bluuebunny/crossref_metadata_2025 huggingface dataset:
FDA analysis: Demographic trends in bladder and renal cancer trials.
Authors: Fernandes Laura L , Lin Zhantao , Fashoyin-Aje Lola A. , Tang Shenghui , Sridhara Rajeshwari , Pazdur Richard
Published: May 2019

e18144

Background: Many publications report under representation of minorities in certain subgroups, which may limit the generalizability of clinical trial (CT) results. This analysis, investigates and reports enrollment trends in CTs submitted between 2006-2017 in support of marketing applications for drugs indicated for the treatment of urothelial (UC) and renal cancer carcinoma (RCC), and compares them to incidence rates of these diseases by Surveillance, Epidemiology, and End Results (SEER) registry and the US census bureau. Methods: We identified all marketing applications for the treatment of UC and RCC that provided the primary evidence of safety and efficacy and aggregated the demographic data across trials and disease. Using these two pooled datasets, we compared the patient proportions enrolled in each of the race, sex and age categories to the corresponding rates in US cancer population estimated based on the corresponding incidence rates reported by SEER and the US census bureau using a Chi-squared test. Results: The pooled seven UC and 14 RCC CTs provided 2035 and 6757 patients respectively. The results are summarized below for the 939 (46%) UC and 1489 (22%) RCC patients enrolled in the US. Conclusions: Our findings indicate that majority of the patients were enrolled outside of the US. There were lower proportion of Black patients (4% vs 8%), older patients, age ≥ 75 years (30% vs 48%) and males (74% vs 80%) enrolled in UC population in the US. Higher proportions were observed in both White (89% vs 85%) and Asian (4% vs 2%) patients in UC and in White (90% vs 79%) patients in RCC.[Table: see text]
Body composition change, safety, and efficacy with everolimus use in ethnic minorities with breast cancer.
Authors: Kaur Gurbakhash , Podolski Amanda , Patel Janki , Anampa Mesias Jesus Del Santo
Published: May 2019

e18145

Background: The mammalian target of rapamycin (mTOR) signaling pathway regulates metabolism and is implicated in pathological conditions including obesity and diabetes. In obese rat models, mTOR inhibition was shown to ameliorate obesity and adipocyte hypertrophy, while exacerbating glucose intolerance. The mTOR inhibitor Everolimus (E), in combination with exemestane, is FDA approved for the treatment of ER+/HER2- metastatic breast cancer (MBC) with hyperglycemia being common toxicity. There is scarce data about the safety & efficacy of E in ethnic minorities. We aimed to assess the effect of E on body composition after 3 & 6 months and to describe toxicity & efficacy in ethnic minorities. Methods: A retrospective study involving patients with MBC treated with E between 1/1/2012-12/1/2018. Total fat area (TFA), visceral fat area (VFA), subcutaneous fat area (SFA), muscle area (MA), and muscle density (MD) were measured before and after 3 & 6 months of E treatment using CT images at the L3 vertebrae. Results: Our cohort included 58 patients with a median age of 69 years (range: 46-97); 22% were Caucasian, 35% were black, and 41.4% were Hispanic. Visceral disease was present in 64%, the median number of prior endocrine therapies was 2 (range: 1-6), and the median number of prior chemo lines was 2 (range 1-7). There was significant decrease in body weight at month 3(-2.9kg, p < 0.0001) and month 6 (-5.2kg, p = 0.006). At month 3, there was a significant decrease in TFA (-2848 mm2, p = 0.004), VFA (-834 mm2, p = 0.004), and SFA (-2021 mm2, p = 0.002), with similar effects at month 6. When compared to baseline, there was no significant change in MA or MD at month 3 or 6. Grade 3/4 adverse events (AEs) were present in 18 patients. The most common AEs were mucositis (22%), rash (21%), fatigue (14 %), hyperglycemia (10%), diarrhea (9%), pneumonitis (9%), and edema (7%). The median PFS was 5.8 months. Conclusions: This is the first report that Everolimus treatment decreases body weight, TFA, VFA, and SFA without significant effect on MA or MD. Our findings are consistent with animal models reports that mTOR inhibition causes a decrease in fat mass in obese rats. We report the median PFS of 5.8 months in a cohort with ethnic minorities.
Racial differences in intravenous bisphosphonate utilization among older patients with multiple myeloma.
Authors: Zhou Jifang , Sweiss Karen , Patel Pritesh Rajni , Nutescu Edith , Ko Naomi , Chiu Brian C-H , Calip Gregory Sampang
Published: May 2019

e18165

Background: Intravenous bisphosphonates (IV BP) reduce the risk of skeletal-related events in patients with multiple myeloma (MM). However, data describing racial differences in utilization of IV BP in non-clinical trial settings is limited. In this study, we evaluated population-level IV BP utilization and factors associated with initiation and discontinuation of IV BP therapy. Methods: We conducted a retrospective cohort study of patients aged 65 years or older diagnosed with first primary MM between 2001 and 2011. Patients were identified using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database and followed through December 2013. Patients were required to have Medicare Parts A and B coverage and patients with end-stage renal disease were excluded. Treatment with anti-MM therapy (chemotherapy and/or proteasome inhibitors) were treated as time-dependent variables. We analyzed cumulative incidences of IV BP initiation from the diagnosis of MM for all patients and separately time to discontinuation from IV BP initiation. In multivariable Fine and Grey models accounting for competing risks, we estimated subdistribution hazard ratios (SHR) and 95% confidence intervals (CI) for initiation and discontinuation. Results: 14,231 eligible patients had a mean [median] age of 76.8 [76] years and 51.8% were male. During a median follow-up of 23.1 months, 53.7% of patients received at least one intravenous bisphosphonate (IV BP) administration. IV BP initiation, duration and treatment frequency differed between racial groups. Among white patients, 64.4% of IV BP were administered every 4 weeks, compared to 59.3% in African Americans, 62.7% in Hispanic, and 64% in Asians. In multivariable models, Black patients experienced a significant delay in IV BP initiation (SHR 0.75, 95%CI 0.70-0.80) and were more likely to have early discontinuation (SHR 1.08, 95%CI 1.00-1.17). Conclusions: Despite recommended therapy with IV BP for MM patients, approximately half of older patients did not receive the therapy, with a significant lag experienced among racial minority groups. Efforts to improve uptake of IV BP and continued management of therapy in minority groups are needed. [Table: see text]
Valuing innovations in cancer treatment.
Authors: Zhao Henu , Tysinger Bryan , Goldman Dana P
Published: May 2019

e18176

Background: Established in 2004 by voter referendum, the California Institute for Regenerative Medicine funds stem-cell research aimed at reducing the burden of diseases, including cancer. Incidence for certain cancer has been reduced by half in the last decades. To better understand the social benefit of medical innovation, we estimate the potential value of interventions to reduce the incidence of selected cancers. Methods: We use the Future Elderly Model (FEM) to simulate scenarios calculating the national and California disease burden of breast, colorectal, lung, and prostate cancer and the societal value of reducing incidence of these cancers by 10% and 50%, respectively. FEM is a well-validated microsimulation model of Americans aged 51 and older that projects future health and economic outcomes for individuals. Starting with a nationally representative sample from the Health and Retirement Study, we estimate two-year transitions between chronic diseases, functional status, and economic outcomes. We predict EQ-5D scores and quality-adjusted life-years (QALY) based on the outcomes and models using Medical Expenditure Panel Survey data. We then aggregate individual results to generate outcomes at the societal level. Results: Social values are measured by QALY, with each unit valued at $150,000. Yearly discount rate for future QALY is 3%. Estimated gains in aggregate social value from 2018 to 2050 are presented below. For the selected cancers, the disease burden of the selected cancers through 2050 ranges from $1.3 trillion to $3 trillion for the U. S. population >50. QALY gains from a 50% reduction in incidence are estimated at $0.5 trillion to $1.4 trillion, while gains from a 10% reduction are $110 billion to $252 billion. Conclusions: A small incidence reduction can result in large returns. There is a lot of potential for innovation in cancer. [Table: see text]
Do oral antineoplastic treatment data differ between Concerto Health AI Definitive Oncology EMR and Symphony Claims Data?
Authors: Chu Laura Kay , Chaudhary Nayan , Chen Li , Wong William Bruce
Published: May 2019

e18180

Background: Electronic Medical Records (EMRs) are increasingly being used for health outcomes research because they contain a rich array of clinical data. Oral medications are captured via structured medication order fields or abstracted from the clinical notes; however, it’s unknown how these correspond with dispensations. The objective of this study was to better understand how oral antineoplastic orders captured from an EMR database compare to dispensations from pharmacy claims. Methods: The Concerto Health AI Definitive Oncology Dataset is a deeply curated cohort of patients (pts) derived from a wide range of oncology practices throughout the United States. Concerto Health AI has a co-exclusive partnership with ASCO CancerLinQ & collects data from multiple other sources. These data were deterministically linked to US Symphony Health’s (SH) Integrated Dataverse, an anonymized, HIPAA-compliant data set. Only advanced (stage IIIb/IV) non-small cell lung cancer (aNSCLC) pts with curated data via manual review by nurse practitioners & oral antineoplastics prescribed for lung cancer were included in this analysis. Among a subset of pts that had a dispensation within 90 days of their 1st EMR order, treatment duration was calculated as time from 1st to last order/claim (before a 30-day gap) plus 30 days supply, for EMR & claims, respectively. Results: Of 19,175 aNSCLC pts from Concerto, 8,864 pts were linked to SH. Among linked pts, there were 2,057 pt-drug instances; 750 (36.5%) were in both Concerto and SH, 1,160 (56.4%) in Concerto but not SH, and 147 (7.1%) in SH but not Concerto. Median time from 1st order in Concerto to 1st dispensation in SH was 16 days (interquartile range (IQR): 6, 78), with 76% of pt-drug instances having a dispensation within 90 days of 1st Concerto order. Median treatment duration was 44 (IQR: 30, 125) and 93 (IQR: 41, 241) days based on Concerto and SH, respectively. Conclusions: Concerto EMR orders identified more pts treated with oral antineoplastics, though treatment durations were longer using SH claims. Limitations of this analysis include use of orders from EMR instead of abstracted start and end dates and use of open claims with limited specialty pharmacy data. Linked datasets may provide more robust capture of orals data and warrant further research.
Development and evaluation of a proxy for baseline ECOG PS in advanced non-small cell lung cancer (aNSCLC), bladder cancer (aBCa), and melanoma (aMM): An electronic health records (EHR) study.
Authors: Sadetsky Natalia , Chuo Ching-Yi , Davidoff Amy J.
Published: May 2019

e18194

Background: Performance status measured by ECOG PS (ECOG) predicts therapy choice, and overall survival (OS), but often not reported in routine care. EHR data include rich clinical information which Methods: In this retrospective analysis using Flatiron Health EHR-derived database we selected patients diagnosed from 2011-2018 with aNSCLC, aBCa, and aMM and ECOG reported between diagnosis and 1) therapy start, or 2) within 90 days. We used multivariable logistic regressions in a 75% development sample to model associations between selected sociodemographic, clinical and laboratory measures and poor ECOG (2+ vs 0-1) for each cancer. Predictive accuracy was assessed in 25% validation datasets. Kaplan-Meier analysis tested the associations between observed and predicted poor ECOG with OS. Results: The non-missing ECOG samples were 20,697 aNSCLC, 2627 aBCa, and 2558 aMM (out of 50,876, 6955, and 7917 respectively). The proportion of patients with ECOG 2+ ranged from 28.5% for aNSCLC to 15% for aMM. Higher number of comorbid conditions, older age, lowest BMI, higher number of metastases, abnormal albumin and hemoglobin and public insurance were associated with poor ECOG status. Predictive accuracy for poor baseline ECOG was 71.8% for NSLCL, 73.8% for aBca, and 85.4% for aMM). There was a consistent association between OS and observed and predicted baseline ECOG (Table 1). Conclusions: In a large cohort of cancer patients, routinely collected EHR data were used to predict baseline ECOG PS status. Complete ECOG status results may enhance evaluation of cancer treatment patterns and outcomes in EHR data. [Table: see text]
Variations in patient-reported outcome (PRO) collection and reporting in novel FDA approved anticancer therapies.
Authors: Singhal Surbhi , Hall Evan Thomas , Gabster Brooke Peterson , Dickerson James , Schapira Lidia
Published: May 2019

e18202

Background: Patient-reported outcomes (PROs) are increasingly valued as a key tool in patient-focused treatment decisions. However, a lack of standardization leads to significant variability in PRO collection and reporting in ground-breaking clinical trials of novel agents. We sought to characterize the mechanisms of assessment and variability by which PROs are reported for newly approved anti-cancer therapies. Methods: We reviewed the U.S. Food and Drug Administration (FDA) approvals between 2011 and 2017 for anti-cancer new molecular entities (NMEs) and new biologic approvals (BLAs). For each therapy, the pivotal clinical trial leading to FDA approval was identified using the national clinical trial (NCT) number and assessed for inclusion of PROs. A separate PubMed search was conducted to evaluate for PRO publication distinct from the original trial based on national clinical trial registry number. Results: From 2011 to 2017, the FDA approved 66 NMEs/BLAs based on 74 clinical trials for cancer treatment. Of the 74 clinical trial publications, 21 (28%) of the trials published PRO data in their original clinical publication, 18 (24%) published a separate PRO analysis, and 35 (47%) did not publish PRO data in either format. Among the 32 clinical trials (43%) that listed PROs as pre-specified outcomes, 72% published PROs (23/32). The separate PRO analyses (N = 18) were published considerably later following FDA approval (mean 605 days) than the original clinical trials (mean 20 days, N = 74, P < 0.001). Conclusions: As cancer treatment options expand, therapy decisions become increasingly nuanced. PROs assist decision-making by providing detailed information on important aspects of quality of life and tolerability. Our research has identified a significant lag in the publication of companion studies of PRO data associated with pivotal clinical trials, representing a meaningful gap in information critical to patients and oncologists in the process of making informed decisions.
Outcomes of immunotherapy administration for hospitalized cancer patients.
Authors: Leblebjian Houry , Duperrault Megan , Glotzbecker Brett , Awad Mark M. , Bartel Sylvia , McDonnell Anne , Bunnell Craig A. , Wagner Andrew J. , Hamel Lauren M. , Dougherty David W.
Published: May 2019

e18225

Background: With approvals across multiple cancer types and favorable toxicity profiles, oncologists may consider using immunotherapy (IMT) while their patients are hospitalized. Inpatient IMT may be cost-prohibitive to administer for most institutions due to high cost and inpatient payment structure, but little data are available to evaluate outcomes for IMT in hospitalized patients. We investigated the survival benefit of administering IMT to hospitalized patients with cancer at an NCI-designated cancer center. Methods: We conducted a retrospective chart review of all patients receiving ipilimumab, nivolumab, or pembrolizumab during inpatient admission at Dana-Farber Cancer Institute/Brigham & Women’s Hospital in 2017. For each patient, we assessed: total dose, indication for dosing, cancer type, time between dose and discharge, time between discharge and death, and total cost (average wholesale price). Study follow up was January 1, 2017 to July 1, 2018. Results: Fifty doses of IMT were administered to 44 patients. Most patients (40) received 1 dose, 2 patients received 3 doses, 1 patient received 2 doses, and 1 patient received a combination of ipilimumab/nivolumab. The most common cancer types were lung (41%), gastrointestinal (18%), and head and neck (16%). Indications for IMT administration were: patient due for next dose (48%), disease progression (42%), and new diagnosis (11%). The majority of doses (70%) were received within 7 days prior to discharge, with 32% of doses within 1 day of discharge. The majority of patients (86%) died in the study period; 14% of patients died during admission. Average survival between discharge and death was 54 days (range: 0-444 days). Total cost of inpatient IMT administration was $413,370, an average of $9,395 per patient. Conclusions: To our knowledge, this is the largest analysis of outcomes for patients receiving IMT during a hospitalization. Inpatient use of IMT in cancer patients is associated with high cost and poor clinical outcomes. Dosing within one week prior to hospital discharge was common. Clinical factors such as PD-L1 status, disease status, and reason for admission, which may be important to understand which patients may benefit most from inpatient IMT, should be examined.
Real-world treatment patterns, survival, and cost among elderly cervical cancer patients.
Authors: Shao Changxia , He Jinghua , Nwankwo Chizoba , Stein Karen , Keefe Stephen Michael
Published: May 2019

e18226

Background: Limited chemotherapy data is available for elderly cervical cancer patients (pts). This study aimed to investigate real-world use of systemic therapies, survival, and costs among elderly pts in U.S. Methods: Pts who aged 65+ years and initially diagnosed with cervical cancer between 2007 and 2013 were identified using the SEER-Medicare data. Regimens were classified into 3 mutually-exclusive categories, i.e. cisplatin (Cis), carboplatin (Car), and Other based therapies. Chemotherapy within 90 days of surgery or radiation therapy were not considered as first line (1L) systemic therapy. All costs were converted to 2016 US dollars. Results: A total of 1 651 eligible pts were identified with 430 (26%) being stage IV at diagnosis. Among pts received systemic therapies, the median overall survival (OS) was 14 m from 1L initiation and 10 m from 2L initiation. Among 225 pts who received 1L, 58% pts received Cis-based therapy, and 17% pts received Car-based therapy. Car + paclitaxel was the most commonly used regimen (44%). Among 73 pts who received 2L, 34% and 15% pts received Cis- and Car-based therapy, respectively. Pts with 2L therapy received a variety of regimens with the top 3 being Car + paclitaxel (19%), gemcitabine (11%), and topotecan (9.6%). Median duration of treatment (DOT) was 4-6 m across line of therapies (LOTs), yet median time to next treatment (TTNT) ranged 10-32 m for 1L, and 9-11 m for 2L. The average per person per month (PPPM) costs were 7.1k for 1L and 8.8k for 2L with primary drivers of spending being outpatient and emergency room visits. Conclusions: Elderly pts with advanced cervical cancer requiring chemotherapy had poor prognosis and had no standard of care for 2L therapy. Per-patient economic burden is substantial for both 1L and 2L therapy, exceeding 7k dollars per month. [Table: see text]
Responder analysis of patient-reported outcomes measurement information system (PROMIS) physical function (PF) and worst stiffness among patients with tenosynovial giant cell tumors (TGCT) in the ENLIVEN study.
Authors: Tap William D. , Speck Rebecca M , Ye Xin , Palmerini Emanuela , Stacchiotti Silvia , Desai Jayesh , Wagner Andrew J. , Alcindor Thierry , Ganjoo Kristen N. , Martin Broto Javier , Wang Qiang , Shuster Dale Edward , Gelhorn Heather , Gelderblom Hans
Published: May 2019

e18236

Background: The double-blind, randomized, placebo-controlled phase 3 ENLIVEN study in TGCT demonstrated a significant tumor response at week 25 by RECIST for pexidartinib (39% vs. 0% for placebo) and improvement in joint function and symptoms. The aim of this analysis was to identify a threshold score for responder definitions for PROMIS-PF scale and Worst Stiffness Numerical Rating Scale (WS-NRS) and compared responder rates for pexidartinib versus placebo. Methods: Anchor- and distribution-based estimates were calculated, and cumulative distribution function (CDF) plots were generated to derive responder definition threshold estimates. Anchor- and distribution-based results and CDFs were evaluated through triangulation, following FDA PRO Guidance, to determine a single responder definition threshold (i.e., meaningful change) for each instrument. The proportion of responders at Week 25 between treatments was compared with Fisher’s Exact Test (2-sided). Results: 120 patients were randomized to pexidartinib (n = 61) and placebo (n = 59) and assessed through 25 weeks of treatment. Anchor-based analysis showed one-level improvement on the patient global rating of PF item was associated with a mean change of 4.0 on PROMIS-PF. Distribution-based estimates (0.5 SD and 1 SEM) for PROMIS-PF were 2.8 and 2.5, respectively. For WS-NRS, a response of “A little improved” by patients on the perception of stiffness item was associated with a mean change of 1.1. The distribution-based estimates for the WS-NRS item were 0.9 and 0.5, respectively. This resulted in the following responder definition thresholds: ≥3 points for PROMIS-PF and ≥1 for WS-NRS improvement. A greater proportion of pexidartinib as compared to placebo patients were responders by PROMIS-PF (30% vs. 5%, p < 0.001) and WS-NRS (39% vs. 19%, p = 0.02) at week 25, respectively. Conclusions: Triangulation yielded responder definitions of ≥3 points for PROMIS-PF and ≥1 for WS-NRS. With these definitions, a greater proportion of patients treated with pexidartinib compared to placebo had meaningful improvement in physical function and stiffness.
Unveiling the real-world outcomes of breast cancer (BC) patients with taxanes-induced neuropathy using a digital patient-powered network (PPN).
Authors: Berger Raanan , Hasid Lior , Deutsch Irad , Malki Eliran , Bivas-Benita Maytal
Published: May 2019

e18248

Background: Taxanes-induced neuropathy is common in BC patients receiving taxanes, forcing dose reductions and treatment delays and posing serious challenges for the long-term patient QoL. Discovering neuropathy predictors in patients could guide better treatment decisions, improved QoL and reduce healthcare costs. Belong digital PPN is a social network for cancer patients and caregivers that supports disease management. In this study we used our artificial intelligence (AI) engine to classify the prevalence, characteristics and taxanes-induced neuropathy status of BC patients. Methods: We analyzed real-world patient-reported outcomes provided voluntarily and anonymously from users on the Belong PPN. Data from BC patients reporting treatment with taxanes was extracted and additional analysis segmented the data to those who experienced neuropathy and those who did not. Further validation of the data was performed by our research team to assure accuracy. Results: We evaluated 169 BC cancer patients from the US treated with taxanes. In the cohort 72% were Paclitaxel-treated and 28% Docetaxel-treated at various disease stages: 68% at early stage BC (0-2) and 32% at the advanced/metastatic stages (3-4). 83% of Paclitaxel-treated patients and 67% of Docetaxel-treated patients reported experiencing neuropathy in the Belong platform. These real-world reports indicated significantly higher incidence of taxane-induced neuropathy in comparison to literature summarizing data from clinical trials, suggesting neuropathy incidence of 27% for paclitaxel and 16% for docetaxel (grades 2-4). Conclusions: Real-world patient-reported outcomes from the Belong PPN captured the prevalence of taxanes-induced neuropathy in BC patients and correlated it to the specific drug in use. Evidence for higher incidence of taxanes-induced neuropathy may lead to lower patient QoL and higher healthcare costs and should stimulate better treatment decisions. Further exploration of the gap between controlled clinical studies and real-world evidence is urgently needed to understand the true patient outcomes and optimize healthcare accordingly.
Adherence and cumulative bisphosphonate dose in relation to risk of skeletal-related events among older patients with multiple myeloma.
Authors: Zhou Jifang , Sweiss Karen , Patel Pritesh Rajni , Nutescu Edith , Ko Naomi , Chiu Brian C-H , Calip Gregory Sampang
Published: May 2019

e18250

Background: Adjuvant intravenous bisphosphonates (IV BP) reduce the risk of skeletal-related events (SRE) in patients with multiple myeloma (MM). We examined the effects of bisphosphonate utilization patterns (adherence, cumulative dose and frequency) on risk of SRE. Methods: Patients aged 65 years or older and diagnosed with first primary MM between 2001 and 2011 were identified using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. Patients receiving at least one dose of IV BP after MM diagnosis were identified and 5-year SRE-free survival was estimated using the Kaplan-Meier method stratified by demographic groups and compared with the log rank test. Cox proportional hazards models were fit to determine the association between IV BP utilization patterns and SRE after propensity score matching. We investigated the outcome of multiple recurrent SRE using the approach of Andersen-Gill, and estimated subdistribution hazard ratios (SHR) and 95% confidence intervals for risk of first SRE, accounting for death as competing risk. Results: The final cohort included 9176 MM patients with a median age of 76 years. The adjusted 5-year competing-risk SRE model showed a 48% reduction in risk of SRE (95% CI 0.49-0.55) with use of IV BP. In multivariable analyses taking into account competing risks, greater adherence to IV BP, higher cumulative IV BP dose and more frequent administration were all associated with a statistically significant reduction in SRE risks (See Table). Conclusions: Use of IV BP in patients with MM was associated with significant reduction in SRE risk over the 5-year period after MM diagnosis. The effectiveness of IV BP therapy was greater with increasing cumulative dose, adherence to and greater frequency of IV BP administration. [Table: see text]
Impact of international collaboration utilizing E-consult and E-tumor board in the multidisciplinary management of cancer patients: A study from Mayo Clinic Care Network (MCCN) members.
Authors: Khan Faraz A. , Maqbool Saima , Elkhoury Maroun , Habermann Thomas Matthew , Dufan Tariq , Siddiqi Abdul Hafeez , Han Aaron , Sayed Kadriya , Ahmed Yasin , Kantawala Karthikh , Hamza Mahmood , Sonal Arjuna , Ahmed Salima , Yang Carolyn , Abdelrahman Dunia ,   AHD-MDT members, Mayo eTumor Board members
Published: May 2019

e18261

Background: Multidisciplinary tumor board meetings have shown to improve quality and outcome in the care of cancer patients. Many tertiary centers conduct site specific tumor board meetings but not all the centers especially community oncology and international centers have the manpower capacity to hold site specific meetings, the overall impact of tumor boards on patients care may vary based on its structure and composition. We propose that institutional collaboration in the comprehensive care of cancer patients utilizing E-consult and E tumor board may help to improve patient care. Methods: Retrospective data of 134 patient cases seen at the American hospital Dubai between 2016-2018 was analyzed. Cases that were reviewed at the American Hospital multidisciplinary tumor board meeting (AHD-MDT) and also referred for second opinion utilizing Mayo e-consult/e-tumor board service were analyzed using electronic health record, AHD-MDT meeting minutes and reports of Mayo e-consult/e-tumor board. 3 major areas of case assessment for review were selected 1. Pathology . 2. Medical imaging. 3. Clinical recommendations. Variation in assessment and recommendations between AHD- MDT and Mayo Clinic were compared. Results: A total of 1018 cases were reviewed in the AHD-MDT between 2016 and 2018. 136 out of the 1018(13%) cases were referred for second opinion utilizing Mayo E-Consult or E-tumor board service. 117 cases were included in the analysis as there was missing data in 4 patients, 9 were duplicate and 4 were cancelled and 7 cases were not reviewed at AHD-MDT. In 78 cases pathology was reviewed at Mayo but 4 (5%) were not reviewed at AHD. In 74 (95%) cases, pathology was reviewed both at AHD and Mayo. There was change (Ch) in 2 (3%), 7(9%)updated(Ud) and no change(Ch) in 65 cases(88%). 97 cases of imaging had change(Ch) in 1 case (1%). 101 cases of e-consult/e-tumor board were assessed for clinical recommendations. There was change(Ch) in 3(3%), 2/3 cases had a change in plan due to change in the pathology. In 35(35%) the plan was updated (Ud) and 7 out of 35(20%) were due to updated(Ud) pathology. Conclusions: Our data indicates that international collaboration as part of MCCN has resulted in significant improvement in the patient care. In a select group of challenging cases, 35% had an improvement in the final treatment plan after utilization of e-consult/e-tumor board service.
Central venous catheter-related complications in the treatment of cancer patients: A prospective study of over 124,000 catheter days.
Authors: Liu Binliang , Xie Junying , Wang Yanfeng , Yi Zongbi , Ma Fei
Published: May 2019

e18264

Background: Central venous catheters (CVCs) play an essential role in the management of cancer patients, however, but it causes some adverse events like catheter-related thrombi, catheter correlation infection, exudate, catheter blockage and catheter exfoliation. This research aims to evaluate incidence and risk factors of CVC-related complications in cancer patents. Methods: A prospective study of cancer patients with CVC insertion was performed from January 1, 2015 to December 31, 2018. Chest X-ray examination was performed to determine the position of the catheter tip after insertion. All patients received catheter care twice a week in our hospital until CVC were removed. Doppler ultrasound was used in all patients during the use of the CVC device or before extubation. Patients without thrombus recorded the value of the D-Dimer at the time of catheterization, while those diagnosed with thrombi recorded the value of D-Dimer the nearest time before the discovery of thrombi. Results: From 5356 patients with 6519 cases, 1398 patients with 1626 cases were enrolled, for a total of 124,242 catheter-days. 207 (12.7%) cases of various complications were recorded, with an incidence of 1.67 per 1000 catheter days. The most common complications were catheter-related thrombi (n = 139, 8.6%), followed by exudate (n = 42, 2.6%), catheter related blood stream infection (CRBSI) (n = 8, 0.5%), catheter blockage (n = 5, 0.3%) and catheter exfoliation (n = 5, 0.3%), local infection at insertion site (n = 3, 0.2%), severe skin allergy (n = 2, 0.1%). The most common site of thrombi was subclavian vein which account for 87.1% (121/139). 22 cases (22/139, 15.8%) found thrombi in two or more vessels at the same time. Multivariate analysis showed that underlying disease, position of the catheter tip, secondary adjustment of CVC position, the value of D-Dimer all closely related to catheter-related thrombi. Conclusions: Catheter-related thrombi was one of the most common complications in CVC patients. Reducing the chance of secondary adjustment, using X-ray to locate the tip of the CVCs, and regular monitoring of vascular ultrasound and D-dimer during catheterization are essential for timely detection and prevention of thrombi, especially for cancer patients with higher risk of thrombi.
Navigating care to reduce emergency room (ER) visits in cancer patients using opioids.
Authors: Pinto Carlos Frederico , Navarro Loiola Fernanda , Coelho Stela Maris , Felix Michele , Gomes Laura , Fernandes Henrique Zanoni ,   Instituto de Oncologia do Vale
Published: May 2019

e18265

Background: Pain is the most frequent and one of the most important cancer related symptom with significant impact in quality of life. It is also the most frequent reason (27% of visits) for a patient to go to an ER and 53% can be prevented with adequate care (Panattoni, JCO 35, 2017 suppl; abstr 6505). Methods: In 2015 IOV developed a patient centered Navigation System based on Kanban (board and visual signals - KNS) for managing treatment plan of our patients that was very successful. In 2016 with support of an educational grant from QTP-ASCO we extended this system to manage pain and other cancer or treatment related symptoms. This study addresses only pain management and ER visits between dec16 and dec18 for a total of 187 patients using opioids. We measured the proportional reduction of ER visits related to pain to the total ER visits in three successive periods: development of the NKS (dec15-jul16), pilot phase (aug16-oct17) and as an adopted best practice (oct17-dec18). The pain KNS comprises a set of standardized procedures and successive checks for patients using opioids based on three procedures: (a) standardized prescription and use of analgesics using WHO’s Pain Ladder; (b) standardized follow up in 24 and 48 hours, 1, 2 and 4 weeks; and (c) manage side effects of opioids or other emerging problem (constipation, confusion, etc). Any patient initiating opioid use is included in the KNS until opioid is discontinued. Once pain is adequately controlled, the frequency of checks become wider up to once a month if no toxicity is identified. Any new condition will restart the 24-48 hours loop. The KNS is managed by oncology nurses using phone or video calls, messaging, and appointments; Mon-Sat from 6AM to 10PM. Results: The KNS managed a median of 132 patients per month during 29 months (aug16 to dec18). Pain represented 20% of ER visits (33.65 UCL and 6.7 LCL); in pilot phase 15% of ER visits (27.34 UCL and 3.70 LCL); and now 4% of ER visits ( 8.46 UCL and 0 LCL), an 80% reduction in pain related ER visits. ER visits represents patients with uncontrolled pain and not effectively managed by the KNS. Conclusions: The development of a simple visual system to manage cancer patients with pain resulted in 80% reduction of ER visits and adequate pain control in our practice.
Hypertension and use of bevacizumab among patients treated in community settings.
Authors: Klepin Heidi D. , Garrett-Mayer Elizabeth , Kaltenbaugh Melinda , Bruinooge Suanna S. , Rubinstein Wendy S. , Meersman Stephen C. , Miller Robert S. , Lyman Gary H. , Gray Stacy W. , Nekhlyudov Larissa , Osterman Travis John , Thota Ramya , Tsimberidou Apostolia Maria , Visvanathan Kala , Schilsky Richard L. , Hershman Dawn L.
Published: May 2019

e18279

Background: CancerLinQ Discovery (CLQD) is a real-world dataset (RWD) derived from electronic health records across the US. This analysis builds on the prior observation of cautioned use of bevacizumab (Bev) among older adults using Medicare claims data. The goals of this study are to estimate the prevalence and incidence of hypertension (HT) and blood pressure (BP) patterns among patients (pts) with breast cancer (BC) or lung cancer (LC) treated with Bev. Methods: The cohort consists of all BC and LC pts in the platform at the time of CLQD dataset creation. At least one administration of Bev was required for inclusion as was diagnosis date and date of first Bev use. Elevated BP was defined as > 140 mmHg for systolic and > 90 mmHg for diastolic BP; elevated and max BP within 90 days of first Bev and 120 after were calculated for each pt. Summary statistics and proportions were calculated within these subgroups: baseline HT, race, age, and ECOG performance status (PS). Results: Overall, 1941 pts with BC and 4590 pts with LC treated from 2005 to 2017 were included. Baseline characteristics included % female (99 BC, 48 LC); % white (71 BC, 81 LC); % age > 65 years (34 BC, 52 LC). PS was available for N = 2118; most pts were PS 0-1 (88% BC, 82% LC). At baseline, more than half of pts were hypertensive (57% BC, 52% LC). An increase of at least 10mmHg in systolic BP within 120 days of treatment occurred in over half of pts with a normal baseline BP (54% BC, 56% LC) and in one-third of those with baseline HT (34% BC, 32% LC.) A significant proportion experienced at least a 20mmHg increase in systolic BP among those normotensive (29% BC, 32% LC) or hypertensive at baseline (16% BC, 16% LC). A majority of pts > 65 years had at least one elevated BP prior to Bev treatment (81% BC, 72% LC) although there were no clinically significant differences in rates of post treatment HT by age, race or PS. Conclusions: RWD provides important insights regarding the use and safety of medications outside the clinical trial population. Bev administration among pts with baseline (or pre-existent) HT is common in these practices. BP elevation post Bev exposure is also common, particularly among those with normal BP at baseline.
Feasibility of text-based symptom monitoring of ovarian and endometrial patients during treatment.
Authors: Naughton Michelle Joy , Salani Ritu , Peng Juan , Backes Floor , O'Malley David M. , Cohn David E. , Bixel Kristin Leigh , DeGraffinreid Cecilia , Moon Jennifer , Loyan Hibaq , Paskett Electra D.
Published: May 2019

e18299

Background: Unreported symptoms during cancer treatment can lead to poorer patient care and quality of life. Newer technology enables effective means to track patients’ health in real time. We evaluated the feasibility of implementing systematic patient symptom monitoring during the first 12 months after diagnosis. Methods: Newly diagnosed endometrial and ovarian cancer patients were enrolled post-surgically to respond to monthly text message symptom surveys. Patients’ fatigue, sleep quality, pain, and quality of life during the past 7 days were rated on a 0 (worst) -10 (best) scale, and depressive symptoms were assessed using the Patient Health Questionnaire (PHQ-9). Patients’ responses were captured in REDCap and monitored by program staff, with patients’ oncologists receiving monthly feedback. Patient navigators were also engaged for patients needing assistance during treatment. We provide the results of the first 6 months of this program. Results: 134 patients were approached, and 120 patients (ovarian [n = 70] and endometrial [n = 50]) were enrolled among 5 physicians. The mean participant age was 63 (range: 35-87), 85% were non-Hispanic White, and 66% had education beyond high school. The most commonly reported monthly symptoms for both cancer types were moderate levels (scores of ≥ 4-7) of fatigue and sleep disturbance. 35 patients with PHQ-9 scores ≥ 10 and/or with suicidal ideation were reported to their oncologists for appropriate follow-up. At the 6 month survey, patients were asked to evaluate the text messaging program: 97% found the symptom surveys easy to complete on their smart phone or computer; 77% believed reporting their symptoms monthly was useful all or most of the time; 78% liked being monitored for symptoms all or most of the time; and 89% liked being asked if they needed any assistance prior to their next clinic visit. Patient navigators were used by 13 patients, and 17 patients dropped from the program over the 6 months due to death (n = 9) or lack of need/interest (n = 8). Average monthly compliance was 81%. Conclusions: We established the feasibility of enrolling patients in a monthly text-based monitoring program to facilitate symptom management during treatment. Patient follow-up is continuing.
Practical exploration and research of Watson for oncology clinical decision support system in real-world and localized practice.
Authors: Yu Zhonghe , Wang Zuochao , Ren Xuemei , Lou Defa , Li Xia , Liu Hongli , Zhang Xiuliang
Published: May 2019

e18304

Background: Watson for Oncology (WFO) is a cognitive computing system developed by the IBM and trained by Memorial Sloan Kettering Cancer Center to provide evidence-based treatment recommendation for cancer patients. This study is to explore the impact on clinical treatment decision and patient communication based on the standard workflow we established of applying WFO in real-world clinical practice. Methods: From May 2018 to January 2019, 57 patients with advanced malignant tumors, including lung, breast, colorectal, gastric, esophageal, liver, ovarian and endometrial cancer, treated at Oncology Department of Beijing Chaoyang Integrative Medicine Emergency Medical Center were included in the study, of which 28 males and 29 females aged 29-89 years old. Treatment plan of each patient generated by WFO was compared with NCCN guidelines and Chinese local CSCO guidelines, and then evaluated and determined by MDT for final decision. Proportion of WFO recommendation fully or partially followed by clinicians was analyzed. Moreover, survey by questionnaire was conducted to collect feedback from these patients on their satisfaction of treatment and communication process. Results: Of all 57 patients enrolled, WFO’s options were highly concordant with NCCN guidelines and CSCO guidelines, and the finally adopted treatment plans after deliberately evaluated and discussed by MDT were 100% in the WFO recommended or for consideration category. Patient satisfaction and the compliance with instruction was significantly improved compared with historical data. Localization was most required in gastric, liver and esophageal cancer due to local drugs and therapies not available in WFO. Conclusions: This study verified that the artificial intelligent clinical decision supporting system can be applied in Chinese clinical practice to achieve high patient satisfaction and good efficacy. WFO meets Chinese and international standards for treatment, which will promote the standardized development of cancer treatment in China. Optimization, iteration, upgrading and localization are required for better practicability of WFO.
Symptoms and characteristics of cancer patient visits to an emergency room.
Authors: Gallaway Michael , Idaikkadar Nimi
Published: May 2019

e18306

Background: Cancer patients are increasingly likely to visit an emergency department (ED) for acute care compared to the general population. Cancer patients who visit the ED often have long wait times, increased exposure to infection, and lesser quality treatment. The Centers for Medicare & Medicaid Services (CMS) is encouraging efforts to decrease survivor acute care visits. The purpose of this study was to examine cancer-related ED visits using a national population-based sample to understand why they are seeking care in an ED. Methods: A retrospective cohort study of U.S. patients who visited EDs between June 1, 2017 and May 31, 2018 was conducted using the National Syndromic Surveillance Program (NSSP) BioSense Platform. Cancer patients were identified using International Classification of Diseases, 10th Revision (ICD-10) codes for any cancer type and specifically for cancers of the bladder, female breast, cervix, colon and rectum, kidney, liver, lung, ovary, pancreas, prostate, or uterus. Symptoms were identified using syndromic definitions and key-word queries. Significance testing (p-value ≤0.01), was used to assess differences in the prevalence of symptoms by cancer type. Results: There were 97 million visits to EDs during the study period, 710,297 (0.8%) were among cancer survivors. Slightly more were female (50.1%) than male (49.5%); more were aged 65 or older (53.6%) than 18-64 (1.4-35.3%). The most common symptoms were pain (19%), gastrointestinal (14%), respiratory (12%), neurologic (5%), fever (5%), and injury (4%). Prevalence of symptoms differed significantly by cancer type. Some symptoms were higher among those with specific cancer types compared to all cancers in aggregate: pain (cervical, liver, pancreas); gastrointestinal (pancreas, liver, colorectal); respiratory (lung); neurologic (liver, lung), fever (pancreas, liver), injury (prostate), and bleeding (colorectal, liver). Conclusions: Use of NSSP data enabled a descriptive characterization of more than half of the U.S. ED visits among cancer patients. These comprehensive findings inform best practices to reduce unplanned acute care and help inform possible modifications in treatment and care protocols among survivors of specific cancers.
Evaluating the challenges of cancer care in Botswana: Chemotherapy utilization and stock outs.
Authors: Kaur Sukhdeep , Chandar Ashwin , Mayer Tina M. , Toppmeyer Deborah , Strair Roger , Marlink Richard , Antony Reena , DiGiacobbe Marilyn , Lebelonyane Refeletswe , Gaolathe Tendani , Ralefala Tlotlo Bathethi
Published: May 2019

e18309

Background: As a significant percentage of cancer deaths are occurring in low- and middle-income countries, there is an unmet need in facilitating cancer care delivery in these countries. Data on stock-outs and shortages of cancer medicines in Botswana have been reported as one of the roots hindering treatment and potentially increasing mortality, with at least 40% of essential drugs being out of stock for at least 30 days in 2015. A methodologic approach was published in 2018 to forecast chemotherapy (CT) volume, however, this was based on incidence and prevalence data, using multiple estimated assumptions. To obtain objective data, we examined trends in CT utilization at Princess Marina Hospital (PMH), largest referral hospital in Botswana, over a 12-month period evaluating indications for CT, dosages, and potential issues with stock outs of essential medications. Here we present the 21 injectable essential CT utilized during this period. Methods: This is a retrospective analysis, with data collected from October 2017 to September 2018 from the log book which is used daily by the pharmacy at PMH to record CT preparations. Data was organized to reflect dosage of CT, regimen used, and its indication. Results: Over 1 year period, 21 injectable CT agents were utilized for cancer therapy, with common treated diseases being Kaposi Sarcoma, Gyn cancer, Breast cancer, and Lymphomas. The 10 most utilized agents are listed with the monthly dosage used. Conclusions: We hope to analyze trends in CT utilization based on the available stocks of drugs at PMH to help optimize plans for purchasing and storing medications, with goal of reducing stock outs. In addition, we will analyze treatment regimens used at PMH and compare to current standard of care CT in the US and Sub-Saharan Africa to optimize cancer pathway protocols used in Botswana. [Table: see text]