bluuebunny/crossref_metadata_2025 huggingface dataset:
Racial disparities in definitive treatment and long-term mortality among US veterans with high-risk localized prostate cancer.
Authors: Parikh Ravi Bharat , Robinson Kyle William , Chhatre Sumedha , Medvedeva Elina , Malkowicz S. Bruce , Jayadevappa Ravishankar
Published: May 2020

e19037

Background: Equal access to care may mediate racial disparities among men with localized prostate cancer. We examined the association between African-American race and long-term mortality among men with high-risk prostate cancer in a large equal-access health system. Methods: In this retrospective cohort study, we used the VA Corporate Data Warehouse to identify African-American (AA) and non-Hispanic White Veterans diagnosed with high-risk (prostate-specific antigen [PSA] ≥ 20 ng/mL, Gleason 8-10, or stage ≥ cT2c) localized prostate cancer between January 1st, 2001 and December 31st, 2011 and followed through January 1st, 2019. Veterans who did not receive continuous VA care were excluded. We used descriptive statistics to compare type of therapy received and multivariable Cox proportional hazards regressions to estimate the association between mortality and race. Cox models were adjusted for age, pre-treatment PSA, year of diagnosis, enrollment priority (an individual-level proxy for income and disability need), marital status, Elixhauser comorbidity index, and primary treatment. Results: Among 14,877 Veterans (median age 67 years [interquartile range [IQR] 62-75]), 4,160 (28.0%) were AA. Median followup was 9.0 years (IQR 6.1-11.4). Compared to White men, AA men were more likely to have PSA ≥ 20 (49.9% vs. 40.9%), be unmarried (59.3% vs. 43.3%), have ≥3 comorbidities (46.4% vs. 41.0%), and have high disability and income need (22.0% vs. 18.6%) (all p < 0.001). Over time, AA Veterans were consistently less likely to receive prostatectomy (18.9% vs. 24.9%). Crude mortality rates were 50.6 and 61.6 deaths per 1000 patient-years for AA and White Veterans, respectively. After adjusting for all covariates, AA Veterans had lower all-cause mortality (adjusted hazard ratio [aHR] 0.83, 95% CI 0.79-0.88, p < 0.001) compared to White Veterans. This association was consistent across pre-specified subgroups (Table). Conclusions: Among men with high-risk prostate cancer who received continuous care within a large equal-access health system, African-Americans had lower all-cause mortality compared to Whites. Equal access to care may mitigate or reverse traditional racial disparities in mortality among men with prostate cancer. [Table: see text]
Geographic and demographic disparities in colorectal cancer: A population-based study.
Authors: Rana Navpreet Kaur , Gosain Rohit , Lemini Riccardo , Wang Chong , Nurkin Steven J. , Gabriel Emmanuel M. , Boland Patrick M
Published: May 2020

e19047

Background: Colorectal cancer is one of the leading causes of cancer deaths in the US. Area of residence affects survival in many cancers, though largely unknown in colorectal cancer. The purpose of this study is to evaluate disparities between the metropolitan, urban and rural populations and the impact on survival in colorectal cancer. Methods: Data was obtained from the National Cancer Database (NCDB) colon, rectosigmoid, and rectal data sets. Patients (pts) were categorized by area of residence: metropolitan (MA), urban (UA), or rural (RA). Gender, race, insurance status, income, marital status, and tumor related data was collected. Univariate and multivariate analyses were performed to evaluate variables affecting overall survival (OS). Results: A total of 973,139 pts, spanning 2004-2013 were included in the study, 83% MA, 15% UA, 2% RA. RA and UA pts were more likely to be white than MA pts (92.7 v 91.4% v 83%). RA and UA were more likely to have lower income, with slightly lesser amounts of women and pts with no comorbidities. Uninsured rates were similar (3.3%). On univariate analysis, OS was worse for RA (HR 1.10) and UA (1.06) pts, as compared with MA. On multivariate analysis, small differences persisted with worse OS for RA (HR 1.02, p = .043) and UA (HR 1.01, p = .003). Black (HR 1.14) and native American (HR 1.17) pts had worse outcomes, while Asian (HR 0.8) pts had improved OS. Women (HR 0.88) and pts with higher incomes ( > 46K or 63K) had improved OS (HR 0.88). Conclusions: This study identifies socio-demographic disparities in colorectal cancer outcomes. Pts from rural and urban areas had worse OS, even though the proportion of minority pts with poor outcomes was lower. The difference in OS for RA and UA remained statistically significant in multivariate analysis, though it was largely corrected when adjusting for influencing variables. Part of this difference may be due to economic disparities, as lower income was linked to worse OS. This can independently limit access to care, especially for geographically isolated individuals. Additional research efforts are needed in order for us to better understand the key issues facing and the optimal means to improve outcomes in at risk populations.
A qualitative study of barriers and facilitators to enrollment of adolescents and young adults onto cancer clinical trials at NCI community oncology research program (NCORP) sites.
Authors: Siembida Elizabeth , Loomans-Kropp Holli Ann , Tami-Maury Irene , Sung Lillian , Pollock Brad H. , Freyer David Robert , Roth Michael
Published: May 2020

e19050

Background: Cancer clinical trials (CCTs) contribute to improving patient survival and quality of life; however, adolescents and young adults (AYAs, 15-39 years old), are underrepresented in CCTs, especially in the community setting. We aimed to identify barriers and facilitators to AYA CCT enrollment in the NCORP. Methods: We conducted 43 one-on-one semi-structured qualitative interviews with key stakeholders involved in the enrollment of AYAs across a diverse group of NCORP primary (n = 5) and affiliate (n = 10) sites. Interviews were conducted remotely by 3 trained interviewers using the Zoom platform. Stakeholders were recruited from high and low AYA enrolling sites (AYA/total site enrollments > 10% and < 3%, respectively). Stakeholders were overall NCORP Site PIs (n = 5), lead NCORP administrators (n = 4), clinical research associates (n = 11), medical and pediatric oncologists involved in the enrollment of AYAs (n = 7), regulatory research associates (n = 5), nurse navigators (n = 6), and patient advocates (n = 5). Interviews were audiotaped and transcribed. Thematic analysis was conducted to identify themes and relate them back to our primary research questions regarding barriers and facilitators to AYA CCT enrollment. Results: Stakeholder views on enrollment barriers centered on 5 main themes: (1) lack of site-level prioritization or discussion of AYA enrollment; (2) limited number of clinical trials for AYAs available nationally, with few trials opened locally; (3) insufficient resources and research staff; (4) concerns about the cost effectiveness of opening AYA trials due to low numbers of eligible patients; and (5) patient misconceptions about CCTs. Stakeholder views on enrollment facilitators centered on 3 main themes: (1) presence of an AYA program focused on increasing enrollment; (2) having a designated site AYA “champion”; and (3) having site leadership identify AYA enrollment as a priority. Stakeholders agreed that incentivizing AYA enrollments via increased reimbursement and/or study credits could potentially lead to increased enrollment. Conclusions: In addition to identifying multiple shared barriers to AYA CCT enrollment, our study also identified possible interventions for enrollment improvement, including designation of AYA “champions”, increased reimbursement for AYA enrollments, and improving AYA’s understanding of CCTs. Further studies are needed to assess the impact of interventions aimed at increasing AYA enrollment across the NCORP.
Differences in clinical characteristics and outcomes between white (W) and non-white (NW) patients with metastatic germ cell tumor (mGCT) treated at Indiana University (IU).
Authors: Espinoza Gutarra Manuel Ricardo , Hanna Nasser H. , Einhorn Lawrence H. , Adra Nabil
Published: May 2020

e19053

Background: Patients (pts) with mGCT are curable even when presenting at advanced stages, however its incidence is rising in NW populations. There is lack of data evaluating differences in disease characteristics and outcomes between W and NW pts. Methods: 701 pts with mGCT treated at IU with first-line chemotherapy (FLC) and 462 patients with relapsed mGCT treated with HDCT (high-dose chemotherapy) between 2004 and 2017 at IU were evaluated. Results: Pts treated with FLC had a median follow-up since diagnosis of 4.9 (0.03-19.46) years. 660 (94.1%) W pts and 41 (5.9%) NW (49% Hispanic, 26% Asian, 20% African American and 5% Native American). There were no significant differences in median age at diagnosis, rates of primary tumor site, pathology type (seminoma vs non-seminoma), metastasis sites, mortality, median hCG levels pre-chemotherapy, rates of progression after FLC, or late relapse rates. Higher rates of good risk disease and lower rates of poor risk disease were present among W compared to NW, as well as higher median AFP levels pre-chemotherapy and rates of platinum refractory disease in NW (p < 0.05). Patients treated with HDCT had a median follow up time of 2.08 (0.02-14.49) years since diagnosis. 412 (89.1%) were W and 50 (10.1%) were NW (48% Hispanic, 18% Asian, 26% African American, 2% Native American and 6% other). There were no significant differences in rates pathology type, disease risk, tumor markers, platinum refractory disease, completion of 2 cycles of HDCT, progression after HDCT or status at last follow up. W pts were more likely to receive HDCT as initial salvage chemotherapy compared to NW (P < 0.05). Conclusions: This single-institution study demonstrates that amongst patients undergoing FLC for mGCT, there were higher rates of poor risk disease and platinum refractory disease amongst NW patients. W patients were more likely to receive HDCT as initial salvage chemotherapy compared to NW patients. However these findings did not reflect a significant difference in disease progression or mortality. [Table: see text]
Getting rurality right: Investigating cancer across the rural-urban interface.
Authors: Taylor Amy K. , Schiefelbein Andrea , Zhang Jienian , Krebsbach John , Skala Melissa C. , Eason John , LoConte Noelle K.
Published: May 2020

e19063

Background: Trends in oncology examine the influence of rural characteristics on cancer patient (pt) treatment and outcomes. Current definitions of rurality are broad and varied, with multiple standardized definitions. Few analyses exist to compare definitions and quality in assessing oncologic outcomes. We aim to determine which index is most suitable to define rurality in cancer research. Methods: 1,567 pancreatic cancer pts from the University of Wisconsin Cancer Registry, representing 84 Midwestern counties and 452 zip codes, were assigned rurality codes based on three indices spanning 1983-2013: Rural-Urban Continuum Code (RUCC), Rural-Urban Commuting Areas (RUCA), and Index of Relative Rurality (IRR). RUCC and IRR were assigned to pts at the county level and RUCA at the zip level. Pt rurality was compared across the three indices and over time via the median and interquartile range and inspected visually with violin plots. We compared indices with Spearman’s Rank Order Correlation (SROC). Results: RUCC 2003, RUCA 2004 (zip), and IRR 2000 were concordant in terms of metropolitan, micropolitan, and rural designations for 66.9% (1,049) of pancreatic cancer registry pts. The rural designation for almost one-third (489, 31.2%) of pts was discordant by one or two levels across the three indices (i.e. classified as metropolitan in one index and micropolitan or rural in another). SROC was 0.73 between RUCC 2003 and RUCA 2004 (zip) indices, 0.82 between IRR 2000 and RUCA 2004 (zip), and 0.85 between RUCC 2003 and IRR 2000. Across the 84 counties of registry pts’ residence, the median and interquartile range of RUCC decreased from 6 (3-7) in 1983 to 4 (2.25-6) in 2013 and of IRR decreased from 0.49 (0.44-0.53) in 2000 to 0.49 (0.43-0.53) in 2010. Across the 452 zip codes, RUCA decreased from 4 (1-10) in 1998 to 3 (1-8) in 2004. Pts’ median RUCC decreased from 3 (2-6) in 1983 to 3 (2-4) in 2013, median RUCA (zip) decreased from 2 (1-7) in 1990 to 1 (1-6) in 2000, and IRR remained constant at 0.42 (0.38-0.49) in 2000 and 2010. Conclusions: RUCC is preferable for state-level cancer studies incorporating rurality as it best distributes pts across the rural-urban interface compared to RUCA (skews urban) and IRR (skews central). County boundaries (RUCC) are consistent over time versus zip (RUCA) and census tract (RUCA). Our findings suggest that while the extremes of rural and urban are well-defined, rurality as a continuum is inconsistently measured. Researchers should continue to incorporate other measures of vulnerability to achieve health equity.
Access to new therapies: FDA accelerated approvals and the corresponding Canadian regulatory and funding decisions.
Authors: Lim Howard John , Hunt Melissa , Beaver Julia A. , Kluetz Paul Gustav , Gravel Christopher , Raven Andrew , Regier Dean , Ho Cheryl
Published: May 2020

e19066

Background: Accelerated approval (AA) by the FDA enables earlier access to promising new therapies while evidence generation is ongoing. Health Canada (HC) has a similar process with a Notice of Compliance conditional (NOCc) before full approval (NOC). Canada implemented health technology assessment (HTA) for determination of funding through the pan Canadian Oncology Drug Review (pCODR) in 2011. This study evaluated timelines and decisions from AA approval to HC NOC/c to HTA approval and formulary listing. Methods: FDA AA malignant hematology and oncology approvals from Jan 1 2000-Dec 31 2019 were reviewed. HC decisions were reviewed to determine submission/approval status and dates of NOC/c. pCODR decisions were reviewed to determine submission/approval status and dates of decision. First date of provincial formulary listing was collected. Results: In the 20 year time frame, there were 97 AA by the FDA. Current FDA status: 48 full approval, 44 pending verification and 5 withdrawn. Of the 92 AA that remain approved, HC status: 44 received NOC, 24 NOCc, 24 were not submitted for review, 2 currently under review. Of the 5 AA that were withdrawn; 3 were submitted to HC and received NOC/c and all were subsequently withdrawn. From 2011, 31 of 45 HC approved indications were reviewed at pCODR: 17 received a positive recommendation conditional on cost-effectiveness, 9 not recommended, 3 withdrawn by company, 2 pending final decision. Of the 10 not recommended/withdrawn, 6 were subsequently re-submitted and approved. Time from AA to NOC/c was 9.4 m, time from NOC/c to pCODR decision 15.0 m and time from pCODR decision to first formulary listing 18.4 m. Conclusions: Despite significant timeline differences between AA and HC NOC/c all indications that received AA submitted to Canada were granted regulatory approval. Since 2011, 74% of HC approved therapies submitted to pCODR were recommended and added to formularies. Collaboration between FDA and HC, independent regulatory agencies, through innovative programs such as FDA Project Orbis, may improve time from AA to NOC/c. Stringent criteria for HTA recommendation results in lower approval rates however, provision of additional data at re-submission may enable subsequent approval and adoption of treatment.
Inflammatory breast cancer (IBC) in native Hawaiians and Pacific Islanders: Frequency of IBC and impact of socioeconomic status on survival outcomes.
Authors: Miyazaki Kyle S.Y. , Acoba Jared David , Fujii Takeo
Published: May 2020

e19083

Background: IBC is one of the most aggressive types of breast cancer, accounting for only 1-4% of all breast cancer cases while causing 8-10% of breast cancer related deaths. Previous studies have demonstrated that IBC has distinct epidemiological characteristics, but the prevalence of IBC particularly in Native Hawaiian (NH) and Pacific Islander (PI) populations, and the socioeconomic disparities related to survival outcomes, are not fully understood. Our primary objective was to determine the frequency at which NH and PI breast cancer patients are diagnosed with IBC, and the association between socioeconomic status and overall survival (OS). Methods: Patients with newly-diagnosed primary invasive breast cancer were identified from January 1, 2000 through December 31, 2018 using Queen’s Medical Center Tumor Registry. Clinical T4d was used to differentiate IBC and non-IBC. OS was defined as the time from diagnosis to death or last follow-up. Patients who were alive at the date of last follow-up were censored. Univariate and multivariate cox proportional hazard models were used to assess the effects of variables of interest on OS. Results: A total of 3,715 patients were included in analysis. There were 98 (2.6%) patients with IBC and 3,617 (97.4%) with non-IBC. Proportion of IBC relative to non-IBC was significantly higher in PI (9.0%) than in White (W) (2.7%) (P < 0.001). Proportion of IBC was higher in NH (4.7%) than W but the difference was not statistically significant (P = 0.08). In multivariate analysis among the non-IBC group, OS was significantly shorter for both PI and NH than W (HR 1.72, [95%CI, 1.13-2.6]; P = 0.01, HR 1.48 [95% CI, 1.14-1.93]; P = 0.003, respectively). There were no significant racial differences seen in OS among IBC patients. Being under or uninsured was also significantly associated with short OS outcomes among patients with non-IBC but not those with IBC. Conclusions: PI have a significantly high proportion of IBC relative to non-IBC. Race and insurance status were not associated with OS in IBC although they were significantly associated with short OS in non-IBC. This result suggests that in IBC, the potential effect of racial disparity on OS is negated by the aggressive and insidious nature of the cancer. The effect of a relatively small sample size cannot be excluded, and further study in a larger population is warranted.
Time delay barriers in diagnosis and treatment of gastrointestinal cancer in Nepal.
Authors: Dulal Soniya , Paudel Bishnu D. , Neupane Prakash C. , Acharya Bibek , Acharya Sandhya Chapagain , Shilpakar Ramila , Paudel Bishal , Acharya Albira , Thapa Rameej Revanta , Martin Michael Gary
Published: May 2020

e19085

Background: Gastrointestinal (GI) cancers represent a major health challenge worldwide including in Nepal where patients (pts) often present with advanced disease and outcomes are poor. The purpose of this study was to quantify and to determine the causes of delay in diagnosis and treatment of GI cancer pts in Nepal. Methods: An IRB-approved cross sectional study was performed in pts with GI cancers at safety net Bir Hospital, Kathmandu, Nepal. All diagnosed consenting pts, both in- and out-pts, were enrolled. Pts were interviewed with a standardized questionnaire from July 2018 to June 2019. The caregivers were allowed to answer on behalf of illiterate pts. Diagnosis delay was defined as days from first symptoms to pathological diagnosis. Patient delay was defined as days from first symptoms to first medical consultation. Treatment delay was defined as days from diagnosis to surgery and/or treatment by medical/radiation oncologist. Differences in median times to delay were compared with two-tailed t-tests (Prism 8.0) based on the identified potential causes of delays. Results: The median age at diagnosis was 53.5 (22-77) years and 62% were males; 46% were farmers, 29% were housewives, and the rest had various occupations. 73% were outpatient at diagnosis. 46% had gastroesophageal cancer (gastric – 38%; esophagus – 8%) and 54% had colorectal cancer (left sided colon - 23%, right sided colon -13%; rectum 18%). No patients with anal or small bowel cancer were identified. 84% presented with Stage III/ IV disease. 68% were illiterate, 89% had a history of self-medication prior to first medical consultation, 74% were from rural areas with limited healthcare facilities and 79% were unaware of causes of GI cancers. Only self-medication was associated with delays in diagnosis and patient delays (Table). Conclusions: Self-medication rather than seeking help from medical professionals led to significant delays in the diagnosis of GI cancers in Nepal. Reasons for these decisions will be explored in future studies and may be amenable to efforts such as lay navigation. [Table: see text]
Chronic opioid therapy among a high-risk cancer survivor population.
Authors: Salz Talya , Lavery Jessica A. , Lipitz-Snyderman Allison , Boudreau Denise , Moryl Natalie , Gillespie Erin F. , Korenstein Deborah
Published: May 2020

e19107

Background: Head and neck cancer (HNC) survivors are at increased risk of opioid dependence, due to exposure to opioids during treatment, history of tobacco and alcohol use, and substantial pain after treatment. Chronic opioid therapy (COT) is a risk factor for dependence, and rates of COT vary widely between populations of cancer survivors. We hypothesized that COT use is greater among HNC survivors than among those who never had cancer. Methods: We used SEER-Medicare to identify adults ≥66 years diagnosed with HNC between 2008 and 2015. HNC survivors were matched 1:3 at date of diagnosis on age, sex, comorbidity, and region with cancer-free controls. Survivors and controls had complete coverage with fee-for-service Medicare Parts A, B, and D for each year after matching. Survivors and controls with no COT in the year prior to matching date and were followed for COT use through 2016. The presence of claims for opioid dispensings over ≥90 consecutive days (COT) was calculated for each year after cancer diagnosis among survivors alive at the start of each year and for controls. We computed odds ratios (OR) for COT use for HNC survivors compared to matched controls in each year after matching date, using a hierarchical logistic regression model accounting for matching and repeated measurements across years. Results: The population of HNC survivors declined from 5,107 in the year after diagnosis to 604 in Year 6. Among HNC survivors, COT use remained relatively steady each year after diagnosis. (Table). For the first 5 years after matching date, rates of COT among HNC survivors exceeded that of controls, with the difference between survivors and controls declining each year (OR 4.36 for Year 1, OR 2.60 for Year 2, OR 2.18 for Year 3, OR 1.85 for Year 4, and OR 1.35 for Year 5, all p-values < 0.05). By Year 6, rates of COT use did not differ between HNC cases and controls. Conclusions: In the first year after diagnosis, HNC survivors have more than 4 times the odds of COT use compared to cancer-free controls. Cancer-associated COT use declines over time. Strategies for appropriate pain management for HNC survivors should balance the risk of opioid dependence, particularly in the early years after diagnosis, with the benefit of improved comfort and function. [Table: see text]
ELderly Functional Index (ELFI): Validation of a self-reported measure of functional status in cancer patients.
Authors: Soo Wee-Kheng , King Madeleine , Pope Alun , Steer Christopher B. , Devitt Bianca Alix , Chua Susan Li Ling , Parente Phillip , Davis Ian D. , Darzins Peteris
Published: May 2020

e19126

Background: Functional assessment of oncology patients can be challenging and is often not performed, or is undertaken by the clinician with minimal direct input from the patient. The ELderly Functional Index (ELFI) is a 12-item composite measure of self-reported functioning in cancer patients. ELFI is derived from four scales from the European Organisation for Research and Treatment of Cancer (EORTC) health-related quality of life (HRQOL) suite: Physical, Role and Social Functioning, and Mobility. This study validated ELFI in patients attending oncology clinics. Methods: For evaluation of validity and internal consistency, 621 cancer patients (31% aged >70 years) fully self-completed the ELFI, cognitive functioning (CF) and emotional functioning (EF) scales of the EORTC QLQ-C30, ECOG-performance status (ECOG-PS), instrumental activities of daily living (IADL) and Clinical Frailty Scale (CFS). For evaluation of test-retest reliability, 278 participants self-completed ELFI, CF, EF, ECOG-PS and Global Rating of Change one week later. Results: ELFI demonstrated excellent internal consistency (Cronbach alpha 0.93, p< 0.001) and test-retest reliability (intraclass correlation coefficient 0.90, p< 0.001). Hypotheses regarding convergent and discriminant validity were confirmed (multitrait-scaling). ELFI was better than its component scales and other function measures at differentiating between participants with different function and frailty scores (known-groups validity, Table). Exploratory factor analysis provided empirical support to the structural validity of ELFI. Strong correlation was observed between ELFI, function and frailty scores. Conclusions: ELFI is a validated patient-reported outcome measure of functional status. ELFI captures broader dimensions of functioning compared to ECOG-PS or IADL. As a composite measure, ELFI has enhanced statistical efficiency, reducing the sample size required to detect a given effect. ELFI could be used as a clinical trial endpoint to assess the functional domains of HRQOL. [Table: see text]
Treatment patterns in men with metastatic castration sensitive prostate cancer (mCSPC) in the United States (US).
Authors: Ke Xuehua , Lafeuille Marie-Hélène , Romdhani Hela , Kinkead Frederic , Francis Peter St. John , D'Andrea Denise , Ryan Charles J. , Freedland Stephen J.
Published: May 2020

e19131

Background: Given recent advances in treatment options for mCSPC, this study assessed US real-world treatment patterns of mCSPC patients over time. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for PC, ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before metastasis). Index (idx) date was the 1st metastasis dx date on or after 1st PC dx and from 2015-2018. Patients were excluded if they had a pre-idx castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-idx or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from idx until CR (i.e., any post-idx CR indicator or initiation of abiraterone acetate [ABI] or docetaxel [DOC] ≥12 mo after post-idx androgen deprivation therapy [ADT] initiation or ≥12 mo post-idx for those with no ADT) or end of data. mCSPC treatment patterns in F/U were assessed overall and in patients with idx years (yrs) in 2015-2016 and in 2017-2018, separately. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: In the 2,825 mCSPC patients identified (age: 75 [9] yrs; F/U: 10.9 [9.0] mo), 43% were in the 2015/16 cohort (age: 75 [9] yrs; F/U: 15.8 [10.2] mo); and 57% were in the 2017/18 cohort (age: 75 [9] yrs; F/U: 7.2 [4.7] mo). The most common first-line (1L) mCSPC therapy was ADT only (Table), but patients in the 2017/18 cohort had fewer ADT only as 1L (43% vs. 52%) and more 1L ABI (10% vs. 4%) compared to the 2015/16 cohort. About 4% (2015/16: 5%; 2017/18: 3%) of patients received second-line (2L) mCSPC therapies, with ABI (74%) and DOC (25%) as the main 2L therapies observed. In patients receiving 2L mCSPC therapies, the 2017/18 cohort had more 2L ABI (81% vs. 68%) and fewer 2L DOC (19% vs. 30%) compared to the 2015/16 cohort. Conclusions: A large proportion of men with mCSPC were untreated/deferred treatment or were treated with ADT only, highlighting unmet needs in this patient group. As additional therapies for mCSPC become available, this trend is expected to improve, as supported by more recent treatment patterns. [Table: see text]
Predictive value of bother by side effects of treatment prior to protocol therapy for early treatment discontinuation in clinical trials.
Authors: Zhao Fengmin , Peipert John , Lee Ju-Whei , Hong Fangxin , Ip Edward , Gareen Ilana F , O'Connell Nathaniel , Carlos Ruth , Mayer Ingrid A. , Miller Kathy , Partridge Ann H. , Shanafelt Tait D. , Stewart A. Keith , Tarhini Ahmad A. , Thomas Mary L , Weiss Matthias , Sparano Joseph A. , Cella David , Gray Robert James , Wagner Lynne I.
Published: May 2020

e19132

Background: The Functional Assessment of Cancer Therapy–General has an item about patient tolerability of treatment: “I am bothered by side effects of treatment” (GP5). We examined the predictive value of this single item for early treatment discontinuation in clinical trials. Methods: GP5 level prior to protocol therapy (rated using a 5-point Likert scale) and treatment start/end dates and off treatment reason data at each treatment phase were drawn from five phase III clinical trials conducted by ECOG-ACRIN. In the present analysis, GP5 was dichotomized as 0 = “Not at all”/“A little bit” and 1 = “Somewhat”/“Quite a bit”/“Very Much”. Early treatment discontinuation was defined either as receiving less than protocol specified cycles of treatment when maximum cycles specified in the protocol (E1A06 induction, E1912 induction, E1609 induction, E1105 induction, E5103 adjuvant), analyzed using logistic regression via odds ratio [OR]), or treatment cessation for reasons other than progressive disease or death when treatment continued until progression or intolerability (E1A06 maintenance, E1912 maintenance, E1609 maintenance, E1105 maintenance), analyzed using Cox proportional hazard model via hazard ratio [HR]. Results: GP5 prior to treatment was significantly associated with early discontinuation of E1A06 maintenance, E1609 maintenance, E1912 maintenance, and E1912 induction. No significant association was found for other therapies examined in the study. Conclusions: High GP5 level prior to treatment is associated with higher likelihood of early treatment discontinuation in patients who have received previous treatment. The limited predictive value of GP5 for treatment naïve patients is more limited, serial on-treatment assessment should be considered in this setting. Clinical trial information: NCT00602641 . [Table: see text]
EUROQoL-5D as a valid patient-reported outcome measurement (PROM) tool to predict health-related quality of life (HRQoL) and survival in patients with hematological malignancies.
Authors: Cordoba Raul , Pascual Adriana , Martinez-Peromingo Javier , Hormigo Ana-Isabel , Askari Elham , Diaz-Aizpun Carola , Llamas Pilar , Perez-Albacete Marta , Jarana Maria , Bonillo Miguel-Angel , Cruz Susana , Pardo Alberto , Herrero Antonio , del Olmo Marta , Arcos Javier
Published: May 2020

e19141

Background: Patient-Reported Outcome Measurement (PROM) is the way to collect not only Health-Related Quality of Life (HRQoL) but also symptoms. EUROQOL-5D is a PROM tool explored widely in patients with cancer, although is not specific for cancer patients. The primary end-point of this project is to analyse the significance of impairments in EUROQOL-5D domains in overall survival of patients with hematological malignances, and the utility to incorporate as a PROM tool in a daily clinical practice. Methods: Patients with hematologic malignancies attended at Fundacion Jimenez Diaz University Hospital were assessed with EUROQOL-5D prior to receive any therapy. Self-reported health status stated as better, equal or worse was recorded at the time of assessment. Other variables such as age, sex, diagnosis and ECOG was collected to analyze their impact in survival. Results: From January 1, 2017 to December 31, 2019, 390 consecutive patients were included. Median age was 72 years (range 18-92), 194 (49.7%) were female, with a diagnosis of lymphoma in 257 (65.9%) and myeloma in 70 (17.9%), and ECOG 0-1 in 78.2% of patients. With a median follow-up of 10.5 months (range 0-32 months), we registered 72 events for overall survival. In the univariate analysis, age > 76 years (AUC 0.739, Likelyhood Ratio 3.321, p < 0.0001), ECOG 2-4 (OR 11.161, 95% CI 5.276-23.610, p < 0.0001), impairment in EUROQOL-5D domains such us mobility (OR 2.896, 95%CI 1.406-5.967, p = 0.003), self-care (OR 3.959, 95%CI 1.732-9.050, p = 0.001) and usual activities (OR 3.190, 95%CI 1.573-6.467, p = 0.001), but not pain/disconfort nor anxiety/depression were identified as prognostic factors for shorter survival. Self-reported health status (OR 3.975, 95%CI 1.845-8.565, p < 0.0001) was also a prognostic factor for survival. Impairments in EUROQOL-5D were also prognostic in patients with ECOG 0-1 (p < 0.001). In the multivariate analysis, only ECOG 2-4 and self-reported health status remained with statistical significance. Conclusions: EUROQOL-5D is a valid tool to be incorporated as a PROM tool in pacients with hematological malignancies. Impairments in mobility, self-care and usual activities will identify a poorer prognosis group that would need closer monitoring.
Improved outcomes among breast cancer patients with more frequent mammography screening.
Authors: Liu Ying , Gordon Aliza , Eleff Michael , Barron John , Chi Winnie
Published: May 2020

e19146

Background: Guidelines for optimal frequency of screening mammography (annual, biennial, never/choice of patient) vary by professional society, due to mixed or insufficient evidence regarding its benefits and harms. Little evidence exists on the impact of screening frequency, rather than any screening, on health outcomes. In this study, we measured differences in cancer stage at diagnosis, treatment rendered, mortality, and cost of treatment for women with different numbers of screenings prior to breast cancer diagnosis. Methods: Utilizing administrative claims, we identified 25,492 women aged 44 or older with various numbers of mammographic screening ≥ 11 months apart during the four years prior to their incident breast cancer diagnosis from 2010 to 2018. Outcomes were assessed during the six months following diagnosis. Regression models were used to compare women with differing numbers of mammograms (0, 1, 2, 3, or 4/5), adjusting for demographic characteristics and baseline comorbidities. Results: More screenings were associated with less advanced cancer at diagnosis, higher rates in lumpectomy and radiation, lower rates in mastectomy and chemotherapy, lower costs and mortality within 6 months post diagnosis (Table). Results were similar in a subgroup with only women aged 44-49 at diagnosis (not shown). Conclusions: Increased frequency of screening mammography is associated with earlier breast cancer stage at diagnosis, less toxic and invasive treatment, lower mortality, and lower cost, including for women under age 50. [Table: see text]
Utilization of liquid biopsy in a large community oncology practice.
Authors: Patel Dipen , Le Thuy , Staszewski Harry
Published: May 2020

e19150

Background: Analysis of tumor cell free DNA, or liquid biopsy, is emerging as a useful adjunct to tissue biopsies in advanced solid tumors. These tests may reduce the need for repeating invasive biopsies, and may be performed serially with minimal risk to patients.The purpose of our study is to document how liquid biopsies are being used in a large, diverse community based practice in Long Island, NY and how often the results lead to changes in treatment. The aim is to derive guidelines within the practice for appropriate use of liquid biopsies going forward. Methods: The practice electronic medical record (EMR) was retrospectively examined for the first 100 patients with solid tumors who had a specimen sent to a commercial laboratory for a liquid biopsy. The EMR was also reviewed to establish the treatment regimens each patient was receiving prior to the liquid biopsy, as well as any changes to the regimen based on liquid biopsy results. Results: This analysis was based on 100 patients: 11 out of 100 patients (11%) were excluded due to loss of follow up and 89 out of 100 (89%) patients were included, 59% female and 41% male. 11 out of 100 patients (11%) were not found to have any tumor alterations on liquid biopsy. The most prevalent cancers were lung (40.4%), ovarian (17.0%), breast (6.4%), colon (5.3%) and prostate (5.3%). Treatment was changed 43% of the time after liquid biopsy results were obtained and there was no change in 57% of the time see Table. This change was irrespective of type of cancer, gender, or types of current regimen. Conclusions: Liquid biopsy has proven to be a useful adjunct to molecular testing of tumor tissue in a large community oncology practice, but ongoing examination of our results should better define its optimal use. [Table: see text]
Opioid safety among high-risk cancer survivors.
Authors: Salz Talya , Mishra Akriti A. , Gennarelli Renee L. , Lipitz-Snyderman Allison , Boudreau Denise , Moryl Natalie , Tringale Kathryn Ries , Korenstein Deborah
Published: May 2020

e19169

Background: To mitigate risks of opioid-related harms, ASCO’s pain management guidelines for cancer survivors recommend that opioids be used in conjunction with other pharmacologic and non-pharmacologic approaches. The guidelines also recommend caution when prescribing opioids and benzodiazepines concurrently. We evaluated these 2 metrics of safe prescribing as applied to chronic opioid therapy (COT) among older survivors of head and neck cancer (HNC) and lung cancer (LC), two growing populations with high pain burden and prevalent risk factors for opioid-related harms (e.g., opioid use during treatment, history of substance use, distress). Methods: Using SEER-Medicare, we identified opioid-naïve adults diagnosed 2008-2015 with HNC or LC. We restricted analyses to survivors with ≥1 COT episode (≥90 days) occurring ≥1 year after cancer diagnosis and ≤120 days prior to hospice entry or cancer-related death (survivorship period). We report 2 opioid safety metrics during the survivorship period: 1) the proportion of survivors with non-opioid pain management (≥1 dispensing for a non-opioid, non-benzodiazepine pain medication or ≥1 claim for pain management procedure) concurrent with the first 90 days of the first COT episode and 2) the proportion of survivors with 0 dispensings for benzodiazepines within the first 90 days of the first COT episode. Results: Among opioid-naïve HNC (N = 5,500) and LC (N = 21,090) patients, 306 HNC (5.6%) and 927 LC survivors (4.4%) received COT during follow-up. Median duration of first survivorship COT episode was 5.2 and 4.9 months for HNC and LC, respectively. 64% of HNC survivors received non-opioid pain management concurrent with their first COT episode; 55% received an analgesic and 24% underwent a procedure. 75% of LC survivors received non-opioid pain management concurrent with their first COT episode; 67% received an analgesic and 35% underwent a procedure. 79% of HNC and 81% of LC survivors did not receive benzodiazepines during the first COT episode. Conclusions: Among older survivors of LC and HNC, less than 6% receive COT. However, of those, one-half of HNC survivors and more than a third of LC survivors receive guideline-discordant care by using COT without other pain management strategies or while using benzodiazepines. To minimize opioid-related harms, efforts should focus on improving safe COT prescribing practices for survivors. [Table: see text]
Real-world practice patterns and barriers to quality care in acute myeloid leukemia (AML).
Authors: Hussein Maen A. , Patel Taral , Ellipeddi Pavani , Farris Breanne , Crawford Rebecca R , Carter Jeffrey D. , Sapir Tamar , Wang Eunice S.
Published: May 2020

e19172

Background: For AML patients who are ineligible for intensive induction, novel therapies have greatly improved treatment options, though practice challenges individualizing care have hindered effective integration. In a quality improvement (QI) program conducted in 3 community oncology systems, we assessed practice patterns and barriers involving the use of novel therapies for AML. Methods: We surveyed 15 hematology team members to assess barriers to quality AML care and audited electronic medical records (EMR) of 100 patients across 3 community oncology centers. EMR demographics, disease characteristics, and treatment selection were reviewed. To address suboptimal guideline-aligned care, teams participated in audit-feedback sessions to develop action plans for resolving identified gaps. Results: The EMR audit demonstrated a lack of documentation for clinically important metrics necessary for individualized treatment selection and monitoring, including performance status and testing for targetable biomarkers (Table). Additionally, there was low documented use of novel therapies, such as venetoclax and gemtuzumab ozogamicin (GO), and no documented use of FLT3 or IDH inhibitors. Further, the audit revealed low adherence to guideline recommendations for frontline regimens – notably, 33.3% patients with FLT3 or IDH mutations (n = 15) were receiving low dose cytarabine alone, and 50% patients with a documented performance status of 3+ (n = 2) received intensive induction therapy. Survey findings indicated very low or low confidence in aligning practice with guidelines (20%), identifying patients who are not candidates for intensive induction (27%), and ordering/interpreting molecular tests (33%). Appropriate treatment selection (47%) and integration of molecular testing (27%) were reported as top challenges for individualized AML care. During audit-feedback sessions, teams identified improved collaboration with hematopathologists, assessment of patient mutational status, and patient engagement in treatment planning as actions they plan to integrate. Conclusions: These findings reveal important performance gaps in individualized AML care in community settings, which may inform future QI initiatives. [Table: see text]
Extent of implementation of low-dose CT in lung cancer screening.
Authors: Jose Merin , Desai Rajesh
Published: May 2020

e19177

Background: Lung cancer is the leading cause of cancer deaths in the United States with only 15% alive 5 years after diagnosis. In 2013, USPSTF recommended annual screening for LDCT in high risk individuals. Studies had shown a 20% lower mortality (NELSON trial showed significantly lower lung cancer mortality) with LDCT screening. We aimed to assess the extent to which the guideline for lung cancer screening is being adopted in a community clinic. Methods: A retrospective review of electronic medical record of patients aged 55-80 years with no history of lung cancer who visited a primary care provider in a community clinic in New Jersey from October 2014- December 2019 was done. All records with any form of documentation of smoking were identified electronically. The records of those meeting the criteria (30 pack-year smoking history and currently smoking or have quit within the past 15 years) were reviewed manually to check 1) whether they are eligible for screening, 2) if eligible whether low dose CT has been recommended by the provider and 3) once recommended has it been done and followed by the patients. Results: 359 individuals with documented smoking history were identified. Of those 38.8 % (139/359) had a proper documentation (includes both PPD and number of years of smoking) of smoking history based on which high risk individuals could be identified. Of those 37 individuals met the criteria for lung cancer screening. 62% (23/37) had CT chest ordered at some point of time (16.2% for a different indication and the rest for lung cancer screening). Only 52.2% (12/23) of the patients followed the recommendations and got a LDCT done. Among those 50% (6/12) had follow up CT, 50 % (3/6) of those did it on a regular annual basis while the rest 50% (3/6) did it irregularly. 3 patients followed the annual CT screening for lung cancer. Conclusions: Based on these we note that almost half a decade since the recommendation has been established only a small proportion received the care and a still smaller minority followed it. It reflects the dearth of information regarding the guideline among providers and the lack of awareness of the need to follow among patients. This puts forward need for further interventions for implementation of the guidelines at all levels of care for lung cancer prevention. Measures include analyzing the areas of deficiency through questionnaires for patients and providers. Creating awareness on the need for accurate documentation of smoking history and the impact it can have on care delivered. Educating patients about the benefits in health outcome by following the recommendations.
Mortality within 30 days of receiving checkpoint inhibitor immunotherapy: An Australian multicenter review.
Authors: Fletcher James , Kang Katherine , Smallwood Gabriella , Sanmugarajah Jasotha , Lyle Megan
Published: May 2020

e19182

Background: Mortality within 30 days of chemotherapy is recognised as an important quality assurance measure. There is limited data regarding mortality within 30 days of immunotherapy and whether the same standards should apply. In contrast to chemotherapy, immunotherapy has a favourable toxicity profile and a higher chance of durable responses. We assess 3 years of data from two regional cancer centres in Queensland, Australia. Methods: Retrospective review of patients treated with checkpoint inhibitor immunotherapy at Cairns Hospital and Gold Cold University Hospital between June 2016 and June 2019. Results: 533 patients received immunotherapy and 59 (11.1%) died within 30 days of treatment. 25 patients died within 30 days of their first treatment (4.7%). Anti-PD-L1/PD-1 was more common than anti-CTLA-4 and combination treatment (84.7% v 1.7% v 13.6%). Median age was 65 years (range 37 – 87). Most patients were treated for non-small cell lung cancer (51%) and melanoma (36%). Poor prognostic features were prevalent: ECOG 3-4 (30%), brain metastases (34%), 3 sites of metastases (59%), and raised LDH (80%). Grade 3+ toxicity was uncommon (3.4%) and there were no treatment-related mortalities. Most patients died due to progressive disease. 67% died in hospital and 25% received acute treatment within 48 hours of their death. Most patients were known to palliative care (85%). Resuscitation plans were documented in 55% before their final treatment. Discussion regarding very poor prognosis was documented in 44%. Conclusions: Thirty-day mortality rates were similar to published data relating to chemotherapy and mortality within 30 days of initiating therapy was low. While there were few significant immune-related toxicities, a quarter of patients received acute treatment within 48 hours of their death. Most patients had documented resuscitation plans and were known to palliative care.