bluuebunny/crossref_metadata_2025_split huggingface dataset:
Distribution and frequency of patient-reported symptomatic adverse events at a comprehensive cancer center.
Authors: Cleveland Jessica , Hassett Michael J. , Lee Sherry , Chua Isaac S. , Dominici Laura Stewart , Schrag Deborah , McCleary Nadine Jackson 
Published: May 2020

e19117 Background: Systematic review of electronic patient reported outcomes (ePRO) has been shown to improve quality of life and overall survival in clinical trial. We previously demonstrated feasibility of ePRO across Dana-Farber Cancer Institute (DFCI). We sought to examine the distribution and frequency of first symptomatic adverse events (SAEs) among ePRO responders in ambulatory oncology practice. Methods: The ePRO tool uses the validated NCI developed Patient Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument to assess attributes of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness) selected by clinician stakeholders and deployed via any internet-enabled device once every 7 days. Responses are viewable in the EHR, scored 0 to 3 using an algorithm, with scores of 3 highlighted to indicate severe grade SAEs. Results: We examined the distribution and frequency of the first 5183 unique ePRO reports for unselected patients seen in the medical, radiation and surgical oncology outpatient clinics of four pilot multidisciplinary clinics (Breast, Genitourinary, Gastrointestinal and Head and Neck) between September 2018-December 2019. Twenty one percent of eligible patients responded to ePRO (5183 of 26,084). Most respondents were female (59%), Caucasian (89%), and age 50-69 years (56% compared to 16% age <50 years, 28% age ≥70; range 19-98 years). The frequency of grade 3 SAEs was pain (10%), fatigue (6%), insomnia (4%), constipation (3%), numbness and tingling/concentration/anxiety/decreased appetite (2%), diarrhea/shortness of breath/sadness (1%), and rash/fever/nausea/vomiting (none) (Table). Conclusions: We observed a consistent distribution of SAEs across cancer types, age and sex. The most frequently reported SAEs are those clinicians struggle to treat with medications - pain, fatigue, insomnia and anxiety. Research to develop effective strategies to address this constellation of SAEs should be prioritized. [Table: see text]
Increase in side effect bother was associated with early treatment discontinuation in a clinical trial among multiple myeloma patients.
Authors: Peipert John , Zhao Fengmin , Lee Ju-Whei , Hong Fangxin , Ip Edward , Gareen Ilana F , O'Connell Nathaniel , Carlos Ruth , Stewart A. Keith , Weiss Matthias , Sparano Joseph A. , Cella David , Gray Robert James , Wagner Lynne I. 
Published: May 2020

e19136 Background: Patient reported side effect bother is needed to understand tolerability of cancer drugs. We examined whether increase in side effect bother from baseline to cycle 7 as measured by a single item (GP5) from the FACT-G, “I am bothered by side effects of treatment”, was associated with early treatment discontinuation (ETD) in a multiple myeloma (MM) trial. Methods: Data were drawn from the induction phase of ECOG ACRIN E1A06, a two arm, phase 3 trial conducted in patients with untreated MM. The induction phase occurred over twelve, 28-day cycles. GP5 was assessed at registration and cycle 7. ETD was defined as completion of less than 12 cycles of treatment. We tested whether increase in side effect bother on the GP5 from baseline to cycle 7 was associated with months to ETD in two ways. At each timepoint, GP5 was rated with these response options: “Not at all”, “A little bit”, “Somewhat”, “Quite a bit”, “Very Much”. First, we stratified Kaplan Meier curves by patients with versus without substantially increased side effect burden from registration to cycle 7 on the GP5, defined as an increase of > 2 response categories; Cox regression was used to calculate a hazard ratio. Second, we fit a joint model of the GP5 change trajectory on months to ETD that substituted the estimated slope of a longitudinal logistic regression model into the hazard function of a Cox model. In this model, GP5 was dichotomized as 0 = “Not at all/”A little bit”; 1 = “Somewhat”/ “Quite a bit”/ “Very Much”. Results: 159 patients were followed during induction for a median of 11 months (range: 0.2-16.0). 10 patients (6%) reported a substantial increase on GP5 from registration to cycle 7. After 16 months, these patients had a significantly higher hazard of ETD as estimated by Kaplan Meier methods: 40% experienced ETD vs. 24% of patients without substantial GP5 increase [hazard ratio (HR): 3.08 (95% CI: 1.18-8.02)]. In the joint model, the effect of GP5 on hazard of ETD was larger [HR: 9.56 (95% CI: 2.41-37.82)]. Conclusions: This study found initial evidence that increase in side effect bother as measured by the GP5 predicts ETD and may therefore reflect treatment intolerability in cancer drug trials. The effects found in this study will be tested for replication in additional ECOG-ACRIN trials with diverse designs, treatments, and cancer types. Clinical trial information: NCT00602641 .
Healthcare resource use (HRU) in men with metastatic castration sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT) only or no treatment 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

e19138 Background: mCSPC is clinically complex. Although consensus on treatments are evolving, ADT remains the backbone of therapy. This study assessed the proportion of mCSPC patients treated with ADT only or remaining untreated and their HRU during the mCSPC period in the US. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for prostate cancer (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 index [date of 1st metastasis dx on or after 1st PC dx and between 2015-2018]). Patients were excluded if they had a pre-index castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-index or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from index until CR (i.e., any post-index CR indicator or initiation of abiraterone acetate or docetaxel ≥12 mo after post-index ADT initiation or ≥12 mo post-index for those with no ADT) or end of data. The proportion of patients receiving ADT only or no mCSPC treatment during F/U was reported. Per-patient-per-year (PPPY) all-cause HRU were evaluated during baseline (12 mo pre-index) and F/U. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: A total of 2,825 mCSPC patients were identified (age: 75 [9] years). Of these, 2,181 (77%) received ADT only or no treatment in a F/U of 10.9 [9.0] mo. Among them, there were more patients with ≥1 inpatient (IP) stay or ≥1 emergency room (ER) visit (F/U vs. baseline; IP: 50% vs. 20%; ER: 57% vs. 44%), and patients had more IP stays and ER visits (IP: 2.0 [4.0] vs. 0.3 [0.7] stays; ER: 3.2 [7.1] vs. 1.1 [2.2] visits) and more IP days (27 [61] vs. 3 [11] days) PPPY in F/U vs. baseline. Trends were similar among patients receiving ADT only (N=1,252 [44%]; F/U of 12.6 [9.0] mo; Table). Conclusions: The majority of mCSPC patients were treated with ADT only or remained untreated and incurred substantial HRU. These findings suggest that improvements in therapy and prompt treatment initiation in men with mCSPC are needed to improve outcomes. [Table: see text]
Relative dose intensity and pathologic response rates in HIV-infected and HIV-uninfected breast cancer patients who received neoadjuvant chemotherapy.
Authors: Martei Yehoda M. , Grover Surbhi , Narasimhamurthy Mohan , Setlhako Dipho Irene I , Ayane Gezahen N , Ralefala Tlotlo Bathethi , Chiyapo Sebathu Phillip , Gross Robert , DeMichele Angela , Shulman Lawrence N. 
Published: May 2020

e19140 Background: HIV-infected (HIV+) breast cancer patients may have significantly worse survival compared to HIV-uninfected (HIV-). If so, identifying the underlying mechanism might lead to effective interventions to reduce the disparity. Relative dose intensity (RDI) < 0.85 has been associated with worse survival outcomes in non-metastatic breast cancer patients. We aimed to determine if RDI of chemotherapy and pathologic complete response (pCR) rates were lower for HIV+ patients who received neoadjuvant chemotherapy (NAC) compared with HIV-. Methods: We conducted a prospective cohort study in newly diagnosed breast cancer patients with locally advanced disease who initiated NAC at Princess Marina Hospital in Botswana between 2/2017 and 9/2019. Clinical and treatment data were collected at baseline and at every treatment visit. Surgical pathology post-NAC was graded as pCR if there was no invasive disease in the breast or lymph nodes. RDI was calculated for each patient, with optimal RDI ≥ 0.85. Dichotomous variables were compared using Fisher’s exact and chi-squared tests; and continuous variables using rank sum tests. Results: 111 patients were enrolled, of whom 84 (75.7%) were HIV-, 26 (23.4%) HIV+ and 1 (0.9%) with unknown status who was excluded from final analysis. HIV+ patients were less likely to receive optimal RDI (0.74 vs. 0.88; p = 0.03). Of the 110 patients 15 (13.6%) were still receiving chemotherapy; 22 (20%) prematurely discontinued chemotherapy of whom 11 (10%) received surgery; 7 (6.4%) completed chemotherapy but had no surgery. 77 (70%) completed surgery which included 11 (10%) with no pathology reports available, 3 (2.7%) inadequate surgical specimens and 63 (57.3%) complete pathology results included in pCR analysis: 1/13 (7.7%) HIV+ patients had a pCR compared to 12/50 (24%) in HIV-(p = 0.27). Conclusions: HIV+ patients were significantly more likely to receive inadequate neoadjuvant chemotherapy dose intensity, and trended towards a lower pCR in this small cohort, which may contribute to adverse treatment outcomes. Further study needed to validate high rate of treatment discontinuation and specific risk factors to inform targeted interventions to improve therapy delivery.
End-of-life health care utilization (EOLHCU) in patients with thoracic, head and neck cancers with or without phase I study participation at a single institution.
Authors: Min-Tran Dominic , Gustafson Annika , Eaton Keith D. , Loggers Elizabeth Trice , Rodriguez Cristina P. , Santana-Davila Rafael 
Published: May 2020

e19153 Background: Several retrospective studies suggest patients enrolled in clinical trials have more end-of-life health care utilization (EOLHCU). This is particularly concerning for phase I clinical trial participants who are known to have therapeutic misconceptions about the purpose and benefits of phase I clinical trial participation. Methods: We identified all phase I participants at the Seattle Cancer Care Alliance (SCCA) with thoracic, head and neck cancers (THNC) who died between July 1, 2014 and June 30, 2018(P1C). We compared them to 139 randomly selected THNC patients who died within the same time period without phase I study participation (NP1C). Patient records were abstracted from the electronic health record (and Epic Care Everywhere if patients received EOL care outside of SCCA). A chi-square test was used to compare categorial variables and t-tests were used for numerical variables. Results: 67 P1C patients were identified; 3 patients had no outside records at the end of life and were removed from the database. No statistically significant differences in gender, ethnicity, marital status, or form of insurance were found between the two groups. P1C patients were younger (median age of 62 (interquartile range (IQR) 55-69) vs. 66 (IQR 59-72), p=0.008) and had more lines of therapy from diagnosis until death (median 4 (IQR 1-3) vs. 2 (IQR 1-3), p=<0.0001). No difference in end-of-life care or quality of death metrics were found between the two groups, however a trend toward more referrals to palliative care were noted in phase I participants. (Table). Conclusions: At our center no differences in EOLHCU or quality of death parameters were seen in THNC patients who did or did not participate in phase I studies. [Table: see text]
Enhancing the effectiveness of chemotherapy prescribing: A validation study of ChemoPalRx.
Authors: Tareen Serene , Ziyeh Sharvina , Powell Leland Duer , Hung Kin Wai (Tony) 
Published: May 2020

e19161 Background: ChemoPalRx is a free iOS mobile application developed for chemotherapy referencing and prescribing. Providers can readily download and use ChemoPalRx to generate and print chemotherapy formatted prescriptions. In the absence of a computerized chemotherapy order entry system, institutions may adopt ChemoPalRx for chemotherapy prescribing in place of traditional methods such as handwritten prescriptions. However, effectiveness of ChemoPalRx in the real-world practices has not been established. Methods: With our aim to determine the effectiveness of ChemoPalRx, we conducted a cross sectional study at an academic institution. Our study primary predictor was the method of generating a chemotherapy order, dichotomized as “handwritten” or “ChemoPalRx”. Primary outcome was corrected order, dichotomized as “corrected” or “satisfactory” order. Corrections were defined as any correction made to an order (e.g. illegible handwriting, modifications in drug dosing, missing chemotherapy or patient’s information). Covariates included fellowship training year (first, second, or third) and complexity of order (“simple” = 2 drugs or less; “complex” = 3 drugs or more). Correction rate (CR) was defined as the proportion of corrected orders. Chi Square test was used for statistical analysis. Results: From October 2019 to December 2019, 288 chemotherapy orders were examined, of which, 226 were handwritten (78.5%) and 62 were ChemoPalRx (21.5%). Of the 226 handwritten orders, 184 (81%) were satisfactory, 42 (19%) were corrected. Of the 62 ChemoPalRx orders, 57 (92%) were satisfactory, 5 (8%) were corrected. CR was significantly reduced by ChemoPalRx compared to handwritten (p = 0.034). Subgroup analysis found that first-year fellows tend to make more corrections on complex orders (CR: 19%) compared to second- and third-year fellows (CR: 6%) (p = 0.19), while second- and third- year fellows made more corrections on simple orders (CR: 22%) compared to first-year fellows (CR: 9%) (p = 0.013). Conclusions: ChemoPalRx significantly enhanced prescription accuracy compared to handwritten chemotherapy orders. Implementation of ChemoPalRx in real-world practices is validly feasible and effective. While ChemoPalRx may support less experienced providers on more complex orders, it may help to catch overlooked simple details for the experienced providers. In the evolving digital era in oncology, ChemoPalRx may be a promising alternative to handwritten prescriptions that can be readily available at one’s fingertips.
Design and implementation of a core tool for quality evaluation of cancer care in 10 oncology institutions in Colombia.
Authors: Pino Luis Eduardo , Triana Ivan Camilo , Potes Diana , Cortes Henry JULIAN , Alcantara Alejandra , Cuervo Angela , Vargas Paola 
Published: May 2020

e19166 Background: Measuring quality in cancer care is a complex process due to the heterogeneity of the medical information and the biological complexity of the disease. There are different tools designed for this purpose, including the ASCO QOPI scale that includes core and specific dimensions for some types of cancer. In Colombia there is no specific quality tools in cancer for the evaluation of providers. Methods: This is an observational study. We designed and applied an oncology quality evaluation tool based in the SCO QOPI scale, but adapted to regional language and available technologies. This tool was based on six dimensions, each one weighted according to its relevance in the quality of cancer care (percentage in parentheses): Patient identification (5), oncologic history (25), physical exam (5), diagnostic tests (20), treatment plan (40) and readability (5).The tool was applied to four diseases: Breast cancer, colon cancer, non-small cell lung cancer (NSCLC) and multiple myeloma. 706 clinical cases were evaluated from 10 hospitals, both general and oncological. After evaluating each case, 171 met with the criteria, however, only 110 had complete clinical records. Four auditor physicians were trained by a clinical expert for each disease. Results: The distribution of cases by disease was: Breast cancer 51%, colon cancer 17%, multiple myeloma 22% and NSCLC 10%. Overall result of quality was 51% (maximum score: 100%) which was considered deficient according to the parameters of the tool. The best performance was obtained for cancer hospitals in Medellín (61%) and for a general hospital in Bogotá (56%). The best disease results were obtained in NSCLC (62,4%) and the worst in breast cancer (47%). These results, according to the dimension evaluated were: 33,6% Patient identification, 44,3% oncologic history, 58,2% physical exam, 71,7% diagnostic tests, 33,8% treatment plan and 98,2% readability. Conclusions: Although Medellin and Bogota had the highest comparative performance in this study, the overall results were low. Oncologic history and treatment plan showed deficiencies in their performance, which should be highlighted due to important items such as evaluation of functional scales (ECOG) and intentionality of interventions were considered within adequate decision making. This quality tool is a contribution to the specific evaluation of quality in oncology for countries like Colombia.
Temporal trends in receipt of adjuvant chemotherapy for veterans with colorectal cancer.
Authors: Martin Richard Lewis , Edwards Gretchen C. , Samuels Lauren R. , Eng Cathy , Roumie Christianne L. 
Published: May 2020

e19171 Background: For patients with National Comprehensive Cancer Network (NCCN) high risk stage II or stage III colorectal cancer (CRC), adjuvant chemotherapy improves disease free (DFS) and overall survival (OS). Rates of use vary significantly across health care settings. Several demographic and healthcare factors are associated with decreased receipt of chemotherapy; however, few studies have assessed utilization patterns over time. We evaluated receipt of chemotherapy from 2000-2015 among patients treated at a Southeast Regional Veterans Health Administration (VHA) facility to determine local targets for quality improvement initiatives. Methods: We reviewed 1,107 electronic medical records of patients undergoing colorectal surgery from January 1, 2000 to December 31, 2015 at VHA Tennessee Valley Healthcare System. We included patients with NCCN eligible pathologic high risk stage II (T4/perf, R1, < 12LN, LVI) or stage III CRC and excluded for age ≥80, age ≥75 hospitalized in the prior year with a major co-morbidity, and death or hospice within 30 days of surgery. The primary predictor was year of surgery, partitioned 2000-2005 (N = 60), 2006-2010 (N = 64), 2011-2015 (N = 56) to reflect changes in NCCN guidelines. The primary outcome was receipt of any chemotherapy. Results: Of 1,107 colorectal surgeries, we excluded 623 for non-cancers, 212 for stage I or low-risk stage II cancer, 47 for metastatic disease, and 45 for age, co-morbidity, death, and hospice, yielding a final cohort of 121 colon and 59 rectal cancers. Most patients were male (96%), white (79%), with median age 64 years [Interquartile Range 60, 70]. Overall, 117 of 180 (65%) received chemotherapy with a median time to treatment of 50.5 days [40,64]. Adjusting for known correlates, receipt of chemotherapy decreased over time; 2000-2005 (72%), 2006-2010 (69%), 2011-2015 (53%) p = 0.02. Regardless of CRC stage, more patients declined chemotherapy in 2011-2015 (27%) compared to 2000-2005 (6%) and 2006-2010 (8%) p < 0.01. Conclusions: We identified decreased utilization of adjuvant chemotherapy in a non-elderly veteran cohort, which appeared to be due to patients declining chemotherapy regardless of cancer stage. Understanding patient and provider decisions around adjuvant chemotherapy and evaluating trends outside the VHA may offer important insights to implementing quality improvement measures.
Real-world data and patient perspectives on quality care and maintenance therapy (MT) decision-making for recurrent ovarian cancer (ROC).
Authors: Coleman Robert L. , Crawford Rebecca R , Carter Jeffrey D. , Sapir Tamar 
Published: May 2020

e19174 Background: Despite clinical evidence illustrating the efficacy of MT for ROC, complexities, such as patient-, treatment-, and disease-related factors, and team-based care coordination, limit its optimal use in ROC. In a quality improvement (QI) program, conducted at 2 oncology systems, we evaluated gaps in evidence-based, quality ROC care. Methods: Between 09/2019-02/2020, retrospective EMR audits of 200 patients with ovarian cancer were analyzed for demographics, disease characteristics, treatment history, and shared decision-making (SDM) involving MT. Surveys were administered to evaluate challenges, barriers and experiences of healthcare professionals (HCP; N = 35) and their patients with ROC (N = 21). The HCP teams participated in audit-feedback sessions and developed action plans for resolving identified gaps. Results: EMR audits revealed low utility of MT among patients with ROC (Table), and only 20% of patients reported that MT was discussed as a treatment option. Lack of access to newer therapies was most commonly identified (27%) by HCP as the biggest challenge in treating patients with ROC. Furthermore, survey results revealed that HCP are challenged to correctly integrate guidelines for patient selection for PARP inhibitor MT based on BRCA mutation status (18% of HCP answered correctly), response to previous chemotherapy (49% correct), and line of therapy (46% correct). Data indicated a low level of SDM – none of the patients indicated a high level involvement in treatment decisions and only 20% indicated a high level of agreement that their care team understood their treatment goals. EMR audits also illustrate low documentation of multiple aspects of SDM (Table). Oncology team members formulated plans to develop guidance documents to assist in therapy sequencing and tools to improve patient education. Conclusions: Overall, data from this QI program indicate gaps, challenges, and barriers in evidence-based, MT decision-making and engagement of patients in SDM. These areas for improvement may be relevant for future interventions to improve the provision of quality ROC care. [Table: see text]