bluuebunny/crossref_metadata_2025 huggingface dataset:
Diabetes mellitus: An adverse prognosis in cancer patients—Study of a cohort treated at Instituto Oncológico Henry Moore (IOHM).
Authors: Gil Deza Ernesto , Bragagnolo Julio Cesar , Morgenfeld Eduardo L. , Dragosky Marta , Gercovich Natasha , Montiel Monica , Niewiadomski Dario , Perez Pamela , Musini Silvina Laura , Rivarola Edgardo G. J. , Gercovich Felipe G.
Published: May 2019

e18212

Background: Numerous studies have evaluated the unfavorable impact of diabetes mellitus (DM) on cancer evolution. The objective of this paper is to study the coexistence of DM and cancer diagnosis; and its influence on the evolution of a cohort followed at IOHM. Methods: Between 9/26/2012 and 11/28/2018 all new patients (Pt) admitted to IOHM filled out a Past Medical History Form (PMHF) (ASCO 2013 ABST. e17539) with their preexisting clinical conditions.The database was locked and anonymized. Those with a history of DM or who were taking insulin and/ or oral antidiabetics were selected (Group A). The stage and evolution of their tumors were compared with those of non-diabetic patients (Group B). Results: Out of 15,617 Pt, 1,829 Pt (11,7%) had DM (Group A); 1,087 Pt were being treated with oral hypoglycemics (59%); 178 Pt with insulin (10%) and 564 Pt (31%) were not on antidiabetics drugs. They were compared to 13,788 Pt without DM (Group B). Oncological treatment was similar in both groups. Mortality was greaterin DM Patients adjusted by sex, age, PS, BMI, Dx and stage; Multivariate Cox Regression (p = 0.0001). The results are presented in the chart below. Conclusions: 1) In a cohort of 15,617 cancer Pt, 11,7% had DM. 2) DM Pt's tumors were more advanced. 3) Under similar treatments, DM Pt presented higher mortality. 4) Based on this, we advocate for DM in oncological Pt to be considered as an independent adverse factor.[Table: see text]
Inclusion of patient-reported outcomes (PROs) in randomized controlled trials (RCTs) with elderly cancer patients: A systematic review.
Authors: Sparano Francesco , Aaronson Neil K , Sprangers Mirjam A.G. , Fayers Peter , Pusic Andrea , Kieffer Jacobien M , Rees Jonathan , Wan Chonghua , Pezold Mike , Fuzesi Sarah , Isharwal Sumit , Anota Amelie , Charton Emilie , Vignetti Marco , Cottone Francesco , Blazeby Jane M. , Efficace Fabio
Published: May 2019

e18217

Background: Inclusion of PROs in RCTs involving elderly cancer patients may be particularly important, as the elderly are often frail and vulnerable, and treatment decisions need to carefully balance potential burden against benefit. We aimed to determine how many RCTs involving elderly patients have included a PRO endpoint, and identified the most relevant PRO information available in this area. Methods: A systematic review in PubMed/Medline and Cochrane Library identified RCTs with PRO endpoint that enrolled a cancer sample (breast, colorectal, lung, prostate, gynaecological and bladder cancer) with a mean/ median age ≥70 years, published from January 2004 to June 2018. The quality of PRO reporting was evaluated using the ISOQOL-PRO recommended criteria. Two reviewers independently performed data extraction. RCTs meeting at least two-thirds of the recommended criteria were considered as “probably-robust” and therefore most likely to be able to inform patient care. Results: Out of the 610 RCTs with PRO endpoint identified, only 67 RCTs (11%) enrolled a sample that met the above criteria. In 19 RCTs (28.4%) PROs were the primary endpoint and 35 RCTs (52.2%) were conducted in a metastatic population. Less than one-third of these trials (n = 21) were considered as probably-robust. In 10 (47.6%) out of the 21 probably-robust RCTs, PROs favored the experimental arm and in 8 (38.1%) the arms did not differ. Overall survival (OS) was an endpoint in 13 of the probably-robust RCTs. In only 3 of these RCTs (23.1%) did OS improve in the experimental arm and in 10 (76.9%) there was no difference in OS between arms. In about half of the probably-robust trials evaluating OS (n = 7, 53.8%), PROs provided information that contrasted with survival findings. In two RCTs, OS improved in the experimental arm, while PROs either did not change between arms (n = 1) or favoured the control arm (n = 1). Conversely, in 5 RCTs (38.5%), OS did not differ between arms whereas PROs favoured the experimental arm. Conclusions: Among cancer RCTs including PROs, the proportion of those conducted in the elderly is low. However, PRO data may provide useful information for these type of patients and their clinicians.
Does the quality of patient-reported outcomes (PROs) assessment in randomized controlled trials (RCTs) differ across cancer types and over time? A pooled analysis of 610 RCTs published between 2004 and 2018.
Authors: Sparano Francesco , Aaronson Neil K , Sprangers Mirjam A.G. , Fayers Peter , Pusic Andrea , Kieffer Jacobien M , Rees Jonathan , Wan Chonghua , Pezold Mike , Fuzesi Sarah , Isharwal Sumit , Anota Amelie , Charton Emilie , Vignetti Marco , Cottone Francesco , Blazeby Jane M. , Efficace Fabio
Published: May 2019

e18218

Background: PRO endpoints are increasingly being used in cancer RCTs. However, the PRO assessment in such trials often suffers from serious methodological shortcomings, and the results seldom impact on clinical policy or practice. Methods: We performed a systematic review to identify RCTs with a PRO endpoint in breast, colorectal, lung, prostate, gynaecological and bladder cancer. A checklist score for quality of PRO reporting (ranging between 0-100), based on that of the International Society for Quality of Life Research (ISOQOL) and the CONSORT PRO extension, was computed for each RCT. Analyses were also conducted by type of PRO endpoint (primary versus secondary) and year of publication (i.e. before and after the publication of the CONSORT PRO extension). Results: We identified 610 RCTs with a total of 323,482 patients. PROs were most frequently used in RCTs of breast (N = 176), followed by lung (N = 123), prostate (N = 108), colorectal (N = 103), gynaecological (N = 83) and bladder (N = 17) cancer. Quality of PRO reporting (mean score: 56.4) was highest in RCTs conducted in prostate cancer (PCa) (Table). Regardless of cancer type, quality of reporting was typically higher in RCTs where PROs were primary endpoints. Quality of reporting was higher for RCTs published after the CONSORT PRO Extension (2013), with the exception of RCTs conducted in PCa, where quality was stable over time. Conclusions: PRO reporting of RCTs conducted in PCa has better quality than in the other cancer sites that were reviewed. Regardless of cancer site, quality of PRO reporting has improved after the publication of the CONSORT PRO Extension. [Table: see text]
Pretreatment symptom prevalence in patients with myelodysplastic syndromes (MDS) across all disease risk categories: Analysis of 914 patients.
Authors: Efficace Fabio , Niscola Pasquale , Patriarca Andrea , Cottone Francesco , Palumbo Giuseppe A. , Breccia Massimo , Caocci Giovanni , Platzbecker Uwe , Specchia Giorgina , Stauder Reinhard , Fianchi Luana , Sanpaolo Grazia , Petranovic Duska , Frairia Chiara , Caers Jo , Santini Valeria , Bergamaschi Micaela , Capodanno Isabella , Di Renzo Nicola , Vignetti Marco
Published: May 2019

e18220

Background: Whilst a substantial body of knowledge is available on the genetics and biology of MDS, very little is known on quality of life of these patients. We aimed to 1) examine patient-reported symptom prevalence in newly diagnosed MDS patients by disease risk at diagnosis; 2) investigate prevalence of other key symptoms by fatigue severity. Methods: Newly diagnosed MDS patients were recruited in an international prospective observational study from Nov. 2008 to Dec. 2018. As per standard practice, all patients were classified according to the International Prognostic Scoring System (IPSS) that identifies four risk subgroups of patients, i.e. low, intermediate-1 (i.e., lower risk, LR), intermediate-2, and high-risk (i.e., higher risk, HR). At baseline (i.e., pretreatment) patients also completed the validated FACIT-Fatigue scale and the EORTC QLQ-C30 questionnaires. Based on the FACIT-Fatigue median score, two groups were also identified: a lower and a higher fatigue group. Results: Out of 929 patients enrolled, 914 patients were available for current analysis of whom 496 with LR (median age of 74 years) and 418 with HR (median age of 72 years). Prevalence (i.e., with any level of concern) of symptoms by disease risk group is reported in Table. Patients with higher fatigue had a significantly higher prevalence of many other symptoms, such as pain (p < .001), dyspnea (p < .001), insomnia (p < .001), appetite loss (p < .001), diarrhea (p < .001) and constipation (p < .001) than patients with lower fatigue. To illustrate, moderate to severe dyspnea was reported by 38% of patients with higher fatigue and only by 5% of patients who reported lower fatigue. Conclusions: Pretreatment symptom prevalence in newly diagnosed MDS is high, and broadly similar in LR and HR patients. Regardless of disease severity at diagnosis, fatigue is associated with a substantial burden of other symptoms. [Table: see text]
A conundrum in cancer quality measurement: Performance on long-term survival reflects performance a long time ago.
Authors: Lipitz-Snyderman Allison , Curry Michael A. , Rubin David M. , Li Diane G. , Duck Elaine , Radzyner Mark H. , Bach Peter
Published: May 2019

e18222

Background: Long term outcomes, such as five-year survival following cancer treatment, are widely accepted as important metrics of cancer care quality. But because they take years to accrue, they reflect the quality of care delivered in the past. The objective of this study was to delineate to what extent measures of long term outcomes related to cancer care could be reliably used to predict care quality in future periods. Methods: Taking advantage of FFS Medicare data from related studies, we assessed survival of cancer patients at one and four years by hospital for four separate index years 2006, 2011-2013. We assembled pairs of years across which we could compare risk adjusted outcomes separated by one year (2011 to 2012; 2012 to 2013), two years (2011 to 2013), and five through seven years comparing 2006 to 2011, 2012, or 2013 respectively. The outcome was risk adjusted mortality rates at the hospital level determined by dividing the observed number of deaths by an expected number, adjusting for age, and median income level of the zip code of residence. For each hospital and for every pair of analytic years we separately compared the correlation of one and four-year risk adjusted mortality using both Pearson and Spearman correlation statistics. A mixed effects model was fit to determine if size and year gap between measurements could explain possible differences in the correlation of hospital performance, while controlling for hospitals as a random effect. Results: There were 1,640 hospitals and more than 350,000 patients in each analysis year. Focusing on the correlation of the four year survival outcomes, the highest volume hospitals have significantly higher correlations compared to the other hospital categories (P < 0.001). The greater the elapsed time between measurement periods the lower the correlation. But in the mixed model analysis neither time elapsed between measurement periods (p = 0.51) nor the interaction between time elapsed and hospital volume (p = 0.95) were significant. Analyses of one-year outcomes produced similar findings. Conclusions: Performance on four-year survival outcomes of cancer patients was reasonably correlated for large volume hospitals, but less so for hospitals with lower volumes.
Effects of online education on the identification and management of immune-related adverse events over time.
Authors: Pender Lori Keys , Kadkhoda Haleh , Lucero Katie S. , Repetto Patti , Warren Charlotte , Gearhart Jacqueline , Weber Jeffrey S.
Published: May 2019

e18224

Background: Immune checkpoint inhibitors (ICIs) are increasingly used in oncology care and produce a wide variety of immune-related adverse events (irAEs) that differ from toxicities of other systemic therapies. The objective of this study was to assess trends over time in oncologists’ knowledge, competence, and confidence managing irAEs. Methods: A series of online continuing medical education (CME) activities addressing irAEs was launched beginning in April 2014; 39 included multiple-choice knowledge/competence questions and a confidence question assessed on a 5-point Likert-type scale before and immediately after the activity. Activities that had at least 30 oncologists participate pre/post are included in this analysis. A pre-/post-assessment study design was used, and educational effect was assessed with chi-square tests. Analyses were conducted to examine trends in knowledge, competence, and confidence recognizing, identifying, and managing irAEs over four years on a quarterly basis. Weighted averages in each of the outcomes were calculated by quarter. Results: A total of 187,800 learners participated from April 2014-March 2018, including 96,177 physicians, of whom 25,127 were oncologists. The average increase pre- to post-test for 22 activities that asked a knowledge-based question was 18% (P < 0.001). The absolute increase from pre-test in 2014 (67%) to post-test in 2018 (87%) was 20 percentage points. For 16 activities with competence questions, the average increase from pre- to post-test was 8% (P < 0.001), and the absolute increase from pre-test in 2014 (39%) to post-test in 2017 (87%) was 48 percentage points. For 5 activities with a confidence question, the average increase from pre- to post-test was 8% (P < 0.05), and the mean rating pre-test in 2016 was 2.85 versus 3.53 post-test in 2018. Conclusions: Online CME is effective to improve oncologists’ knowledge, competence, and confidence managing irAEs; however, pre-test outcomes in 2018 demonstrate ongoing knowledge and competence gaps that should be addressed, and post-test confidence data indicate a persistent lack of confidence among oncologists even after participating in online CME.
Estimation of U.S. patients with cancer who may respond to cytotoxic chemotherapy.
Authors: Maldonado Edward , Parsons Scott , Chen Emerson Yu-sheng , Haslam Alyson , Prasad Vinay
Published: May 2019

e18228

Background: Oncology drug development has shifted away from cytotoxic agents, while they remain widely used in clinical practice. We sought to estimate the proportion of U.S. patients with advanced or metastatic cancer who are eligible for and may respond to standard first-line cytotoxic chemotherapy alone based on National Comprehensive Cancer Network (NCCN) treatment guidelines. Methods: This retrospective review used publicly available annual mortality data from the American Cancer Society to estimate the number of patients who would have presented with advanced or metastatic disease. Published clinical trials of first-line cytotoxic-only regimens as advised by the NCCN were used to calculate overall response rates (complete plus partial response) for each cancer type. Chemotherapies in combination with immunotherapy or biologic agents were excluded. Mean response rate was used when there was more than one recommended regimen. The main outcome was to identify the proportion of patients with advanced or metastatic cancer who are eligible for and may respond to standard first-line cytotoxic chemotherapy regimens based on cancer type. Results: We identified 92 different cytotoxic chemotherapy regimens used in 25 cancer types. Among an estimated 609,640 cancer-related deaths in 2018, 479,823 (78.7%) would be eligible to receive standard first-line cytotoxic chemotherapy. We estimated 189,159 of 609,640 (31.0%) patients to achieve at least partial response. The median objective response rate was 48.6% (range 9.2%-90.6%). The following cancers had the highest response rate to cytotoxic chemotherapy: acute lymphoblastic leukemia (90.6%), acute myeloid leukemia (76.7%), and uterine cancer (75%). The following had the greatest number of patients who may respond to cytotoxic chemotherapy: lung cancer (60,234 of 609,640; 9.9%), colorectal cancer (23,138; 3.8%), and non-Hodgkin lymphoma (14,773; 2.4%). Conclusions: Given the large proportion of patients who may benefit from cytotoxic agents, drug development in this space may warrant continued interest in specific cancer types. Also, the regulatory approval of novel oncology drugs may justify head-to-head comparison against modern chemotherapy regimens.
Population health impact of genome-driven oncology by race and ethnicity.
Authors: Smieliauskas Fabrice , Sharma Hari , Catenacci Daniel V.T. , Huo Dezheng
Published: May 2019

e18229

Background: The magnitude of clinical benefit from genome-driven oncology is the subject of controversy. Past estimates of the population health gains from genomic therapies have not explored differences by race and ethnicity (R/E) nor accounted for the lack of representativeness of commonly used tumor genomics databases. We assessed the attainable population health gains by R/E from cancer drugs with genomic biomarker indications for use. Methods: We used all patient (pt) samples of solid tumors from the AACR Project GENIE v3.0.0 tumor genomics data sharing initiative that met criteria for comprehensiveness of sequencing. We categorized biomarker-tumor site indications as actionable if FDA-approved or considered standard of care in the OncoKB Knowledge Base as of 1/25/19, and estimated actionability rates from genomic therapies. We modelled attainable median overall or progression free-survival gains for actionable pts and all pts from these therapies using results from registrational trials in pts with metastatic cancer. Analyses were performed for all pts and for Black, Asian, Hispanic, and non-Hispanic White R/E groups. To test for disparities in actionability rates (survival gains), we estimated logistic regression (least squares regression) models of having a clinically actionable gene abnormality (survival gains) regressed on minority R/E indicator variables and performed overall Chi-squared tests (F-tests) of whether the R/E coefficients were jointly equal to zero. All analyses were weighted to be representative of the U.S. cancer incident pt population by demographic and tumor site subgroup. Results: Data for 24,255 adult cancer patients met our criteria, including over 900 patients of each of the three minority R/E. Population-weighting showed that the Black and Hispanic pts were heavily underrepresented in the original sample. Weighted actionability rates were 18.2%, with disparities across R/E groups (p < 0.01) and Asians having the highest rates (24.0%). Median survival gains were 10.3 months among actionable pts (disparities test p < 0.10) and 1.9 months among all pts (disparities p < 0.01). Conclusions: Attainable population health gains from genome-guided oncology are modest with disparities across R/E groups.
Impact of dental insurance coverage on presentation, long-term outcomes, and symptom burden in locally advanced head and neck cancer.
Authors: Kacew Alec , Harris Ethan , Hanna Glenn J. , Haddad Robert I. , Tishler Roy B. , Schoenfeld Jonathan Daniel , Margalit Danielle Nina , Villa Alessandro , Limaye Sewanti Atul , Sanborn Matthew , Bae Ji Eun , Mahmood Umair , Cutler Jennifer , Criscitiello Shana , Huang Julian , Partridge Ann H. , Lorch Jochen H.
Published: May 2019

e18230

Background: Medical insurance coverage is known to correlate with improved long-term (LT) outcomes in head and neck cancers (HNC) patients. However, associations with dental insurance coverage (DI) are not established. Methods: In 2012, we sent surveys to determine DI and LT symptom (Sx) burden (EORTC QLQ-30, National Health and Nutrition Examination Survey Oral Health, and Vanderbilt Head and Neck Sx Survey) to patients who had completed definitive chemoradiotherapy (sequential or concurrent) for locally advanced (LA) HNC at the Dana-Farber Cancer Institute from 2002-2011 (2013 ASCO annual meeting, abstract 9530). In 2019, we retrospectively collected demographic and clinical information from patient charts and publicly available records and correlated these data with 2012 survey data. We used Fisher’s exact tests for association of categorical variables and Student’s t-tests for continuous variables. We used univariate and multivariate Cox proportional hazard modeling for hazard ratios (HRs). Results: Of the 103 survey responders, 84% were male. Most had oropharyngeal (90, 88%) or unknown primary (9, 9%) and 52 (50%) tested positive for human papilloma virus-associated disease (40% not tested). 71 (69%) had DI, while 100 (98%) had medical health insurance. Subjects with DI were diagnosed (Dxed) at a younger age (53 vs. 59, p < 0.01). Stage at Dx did not vary by DI status (p = 0.27). At median follow-up of 10.4 years from Dx (range 2.0 -16.6), recurrence was not associated with DI status (6 (8%) for DI vs. 4 (13%) for no DI, p = 0.27, HR 0.55, 95% CI 0.15-1.93, p = 0.35). We identified 9 subjects (9%) who had died of any cause. Subjects with DI experienced lower mortality from all causes than those without (3% vs. 19%, p = 0.01) and longer median overall survival (OS) (range 4.3 - 16.6 years, HR 0.19, 95% CI 0.05-0.76, p = 0.02) on univariate analysis. The longer OS was not significant when controlling for age and stage at Dx (p = 0.12). DI was also associated with less frequent need for liquid supplements to maintain weight (p = 0.01). Conclusions: In our cohort, DI was associated with Dx at a younger age and longer OS, although future work should consider possible confounding factors such as differences in socioeconomic status. Our data highlight the need for further research to investigate the importance of DI in improving LT outcomes in HNC patients.
Flu vaccination rate of patients with severe immune-related adverse events.
Authors: Allen Ian Matthew , Murciano-Goroff Yonina Robbie , Zubiri Leyre , Li Qun , Hughes Michael Sang , Velimirovic Marko , Chu Jacqueline N. , Durbin Sienna , Klauer Matthew J , Awadalla Magid , Petrillo Laura A , Dougan Michael , Letourneau Alyssa R , Mansour Michael , Neilan Tomas G. , Cohen Justine Vanessa , Bardia Aditya , Reynolds Kerry Lynn
Published: May 2019

e18234

Background: Infection with influenza in adults with cancer carries an increased risk of morbidity and mortality. Vaccination against seasonal influenza (Flu-V) can decrease the incidence of influenza, shorten its course, and reduce influenza-associated morbidity. Recent data has suggested that the administration of the Flu-V to patients on an ICI leads to an exaggerated inflammatory response and an increased risk of irAE. However, this trend was demonstrated in a small cohort of patients with lung cancer. Current recommendation for annual Flu-V in patients treated with ICI is unclear and literature about safety is limited. We compared rates of Flu-V for patients on ICI admitted with severe toxicity vs those patients on ICI who were admitted for reasons other than toxicity. We also evaluated rate of Flu-V among oncology patients who had received non-immunotherapy modalities. Methods: We retrospectively evaluated patients treated with ICI who were admitted to Massachusetts General Hospital from February 5, 2011- June 12, 2017. Patients received ipilimumab, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, or a combination in treatment of an advanced solid tumor malignancies including melanoma, NSCLC, SCCHN. Admissions due to irAE were confirmed by review of clinical, radiologic, and pathologic features. Flu-V status was determined by rigorous chart review. Nearest neighbor matching was used to create a control group of cancer patients treated with non-ICI modalities. Descriptive statistics compared rates and timing of Flu-V relative to admission. Statistical significance was determined using Fischer’s Exact Test, p < 0.05. Results: Of 540 patients on ICI, 28% were admitted for irAE, 72% had a non-irAE reason for admission. The rate of Flu-V in the flu season prior to admission for irAE group was lower than for non-irAE (18.5% vs 29.6%; p value = 0.01). There were no differences in vaccination rates within ≤30 days (2.7% vs 3.6%, p = 0.80), ≤90 days (4.0% vs 9.3%, p = 0.05), or ≤180 days of admission (11.9% vs 18.5%, p = 0.07). Flu-V rate overall in patients on ICI was 26.5%. In comparison, Flu-V rate in the nearest neighbor non-immunotherapy oncology patients was 67% (n = 101). Conclusions: Flu-V rates were much lower in patients treated with ICI compared to patients treated with non-ICI modalities. We did not see a higher rate of Flu-V in patients admitted with irAE compared to non-irAE which suggests that Flu-V and severe irAE may not be linked in clinical practice. Additional studies are needed, but Flu-V in patients on ICI holds potential to improve care.
Pregnancies in subjects on oncology clinical trials: Analysis from the Cancer Therapy Evaluation Program (CTEP) database.
Authors: Mittra Arjun , Murray James , Takebe Naoko , Chen Alice P. , Ivy S. Percy
Published: May 2019

e18239

Background: The NCI Cancer Therapy Evaluation Program (CTEP) has developed guidance and reporting measures to balance inclusion of younger cancer patients on trials with minimizing potential risks. CTEP began mandating the use of 2 forms of contraception for all participants of child bearing potential starting in the early 2000s in trials of thalidomide in multiple myeloma. The development of oncology clinical trials using other known teratogens such as Hedgehog Inhibitors led to development of comprehensive guidance on enrolling women on clinical trials. In 2012, CTEP further updated its guidelines to develop a reporting system for pregnancies occurring on clinical trial. Methods: We performed a retrospective analysis of the CTEP Adverse Event Reporting System (AERS) to identify unanticipated pregnancies in subjects or their partners while on oncology clinical trials. Results: 33 events were identified between 2011 and 2018, including 21 female and 11 male. One female subject got pregnant twice on the same trial. In female subjects, there were 4 live births, 1 active pregnancy, 5 spontaneous abortions, 5 medical termination of pregnancy and 1 death of the mother due to cancer. Outcome of pregnancy was not reported for 6 female subjects. Of the live births: 3 received an immunotherapy checkpoint inhibitor, and 1 received trastuzumab. Of 5 spontaneous abortions: 3 received cytotoxic chemotherapy, one radiation and one trastuzumab. Of 12 male subjects whose partners got pregnant: 3 live births, 2 active pregnancy, no pregnancy loss. Outcome of pregnancy was not reported for 6 male subjects. Conclusions: Though uncommon, pregnancies on clinical trial still occur despite requiring subjects to use 2 effective forms of contraception. With the increasing number of younger subjects being included in clinical trials for cancer, information about pregnancy outcomes in patients being treated with experimental agents is scientifically valuable and important to collect from study subjects and their partners. Since not all anti-cancer agents are of equal teratogenic potential, it is vital that this data continues to be collected and reported, including long term follow up of the pregnancy and the health of the child.
Elucidation of qualitative patient-reported outcome (PRO) data using latent dirichlet allocation (LDA) in patients (pts) undergoing radical cystectomy.
Authors: Atkinson Thomas Michael , Rapkin Bruce D. , Schofield Elizabeth , Bochner Bernard H. , Li Yuelin
Published: May 2019

e18245

Background: As PROs become commonplace in clinical trials and routine care, we must identify efficient analytic methods to better understand and ultimately integrate this information into clinical decision-making. While PROs are often captured via qualitative methods to provide context and pt voice to traditional objective and/or quantitative assessments, the current analytic standard is resource intensive and impractical for timely delivery of this information to clinicians and trialists. To address this problem, we propose the use of LDA, a natural language processing technique that automates the distillation of vast amounts of free-text data into underlying topics. Methods: As part of a prospective longitudinal trial of pts ( N = 200; M age = 63.8; 20% female; 46%) undergoing radical cystectomy (52% stage T2-T4) and urinary diversion (49% continent) for bladder cancer (ClinicalTrials.gov identifier NCT00745355), pts completed 30 minute interviews at baseline and 6-months post-surgery where they were asked to characterize their quality of life with respect to goals or milestones they would like to reach, problems they would like to solve, situations they would like to prevent, things they would like to remain the same, and commitments they would be willing to let go. LDA was used to extract latent topics and themes, stratified by time. Results: LDA extracted 7 latent topics and showed shifting patient priorities. At baseline, pt primary concerns were related to surgery and recovery. Six months post-surgery, pt goals transitioned toward themes related to concerns about cancer recurrence, regaining a sense of normalcy, return to work, enjoyment of life and increased appreciation of friends and family. Conclusions: LDA was used as an automated tool to illustrate a shift in pt goals and concerns as they transition into survivorship. This novel data analytic technique offers the possibility of significantly reducing the resources required to summarize qualitative PRO data. As such, this information may now be more readily available for immediate inclusion in the decision-making process as part of routine care and clinical trials. Clinical trial information: NCT00745355.
Utilization and outcomes of high-dose chemotherapy and stem-cell rescue in patient with testicular cancer from 2005 to 2014 in United States.
Authors: Desai Aakash , Desai Devashish , Khandwala Pushti , Giri Smith , Appleman Leonard Joseph , Parikh Rahul Atul , Mehta Kathan
Published: May 2019

e18246

Background: Testicular tumors are potentially curable by means of high-dose chemotherapy plus hematopoietic stem-cell rescue. This regimen is commonly used as salvage therapy, third-line or later therapy in patients with platinum-refractory disease. The utilization and real-world outcomes and complications of patients with testicular cancer undergoing autologous hematopoietic stem cell transplant (aHSCT) in United States are unknown. Methods: We queried National Inpatient Sample, a large inpatient data set in the United States, from 2005 to 2014 for male patients with testicular cancer or multiple myeloma (control group) receiving aHSCT and compared outcomes between these groups. The primary outcome was in-hospital mortality rate, and the secondary outcomes included in-hospital complications of aHSCT, length of stay and total charges. Outcomes were assessed by means of univariate analysis, multivariate regression and propensity score matched-pair analysis. Results: A total of 391 patients (weighted N = 1,909) with testicular cancer and 4,809 male patients (weighted N = 23,501) with multiple myeloma who underwent aHSCT from 2005 to 2014 were identified. Mean age of patients with testicular cancer was 32.3 years vs 59 years for multiple myeloma patients (p < 0.001) There were no differences in in-hospital mortality rates (1.5% vs 1.4%, p = 0.85) or rates of intubation (2.3% vs 1.6%, p = 0.36), sepsis (7.7% vs 7.5%, p = 0.94), bacteremia (13.5% vs 15.6%, p = 0.42), or stomatitis (43.8% vs 38.8%, p = 0.87) between patients with testicular cancer and multiple myeloma receiving autologous HSCT. However, utilization of total parenteral nutrition was higher in patients with testicular cancer (12.9% vs 4.7%, p < 0.001). There was no difference in length of stay (17.5 vs 17.5 days, p = 0.77) and total charges (121,120$ vs 123,729$, p = 0.74) between two groups. The results were consistent in multivariate and propensity score matched-pair analysis. Conclusions: The in-hospital outcomes of patients with testicular cancer receiving aHSCT appears to be similar to patients with multiple myeloma. However, overall utilization of aHSCT for testicular cancer appears to be low in United States.
Immune-related adverse events in melanoma: A nationwide analysis 2016.
Authors: Rai Manoj P. , Bedi Prabhjot Singh , Vishwanth Rohanlal , Rous Fawzi Abu , Shrotriya Shiva , Dhakal Prajwal
Published: May 2019

e18253

Background: Melanoma is an aggressive skin cancer. Immunotherapy is currently used as a first-line treatment for unresectable metastatic disease. Combination immunotherapy has been shown to improve overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) compared to single-agent immunotherapy. However, immunotherapy related adverse events (irAE's) are being increasingly seen. This study analyses the incidence of irAE's and the variation in the length of stay, and mortality. Methods: This is a retrospective cohort analysis of the 2016 NIS database. We identified hospitalizations with either primary or secondary diagnosis of Melanoma. Logistic regression of irAE's such as pneumonitis, colitis, hypophysitis, adrenal insufficiency, encephalitis, myocarditis was performed. We evaluated the association between irAE's and various parameters. Results: We identified 13170 hospitalizations with primary or secondary diagnosis of melanoma. Univariate logistic regression showed pneumonitis (OR: 1.39; p value: < 0.01), hypophysitis (OR: 20.61; p value < 001), adrenal insufficiency (OR: 10.36, p value = < 0.01), colitis (OR 23.94, p value < 001), myocarditis (OR: 1; p value was n/a), encephalitis (OR 1.71; p value was 0.5). Univariate logistic regression for LOS showed colitis (OR 1.23; p value: 0.01), adrenal insufficiency (OR 0.20; p value: 0.748), hypophysitis (OR -2.50; p value: 0), myocarditis no admissions, encephalitis (OR -2.15; p value 0.01). Univariate logistic regression for mortality showed pneumonitis (OR 6.07; p value: < 0.01), colitis (OR 0.86 p value: 0.721), adrenal insufficiency (OR 1; p value: 0.996). Conclusions: The above results suggest that the incidence of colitis is the highest among irAE’s in melanoma patients likely due to immunotherapy. Hypophysitis is the next most common side effect, it’s followed by adrenal insufficiency which can be life-threatening. A high index of suspicion and anticipation of the above complications can lead to their timely detection and treatment.
HIV associated cancers.
Authors: Bedi Prabhjot Singh , Rai Manoj P. , Rous Fawzi Abu , Vishwanth Rohanlal , Basnet Nishraj , Abro Calvin , Enofe Ikponmwosa , Kavuturu Shilpa , Rayamajhi Supratik
Published: May 2019

e18254

Background: The incidence or the prevalence of AIDS-defining cancers has reduced drastically (70% or more in the United States) since the introduction of three-drug antiretroviral therapy (ART) in the mid-1990s. However, the data from the inpatient sample is lacking. Methods: This is a retrospective analysis using data from the 2014 National Inpatient Sample database. We identified patients with either primary or secondary diagnosis of human immunodeficiency virus (HIV). Then we identified patients with various cancers including AIDS-defining cancers. Afterward, we ran logistic regression to check the degree of association between the diagnosis of each cancer with the diagnosis of HIV during the identified hospitalizations. We also assessed the prevalence of each of the cancer among the identified HIV patients, as well as the mortality in this cohort. Results: A total of 115955 hospitalizations with a diagnosis of HIV were identified. Among them, there were 6985 hospitalizations with Non-Hodgkin lymphoma, 2230 with rectal and anal cancer, 1170 with Kaposi sarcoma, 870 with head and neck cancer, 865 with skin cancer, 840 with cervical cancer. Logistic regression showed odds ratio (OR) of 1632.857 (95% CI 1168 - 2284, p < 0.01) for Kaposi sarcoma, 9.13 (95% CI 5.7-14.5, p-value < 0.01) for other male cancer, 8.34 (95% CI 7.68-9.06; p-value < 0.01) for Non-Hodgkin's lymphoma, 6.65 (95% CI was 5.5-8, p-value < 0.01) for Hodgkin's lymphoma, 5.04 (95% CI 4.5-5.6 p < 0.01) for rectal and anal cancer, 2.33 (95% CI 1.9-2.8, p < 0.01) for cervical cancer. Mortality was statistically significant with liver cancer, lung cancer, brain cancer, Hodgkin lymphoma, and Kaposi sarcoma. Conclusions: The prevalence of Kaposi sarcoma, Non-Hodgkin lymphoma, and cervical cancer are found to be high among hospitalized patients with HIV most likely because of nonadherence to their HIV medications. Future studies to check their correlation of these cancers with disease control is required. It is interesting to note that the prevalence of rectal and anal cancer, head and neck cancer, and skin cancer is high in this cohort.
Lung cancer in African-Americans and analysis of estrogen plus progestin use.
Authors: Amanam Idoroenyi Usua , Chlebowski Rowan T. , Nelson Rebecca A. , Salgia Ravi
Published: May 2019

e18258

Background: The 15-year Women’s Health Initiative (WHI) sponsored by the NIH has provided a robust dataset on health risks for post-menopausal black women (BW), including the impact of hormone therapy (HRT) on cancer risk. Women enrolled in the WHI randomized, placebo-controlled trial and taking HRT demonstrated no increase in lung cancer incidence, but a statistically significant increase in mortality. However, effects of estrogen plus progestin on non-small cell lung cancer (NSCLC) incidence and outcomes has not been extensively examined, especially in African Ancestry (AA) and smoking history. Methods: Study participants were identified who met WHI clinical trial entry criteria. Cox regression models and Kaplan-Meier method plots were utilized. Analyses adjusted for age, BMI, education, smoking status, alcohol use, health status, and physical activity. A secondary analysis was performed on BW based on AA via Affymetrix Human SNP Array. Results: 161, 808 pts were enrolled from October 1993 to December 1998 (after exclusions total analytic cohort = 142,503). 128,682 (90%) were white (WW) and 13,821 (10%) were BW. BW had lower incidence of NSCLC compared to WW (HR 0.68; P < .0001). HRT participants had a 55% increase in incidence of NSCLC (p < .0001). Former alcohol users had highest risk of NSCLC incidence (HR 2.72; p < 0.0001). Age groups (55-59 years; 60-69 years; 70-79 years) were significantly less associated with BW compared to the youngest(50-54 years; P < .0001). HRT participants were more likely BW (OR 1.17; p < .0001). More current smokers were BW compared to WW (OR 1.75; p < .0001). HRT participants had increased risk of death to NSCLC (HR 1.29; p < .001). There was a trend for survival (p = 0.3667) in WW participants compared to BW (32 vs 28.0 months, respectively). BW who had > 80% AA had a decreased incidence NSCLC trend compared to BW with < 80% AA (HR 0.81; p = 0.2806). Conclusions: BW, especially those with high levels of AA had decreased incidence of NSCLC. Those patients who received HRT had higher incidence and death from NSCLC. Further investigations are required to understand the mechanisms that AA and HRT alter risks associated with NSCLC.
Improving quality care through it/analytics for team-based care interventions.
Authors: Rodgers Georgina T. , Lindberg Jacob
Published: May 2019

e18263

Background: Team based care is essential to achieve coordinated, high-quality care. We recognized a responsibility to identify new treatment patients to provided targeted, team based interventions. Previous attempts at identifying new patients were difficult, manual, and delayed. Our aim was to provide personnel with the appropriate means to identify new patients for services such as patient education, financial navigation, social work assessments and outreach calls for care coordination. As a result of multiple barriers and challenges, only 51% of our new patients were being identified. This project fit well in the larger context of the transformation of health care delivery through our participation in the Oncology Care Model, which places an emphasis on team based care. Methods: We used the Plan-Do-Study-Act continuous improvement model to develop an automated data set to identify new treatment patients across the oncology service line and leveraged our Information Technology (IT) Analytics team. A report was established based utilizing logic to identify the first appointment scheduled within the department and a secondary tab to look back at new patients within a three week time frame. Information is housed within a business intelligence software system that is easy for end users to see and understand. The initial report was validated for accuracy at an identification rate of 93% and the 3 week “look back” report gives the ability to identify the remaining patients. Results: We have seen marked improvements metrics as a result of the utilization of this report. Our Financial Navigators have been able to sustain out of pocket estimate calls at > 94% YTD 2018. Social Work initial patient assessments have sustained at 79% for the last 6 months, and we have seen nearly 400 documented oncology patient education encounters each month. Identification of these patients allows us to target patient education, outreach, and psychosocial assessments at initiation of therapy. Care Coordinators are able to establish patient lists to track eligibility for survivorship at the appropriate time points. Conclusions: This project demonstrates the value of using IT/Data Analytics for continuous quality improvement projects related to patient centered team based care. The cross collaboration of stakeholders in data analysis should be explored as a mechanism to transform care through key services and interventions.
Assessment of contraception and fertility knowledge among female oncology patients of child bearing age and their providers.
Authors: Betman Samantha , Madrigal Jessica M , Stempinski-Metoyer Kelly , Rao Ruta D. , Patel Ashlesha
Published: May 2019

e18270

Background: Understanding the implications for future fertility is a growing concern among young women diagnosed with cancer. Women are less likely than men to receive information regarding fertility preservation and possible infertility following cancer treatment. Our goal was to examine knowledge of contraception and cancer-related changes in fertility among women of childbearing age treated at John H. Stroger, Jr. Hospital of Cook County and to assess whether or not medical providers prioritized having these conversations with female patients. Methods: We interviewed 20 female oncology patients, and 14 completed an additional 12 question true/false question fertility knowledge survey. We administered a survey to providers in the Medical Oncology department to assess how they prioritize talking about contraception and fertility preservation with their female patients of childbearing age. Providers rated ten items using a five-item Likert scale ranging from strongly disagree to strongly agree. Data was summarized as frequencies and percentages. Results: Among the 20 patients interviewed, six (30%) were under age 35 and 14 (70%) had an income of under $30,000. Of these, only 50% had tried a tier 1 long acting reversible contraceptive method and 43% had tried a tier 2 method. Fertility knowledge scores ranged from 0 to 8, out of 12 (Table). The median score was 2 (IQR 3). Among the 17 oncology providers surveyed, only 24% (n = 4) agreed that they were confident educating their patients about fertility preservation, and only 35% (n = 6) prioritized talking to their female patients of reproductive age about different methods of contraception. Conclusions: Health disparities in cancer care are well-known. Low-income women who seek cancer care at a safety-net institution may have limited knowledge on contraception and fertility. A better understanding of how oncology providers can prioritize these topics when talking to patients about their cancer diagnosis is needed. [Table: see text]
Patients’ understanding and adherence to oral anti-cancer medication (OAM): Results of an institutional pilot study.
Authors: Rodday Angie Mae , Hackenyos Douglas W , Masood Raisa , Savidge Nicole , Lin Mingqian , Mao Daqin , Wang Feng Qing , Murphy-Banks Rachel , Weidner Ruth Ann , Buchsbaum Rachel J. , Erban John Kalil , Parsons Susan K.
Published: May 2019

e18280

Background: Advancements in biopharmaceuticals have led to increasing availability and use of OAM. While oral medications allow patients (pts) to receive treatment at home, OAM use introduces new challenges related to prescription filling, monitoring for and reporting of side effects, safe medication handling, and adherence. We assessed understanding of and adherence to OAM in pts vulnerable to these home-based challenges. Methods: This 2018 pilot study defined vulnerable pts based on spoken language (Chinese), older age (≥65 yrs), and public insurance ( < 65 yrs). All pts had a cancer diagnosis, had been taking an OAM, and received prescriptions through the hospital’s specialty pharmacy. Prior to a clinic visit, pts completed patient-reported measures about OAM taking and handling. Clinical characteristics were extracted from medical records; medication information was extracted from pharmacy records. The study team’s specialty pharmacist (DH) classified patient-reported responses about OAM taking (days per week, times per day, special instructions) and handing (handling, storage, disposal) as adequate or inadequate. OAM regimens were classified by complexity based on number of drugs and schedule. Results: Of 61 eligible pts, 55 participated (90%). Mean age was 68 yrs (SD 12) and 53% were female. Pt subgroups were: 27% Chinese, 64% ≥65 yrs, and 9% < 65 yrs with public insurance. 33% had solid tumor and 67% had hematologic malignancy; tyrosine kinase inhibitor was the most OAM type (42%). 49% of pts were on front-line therapy and overall median time on OAM was 1 year (Q1 0.4, Q3 1.7). Adequacy of OAM taking (30%) and handling (15%) were low; only 15% had adequacy in both. Pt subgroup and regimen complexity did not vary by adequacy of OAM taking or handling. Patient-reported adherence was high 5.4 (SD 1) (possible range 1-6) and did not vary by adequacy of OAM taking or handling. Conclusions: Understanding of how OAM should be taken and handled in a group of vulnerable pts was strikingly low and did not align with pts’ self-reports of adherence. Future interventions are needed to ensure that pts understand how to safely take and handle OAM, thereby optimizing their therapeutic potential.