bluuebunny/crossref_metadata_2025 huggingface dataset:
Automated identification of lymphoma involving the bone from PET/CT reports using natural language processing and adaptive learning.
Authors: Navitski Anastasia , Goyal Piyush , Ahsanuddin Salma , Zheng Serena , Joffe Erel
Published: May 2020

e19201

Background: Automated extraction of key clinical features from imaging reports, such as the site, size and FDG avidity of lesions would allow for automatic determination of disease stage, response to treatment and relapse. Since the language used in clinical notes is domain and often task-specific, generic Natural Language Processing (NLP) tools are of limited utility. We describe a strategy for a rapid construction of task-specific NLP algorithms. As a test case, we aimed to identify bone involvement with lymphoma from PET/CT reports. Methods: We use an adaptive-learning approach to facilitate the generation of task-specific lexicons by a domain expert. In the case of identifying bone lymphoma, these include words describing the primary aspect (PA: e.g., “ uptake”, “SUV”); the secondary aspect, in this case, osseous sites (SA: e.g., “skeleton”, “T5”); modifiers such as context-specific affirmation/ negation/ uncertainty (e.g., “increased”/ “likely reactive”/ “possibly disease”) and generic negation (e.g., “no evidence of”). Presented with sentences containing seed PA terms, an expert is tasked with an exhaustive identification of terms for the other lexicons. In an iterative process, unseen sentences that do not include terms previously identified are presented for lexicon expansion. The process is repeated until no further expansion is possible. An explicit rule-based algorithm is built based on the lexicons to classify sentences as supporting, negating or inconclusive (i.e., requiring manual review) for the feature of interest. We used 500 reports to develop the algorithm, evaluated performance against 516 unseen reports that were independently classified by a blinded annotator, and measured the amount of effort (number of iterations) required to complete the PA and SA lexicon expansion. Results: Of 44 reports with bone involvement identified by the algorithm, 43 had an actual involvement and 1 was a negative case (PPV: 98%). Of 380 reports flagged as negative, 379 were truly negative and 1 was positive (NPV: 99.7%). Sensitivity was 64% (43/67); specificity 84% (379/449); 18% (93) reports were flagged for manual review. It took 13 and 5 iterations to build the PA and SA lexicons, each involving the review of up to 10 sentences. Conclusions: With minimal effort, we were able to construct a high-accuracy NLP system specific for identifying bone lymphoma. This approach can be extended to other contexts (e.g., lung involvement), domains (e.g., pathology reports), or to be utilized in machine learning.
Retrospective chart review to characterize admission to the ICU in the last 30 days of life and use of systemic anticancer therapy in the last two weeks of life at the Lifespan Cancer Institute.
Authors: You Han , Dizon Don S. , Wong Nathan , Martin Edward W. , Fenton Mary Anne
Published: May 2020

e19202

Background: Admission to the ICU in the last 30 days of life and use of systemic anticancer therapy in the last 2 weeks of life are indicators of overly aggressive end-of-life care and have been incorporated into the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) as benchmarks to assess care across cancer centers. We sought to better define the proportion of patients at our institution who met either of these endpoints and to delineate factors that might be associated with them. Methods: A retrospective chart review was conducted on patients with solid tumors, who underwent anticancer therapy at the LCI, and died in timepoints ending in January, July and November of 2017. After IRB approval, patients were identified through our tumor registry. Patients’ electronic medical records were reviewed for past history, cancer stage, type of care received, palliative care contact, site of death, ICU admission in last 30 days of life, receipt of immunotherapy and biologic (precision) therapy in last 6 months of life, and systemic anticancer therapy (excluding antihormonal therapy) in last 2 weeks of life. Results: A total of 134 patients died in this time period; 18 were excluded (leukemia/myeloma) leading to 116 patients for this analysis. Our review showed that 16.4% of LCI patients were admitted to the ICU in the last 30 days of life and 9.5% received systemic anticancer therapy in the last 2 weeks of life. Significant factors associated with an ICU admission in the last 30 days of life were receipt of biologic (precision) therapy in the last 6 months of life (41.7% vs. 13.9%; P<0.05) and never having been married (30.4% vs. 13.3%; P=0.05). Significant factors that were associated with death in the hospital were lack of palliative care team contact (34.3% vs. 13%; P<0.05) and male gender (24.1% vs. 9.1%; P<0.05). Conclusions: Understanding the factors associated with intensive care at the end of life is critical to the provision of value-based cancer care. In this study, the receipt of precision therapy in the last 6 months of life and never having been married were associated with ICU stays in the last 30 days of life, while lack of palliative care involvement and male gender were associated with greater chances of death in the hospital. Further understanding of the complex interplay that governs care and decision making in the end of life is required.
Treatment patterns in pancreatic cancer: Differences between expert and community practitioners.
Authors: Topping Ryan P. , Chiorean E. Gabriela , Laheru Dan , Pishvaian Michael J. , Wang-Gillam Andrea , Quill Timothy A. , Ko Andrew H.
Published: May 2020

e19207

Background: Expanding systemic therapy options continue to improve outcomes for patients (pts) with pancreatic cancer (PCa) in both the unresectable and resectable disease settings. We developed an online treatment (Tx) decision support tool designed to provide community healthcare providers (HCPs) with case-specific recommendations from 5 PCa experts. Here, we report an analysis of cases entered into the tool by HCPs, comparing their planned Tx with expert recommendations and assessing the impact of those recommendations on intended HCP Tx decisions. Methods: In July 2019, 5 expert panelists provided Tx recommendations for numerous distinct PCa cases. To use the tool, HCPs entered specific pt/disease factors along with their intended Tx plan for the case, after which they received expert Tx recommendations followed by a survey asking if the recommendations had changed their planned Tx course. Results: 251 HCPs entered 347 pt cases into the tool (83% by physicians). 68% of respondents reported treating < 15 pts with PCa per yr, and 60% sought recommendations for a specific pt. Variance was observed between experts and HCPs for cases in several Tx settings (Table); eg, although FOLFIRINOX was the primary panel recommendation for many younger, healthier pts requiring neoadjuvant or adjuvant therapy or first-line Tx for unresectable disease, most HCPs did not select this therapy for these pts at baseline. Among HCPs whose planned Tx differed from the experts, 51% indicated that they would change their Tx based on panel recommendations. Conclusions: Analysis of data from an online Tx decision support tool for PCa revealed variance between expert recommendations and the intended Tx of HCPs for numerous scenarios, with education provided by the tool potentially increasing the number of clinicians who made optimal Tx decisions. A full analysis of Tx trends will be presented. [Table: see text]
Choosing Wisely Africa: 10 low-value or harmful practices that should be avoided in cancer care.
Authors: Rubagumya Fidel , Mitera Gunita , Ka Sidy , Manirakiza Achille Van Christ , Kibugu-Decuir Phillipa , Msadabwe Susan Citonje , Adani-Ife Ablavi Ahoefa , Nwachukwu Emmanuella , Ohene Oti Naomi Oyoe , Borges Hirondina , Mutebi Miriam Claire , Abuidris Dafalla , Vanderpuye Verna D. , Booth Christopher M. , Hammad Nazik
Published: May 2020

e19213

Background: Choosing Wisely Africa, builds on Choosing Wisely (CW) in the USA, Canada and India, and aims to identify low-value, unnecessary, or harmful cancer practices that are frequently used on the African continent. Methods: The CWA Task Force was convened by African Organization for Research and Training in Cancer (AORTIC) and included representatives in surgical, medical and radiation oncology, the private and public sectors and patient advocacy group. Consensus was built through a modified Delphi process shortening a long list of practices to a short list then to a final list. Results: Of the 10 practices on the final list, one is a new suggestion, 9 are revisions or adaptations of practices from previous CW campaign lists. One item relates to palliative care, 8 concern treatment, and 1 relates to surveillance. Conclusions: The success of this campaign will be measured by how the list is implemented across sub-Saharan Africa and whether it improves the delivery of high-quality cancer care. [Table: see text]
Characteristics of end-of-life (EOL) chemotherapy (CTx) received by patients with advanced cancers and association with EOL emergency department (ED) and intensive care unit (ICU) care.
Authors: Zhang Cathy , Beiter Mark W. , Gonzalez Maria Magdalena , Gebremeskel Emebet T. , Kashyap Gunita , Hemeon Karen , Rosales Joseph Grant F , Kennecke Hagen F.
Published: May 2020

e19222

Background: Use of EOL CTx is an established quality metric in patients with advanced malignancies but less is known about which types of CTx are most commonly used and association with ED and ICU utilization. We sought to describe the different types of EOL CTx and to quantify the frequency of EOL ED and ICU care associated with them. Methods: Patients in the cancer registry of an urban cancer center who died between January 1, 2018 and October 10, 2019, and ever received CTx were included. EOL CTx was defined as any CTx given within 30 days of death, while any ED visits or ICU admissions in the last 30 days of life were defined as EOL ED and ICU care, respectively. CTx was categorized by administration route (intravenous (IV), oral (PO), other), and by type (immunotherapy (IMT), non-immunotherapy biologics (NIB), other). We used Pearson’s chi-squared to measure associations between EOL CTx and EOL ED and ICU care, logistic regression to assess how CTx type modulates those associations, and Mood’s median test to compare median IMT doses between groups. Results: Among 390 eligible patients, 32% received EOL CTx, 30% EOL ED care, and 11% EOL ICU care. Most received IV CTx (78%), and 10% received IMT. Median age at diagnosis was 69 years (interquartile range (IQR) 62 - 77), and median days from diagnosis to death was 390 (IQR 185 - 665). Most common malignancies were pancreatobiliary (40%), other gastrointestinal (15%), lung (13%) and hematologic (6%). Patients treated with EOL CTx were significantly more likely to receive IMT (p = 0.03). Receipt of any EOL CTx was significantly associated with EOL ED care (p < 0.0001) and EOL ICU care (p < 0.0001). Subgroup analyses showed significant modulatory effect of IMT on association of EOL CTx with EOL ED care (b = -0.89, p = 0.046), but was not significant for ICU care (b = -0.67, p = 0.29). Median doses of IMT was 2.5 (IQR 2 - 3.8) among patients who were given EOL IMT and 4 doses (IQR 2 - 6) in those that discontinued IMT before EOL (p = 0.06). Conclusions: EOL CTx is associated with significantly increased rates of EOL ED and ICU care, which may indicate poorer quality of life. While rates of use of other CTx modalities did not significantly differ at EOL, patients were more likely to receive IMT within 30 days of death, which could be due to the belief that IMT is more tolerable or more effective than other CTx modalities at EOL. IMT at EOL is associated with a reduced risk of EOL ED care, but not ICU care. Further research on strategies to reduce EOL CTx and appropriateness of IMT at EOL is warranted.
Implementing a tumor program strengthening initiative in western Sydney.
Authors: Evans Lynleigh , Liu Yiren , Kwan Terence , Donovan Brendan , Byth Karen , Harnett Paul R.
Published: May 2020

e19223

Background: While multidisciplinary teams (MDTs) are well-established in many healthcare institutions, both how they function and their role in decision making vary widely. This study assessed the effectiveness of a multipronged approach to strengthening multidisciplinary team performance for a cancer service over three years. Methods: The study comprised the introduction of a structured quality improvement program, the Tumour Program Strengthening Initiative (TPSI), to improve MDT performance, and an annual survey to evaluate MDT members’ perceptions of their teams’ performance. Three iterations of the survey have been completed. Results: 12 teams participated in TPSI with 129, 118, and 146 members completing the MDT member survey in 2017, 2018, and 2019 respectively. Of the 18 questions that were asked throughout the study, nine showed significant improvement, and of these, seven were highly significant. Questions related to patient wellbeing and to audits and quality improvement showed no significant change. Conclusions: The Tumour Program Strengthening Initiative resulted in sustained and significant improvement in MDT performance over three years. The MDT survey proved to be useful not only for cancer care teams to identify their strengths and weaknesses and monitoring performance but also for management to flag priority areas for improvement and further support. The significance of this initiative is that overall program improvement reflects the strengthening of the weakest teams as well as further improvement in highly performing MDTs. [Table: see text]
Multidisciplinary tumor boards: A prospective study of the impact on patient management in a community-based Brazilian cancer center.
Authors: Costa Marcos , Teixeira Carlos Henrique , Peixoto Renata , Jorge Waldec , Ades Felipe , Kann Ariel Galapo , Caponero Ricardo , Tzu Cheng , Ricardo Eliza Dalsasso , Mutão Taciana , Machado Larissa , Pimenta Jefferson , Santos Marcelo
Published: May 2020

e19261

Background: MDTB have emerged as a valuable forum to address questions related to patient management. There is a general data lack of its overall benefit by attending physicians. However, few reports describe numerical impact on patient care of this tailor-made and shared model of medical decision. Methods: We describe, in this prospectively-collected study, data from a Cancer Center (HAOC) regarding multiple weekly, 1h-long discussions, as part of MDTB (GU, neuro-oncology GI, thorax, HN, breast, gyneco, melanoma/sarcoma and palliative care). Only newly-diagnosed or on-treatment challenging cancer cases were included. Attendees (onco, surgeons, RT, paths and radiologists) pooled their expertise to warrant quality and maximize resources. The primary endpoint was change in the medical planning. In our institution, further adherence to MDTB recommendations are left totally at physician discretion. Results: From Oct/17 to Feb/19, 413 cases were discussed (60% female), mean of 2.9 cases/MDTB, but GI (3.8), thorax (3.7) and breast (2.94) were above the median. Mean was 13.4 doctors/MDTB - more in breast (16.5), GI (15.8) and uro (15.1). Mean of oncologist/MDTB in general was 6.1, but 8.1 in GI, 7.8 thorax, breast 6.8 and 6.7 uro. Mean of surgeons/MDTB in general was 3.5, but 6.2 in breast, 5.8 uro and 5.5 GI. 100% of all had at least 1 oncologist and uro/GI/breast had at least 1 surgeon in 100% of them. In 50% (uro), 44% (neuro), 23.5% (breast), 6.4% (thorax) and 3.7% (GI) had at least 1 physician of 5 major areas. Oncologists engaged with more cases: 80.4% (thorax), 70.6% (uro), 59.6% (GI), 56.5% (HN). Prostate (38.2%), metastasis (neuro, 28.9%), colorectal (18.2%), lung adenoCA (43.5%), mouth (30.4%), ductal carcinoma (35.8%) were the more frequently discussed per system. In 25.7%, MDTB changed original medical planning. By site: GI (35,6%), thorax (24,7%), breast (22,6%), neuro (21,7%), uro (17,7%) and HN (17,4%). Oncologists were responsible more in thorax (73,9%) and less in breast (33%) and surgeons more in breast (50%) and less in GI (33%). Adherence to NCCN guidelines was total. Finally, but not measurable, a sizeable number of cases requires significant weekly time-effort. Conclusions: This study confirms MDTB leading role in cancer care, highlighting the importance of teamwork for more precise patient care. We point out that it led to substantial practice-changing in our institution, reinforcing its importance in a scenario which doctors are confronted with increasing complexities in patient management.
Cancer types applicable to efficacy assessment using real-world data analyzed from PMDA-approved data.
Authors: Kato Yuka , Hirase Chikara , Hatogai Ken
Published: May 2020

e19272

Background: Clinical development of anti-cancer agents has been accelerated due to emergence of new therapies. Although randomized comparative trials are the gold standard for the evaluation of clinical utility, it is often impossible to conduct such trials. At ASCO 2019, 89 real-world data (RWD) studies were presented. These studies highlighted the increasing awareness of the value of RWD. We here investigated for which cancer types RWD could be applicable to efficacy assessment based on the previous reviews of Pharmaceuticals and Medical Devices Agency, Japan (PMDA). Methods: Review reports and Summaries of submitted documents publicly available on the website of PMDA and research articles of trials included in the new drug applications of anti-cancer agents approved in Japan between 2006 and 2019 were reviewed. Results: Among 209 anticancer-agents approved for a new indication based on clinical trial (CT) data, 42 agents and 167 agents were approved based on results of single-arm CTs and those of comparative trials, respectively. The numbers of agents for hematological malignancies and solid tumors were nearly same. Among agents approved based on single-arm CT results, most of them (85.7%) were designated for orphan drug (OD), and 1/3 of them were specified for a biomarker (BM), such as ALK fusion gene in non-small cell lung cancer (35.7%). Among 42 single-arm CT-based approvals, a threshold for efficacy endpoint was set at least in one pivotal trial in 30 items based on the following references: (i) results of CTs for the same population (11), (ii) no standard therapy (10), (iii) clinical trial plans of other agents for the same population (7), (iv) others such as values defined by the investigators’ discretion (14). Regardless of BM, only 1/4 had a pre-defined threshold for efficacy evaluation in the pivotal trial based on the results of CTs for the same population. Among 15 BM-related agents, most of them (93.3%) had been designated for OD. Meanwhile, among the agents without biomarker and OD, the setting was (ii) or (iv). Conclusions: RWD could be applicable for efficacy evaluation of BM-related agents with OD designation, agents for BM-unrelated tumor types with no established standard treatment, and agents for those in which drug development has not been advanced enough to set a threshold for efficacy evaluation.
What are the challenges for building real world comparative cohorts in oncology?
Authors: Jeswani Nikita , McDonell Amanda , MacDougall Finlay , Hodge Jeff Paul
Published: May 2020

e19285

Background: There has been a proliferation of single arm trials in oncology being presented to regulators. An external comparator using real world data (RWD) can help establish context to trial results and direct comparison to the treatment arm by mirroring the inclusion/exclusion criteria for the trial and examining trial outcomes in an RWD external comparator cohort. RWD has successfully supported some regulatory submissions, although there have been failures as well, with comparability of patients and endpoints under scrutiny. Methods: IQVIA has partnered with life sciences companies on > 20 external comparator projects from 2017-present using a mix of data acquisition strategies (e.g., chart review, database extraction) and methods (e.g., real-world cohort vs. real-world benchmark, propensity matching vs. inverse probability treatment weighting). We collated, reviewed, and synthesised the challenges and risk mitigations documented throughout study execution in aggressive and indolent lymphomas, multiple myeloma, Merkel cell carcinoma, and synovial sarcoma. Results: Patient characteristics used to assess trial eligibility (e.g., biomarker expression, International Prognostic Index, ECOG status) and outcomes (e.g., response rate) are not often captured in a structured format in RWD or recorded in routine clinical practice. As a result, there is a greater reliance on chart reviews today over database extractions to fulfil external comparator requirements, though in some diseases, databases have proven to be a faster and more cost-effective solution. Conclusions: To improve the success of external comparator studies, trial design should be informed by existing RWD so that relevant real-world endpoints and outcome evaluation criteria are included alongside RCT standards. Advances are needed to facilitate RWD capture that matches trial data more closely. This could include bespoke data collaborations, biobank linkage, and natural language processing to drive study execution in databases in the future.
Do assumptions in health economic evaluations hamper drug uptake?
Authors: Franchini Fanny , Degeling Koen , Pereira-Salgado Amanda , Tran Ben , Au-Yeung George , McArthur Grant A. , Lee Belinda , Solomon Benjamin J. , Gibbs Peter , IJzerman Maarten J.
Published: May 2020

e19289

Background: Health economic studies of anti-cancer systemic treatments typically make strong assumptions regarding the number of drug lines received after initial therapy. This may have a substantial effect on health economic outcomes and impact drug reimbursement and uptake in practice. This study aims to quantify the real-world systemic treatment patterns in 4 metastatic cancers using clinical registries to explore whether health economic assumptions are justifiable. Methods: Data from 4,431 metastatic cancer patients were extracted from Australian clinical registries: colorectal (COL, n = 3087), non-small cell lung (LUN, n = 705), pancreatic (PAN, n = 459), and melanoma (MEL, n = 180). A set of criteria was defined to consistently identify drug lines across the cancer-specific registries. These criteria were based on the type of drug (biological agent or chemotherapy), switches in chemotherapy regimen (whether a chemotherapy agent was added or removed) and the timing of such changes. Consequently, the identified drug lines provide a more detailed view on treatment patterns compared to clinical treatment lines (defined by disease progression), the latter typically including multiple drug lines. Censoring in the number of drug lines received due to ongoing treatment was accounted for in all analyses. Results: Most patients started treatment after diagnosis: 77% (COL), 89% (LUN), 56% (PAN) and 79% (MEL). For COL, LUN, PAN and MEL respectively, the proportion of patients starting a 2nd drug line was 51%, 60%, 19% and 24%, whereas 28%, 35%, 6% and 8% of patients started a 3rd drug line. In all cancers, patients were most likely to receive only a single drug line, i.e. the mode number of drug lines was 1. For all patients, the median number of drug lines were COL: 2, LUN: 2, PAN: 1, MEL: 1. For treated patients only, the median (range) number of drug lines received was COL: 2 (1-9), LUN: 2 (1-8), PAN: 1 (1-5), MEL: 1 (1-5). Conclusions: We show that patients are most likely to receive a single drug line. Considering our findings, most health economic analyses likely overestimate the intensity of drug treatment in metastatic disease, thereby underestimating the impact of initial treatment relative to downstream treatments. This is likely to bias estimates of total treatment cost, cost-effectiveness and budget impact, which will hamper the uptake of novel anti-cancer agents and may lead to suboptimal decisions regarding treatment strategies.
Real-world outcomes of patients with metastatic breast cancer (BC) treated with osteoclast inhibitors (OIs).
Authors: Karimi Yasmin , Purington Natasha , Liu Mina , Kurian Allison W. , Sledge George W. , Blayney Douglas W.
Published: May 2020

e19314

Background: Patients with metastatic BC have a high incidence of bone metastasis with associated morbidity and mortality. OIs including denosumab and zoledronic acid reduce the rate of skeletal-related events (SREs). Since denosumab was approved in 2011, there have been no analyses about the comparative effectiveness and safety of denosumab versus zoledronic acid. Methods: Patients with BC treated with three or more doses of either denosumab or zoledronic acid after 2011 were identified in Stanford’s BC research database, Oncoshare. SREs were defined as a composite measure of spinal cord compression, pathologic fracture, surgery or radiation to bone. Unadjusted Cox proportional hazard models were fit to time to: first SRE, subsequent SRE, overall survival (OS) and BC-specific survival. Results: 515 patients were identified: 388 and 127 treated with denosumab and zoledronic acid per oncologist’s discretion, respectively. Groups were well balanced for age at diagnosis, race/ethnicity, tumor grade, prior chemotherapy use and median time from first OI therapy to last follow-up. More patients with triple-negative BC (TNBC) received zoledronic acid. Median follow-up time from first OI dose was 28 months. 42% of patients experienced at least one SRE and there were no differences in incidence of first or subsequent SREs between groups (Table). Median OS was 91 months with no statistically significant difference between groups. Median BC-specific survival was not reached (78% of patients survived), however, patients in the zoledronic acid group had over twice the risk of BC-specific mortality, a difference that remained significant after adjustment for TNBC status. There was no difference in adverse events including osteonecrosis of the jaw, vertebral fracture or hypocalcemia. Conclusions: In a contemporary, real-world care setting, we observed no difference in the incidence of SREs or OS between metastatic BC patients treated with denosumab or zoledronic acid. [Table: see text]
Preferences for research participation among individuals with Lynch syndrome: Findings from the HEROIC Registry.
Authors: Dubin Robin Beth , Burton-Chase Allison
Published: May 2020

e19317

Background: AliveAndKickn, whose mission is to improve the lives of individuals and families affected by Lynch Syndrome (LS) through research and education, maintains the HEROIC Registry. It is the first-of-its-kind, patient-centric, genetic database that enables individuals to take an active role in furthering LS research. Methods: The HEROIC Registry allows patients to contribute medical information and their experiences living with LS and its associated cancers to help researchers develop new treatments, understand the various genetic mutations, and conduct further studies. It also asks individuals about their preferences for participating in different types of research studies. Results: The HEROIC Registry was launched in February of 2016. Potential participants were notified about the availability of the Registry in multiple ways, including social media and patient conferences. As of January 2020, 269 individuals have added their data to the Registry. Of those, 217 have a known LS mutation and were on average 42.5 years old at the time of diagnosis. 38% report having had a diagnosis of colorectal cancer with an average diagnosis age of 43; 23% of female respondents report having had endometrial cancer with an average diagnosis age of 48. 37% are cancer-unaffected. For interest in participating in future research, 69% are somewhat or very likely or definitely want to participate in research that involves a LS treatment, with rates ranging from 62-80% based on the delivery method of the treatment. For non-treatment studies, the percentage of individuals that are somewhat or very likely or definitely want to participate in research that involves community meetings, hospital stays, a medical procedure, wearing a device, or providing information by phone are text are 76%, 46%, 52%, 83%, and 78%, respectively. The percentage of individuals willing to donate a blood sample used to study their DNA is 95%. Conclusions: The HEROIC Registry provides a unique opportunity for health care providers and researchers to partner directly with a patient-advocacy organization for the purpose of improving LS care. It also has the benefit of including a diverse set of patients who are being seen in a variety of health care settings, which can aid in exploring research questions outside of a single institution. However, individuals show clear preferences for the types of research they are likely to participate in, a fact that should be taken into consideration when researchers are planning new studies in this population.
Outpatient cancer rehabilitation to improve patient reported and objective measures of function.
Authors: Pergolotti Mackenzi , Covington Kelley Renee , Lightner Ashley N , Bertram Jessica , Thess Melissa , Sharp Julia L , Spraker Matthew B , Williams Grant Richard , Manning Peter
Published: May 2020

e19325

Background: Adults with cancer often struggle with persistent symptoms that negatively impact quality of life (QoL), physical and social function. Cancer rehabilitation delivered by a trained physical and/or occupational therapist (PT/OT) is recommended. However, evidence is lacking regarding the impact of community-based PT/OT on patients' functioning. Methods: We assessed adults (≥ 18 years) who completed cancer-specific visits in routine care at two outpatient rehabilitation clinics. Demographic and clinical data was patient-reported. Patient-Reported Outcomes Measurement Information System (PROMIS) measures included: Global Physical Health (GPH) and Mental Health (GMH) scale (10 item); Physical Function (PF; 4-item), and Ability to Participate in Social Roles and Activities (SRA; 4-item). Hand grip strength (HGS) and the Timed Up and Go (TUG) were administered by PT/OT. We compared outcomes collected during the first and final therapy evaluations using paired samples t-test and calculated effect size using Cohen’s d. We used independent t-test to compare mean pre-post change between patients on active treatment versus post-treatment. Results: Patients (N= 185) were predominantly female (75%), 41-64 years old (57%), and majority receiving cancer treatment (58%). Most (N =115, 62%) completed at least one follow-up evaluation over 6 weeks. From pre to post therapy, a significant (p<.05; d = 0 .35-.21) effect was observed for GPH, SRA, HGS, and TUG. There was no difference in the average improvement between active and post-treatment groups. Conclusions: Community-based cancer-specific PT/OT has a significant impact on the well-being and functioning of adults with cancer. Evidence supports the utilization of community-based, cancer-specific PT/OT throughout the cancer-care continuum. [Table: see text]
Is scalp cooling system effective in chemotherapy induced alopecia? A real-world experience in Asian patients.
Authors: Kate Shruti , Patil Roshan , Dhande Sonal Chandrakant , Shaikh Dina , Vyavahare Rohini , Joseph Sheela , Ramesh Yasam Venkata , Nagarkar Rajnish Vasant
Published: May 2020

e19334

Background: Chemotherapy induced alopecia(CIA) is the most common and afflicting chemotherapy side effect. Data on the use of scalp cooling (SC) to prevent CIA is limited and debatable due to lack of experience. This study analyzed the effectiveness and tolerability of SC in clinical practice. Methods: We prospectively analysed 100 consecutive patients who opted for Paxman scalp cooling. The assessment of alopecia was done by WHO grading system. The extent of alopecia was analyzed at baseline, during each session, and 4 weeks from the last SC session. Results: A total of 100 (94 females, 6 males) patients were enrolled. Amongst them, 69% had breast cancer, 18% had ovarian cancer and 26% had various other cancers. Majority of patients were treated with a curative intent (69%) and had a good performance status (ECOG PS 0-1). Overall 40% patients received anthracyclines, 45% received taxanes, 9% received both and 6% patient received other chemotherapeutic agents. Hair preservation rate was in 31% (Grade 0 alopecia 12%, Grade 1 alopecia 19%). After a single SC session, 30% of patients discontinued due to grade 2 alopecia. On cox regression analysis, onset of grade 2 alopecia on SC was significantly longer in patients on taxanes compared to anthracyclines (1.357 HR, 0.98-1.87 CI, p= .05). One out of 100 patients developed scalp metastases. Majority of the patients experienced mild side effects [chills (30%), headache (12%)]. One out of 100 patients discontinued SC due to intolerable side effects. None of the other predetermined factors (age, menopausal status, ECOG performance status, body mass index), were found to delay the onset of grade 2 alopecia amongst the male patients, hair preservation rate was 100% . Conclusions: Scalp cooling is very effective for hair preservation for some chemotherapy patients. In our study, we found that it is more effective in reducing alopecia in taxane chemotherapy. Scalp metastasis and SC discontinuation were observed to be very rare.
Bevacizumab for the treatment of brain radionecrosis in cancer patients.
Authors: Raez Luis E. , Khan Alina , Botero Ana , Domingo Gelenis Calzadilla , Izquierdo Paola , Castellon Ignacio , Below Jameshia
Published: May 2020

e19352

Background: Brain radionecrosis (BRN) occurs as a result of radiation therapy for brain tumors or metastatic brain lesions. BRN is characterized by an increase in permeability and disruption of the blood-brain barrier (BBB). There are currently no standard treatment options for BRN. While the mechanism of BRN is unknown, it is hypothesized that there is an inflammatory reaction of the local tissue to radiation which results in a continuous process involving endothelial cell dysfunction. This leads to tissue hypoxia and increased vascular endothelial growth factor (VEGF) which in turn causes capillary leakage, progressive BBB dysfunction, and cerebral edema. Bevacizumab (BEV), a humanized monoclonal antibody with action against VEGF, has recently been used in some studies for the treatment BRN. BEV essentially blocks VEGF from reaching its targets on the endothelium, thus making it an ideal treatment modality for BRN. Methods: The primary purpose of this study is to assess the effectiveness and safety of BEV for the treatment of BRN. Fifteen patients (pts), 14 diagnosed with lung cancer and one with breast cancer, that had BRN and treated with BEV between January 2014 and November 2019 were identified from Memorial Cancer Institute's database. A retrospective chart review analyzing pts's age, sex, BEV dose, dosing frequency, number of treatments received, medication-related adverse effects, and clinical benefit was conducted. Brain imaging pre-treatment and after four cycles of therapy were compared to assess the efficacy of BEV. Pts who exhibited clinical benefit (complete response (CR), partial response (PR), or stable disease (SD)) received an additional four cycles of treatment. Results: The median age was 65 years (y) (49-78y) and 10/15 (67%) of pts were female. Clinical benefit was achieved in 13/15 (87%) of pts. The most frequent dosing regimen administered was 10 mg/kg every two weeks and the median number of cycles given was eight cycles (1-12). Treatment with BEV was well tolerated with eight pts (53%) experiencing BEV-related Grade 2 or less adverse effects (AE), including hypertension (27%), proteinuria (13%), thrombocytopenia (7%), and mild nose bleeds (7%). There were no Grades 3-5 AE. Conclusions: This study demonstrates that there is a clinical benefit when administering BEV for the treatment of BRN. BEV was well tolerated and has an acceptable safety profile.
Real-world healthcare resource utilization (HRU)/costs associated with venetoclax treatment among chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients.
Authors: Rogers Kerry Anne , Emond Bruno , Manceur Ameur M , Kinkead Frederic , Lafeuille Marie-Hélène , Lefebvre Patrick , Huang Qing
Published: May 2020

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Background: Ibrutinib (Ibr) is an established standard of care in CLL/SLL patients across lines, regardless of age, comorbidities and risk status. With the introduction of venetoclax (Ven) in the treatment landscape, there is a need to understand the real-world treatment sequencing of targeted oral agents, and the implication of sequencing on HRU/costs. This retrospective study evaluated HRU/costs associated with Ven treatment in various sequencing scenarios, including prior use of Ibr. Methods: Optum Clinformatics Extended DataMart De-Identified Databases (4/11/2015-6/30/2019) were used to identify adults with CLL/SLL treated with Ven (excluding investigational combination therapies). The index date was the start of the first Ven-based line of therapy (index LOT) and the baseline period was the 12-month period pre-index. Mean all-cause HRU/costs per patient per month (PPPM) were calculated during the index LOT and the Ven ramp-up period (first 30 days post-index). Results: Among a total of 11,861 CLL/SLL patients receiving ≥1 LOT, 121 patients (1.0%) were treated with Ven, including 25 patients (64.0% single agent) using Ven in first line (1L cohort), 30 (90.0% single agent) in second line (2L cohort), and 66 (83.3% single agent) in third line or later (3L+ cohort). Mean age was 71.6 years; 33.1% were female; mean baseline Quan-Charlson Comorbidity Index score was 4.7; median follow up from the start of 1L was 25.3 months; median duration of index LOT was 4.2 months. The majority of 2L+ Ven patients were previously treated with Ibr (2L: 56.7%, 3L+: 74.2%). Patients in all 3 cohorts had frequent outpatient (OP) visits PPPM during their index LOT (1L: 4.58; 2L: 4.75; 3L+: 5.71). Total costs PPPM during the index LOT were highest in the 1L cohort (1L: $21,762; 2L: $17,697; 3L+: $20,900), driven by higher OP costs (1L $9,402; 2L: $5,633; 3L+: $7,701). Increased total costs PPPM were observed during Ven ramp-up (1L: $31,707; 2L: $21,036; 3L+: $25,362). Compared to the overall 2L cohort, those treated with Ibr in 1L had lower total costs PPPM (index LOT: $15,350; V ramp-up: $15,882). Conclusions: In this descriptive study, the highest costs PPPM were observed for Ven treatment in the 1L. Prior treatment with Ibr was common among 2L and 3L+ CLL/SLL patients treated with Ven. Among 2L Ven patients, those previously treated with Ibr in 1L had $2,347 and $5,154 lower costs PPPM during 2L and Ven ramp-up, respectively, suggesting that previous Ibr treatment may help reduce costs in subsequent V treatment.
Real-World data (RWD) of physician’s advice on BRCA genetic testing for ovary (OC) and breast cancer (BC) patients (pts).
Authors: Vorobiof Daniel A.
Published: May 2020

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Background: The 2019 US Preventive Services Task Force (USPSTF) recommends that women with a personal and familiar history of BC and OC undergo a BRCA genetic testing so that risk assessment, prevention options and treatment changes are considered. Methods: BC and OC members of Belong.life global mobile application for cancer pts and caregivers, replied to a 9 question's survey regarding the incidence of BRCA testing. The survey included questions on demographics, BRCA testing performed, who advised it, and on treatment changes. This RWD was analyzed by data scientists using AI and machine learning engines. Results: 377 pts with BC (302/80%) and OC (75/20%) replied to the survey. BC pts ages were < 50 yrs in 32%, 36% were 51-60 yrs and 32% > 61 yrs. 24% of OC pts were < 50 yrs, 35% were 51-60 yrs and 41% > 61 yrs. 73% of BC pts were USA based and 27% from rest of the world (RoW). OC pts were 62% from USA and 38% from RoW. Most of BC pts were stage 1-2 (58%) and 35% stages 3-4. OC pts stages were 3-4 (73%) and 15% stage 1-2. BRCA testing was performed in 192/302 BC pts (64%). In the OC group 60/75 pts (80%) had BRCA testing. Physicians advised to have BRCA testing to 57% of BC pts and 76% of OC, while families/friends suggested it to 4% of BC and OC pts. BRCA test was positive in 19% of BC and 48% of OC pts. 110 BC pts(36%) didn’t undergo the test of whom 74 pts (67%) didn’t receive physician’s advice to have it . Of those pts, 24 (32%) fell under the USPSTF recommendation criteria for testing. Conclusions: BRCA testing should be recommended for all pts with recently diagnosed BC and OC and in those with a higher chance of having a mutation, as defined by the USPSTF guidelines. In this RWD evaluation of Belong.life BC and OC pts, BRCA testing in BC was done in 192/302 pts (64%) while in OC pts it was done in 60/75 pts (80%). Overall, physicians requested the BRCA test in only 57% of BC pts and 76% of the OC pts. In spite of the current USPSTF guidelines, a number of BC pts who didn’t receive advise from their physician (32%) fell under those recommendations, most having their disease diagnosed at < 50 yrs and triple negative disease < 60 yrs. Physicians should be encouraged to follow published guidelines recommendations for BRCA testing for all newly diagnosed BC and OC pts.
Incidence and economic burden of infections in cancer patients receiving immune checkpoint inhibitors.
Authors: nalluru swarna sri , Piranavan Paramarajan , Narimiti Anvesh , Shah Shanil , Siddiqui Ahmad Daniyal , Abraham George
Published: May 2020

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Background: Along with antitumor effects, Immune Checkpoint Inhibitors (ICPI) have shown great potential in treating chronic infections such as HIV, Hepatitis B, and malaria, in ex-vivo studies. However, several case reports and case series suggested increased infection risk in cancer patients receiving ICPI. The purpose of our study is to assess the risk of infections in cancer patients receiving ICPI. We also attempted to evaluate the role of a multidisciplinary approach (Oncology and Infectious disease specialists) and the cost associated with treatment. Methods: Records on all cancer patients over age ≥18 years old who had received at least one dose of ICPI from 2015 to 2018 at two major community teaching hospitals in the Central Massachusetts region were reviewed. Several risk factors associated with infection were identified. Two-tailed unpaired t-test was used to analyze the association between risk factors and infection. We calculated the average length of stay (LOS) and cost per admission with a multidisciplinary vs. non-multidisciplinary approach. The calculated total average cost per admission was compared with a random set of non-oncologic population admitted with similar infections noted in our study to estimate the economic burden. Results: Thirty-seven (21.8%) patients developed sixty-two episodes of infection. Microbiological confirmation was available in 13 episodes. Risk factors like COPD (P = 0.01), prior chemotherapy (P = 0.03), and steroid use (P = 0.003) were significantly associated with infections. An infection-associated mortality rate was noted to be 2.3%. With the involvement of multidisciplinary team, the average LOS increased from 5.9 to 8.1 days. Yet, the average cost per admission approximately remained the same (52,047$ vs. 54,510$). Upon comparison with a non-oncologic patient, the average cost per admission for an infection in cancer patients receiving ICPI increased from 11,527$ to 35,484$. Conclusions: Surprisingly, a significant incidence of infections and associated health care resource utilization continue to prevail in cancer patients despite the utility of ICPI. Although the economic burden due to the infections in this set of patients is remarkably high when compared to the general population, the multidisciplinary approach did not increase the hospital costs.
Watch-and-wait policy versus robotic resection in locally advanced rectal cancer patients after clinical complete response following chemoradiotherapy: A cost-effectiveness study (RECCOSTE).
Authors: Rodriguez-Pascual Jesus , Nuñez-Alfonsel Javier , Ielpo Benedetto , Lopez Mercedes , Alvarez-Gallego Rafael , Muñoz Cesar Gregorio , Quijano Yolanda , De Vicente Emilio , Cubillo Gracián Antonio , Saborido Carlos
Published: May 2020

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Background: Chemoradiotheray (CR) followed by standard Surgical Resection (SR) is the standard treatment for distal locally-advanced rectal cancer (LARC) patients after a clinical compete response (cCR). Some novel approach suggested better functional results using robotic rectal resection (RRR) or avoiding surgical procedure, called Watch and Wait (WW) strategy. Methods: A Markov model-based, cost-utility analysis estimating mean costs and QALYs per patient was performed to compare SR, RRR and WW strategies for patients achieving a cCR to CRT. Rates of local regrowth, recurrence and distant metastasis were derived from series comparing WW to SR and from our previous comparative study of RRR versus SR. Lifetime incremental cost-utility ratio was calculated between strategies, and sensitivity analysis were performed to study model uncertainly. A willingness-to-pay of 30.000 per Quality Adjusted-Life Year (QALY) was used as a threshold to determine the most cost-effective treatment. Results: The base case 15-years cancer-specific survival was 93.5% (95% confidence interval [CI] 91.5-94.9] on a WW program, compared to 95.9% [95%CI 93.6-97.7] after RRR. WW was dominant relative to RRR with cost savings of $48,566.58 (95%CI $47,635.77 - $49,497.39 ) and incremental QALY of 7.47 (95%CI 1.46 – 7.48). WW was also dominant relative to LRR, with cost savings of $48,764.49 (95%CI $47,768.49 - $49,760.48 ) and incremental QALY of 7.44 (95%CI 7,43 – 7.45). WW remained dominant in sensitivity analysis unless the rate of SR fell to 73.0%). Conclusions: This study provides data of cost-effectiveness differences between SR, RRR, WW approaches in LARC after cCR, showing a benefit for WW.