO) were collected across 42 practice locations. Methods: EDS has 39 questions related to cancer related distress including: distress, cancer symptoms/side effects, malnutrition, depression, anxiety, social/family support, financial, and spiritual concerns. 27,106 patients completed screens between 2017-2018. Multivariate analysis and logistic regressions determined predictors of distress for completed screens overall, registry matched, and within 60 days of diagnosis. Results: Median age was 59 (IQR 18-101) and 65% were female. Five symptoms consistently predicted clinically significant distress ≥ 4: anxiety, fatigue, pain, poor emotional coping, and sleep. Diagnosis (dx), staging at time of dx, and timing of screen did not independently predict distress. Factors predicting clinically significant distress varied across geographic regions. Conclusions: In large patient population, five key PROs are predictive of clinically significant distress and could potentially impact clinical outcomes. Early PROs predictive of distress were consistent along the continuum, thus the importance of early symptom identification. EDS can help custom tailor supportive oncology programs to mitigate symptoms related to cancer distress. [Table: see text]
Unique perspectives from the transgender community: A retrospective chart review of cancer care needs for transgender patients.
Authors: Moloney Carolyn , Allen Margaret , O'Mahony Deirdre , Power Derek , Bambury Richard , O'Reilly Seamus , Collins Dearbhaile Catherine
Published: May 2019

6566

Background: It is estimated that 1% of a population experience some degree of gender non-conformity. There is scant information worldwide on cancer incidence and mortality for this population however due to a lack of investigating large-scale prospective studies. National cancer registries do not hold demographics on this population. Current literature indicates transgender people may face an increased cancer risk. Transgender patients may avoid screening programmes for cancers which are themselves gendered. Transgender patients can feel excluded from gender specific cancer support groups. We set out to identify how cancer services in Ireland can better meet transgender people’s unique needs. Methods: Medical oncology consultants in the South/South-West of Ireland were contacted to identify patients who identified as transgender or gender non-conforming. We carried out a retrospective chart review of the four transgender patients identified. We analysed staging at diagnosis, family supports, smoking history, alcohol use and whether cancer treatment affected gender transitioning treatment and if this had documented effects on mental well-being. We also noted if medical records reflected a new name or change of gender and if not, whether original name and gender used for chemotherapy and blood product administration. Results: All four patients were diagnosed with relatively advanced disease at diagnosis- Stage IIIc high grade ovarian cancer, stage IV gastrointestinal tumour, stage IVb diffuse large B Cell and locally advanced extra-abdominal desmoid tumour. Of the four patients, three had a smoking and alcohol history on diagnosis. All four patient’s recent medical correspondence reflected a name and gender change but the medical records did not reflect this. Three patients had documented depression for which they were attending psychiatry services. It was noted that two patients had gender transitioning treatment postponed due to cancer care. Minimal family support was noted for two patients. Conclusions: The transgender community is a growing population that will continue to integrate into mainstream society. Our retrospective chart review adds to a growing body of evidence which suggests gender minorities may suffer from cancer-related disparities and have an increased need for psychosocial support. As in other studies, it is difficult to identify these individuals. We should identify gender minority individuals and report this data in medical records in order to build much needed epidemiological information.
Impact of race/ethnicity in the clinical presentation and outcomes of patients with multiple myeloma in an underserved urban population.
Authors: Torres Christian , Andrade Gonzalez Xavier Alberto , Katiyar Vatsala , Del Cid Juan , Mendez Hernandez Andres , Munoz Ezequiel , Sumoza Luis David
Published: May 2019

6570

Background: Patients with multiple myeloma (MM) who are part of racial/ethnic minority groups have been typically underrepresented in large descriptive and randomized-controlled studies. Despite the identification of biological and genetic risk factors, the impact of race/ethnicity in the outcomes of patients with MM remains largely unknown. We aimed to describe the racial/ethnic differences in clinical presentation and outcomes of patients with MM in an ethnically-diverse underserved urban population. Methods: We conducted a single-center retrospective study of patients with MM from Jan 1st 2008 – Dec 31st 2016 using ICD coding from our tumor registry. We abstracted demographic, clinical and treatment variables. We used Chi-square to compare categorical variables and Kaplan-Meier method for survival analysis. Statistical analysis was performed using IBM SPSS version 25. Results: We identified 73 patients with MM with a median follow up time of 42 months (Range 1 to 81 months). Patients had a median age of 59 years (Interquartile Range [IQR] =17) and were predominantly male (54.8%). The most frequent racial/ethnic group was African American (AA) (59%) followed by Hispanic (27%) and Caucasian (8%). When compared to other ethnicities, patients who were AA had higher ISS-3 scores (41% vs 23% p=0.101) worse cytogenetic risk (65% vs 30% p=0.009) and worse response after induction (Complete response [CR] 47% vs 77% p=0.047). They were also more likely to have medical insurance coverage than other ethnicities (67% vs 27% p=0.003) but had similar access to autologous bone marrow transplant (23% vs 23% p= 0.99). Overall, AA patients had worse overall survival (OS) compared to all other ethnic groups (mean OS: 58.3 months vs 79 months p=0.014). Conclusions: AA patients with MM had more aggressive disease and worse OS compared to other ethnicities which may suggest an underlying genetic predisposition towards high-risk genetic features. Improvement of access to autologous bone marrow transplantation may improve survival in high-risk racial/ethnic groups.
Cervical cancer screening in incarcerated women: An experience from the first cervical cancer screening campaign in a southern Thailand correctional facility.
Authors: Jiamset Ingporn , Sakdejayont Siwat , Rattanakhot Nanthiya , Peeyananjarassri Krantarat , Dechaphunkul Arunee , Sunpaweravong Patrapim
Published: May 2019

6572

Background: Cervical cancer is one of the most preventable cancers, not only presence of effective HPV vaccination but also simple and robust screening methods such as Pap test. Nevertheless, there were some women at risk whom were unable to access screening cause of incarceration. Hence, in 2018, together with Songkhla Woman Correctional Institute, we launched a cancer screening campaign including clinical breast exam, mobile mammography and Pap test. This is the first report of cervical cancer screening result demonstrated the essential of cervical cancer screening in these disadvantaged women. Methods: Due to the regulation of the jail, we had to limited bring-in tools, allowed staffs and operating-time, therefore we used a pre-screening questionnaire, included 5 items: HIV infection, number of partner, parity, age at first sexual intercourse and number of term baby and each of them scored as 2 for “high-risk” and 1 for “low-risk”, total score ranged from 5 to 10. We ranked and chose the volunteer participants, who have HIV infection and/or with highest risk score, to undergo Pap test. Results: Of the 1328 questionnaire responders, Their mean risk score was 7.3 (SD= 1.3). HIV infected participants number were 34 (2.5%). Of the 200 screened-participants, None of them had ever received HPV vaccination before, and all participant did not have Pap test since imprisonment. (mean 53.8 m, range 13-236 m, SD 36.7). Their score ranged between 8 to 10, 42.5% of them had score level 8, 54.5% had score level 9 and 3% had score level 10. Mean age was 37.7 years. 10 (5%) of them had abnormal Pap test; 1 of them showed ASC-US, 1 was LSIL, 1 was ASC-H, 5 of them showed HSIL and 2 of them showed squamous cell carcinoma and small round cell carcinoma. Final histopathological test resulted in 6 of cervical intraepithelial neoplasia (CIN) I, metaplasia and cervicitis, 3 were diagnose CIN III and 1 diagnosed microinvasive carcinoma. Incidence of cervical cancer was higher than normal population in this region. (0.5% vs 0.02%). Conclusions: Incarcerated women were at high risk of cervical cancer compared to normal population. Unfortunately, in many places, they were unconditionally inaccessible to the cervical cancer preventive healthcare system for years. Social should increase awareness to decrease this health disparity.
Diagnostic and treatment delays in young women with breast cancer.
Authors: Poorvu Philip D , Zheng Yue , Sella Tal , Rosenberg Shoshana M. , Ruddy Kathryn Jean , Gelber Shari I. , Tamimi Rulla M , Peppercorn Jeffrey M. , Schapira Lidia , Borges Virginia F. , Come Steven E. , Warner Ellen , Partridge Ann H.
Published: May 2019

6575

Background: Delays in diagnosis (dx) and treatment (tx) affect breast cancer (BC) outcomes. We sought to identify factors associated with delays among young women, who do not undergo routine screening and often have pregnancy or breastfeeding-related breast changes that may mask a BC. Methods: The Young Women’s Breast Cancer Study is a multicenter, prospective cohort that enrolled 1302 women with newly dx BC age ≤40 between 2006-2016. Women reported the method and timing of cancer detection on the baseline survey. 231 were ineligible or excluded due to missing information. Among those reporting self-detected cancers, using multivariable regression we evaluated factors associated with delays ≥90 days (d) from symptom to presentation (self delay) and presentation to dx (care delay); in stage 0-III BC we evaluated delays ≥60d from dx to tx (tx delay). Results: 1071 eligible women had median age at dx of 37 yrs (17-40) and 74% reported self-detected cancers. Self delay or care delay ≥90d was reported in 17% and 13%, respectively. Factors inversely associated with self delay included pregnancy at dx (vs nulliparous, OR 0.10, CI 0.01-0.78) and perceived financial comfort (vs not, OR 0.62, CI 0.41-0.93). Women dx ≤1 year post-partum who breastfed (vs nulliparous, OR 2.60, CI 1.14-5.93) and those with a family history of breast/ovarian cancer (vs none, OR 1.79, CI 1.00-3.19) were more likely to have a care delay. Age was inversely associated with care delays (OR 0.94, CI 0.89-0.99). Tx delay was reported by 10% (105/1015), and associated with being single (vs partnered, OR 1.61, CI 1.02-2.56 ), non-white (vs white, OR 1.85, CI 1.09-3.13) and having Stage 0 BC (vs stage 1, OR: 3.08, CI 1.65-5.77); women with stage 3 BC (vs stage 1, OR 0.13, CI 0.03-0.56) were less likely to have a tx delay. Conclusions: In this cohort, most young women with BC underwent timely dx and tx initiation. Women dx ≤1 year post-partum who breastfed were more likely to experience a care delay, likely because lactational changes may mask BC signs and symptoms. The associations of perceived financial status with self delay and non-white race with tx delay underscore the need for additional support to ensure timely care for underserved populations with the goal of eliminating disparities in outcomes.
Association of diagnosing physician and hospital characteristics with the use of radical cystectomy among patients with muscle-invasive bladder cancer.
Authors: Mehta Hemalkumar B , Golla Vishnukamal , Ray-Zack Mohamed Danny , Shan Yong , Kuo Yong-Fang , Chamie Karim , Williams Stephen Bentley
Published: May 2019

6576

Background: Only one out of five muscle-invasive bladder cancer patients receive radical cystectomy, a guideline-recommended treatment. Prior studies evaluated patient characteristics associated with radical cystectomy use. We aimed to determine bladder cancer diagnosing physician and hospital characteristics associated with the use of radical cystectomy. Methods: This cohort study used linked SEER-Medicare Data from 2002 to 2011. We included older adults (age>65 years) diagnosed with muscle-invasive bladder cancer. For each patient, a urologist who performed transurethral resection of bladder tumor was assigned as a diagnosing physician. The diagnosing physician was assigned to one hospital based on where he/she performed more than half of all urologic surgeries. Two-level hierarchical model (patients nested within hospitals) were constructed to determine the association of patient, physician and hospital characteristics with radical cystectomy use. Results: A total of 7,097 patients were diagnosed by 4601 physicians who were affiliated with 822 hospitals. Overall, the radical cystectomy utilization rate was 26.5%. Only 4.8% of the variation in radical cystectomy was attributed to the hospital level. In the two-level hierarchical model, patients diagnosed by female physicians were more likely to undergo radical cystectomy (32.8% vs. 25.8%; OR=1.63, 95% CI=1.31-2.02). Higher radical cystectomy volume by diagnosing physicians and hospitals increased the radical cystectomy use (Table). Diagnosing physician characteristics (age, years in practice, employment status), and hospital characteristics (teaching states, location, type of hospital) were not associated with radical cystectomy use. Patient characteristics such as age, male, higher comorbidity burden were associated with lower likelihood of radical cystectomy use. Conclusions: Physician and hospital factors do not largely contribute to the receipt of radical cystectomy. Radical cystectomy volume by diagnosing physicians and hospital drives radical cystectomy use.[Table: see text]
Disparities in lung cancer outcomes for veterans with comorbid mental disorders.
Authors: Berchuck Jacob E , Meyer Craig , Zhang Ning , Trivedi Neil , Cohen Beth , Wang Sunny
Published: May 2019

6577

Background: Emerging evidence suggests that cancer patients with comorbid mental disorders have worse outcomes. Lung cancer is the leading cause of cancer-related death in the United States, yet the impact of specific mental disorders on outcomes for patients diagnosed with lung cancer is not well known. Methods: Stage at diagnosis and receipt of stage-appropriate treatment were assessed for 55,315 Veterans with non-small cell lung cancer (NSCLC) in the Veterans Affairs (VA) Central Cancer Registry from 2000 to 2011. Patients were stratified by the presence of specific comorbid mental disorders. Multivariate analysis evaluated the association between mental disorders and survival, as well as the impact of VA treatment programs on survival. Results: Patients with schizophrenia had lower rates of localized disease at diagnosis compared to those without mental disorders. Schizophrenia and dementia were associated with significantly lower rates of stage-appropriate treatment for localized, locoregional, and metastatic disease. Conversely, patients with depression or PTSD were more frequently diagnosed with early-stage disease and significantly more likely to receive stage-appropriate treatment across all stages. After adjusting for baseline differences, stage, and rates of stage-appropriate treatment, hazard of death was higher for patients with schizophrenia (hazard ratio [HR] 1.10; 95% CI, 1.03-1.16; P < .005) and dementia (HR 1.11; 95% CI, 1.06-1.18; P < .0005). Participation in VA-based programs to address mental illness, substance use, and homelessness was associated with a significant reduction in all-cause mortality (HR 0.71; 95% CI, 0.68-0.75; P < .0001) and lung-cancer specific mortality (HR 0.73; 95% CI, 0.69-0.77; P < .0001). Conclusions: Schizophrenia and dementia are strong negative predictors of survival among Veterans diagnosed with NSCLC. VA-based mental health treatment programs are associated with reductions in all-cause and lung cancer-related mortality, highlighting the importance of funding and promoting mental health and supportive programs.
Impact of smoke-free ordinance strength on smoking prevalence and lung cancer incidence.
Authors: Nguyen Ryan , Vater Laura , Timsina Lava R , Durm Greg Andrew , Rupp Katelin , Wright Keylee , Spitznagle Miranda , Paul Brandy , Jalal Shadia Ibrahim , Carter-Harris Lisa , Hudmon Karen S , Hanna Nasser H. , Loehrer Patrick J. , Ceppa DuyKhanh
Published: May 2019

6578

Background: Smoke-free ordinances (SFO) have been shown to decrease the prevalence of cardiovascular and pulmonary disease, but there is limited data on the impact of such policies on lung cancer incidence. We investigated the relationship between strength of county-level SFO with smoking prevalence and lung cancer incidence in Indiana. Methods: Following IRB approval, we queried the Indiana State Cancer Registry and Indiana Tobacco Prevention and Cessation Commission’s policy database between 1995 and 2016. County-level characteristics included population, income, poverty, education, race/ethnicity, sex, and rurality. Lung cancer diagnosis and stage were also collected. Using generalized estimating equations (GEE) with robust standard errors and accounting for the clustering effect at county level, we performed multivariable analyses of smoking prevalence and age-adjusted lung cancer rates with respect to the strength of smoke-free ordinances at the county level over time. Results: Indiana consists of 92 counties, 24 of which had SFO by 2011. In 2012, Indiana enacted a law mandating at least a moderate state-wide SFO. From 1995 to 2016, 110,935 Indiana residents were diagnosed with lung cancer. Indiana also had an average age-adjusted yearly lung cancer incidence of 76.8 per 100,000 population and average yearly smoking prevalence of 25% during this time. Smoking prevalence was 1.2% (95% CI [-1.88, -0.52]) lower in counties with comprehensive or moderate SFO compared with those with weak or no SFO. Counties that had comprehensive or moderate SFO had an 8.36 (95% CI [-11.45, -5.27]) decrease in new lung cancer diagnosis per 100,000 population per year compared with counties that had weak or no SFO. Conclusions: Stronger municipal smoke-free air ordinances are associated with decreased smoking prevalence and fewer new lung cancer cases. Strengthening smoke-free ordinances is paramount to decreasing lung cancer incidence.
Low nationwide utilization of adjuvant chemotherapy (AC) in elderly patients with localized non-small cell lung cancer (NSCLC).
Authors: Parikh Kaushal , Durani Urshila , Inselman Jonathan , Funni Shealeigh , Goyal Gaurav , Go Ronald S. , Leventakos Konstantinos , Mansfield Aaron Scott
Published: May 2019

6581

Background: While AC is recommended for all patients with stage IIA, IIB, and IIIA NSCLC, its use and benefit among the elderly population is unclear. Methods: We identified patients with stage IIA, IIB, or IIIA NSCLC using the National Cancer Database from 2006-2014. Patients were divided into age groups ≤65, 66-70, 71-75, 76-80, > 80 years. Trends in AC use, factors influencing AC administration, and outcomes associated with AC were studied. Results: Out of 27368 patients, 13464 received AC and 13904 did not. 11% had stage IIA disease, 50% had stage IIB disease and 39% had stage IIIA disease. AC use was lower with increasing age (49% age ≤65 vs. 3% age > 80 (P < 0.0001)). Temporal use of chemotherapy for each age group was unchanged from 2006-2014. In multivariate logistic regression analysis, factors predictive of lower AC use were older age, Medicare or Medicaid insurance, academic center, and higher Charlson Comorbidity Index (CCI). Stage IIIA (OR 1.4, 95% CI 1.3-1.6) and Stage IIB (OR 1.3, 95% CI 1.2-1.4) had a higher chance of receiving AC than stage IIA. In a Cox proportional hazard model, younger age, female sex, academic center, private insurance, higher income, lower CCI, West coast center and AC were associated with better outcomes. When stratified by age and stage, AC was still associated with better survival (Table). Conclusions: AC utilization in stages IIA, IIB and IIIA NSCLC remains low, despite its association with improved survival in the elderly. Future clinical trials may be needed focused on elderly patients to establish the best regimen to optimize outcomes. [Table: see text]
Self-reported health and survival in older patients diagnosed with multiple myeloma.
Authors: Nabulsi Nadia Azmi , Alobaidi Ali , Talon Brian , Asfaw Alemseged Ayele , Zhou Jifang , Sharp Lisa K. , Sweiss Karen , Patel Pritesh Rajni , Chiu Brian C-H , Ko Naomi , Calip Gregory Sampang
Published: May 2019

6582

Background: The strength of associations between pre-diagnosis self-reported health (SRH) and mortality differ by medical condition, with a moderately strong association reported among cancer patients. Less is known about the impact of SRH on survival among patients diagnosed with multiple myeloma (MM). We aimed to evaluate pre-diagnosis SRH in relation to survival in a cohort of older MM patients. Methods: We analyzed a prospective cohort from the Surveillance, Epidemiology, and End Results (SEER)-Medicare Health Outcomes Survey (MHOS) database of patients 65 years and older diagnosed with first primary MM. Survey responses to a single general health question (asking patients to self-report their health as excellent, very good, good, fair, or poor) were used to determine pre-diagnosis SRH, grouped as high (excellent/very good/good) or low (fair/poor). We used multivariable Cox proportional hazards models to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI) for associations between SRH and risks of all-cause and cancer-specific mortality. Results: Of 521 MM patients with pre-diagnosis SRH data, the mean (SD) age at diagnosis was 76.8 (6.1) years with 60% of patients identifying as white, 18% as black, and 32% reporting low SRH. Compared to patients reporting high SRH, patients reporting low SRH were older, had lower education levels, more comorbidities, and lower Veterans-RAND 12 physical health and mental health component summary scores. In multivariable analyses, MM patients with low SRH had a 28% increased risk of all-cause mortality (HR = 1.28, 95% CI = 1.00, 1.64) and a non-statistically significant 19% increased risk of cancer-specific mortality (HR = 1.19, 95% CI = 0.87, 1.61) compared to MM patients reporting high SRH. Conclusions: Our findings suggest that lower SRH is highly prevalent among MM patients prior to diagnosis and is associated with modestly increased all-cause mortality. At a minimum, low SRH deserves clinical attention to determine how older MM patients’ quality of life may be compromised. The mechanism by which SRH affects mortality in MM should be further assessed and efforts should be made to identify whether any of the underlying mechanisms linking SRH and mortality in MM are mutable.
Real-world prevalence of autoimmune disease (AD) among patients (pts) receiving immune checkpoint inhibitors (ICI) in ASCO’s CancerLinQ database.
Authors: Chen Li , Walker Mark S. , Zhi Jizu , Komatsoulis George Anthony , Jun Monika , Stepanski Edward , Fukushima Ryan , Lau Denise , Roberts Jeremy , Hyde Brigham , Miller Robert S. , Khozin Sean , Rubinstein Wendy S.
Published: May 2019

6583

Background: Although pts with AD are routinely excluded from ICI clinical trials, evidence suggests they may be receiving ICI therapy once approved. We sought to understand the prevalence of AD among all pts receiving ICIs in real world clinical care, as well as in advanced non-small cell lung cancer (aNSCLC) alone, and to describe the characteristics of ICI pts with and without evidence of AD. Methods: We conducted a retrospective, observational cohort study using statistically de-identified data from January 2011 to November 2018 in CancerLinQ, ASCO’s real-world oncology database. Adult pts who received ≥ 1 dose of an ICI and had ≥ 2 clinical visits were eligible for inclusion. A sub-analysis examining only aNSCLC pts was also carried out. To reduce the likelihood of capturing pts who may have been on a clinical trial, pts were excluded if they received the ICI prior to its first FDA approval date. AD status was determined by the presence of select ICD-9/ICD-10 codes or a medication used to treat autoimmune disease (including steroids) prior to ICI treatment start date. Symphony claims data were linked to CLQ via tokenization to build out cohorts. Characteristics of pts with and without autoimmune disease were compared using Chi-square or Fisher’s exact tests. Results: Prevalence of AD was 23% (538/2425 pts) in the aNSCLC population and 27% (3407/12712 pts) in the all ICI patient population. Median age did not differ between AD pts and those with no evidence of AD (All ICI: 67.6 v 67.3 years; aNSCLC: 68.5 v 67.9). AD pts were more likely to be female (All ICI: 46% v 40%, p < 0.001; aNSCLC: 55% v 44%, p < 0.001). Among all ICI pts, AD pts were less likely to be Stage IV (62% v 65%) or to have melanoma (4.6% versus 8.7%) compared to pts with no evidence of AD. The most common ADs among all ICI and aNSCLC patients were glucocorticoid deficiency (6.3% and 3.9%), rheumatoid arthritis (4.2% and 5.8%), and sacroiliitis (2.7% and 3.9%), respectively. Conclusions: This analysis of real-world data finds that a large proportion of pts receiving ICI may have pre-existing AD. Further examination is warranted to examine how AD status may impact outcomes.
Can high-volume surgeons achieve optimal outcomes at low-volume hospitals? Implications for the Leapfrog Initiative and regionalization of high-risk surgical oncology procedures.
Authors: Aquina Christopher Thomas , Becerra Adan Z , Xu Zhaomin , Justiniano Carla , Peyre Christian G , Linehan David , Temple Larissa K. F. , Fleming Fergal J.
Published: May 2019

6585

Background: The Leapfrog group recently released surgeon and hospital procedure volume standards for several surgical oncology procedures. This study investigated trends in volume and whether high-volume surgeons at low-volume hospitals achieve equivalent outcomes to high-volume surgeons at high-volume hospitals. Methods: New York’s Statewide Planning and Research Cooperative System was queried for esophagectomy, lung resection, pancreatectomy, and proctectomy for cancer from 2004-2015. Mixed-effects analyses assessed the association among Leapfrog surgeon/hospital volume standards and 90-day mortality. Results: Among 55,528 cases, high-volume surgeons performed 64.7% of cases (esophagectomy = 52%; lung resection = 75.6%; pancreatectomy = 56.7%; proctectomy = 53%), and high-volume hospitals performed 59.5% of cases (esophagectomy = 55.5%; lung resection = 58.3%; pancreatectomy = 63.4%; proctectomy = 61%). After risk-adjustment, high-volume surgeons at high-volume hospitals had lower odds of 90-day mortality compared to high-volume surgeons at low-volume hospitals for each organ system except for pancreas. Despite trends toward regionalization, between 2012-2015, there were large differences in the number of hospitals and median annual case number between high-volume and low-volume centers for esophagectomy (8 vs. 56 hospitals; 31.5 vs. 3 cases), lung resection (22 vs. 89 hospitals; 69.5 vs. 7 cases), pancreatectomy (15 vs. 56 hospitals; 36 vs. 3 cases), and proctectomy (38 vs. 117 hospitals; 28 vs. 3 cases). Conclusions: This study supports the Leapfrog initiative for performance of high-risk surgical oncology procedures by high-volume surgeons at high-volume hospitals. However, it remains unclear whether full regionalization to high-volume centers is feasible. [Table: see text]
Impact of cardiovascular comorbidities on mortality in patients admitted for neutropenic fever in 2016.
Authors: Atallah-Yunes Suheil Albert , Haddadin Faris , Kadado Anis , Ali Syed S.
Published: May 2019

6586

Background: Neutropenic fever (NF) remains one of the most common causes for hospitalization and mortality in oncology patients. Concomitant cardiovascular disease in patients with cancer is not uncommon. There is limited data on the impact of cardiovascular (CVS) comorbidities on mortality in cancer patients with NF. Methods: This is a retrospective cohort study using the 2016 National Inpatient Sample database (NIS) of adults ( > 18 years) admitted for NF based on the ICD-10 code. Mortality was the primary outcome. Multivariate linear regression adjusted for potential confounder of age, sex, race, Charlson comorbidity index and all the CVS comorbidities of the study including atrial fibrillation (AF), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), coronary artery disease (CAD), peripheral vascular disease (PVD), hypertension (HTN), history of smoking, history of cerebrovascular accident (CVA) or TIA and dyslipidemia. STATA 15 was used for analysis. Results: We identified 31,310 patients (mean age 44.6) (49.6% females) admitted with NF, among which 250 died during same admission. On multivariate linear regression there was a significant increase in adjusted all-cause mortality in patients with AF (OR: 2.39; 95%-CI 1.06- 5.40, P = 0.035) and HFpEF (OR: 4.30; 95%-CI 1.08- 17.17, P = 0.039). There was no significant increase in mortality in patients with HFrEF, dyslipidemia, HTN, PVD, CAD, history of CVA/TIA and smoking. Conclusions: Patients with NF and concomitant history of AF or HFpEF have an increased risk of mortality during hospitalization. Inflammation is emerging as a key player in AF pathogenesis. This may explain why AF appears to correlate with mortality, as those with more severe presentations are more likely to have a heightened state of inflammation. Patients with NF are more likely to receive fluids in the setting of infectious complications which could explain the increased mortality in CHF patients with NF. Identifying risk factors for increased mortality in patients with NF is important for risk stratification and in guiding clinicians in the management of this delicate population. [Table: see text]
Prospective study of pain outcomes associated with contralateral prophylactic mastectomy in women with nonhereditary breast cancer.
Authors: Smith-Graziani Demetria Joy , Parker Patricia A. , Peterson Susan K. , Bedrosian Isabelle , Shen Yu , Black Dalliah MaShon , DeSnyder Sarah Marie , Hunt Kelly , Dong Wenli , Brewster Abenaa M.
Published: May 2019

6587

Background: Women with nonhereditary breast cancer are increasingly undergoing contralateral prophylactic mastectomy (CPM). We examined pain severity and the impact of pain on the lives of women who underwent CPM compared to those who did not. We also examined the associations between age, race/ethnicity, reconstruction and pain outcomes. Methods: Between 2012 and 2015, we recruited women with newly diagnosed nonhereditary breast cancer who were planned for surgery. We assessed pain with the Brief Pain Inventory at initial surgical consultation and at 1, 6, 12, and 18 months after surgery. The repeated measures model was used to assess the association between pain severity or interference and CPM status over different time points adjusting for other covariates. Results: Of 288 women enrolled (mean age 56 years, 58% non-Hispanic White, 17% non-Hispanic Black), 50 underwent CPM, 163 had unilateral mastectomy, and 75 had breast conserving surgery. Mean pain severity was higher at 1 month (2.78 vs 1.9, p = .01) and 6 months (2.79 vs 1.96, p = .03) after surgery in women with CPM versus those without. In the multivariable repeated measures model adjusted for time, age, race/ethnicity and reconstruction status, there was a significant interaction between time and CPM for pain severity (p < .01) but not interference (p = .13). This suggests that CPM patients had higher pain severity in the first 6 months after surgery, but their pain scores decreased by 12 months becoming similar to women without CPM. Black women had higher pain severity (mean difference 1.35, standard error [SE] 0.35; p < .01) and interference (mean difference 0.91, SE 0.32; p < .01) compared to White women with or without CPM. There was no association between age or reconstruction status and pain severity or interference. Conclusions: Pain severity in patients undergoing CPM is highest during the first 6 months after surgery. Women considering CPM should be counseled about this potential outcome. Race/ethnic disparities exist in pain management, pain perceptions and communication of pain. Black women undergoing breast surgery report worse pain outcomes than White women regardless of CPM status.
Analysis of racial distribution amongst patients in phase III cancer clinical trials.
Authors: Gopishetty Swathi , Gupta Shruti , Kota Vamsi , Guddati Achuta Kumar
Published: May 2019

6588

Background: Minority races are often under-represented in cancer clinical trials as enrollment often occurs in large centers. Racial diversity may vary by geographical location and socio-economically backward areas may have a very different racial mix. This study explores the representation of different races in phase 3 clinical trials conducted in the past 10 years. Methods: Details about adult patients involved in phase 3 trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The racial distribution of the patient population in these trials was analyzed. Results: African American and Asian patients are under-represented in all phase 3 cancer clinical trials. The table shows the average racial distribution in clinical trials for each organ specific malignancy. Conclusions: Most phase 3 clinical trials except for lung cancer, predominantly consisted of Caucasian patients. Applying the results of these trails to patients of other races should be done with caution. This study highlights the disparity of race in patients enrolled in clinical trials when compared to diverse and different populations that are encountered in practice. [Table: see text]
Impact of timing of lung resection on survival for clinical stage I and II lung cancer.
Authors: Emmerick Isabel M , Powers Maggie M , Aldrich Melinda C , Lou Feiran , Lin Poliana , Maxfield Mark , Uy Karl
Published: May 2019

6598

Background: Lung cancer has the highest mortality among the leading cancers in the U.S. Surgical resection is considered as the most effective treatment for lung cancer in early stages, providing greater long-term survival. Clinical guidelines on delays in resection of early-stage lung cancer do not exist. This work aims to assess whether increasing time between diagnosis/first doctor visit and surgery for early stage non-small cell lung cancer (NSCLC) is associated with poorer survival. Methods: We identified a retrospective cohort of incident lung cancer cases who had surgical treatment for lung cancer at our institution between January 2009 and December 2017, and no prior radiation or chemotherapy. We assessed overall survival (OS) and predictors included a) time from first contact to surgery; and b) time from diagnosis to surgery. The association between time from diagnosis and time from first contact to surgery, and survival for patients with early stage NSCLC was assessed using multivariable Cox proportional hazard. We investigated four cut-off points: surgery within 15 days, 30 days, 60 days and 90 days. We controlled for sociodemographic characteristics as well as clinical outcomes. Results: Our cohort comprised 491 patients. The age average was 66.9 years, 61% female, 94.7% white, and 9% never smoked. Clinical Stage 1A and 1B corresponded to 86.5% of patients while in pathological stage it was 76%. The 5-year overall survival was 56.0%. Surgery occurred a median 40 days after the diagnosis and 43 days after the first visit and within 35 days if the first appointment was with a thoracic surgeon. The threshold time associated with statistically significant worse survival was 60 days after diagnosis. Surgery was performed more than 60 days of diagnosis in 115 (25.7%) patients, their OS was significantly worse than patients who had surgery earlier (HR=1.7 [95% CI: 1.1-2.6]). Conclusions: Greater intervals between diagnosis of early-stage NSCLC and surgery are associated with worse survival. Efforts to minimize delays, particularly factors that prolong the period from diagnosis to first contact with a lung cancer provider may improve survival. [Table: see text]
Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancer receiving larotrectinib.
Authors: Kummar Shivaani , Mascarenhas Leo , Geoerger Birgit , Turpin Brian , Cox Michael Craig , Yu Sandie , Nanda Shivani , Hiemeyer Florian , Keating Karen N , Chirila Costel , Gnanasakthy Ari , Davenport Eric , Hong David S. , Drilon Alexander E.
Published: May 2019

6602

Background: TRK fusions involving NTRK1, NTRK2, and NTRK3 occur in diverse tumor types in children and adults. Larotrectinib, a selective TRK inhibitor, was recently approved by the FDA based on high objective response rates, durable disease control, and a favorable toxicity profile in in patients with tumors harboring TRK fusions (Drilon et al, NEJM 2018; Laetsch et al, Lancet Oncol 2018). To explore the impact of larotrectinib on quality of life (QoL), patient-reported outcomes (PROs) are reported here for pediatric patients (SCOUT; NCT02637687) and adolescents and adults (NAVIGATE; NCT02576431). Methods: Patients completed questionnaires assessing QoL (i.e., PedsQL, FACES, EORTC QLQ-C30, EQ-5D-5L) at baseline and planned cycle visits. Data were analyzed using descriptive statistics, longitudinal data models, and graphical displays. Results: As of July 2017, 37 patients (13 pediatric and 24 adolescent or adult) completed questionnaires at baseline and had at least one post-baseline measurement. Improvements compared to baseline in PROs were seen in both groups of patients in all functional domains of the PedsQL (physical, emotional, social, and school) and of the EORTC QLQ-C30 (physical, role, cognitive, emotional, and social). Number of patients with MID-improvement for PedsQL (Total Score), EORTC QLQ-C30 (Global Health Score), and EQ-5D-5L (VAS) are presented in the table below. Improvements were rapid (by cycle 3 or 5), seen across most tumor types and sustained a minimum of 2 cycles. Conclusions: Although necessarily viewed with caution due to relatively small sample sizes, these results nonetheless show a meaningful early improvement in QoL in pediatric and adult patients with TRK fusion cancer treated with larotrectinib. Clinical trial information: NCT02637687 and NCT02576431. [Table: see text]
QOL assessment integrated into the clinical care of cancer survivors to identify needs and direct care.
Authors: Adonizio Christian S. , Weeder Jamie , Benner Erin , Manikowski Jesse , Hergenrather Julie , Wojtowicz Mark , Woods Julie I
Published: May 2019

6611

Background: Validated survey tools have been used to measure the quality of life (QOL) of patients treated for cancer, however, there are newer studies that have shown both an improvement in QOL, and improvement in overall survival using these tools. We integrated the Functional Assessment of Cancer Therapy – General Population (FACT-GP v.4) to direct the deployment of resources and interventions to improve the care of patients who have completed potentially curative therapy for cancer. Methods: This is an observational study of patients who received cancer therapy with curative intent in the last 18 months. The FACT-GP was administered by an RN via telephone. Patients contacted received and reviewed a Survivorship Care Plan (SCP) as defined by the American College of Surgeons Committee on Cancer. Patients who had a total score less than 60 on FACT-GP and/or had a score less than 12 on the Emotional Well-Being subscale (EWB) were considered high-risk and were referred to the Survivorship MDC for in-person evaluation. Results: From 10/1/2018 to 12/31/2018, 114 patients were referred to the cancer survivorship program. Of these, 64 (56%) patients had FACT-GP administered and were evaluated. 45 of these (70%) only completed the FACT-GP and received an SCP. 21 patients had a total score less than 60 and/or an EWB sub-score less than 12 and were identified as high-risk. 15 (72%) patients were seen in MDC, 4 (19%) patients were seen in conjunction with a scheduled appointment by the MDC team, 2 (9%) patients refused further evaluation. 66.7% of patients in the survivorship program were referred to Oncology Behavioral Health compared to 18.2% of all oncology patients. Survivorship patients in the cohort had a baseline utilization of the emergency department (ED) of 4.1% (10 of 241) from 1/1/2018 to 9/30/2018 and 0 (0 of 64) after the initiation of the intervention from 10/1/2018 to 12/31/2018. Conclusions: Integrating a validated QOL tool (FACT-GP) as a therapeutic intervention is feasible and may both identify needs and direct services for cancer survivors while possibly decreasing ED utilization. Clinical trial information: NCT03835052.