bluuebunny/crossref_metadata_2025_split huggingface dataset:
Building a survivorship care plan delivery process: Experience in an academic center.
Authors: Dayao Zoneddy R. , Tawfik Bernard , Abernathy Janet , Wiggins Charles , Gundelach Amy , Lauer Richard C. 
Published: October 2019

69 Background: The Institute of Medicine endorses delivery of survivorship care plans (SCPs) to the growing number of cancer survivors in order to improve the coordination of care between oncologists and primary care providers (PCPs). In response, the Commission on Cancer (COC) has increased the SCP delivery requirement to >50% of eligible patients, a goal that is difficult to meet given limited resources. Here we outline the initiatives taken to achieve this goal at the University of New Mexico Comprehensive Cancer Center (UNMCCC). Methods: Prior to 2017, SCPs were not routinely delivered. Beginning 2017, providers were tasked to complete and deliver printed SCPs , resulting in a 17% rate of SCP completion. However, there was general lack of provider support and enthusiasm as the process was time consuming with no method for identifying eligible patients and tracking SCP delivery. In 2018, designated staff was assigned to partially complete the SCPs to assist providers, resulting in an increase in SCP delivery rate to 41%. However, the same barriers existed. SCP softwares, although available, were expensive. A cost effective process therefore was needed. A committee was then formed to create a system-wide process utilizing the existing electronic health record (EHR) MOSAIQ. ASCO based SCPs were created. Once providers identify eligible patients, an SCP electronic order was initiated. Designated staff then partially completes the SCPs based on review of medical records. The EHR extracts data items including demographics, PCP information, cancer type and stage. The EHR is programmed to flag SCPs ready for delivery which the provider then edits and approves. This system tracks multiple time points including referral, completion and delivery of SCPs. This new process was implemented in April 2019. Quarterly reviews are set to assess metrics. Results: Utilizing existing EHR (MOSAIQ), a new SCP delivery process was created that allows tracking of assembly, completion and timing of delivery. Conclusions: To overcome existing barriers to SCP completion and delivery, a new cost effective process was created utilizing existing staff and EHR resources. Institutional support is key to the success of this initiative.
Enhancing rural and regional access to clinical trial using the Australasian Teletrial Model (ATM): Experience from MonarchE adjuvant breast cancer trial in Queensland, Australia.
Authors: Sabesan Sabe S. 
Published: October 2019

7 Background: Australasian Teletrial Model (ATM) was developed in Australia to enhance rural and regional access to clinical trials using Telehealth. Under this model, trial clusters are established by connecting smaller satellite centers with larger primary sites using telehealth; governed by standard operating procedures and streamlined approval and contractual processes recently developed by the department of health of state of Queensland. Principal Investigator oversight and roles and responsibilities of sites are documented on supervision plans. We describe the implementation of an Eli Lilly’s adjuvant breast cancer trial MonarchE using ATM in Queensland. Methods: Two larger trial sites as primary sites were linked to four smaller centres to form Northern and Goldcoast clusters. This is a descriptive study of implementation research including perspectives of clinical trial staff. Results: Between February 2018-Feb 2019, four new sites and eight new satellite staff acquired clinical trial capabilities locally. Site initiation and regular trial meetings within clusters were conducted via telehealth. 11 patients were enrolled at satellite sites. No protocol violations occurred at any of the sites including documentation and investigator product handling. Staff (six trial nurses, and 10 medical oncologists) welcomed the model for facilitating inter-site collaboration and enhancing trial access to patients. Eli Lilly incurred additional cost for conducting one-off site visits to satellites and managing medication transport to satellites. Staff spent additional time for cluster coordination and development of new processes. Conclusions: Regional sites and their staff can acquire capabilities to offer clinical trials locally using the teletrial model. Consequently, rural patients can gain access to clinical trials closer to home without needing to travel long distances. Staff welcome this model for its many benefits to patients and the system. Initial increase in set-up cost is likely to be offset by better recruitment rates. With maturity, set-up costs and time to coordinate cluster processes are likely to lessen.
Change in neutrophil-lymphocyte ratio after initiation of chemotherapy can be a prognostic indicator in de novo stage IV breast cancer patients.
Authors: Shin Hae-Na , Kim Jisun , Kim Hee Jeong , Lee Jong Won , Ko Beom Seok , Son Byung Ho , Ahn Sei Hyun 
Published: October 2019

70 Background: The de novo stage IV breast cancer has poor prognosis, predicting response to treatment in the affected patients is difficult. We investigated whether the initial neutrophil to lymphocyte ratio (NLR) at diagnosis and NLR change after the first palliative chemotherapy cycle can be a prognostic indicators. Methods: We retrospectively reviewed 218 de novo stage IV breast cancer patients with available NLR values who underwent palliative chemotherapy as an initial treatment. We analyzed cancer specific survival (CSS) according to initial NLR (iNLR), NLR change after the first chemotherapy cycle (ΔNLR), and a combination of these two. Results: The mean patient age was 47.2 years; the median follow-up period was 29.8 months. The mean iNLR and ΔNLR values were 2.83 ± 2.19 and 0.39 ± 3.74, retrospectively, amd were used as cut off points. There was no significant difference between low and high iNLR groups (p = 0.431); however, there was a significant correlation between ΔNLR and CSS (p = 0.031). The 1-, 3-, and 5- year CSS rates of patients in the increased ΔNLR group were significantly lower than those of patients in the stationary or decreased group. (78.4%, 35.4%, 20.8% vs 88.9%, 52.6%, 27.1%; p = 0.031). Multivariate analysis suggested that ΔNLR was an independent prognostic factor (hazard ratio (HR) = 1.748, 95% confidence interval (CI) = 1.084 - 2.818). The analysis of the combination of iNLR and ΔNLR showed that patients in the high iNLR and increased ΔNLR group had poorer prognosis than those in the low iNLR and stationary or decreased ΔNLR group (HR = 4.294, 95% CI = 1.586 - 11.629). Conclusions: Initial NLR alone was not a prognostic indicator among de novo stage IV breast cancer patients. However, patients with increased NLR after palliative chemotherapy exhibited worse CSS. Patients with high initial NLR and increased NLR after treatment might be a non responder to treatment.
In rheumatoid arthritis, the incidence of malignancies that are indicated for immune checkpoint inhibitors is increasing.
Authors: Urata Yukitomo 
Published: October 2019

72 Background: An important side effect of immune checkpoint inhibitors (ICI) is immune related side effects, and in autoimmune diseases, the incidence is increased. For this reason, ICI for autoimmune diseases are carefully administered. However, among the malignancies that develop in autoimmune diseases, the frequency at which the (ICI) is indicated is unclear. This study is to clarify the incidence of malignancies to which ICIs are indicated in rheumatoid arthritis (RA), a typical autoimmune disease. Methods: In RA patients, the development of malignant tumors that can be indicated for IC was investigated at every year from September 2014, (September 2014 - August 2015: 2014 group; September 2015 - August 2016: Group 2015; September 2016 - August 2017: 2016 Group; September 2017 - August 2018: 2017 group). Patients with a history of malignant tumor treatment within 10 years were excluded at registration. IC adaptation was judged by the presence or absence of IC adaptation approval at diagnosis of malignant tumor. Results: The number of RA patients, age (year), disease duration (year), malignant tumor incidence (%), IC adaptive malignant tumor incidence (%) of each group are shown; [n = 479, 68(61-77), 8.8 (4.4-13.9), 9 (1.9%), 0 (0%)], [n = 504, 68 (61-77), 8.0 (3.7-12.8), 12 (2.4%), 0 (0%)], [n = 514, 68(61-77), 7.4 (3.4-12.7), 7 (1.4%), 1 (0.2%)], [n = 526、67 (60-76), 7.3 (3.1-12.6), 37 (7.0%), 9 (1.7%)]. Conclusions: The incidence of IC-adapted malignancy has increased in RA due to an increase in malignant tumor incidence, development of a new IC (methods), combined use of IC and other cancer treatment methods, and expansion of IC indication diseases. Due to the coexistence of autoimmune diseases and malignancy therapy, familiarity with malignant tumor treatment is essential for rheumatologists.
ChemoPalRx: Development and implementation of a chemotherapy mobile provider order entry system in a safety net hospital.
Authors: Hung Kin Wai (Tony) , Banerjee Natasha 
Published: October 2019

73 Background: Computerized provider order entry (CPOE) systems have been shown to enhance the safety and efficiency of prescribing chemotherapy over the handwritten ordering process. However, many institutions lack the financial ability, technological capability, or operational flexibility to invest in and implement such a system. In particular, Olive View-UCLA Medical Center (OVMC), a Los Angeles County safety net hospital, is among these institutions with unique restrictions that preclude the use of chemotherapy CPOE and mandate handwritten orders. Methods: In an effort to bridge the gap for safe chemotherapy prescribing, we aimed to develop and implement an effective, scalable, and sustainable chemotherapy provider order entry solution that was operationally sensitive to institutions without a chemotherapy CPOE. The solution was designed as a mobile application using Xcode, the integrative development environment of Apple Inc., with the Swift programing language. Results: On September 5th, 2018, we launched a free, chemotherapy provider order entry solution on the worldwide Apple App Store – ChemoPalRx. Using ChemoPalRx, providers can search, customize, and print common chemotherapy regimens in prescription format. Along with a reference library of over 120 order set and 450 medications, ChemoPalRx is equipped with the functions to automate dosage calculation, suggest pre-medications and safety parameters, and trigger alerts for missing prescribing information. As a quality improvement initiative, we implemented ChemoPalRx at OVMC. Implementation stages include obtaining administrative buy-in, consulting with multidisciplinary staffs, investing $100 USD for a prescription printer, and encouraging providers to download ChemoPalRx on their own mobile devices. An ongoing prospective cohort study is being conducted to determine ChemoPalRx effectiveness in reducing errors compared to handwritten orders. Conclusions: ChemoPalRx is developed to enhance the safety and efficiency of chemotherapy prescribing. Implementation of this mobile application is feasible in the safety-net hospital setting and has the potential to transform oncology practices globally.
Innovation in evidence synthesis: A living systematic review of immune checkpoint inhibitors in cancer patients.
Authors: Riaz Irbaz Bin , Rawal Samarth C , Siddiqi Rabbia , Asghar Noureen , Akhtar Maheen , Gajic Ognjen , Wang Zhen , Montori Victor , Herasevich Vitaly , Go Ronald S. , Baral Chitta , Rajkumar S. Vincent , Murad M. Hassan 
Published: October 2019

80 Background: Several previous systematic reviews and meta-analyses have attempted to summarize toxicity of Immune Checkpoint inhibitors (ICIs). However, very soon after each one of these reviews has been published, it became outdated. ICIs are currently used in 14 different cancers and data is rapidly evolving from new clinical trials. A living Systematic review, which is defined as a systematic review that is continually updated to incorporate relevant new evidence as it becomes available, is necessary in this situations. Methods: In order to dynamically display content -- including textual data, tables, charts, and graphs – standard data formats and protocols were designed for various components of the systematic reviews carried out by researchers. Given these standardized formats, software was written to interpret this data and output the information in the appropriate format, such as a forest plot or data table. Finally, a dynamic interface that enables user inputs (such as which aspect of the meta-analysis to view) and displays the associated output was designed. The overall living Systematic Review infrastructure includes monthly literature searches, cumulative meta-analysis, and an online reporting platform. Results: We have developed a Living Systematic Review engine that can take in standardized data and reflect this data in an interactive, intuitive manner in the form of text, tables, and plots. This interface can also be manipulated via user input to organize and sort data tables or omit/highlight specific pieces of data. Conclusions: We have initiated the first living systematic review in immune-oncology that will be continuously updated, incorporating relevant new evidence as it becomes available, and will provide accurate and up to date toxicity estimates to support clinical decision making. The Living Systematic Review interface allows users to easily and intuitively access the most recent available clinical evidence on toxicity of ICIs.
Development of hematologic toxicity with sequential treatment of Y90 followed by PRRT in five patients at single institution with metastatic neuroendocrine patients.
Authors: Singh Jaswinder , Singh GINA J 
Published: October 2019

81 Background: In metastatic neuroendocrine tumors (NET) peptide receptor radionuclide therapy (PRRT) using radiolabeled somatostatin analogues (Lu-177-DOTATATE) and selective intra-arterial radio-therapy (SIRT) with Y-90-microspheres are increasingly used promising treatment options. Rarely patients have been treated with sequential use of both treatment modalities . Severe adverse effects are rare and mainly concern hematologic changes and development of prolonged cytopenias . There is no data about possible cumulative side effects particularly regarding hematologic toxicity in the case of sequential use of both treatments. Methods: 5 Patients with hepatic metastasized NET treated both with SIRT and PRRT during 2010 - 2019 were included. Average time interval between treatment of y90 and PRRT was 2.5 years. All of them were treated with y90 before PRRT. Average treatment with Y90 was 3 doses. Results: In the follow up Platelets (159 to 89), leukocytes (7.5 to 3.7) and hemoglobin (13 to 11.6 ) decreased significantly, LFTs, bilirubin and creatinine did not change significantly. No severe toxicity (Grade 3 or 4) was experienced. 80 % of the patients showed decreasing blood counts after the therapies and was prolonged for average of 9 months. Conclusions: In metastatic neuroendocrine tumors (NET) sequential treatment with peptide receptor radionuclide therapy (PRRT) using radiolabeled somatostatin analogues (Lu-177-DOTATATE) after selective intra-arterial radio-therapy (SIRT) with Y-90-microspheres is possible and well tolerated except for hematological toxicity.
Adjuvant nab-paclitaxel plus gemcitabine versus gemcitabine in resected pancreatic ductal adenocarcinoma: A Chinese single institution experience.
Authors: Yin Zhuzeng , Liu Rong 
Published: October 2019

85 Background: Adjuvant chemotherapy with gemcitabine (GEM) is standard care for resected pancreatic ductal adenocarcinoma (PDAC). Nab-paclitaxel plus gemcitabine (AG) vs gemcitabine (GEM) have shown better survival and tumor response with in advanced or metastatic PDAC. We aimed to determine the efficacy and safety of AG compared with GEM for resected PDAC. Methods: We retrospectively reviewed resectable PDAC patients (pts) who received AG or GEM as adjuvant chemotherapy from January 2013 to December 2016 at the Chinese PLA General Hospital, Bei Jing, China. Pts received nab-paclitaxel (125mg/m2) followed by GEM (1,000 mg/m2) on days 1, 8 every 3 weeks or GEM (1,000 mg/m2) alone on days 1, 8 every 3 weeks for 6 cycles unless disease progression or there was unacceptable level of adverse events. Disease free survival (DFS), overall survival (OS) and toxicity were analyzed. Results: Among 70 pts received AG or GEM as adjuvant chemotherapy, 10 pts were excluded due to the serious complication or R2 resection. The analysis was based on 30 pts in each group undergone complete macroscopic (R0 or R1) resection. Median DFS was 15.8 months (95% CI 13.1-18.5) in AG group (6 pts not arrived) compared with 12.2 months in GEM group (95% CI 9.6-14.8, P = 0.039, 3 pts not arrived). Median OS was 28.3 months (95% CI 21.9-34.6) in AG group (11 pts not arrived) as compared with 20.6 months in GEM group (95% CI 11.2-29.9, P= 0.028, 7 pts not arrived). The 2 years survival rate was 63.3% versus 43.3% in AG group versus GEM group. The most common adverse events of grade 3 or higher were leukopenia (32.3% in AG group vs. 20.7% in GEM group, P= 0.387), neutropenia (45.2% vs.31%, P= 0.298), G-CSF use (41.9% vs. 24.1%, P= 0.177), sensory peripheral neuropathy (51.6% vs. 24.1%, P= 0.036) and fatigue (3.2% vs. 3.4%, P= 0.737). Conclusions: Our results provide the evidence that the adjuvant combination of nab-paclitaxel plus gemcitabine significantly improved DFS and OS of resected PDAC.
Generation of personalized tumor Biopsy-Derived Natural Killer (BDNK) cells.
Authors: Teo Hui Min Vivian , Goh Si Wei , Sari Intan Permata , Chew Wei Leong , Lim Hsuen Elaine , Dasgupta Ramanuj , Sharma Ankur 
Published: October 2019

86 Background: Natural killer (NK) cells play promising roles in cancer surveillance and possess multiple unique characteristics for allogenic cell transfer (ACT) in the cancer immunotherapy. However, most studies were applicable to ex vivo expanded NK cells from the peripheral blood, which requires massive amount of cell numbers for the initial isolation and expansion. Moreover, recent studies have demonstrated a phenotypic heterogeneity between peripheral and tissue resident NK cells. Methods: In this study, we aim to establish the ex vivo expansion of tumor infiltrating NK cells directly from diagnostic breast core biopsies followed by functional validation through in vitro assays. Results: A total of 20 breast TILs models, including T and NK cells, were successfully established through genetically modified K562 feeder cells co-culture approach. These models represented all the major sub-types (hormone positive and negative) of breast cancers. Next, we extensively evaluated the tumor-reactivity of the selected NK models via effector:target cytotoxicity assays. Interestingly, non-invasive breast tumor line has exhibited a strong preferential kill by NK cells whereas the invasive line counterpart was able to escape NK cell-mediated cytotoxicity. Conclusions: The resource generated in this study has revealed tumor infiltrating NK cells as a potential tool for cell-based therapy in solid tumors. Furthermore, this study provides a platform to investigate the immune-resistance mechanism involved between tumor and NK cells, thus, paving the way to the discovery of novel cancer immunotherapy targets.
Progression-free survival as a predictor of overall survival in patients with advanced breast cancer: A real-world study from the China National Cancer Center and validation in the Memorial Sloan Kettering Cancer Center Cohort.
Authors: Mo Hongnan , Xu Binghe , Ma Fei , LI Qing , Zhang Pin , Yuan Peng , Wang Jiayu , Luo Yang , Cai Ruigang , Li Qiao , Li Yiqun , Guan Xiuwen , Lin Shaoyan , Chen Yimeng , Wang Zijing 
Published: October 2019

88 Background: Breast cancer is a clinically heterogeneous disease. The aim of our study was to evaluate the effect of progression-free survival (PFS) in predicting overall survival (OS), and to explore whether PFS in the first-line treatment could help in the choice of posterior regimens. Methods: Data from the China National Cancer Center database that recorded 2061 women from February 1992 to March 2018 were pooled as the study cohort. Women were eligible if they had metastatic breast cancer and had not received systemic treatment for the advanced disease. The independent validation cohort was composed of 1756 patients with advanced breast cancer from the Memorial Sloan Kettering Cancer Center. Results: The correlation coefficient between PFS and OS was 0.862 in patients receiving endocrine therapy alone as first-line treatment, and 0.647 in the whole study cohort (all P < 0.0001).Receiver operating characteristic curve indicated that PFS = 12 months was the optimal cutoff value for predicting patient’s survival(P < 0.0001). In the study cohort, the median survival time among patients who experienced any PFS at 12 months was 29.0 months, compared with 72.6 months in those patients who did not experience any PFS at 12 months (HR = 2.736, P < 0.0001). Meanwhile, the median PPS after progression was 22.6months in patients whose PFS < 12 months, which was also significantly worse than that in patients who did not progress at 12 months (median 31.3 months, P = 0.001).Notably, in the subgroup analysis of 732 with hormone receptor positive and HER2 negative disease, combined chemotherapy assecond-line treatment could significantly improve patient survival compared with single agent chemotherapy (HR = 0.597, P = 0.040) in patients with first-line PFS > 12m, but not in patients with first-line PFS < 12m (P = 0.109).A similar pattern is observed in the validation cohort. Conclusions: First-line PFS at 12 months predicted OS in patients with advanced breast cancer, and could potentially serve as a convenient identifier in clinical practice to precision medicine approach.