bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.