bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and validation of a NCC-BC-A scale to assess patient-reported outcomes for advanced breast cancer patients in China.
Authors: Guan Xiuwen , Ma Fei , Yan Xiaoyan , Liu Tianmou , Shen Ning 
Published: June 2023

e13125 Background: The primary therapeutic objectives for advanced breast cancer (ABC) are to extend patients’ survival time and to maintain their quality of life (QoL). Patient-reported outcomes (PROs) symptom could improve communication with physicians, and decreased utilization of unplanned healthcare. However, localized PROs scales for ABC were seldomly used in China. This study aimed to develop a specific PROs scale for ABC patients in China and optimize the management model for breast cancer. Methods: A literature search was conducted in PubMed, Embase, Wanfang, and CNKI databases, and the dimensions and items of the scale in the literature were extracted for the item pool. Delphi method was used to modify, add, subtract, and adjust the language of scale items until the experts' suggestions or opinions reached a consensus, and the first draft of the scale was formed. The first draft of the scale was further optimized by cognitive test and pre-survey. The optimized scale was used for formal survey, and the items of the scale were further analyzed and screened by coefficient of variation, correlation coefficient, internal item consistency, factor analysis, reliability, and validity. All tests were two-sided tests, and the test level was α=0.05. Results: A total of 10945 articles were analyzed, and 237 were finally included to form an item pool containing 277 PRO items. Two rounds of Delphi expert consultation were conducted, and the average authority coefficient of experts was Cr>0.7. Based on the results of cognitive test, the corresponding items were revised by language description to facilitate understanding. After adjustments according to the pre-survey of 200 ABC patients, the PROs scale NCC-BC-A was finally formulated with a total of 38 items, including 9 physiological dimension items, 4 psychological dimension items, 9 social dimension items, 11 treatment-evaluation items, 4 overall self-evaluation dimension items, and 1 other dimension. A total of 588 ABC patients participated in the national formal survey of NCC-BC-A with the average answer time of 6 minutes, and no floor or ceiling effects were observed. A series of statistical tests were conducted on the result. A principal component analysis revealed that the items in PROs scale have great consistency while preserving enough differences between different dimensions. The results were tested to be normally distributed with good variation. Also, the PROs scale survey result has an excellent Cronbach's α coefficient of 0.925 and an excellent test-retest reliability of 0.9041. Conclusions: The PROs scale NCC-BC-A has high validity and reliability, can objectively measure the QoL of ABC patients. NCC-BC-A fully considered the characteristics of treatment status for ABC patients, and the realistic situation in China, which may help clinicians to pay more attention to QoL of ABC patients and to optimize management system for ABC.
Efficacy and safety of eribulin as a front-line treatment in patients with advanced breast cancer: The first large scale prospective real-world study in China.
Authors: Zhao Jianli , Dinglin Xiao-Xiao , Yang Ya-Ping , Luo Si-Min , Cai Yang-Yang , Chai Jie , Liu Donggeng , Wang Ying , Yao He-Rui 
Published: June 2023

e13127 Background: Eribulin is a non-taxane microtubule inhibitor, which was approved for third-line treatment of advanced breast cancer (ABC) in China in 2019. However, efficacy and safety data for eribulin in Chinese patients with ABC are lacking, regardless of the therapy line. This study evaluated the efficacy, safety, and treatment pattern of eribulin in first- to third-line settings in Chinese patients with ABC. Methods: Patients with histologically confirmed ABC who had received ≤2 lines of prior treatment for metastatic disease were enrolled. Patients with HR+/HER2- ABC received eribulin monotherapy; those with HER2+ ABC received eribulin plus anti-HER2 targeted therapy, and those with metastatic triple-negative breast cancer (mTNBC) received eribulin plus immunotherapy/chemotherapy. The primary outcome was progression-free survival (PFS). Secondary outcomes included disease control rate (DCR) and safety. This study was approved by the SYSMH and SYSUCC Ethics Committee (approval No. 2020-KY-064). Results: In total, 160 patients were enrolled from 1 January 2021 to 31 December 2022 and 142 received study treatment. Eribulin was administered as first-line therapy in 41 (28.9%) patients, second-line therapy in 50 (35.2%), and third-line therapy in 51 (35.9%). The DCR was 71.6%; 55 patients (45.8%) had stable disease and 31 patients (25.8%) had complete or partial remission. The 6-month PFS rates (95% confidence interval [CI]) were: overall, 68.4% (58.0%, 76.8%); first-line eribulin, 75.4% (54.9%, 87.6%); HR+/HER2- ABC, 67.4% (53.8%, 77.7%); HER2+ ABC, 70.1% (38.5%, 87.6%); mTNBC, 69.5% (46.3%, 84.2%). PFS data were immature; the median (range) PFS was not reached with first-line eribulin and was 11.8 (3.3, 11.8) months with second-line eribulin. Subgroup analyses are shown in the Table; the 6-month PFS rate was 64.3% versus 74.0% in patients with versus without visceral metastases (p=0.25364). Common treatment-related adverse events (AEs) were hematological toxicities including leukopenia (9.5%), neutropenia (5.3%), and hypochromia (7.3%). There were no grade ≥3 AEs or AE-related treatment discontinuations. Conclusions: There was no significant difference in the efficacy analysis between the subgroup with visceral metastases and the subgroup without visceral metastases. Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity in patients with ABC. Clinical trial information: NCT04683445 . [Table: see text]
A novel pan-RAS inhibitor for luminal B breast cancer.
Authors: Arshad Tariq , Donninger Howard , Burlison Joe , Sabo Mike , Trent John , Clark Geoffrey J. 
Published: June 2023

e13132 Background: Luminal B breast cancer makes up between 10-20% of cases and is among the most lethal forms of breast cancer. Prognosis is little better than that of the notorious Triple Negative disease. There is currently no effective treatment for Luminal B breast cancer. Recently it has been found that, although mutations in the RAS oncogene are rare in Luminal B, hyper activation of the wild type RAS protein is common due to inactivation of key negative regulators of RAS such as DAB2IP and RASAL. Therefore, targeting RAS is a logical novel approach to developing enhanced therapy for this disease. There are three main isoforms of RAS and there are no currently approved pan-RAS inhibitors. We have developed a small molecule pan-RAS inhibitor which binds directly to all forms of RAS. It acts to block the ability of RAS and to bind and signal through its effectors by disrupting the RAS effector domain. It is active in vitro and in vivo against models of Luminal B breast cancer. Methods: In silico screening of a virtual compound library was performed to identify an initial candidate inhibitor. Iterative rounds of Medicinal Chemistry informed by structural modeling and bioassay in 3D vs 2D growth assays were performed to identify an enhanced activity derivative. Target binding was confirmed by Microscale Thermophoresis and NMR. RAS/RAF complex status was measured by co-immunoprecipitation of the endogenous proteins. Ras signaling was assayed by Western analysis of Phospho-ERK and RAL-GTP pull down assays. In vitro activity was measured using 3D soft agar assays. In vivo activity was measured by ip or po administration against a Luminal B breast cancer cell line. Results: The current lead, designated RAS-F binds all three main isoforms of RAS at low uM kd and modulates the RAS effector domain in NMR studies. It suppresses RAS signaling pathways in transient assays and suppresses Luminal B tumor cell tumor cell growth in soft agar and in vivo. Conclusions: We have developed a pre-clinical pan-RAS inhibitor that is active in vitro and in vivo against Luminal B breast cancer models. The agent also has potential uses against other tumor types partially driven by deregulated wild type RAS such as triple negative breast cancer.
Evaluating the impact of a molecular tumor board in a community oncology center: Results from the Avera Cancer Institute's experience.
Authors: Elsey Rachel , Meissner Tobias , Sun Yuliang , Hattum Crystal , McKean Heidi Ann , Solomon Benjamin Maurice , Starks David , Rojas-Espaillat Luis Alexander , Spanos William Charles , Lee John H. , Williams Casey B. 
Published: June 2023

e13500 Background: The use of molecular tumor boards (MTB) has been widely documented at large academic medical centers, but there is limited experience and data available in smaller settings like community oncology centers. The Avera Cancer Institute has had a molecular tumor board in place since 2014, but the composition and methodology have changed over time. Our 10 years of hands-on experience and involvement in studies like I-PREDICT showed that in addition to molecular matching, considering factors like tumor type, previous treatment responses, comorbidities, medication coverage, and treatment availability provide crucial insights for determining optimal therapy for patients. Methods: We analyzed next-generation sequencing (NGS) testing results from August 2019 to December 2022. At the time of NGS testing result, providers were offered to have the case reviewed and presented at MTB. Our multidisciplinary team consists of members with backgrounds in bioinformatics, medical oncology, pathology, translational science, trial coordination, and pharmacy. Recommendations from the MTB discussions were provided in three categories: standard of care, clinical trials, and off-label options. Results: From August 2019 to December 2022, 1,514 qualified or resulted NGS reports were returned and considered for analysis. 733 (48%) were presented at the molecular tumor board and from this group, 629 patients were evaluable. Oncologists chose a recommended therapy 66% of the time. Of the remaining 34%, the most common reason for not utilizing recommendations was that patients were unable to receive further lines of systemic therapy. A subset analysis of 202 cases (June 2021 – August 2022) who either received a recommended therapy (n = 88, 43.6%, group 1) or not (n = 114, 56.4%, group 2) showed a survival benefit. Median overall survival was not reached in group 1, as compared with 14 months in group 2 (HR = 0.58; 95% CI, 0.37 – 0.92; p< 0.02). The median PFS was 8.2 months in group 1 versus 5 months in group 2 (HR, 0.67; 95% CI, 0.48 - 0.92; p< 0.017). Conclusions: The results of our study demonstrate the positive impact of a molecular tumor board review in helping oncologists determine the best treatment options for their patients. Our findings show that recommendations made by the board are well received and frequently adopted by providers. While providers generally prefer standard of care options or clinical trials, they are open to considering all available options to make informed therapy decisions.
Network-enabled rapid growth of a US-based remote asynchronous oncology subspecialist case review service.
Authors: West Howard Jack , Wong Debra A. , Nathwani Nitya , Wright Carol , Liang Crystal , Sachs Todd M. , Barzi Afsaneh 
Published: June 2023

e13507 Background: AccessHope (AH) is a company that provides remote subspecialist insight on cancer care for patients via an asynchronous model of review of medical records followed by a detailed assessment of current and potential future management options sent to the patient’s local oncologist. This summary characterizes the rapid and ongoing scaling and growth as demand for this service has expanded and as AccessHope has transitioned from a single site to a geographically diverse US-based network of National Cancer Institute-designated comprehensive cancer centers (NCI-CCCs) as foundational partners. Methods: Cases were identified based on a trigger list of high complexity cancers or by request for case review by participating patients with cancer. Using descriptive statistics, we assessed measures of eligible patient, completed case volumes, and number of unique expert reviewers over time; the distribution of cancer types; the extent of concordance between care outlined by the local care team and that recommended by the reviewing expert; and potential cost savings from recommended changes. Results: From 1/2019-9/2022, the number of sponsor organizations and eligible “covered lives” increased by 1462% and 393% respectively; case volume increased from 42 to 525 cases/quarter over this interval. The most common cancer diagnoses were gastrointestinal (30%), hematologic/lymphoid (18%), lung (14%), and breast (12%). While reviewers recommended an alternative treatment in 29% of cases and agreed overall with current management in 71%, only 4% agreed and had no proposed refinements associated with anticipated evidence-based improvements. Recommendations leading to cost savings if adopted were identified in 16.1% of cases, translating to projected cost savings of $13,008/patient. Conclusions: After initially demonstrating the feasibility of completing a rapid turnaround of cases of lung cancer either patient-initiated for review or prospectively triggered by diagnosis and stage, this program of asynchronous second opinions has grown from a single institution to a network of five NCI-CCCs around the US. Demand for this service has rapidly escalated, so that AH has been able to provide input and support to local oncologists for many-fold more physicians and patients over the past few years.
Improving compliance with post-hospitalization follow-up visits: A single community cancer center experience.
Authors: Venigalla Tejaswi , Anipindi Manasa , Patel Dhaval , Morginstin Mark S. 
Published: June 2023

e13508 Background: Hospital discharge follow-up visits are crucial for the continuity of care and for reducing rehospitalizations. They prevent medication disruptions, missing opportunities for making a post-discharge treatment plan, and identifying complications. Our aim is: 1. To review the compliance of post-hospitalization follow-ups for a medical specialty. 2. To study the timeline from the discharge to the time they were seen in the hematology-oncology clinic. 3. To identify why patients seen in the hospital were lost to follow-up. 4. To improve compliance with post-discharge follow-up visits. Methods: This is a retrospective chart review of patients seen by our Hematology-oncologists at Einstein Medical Center Montgomery between January 2021 to December 2021. Data collected included: Specialty consulted- Hematology versus Oncology; if follow-up is indicated; if they have a Hematology Oncology provider elsewhere; if they were seen in the clinic and how long did it take for the patient to be seen after discharge; if they did not follow-up, the reason for failure to follow-up was reviewed. We defined “No contact from our office” when there was no documentation that our office staff tried to contact the patient to make a follow-up appointment. Results: Out of the total 526 inpatient consultations, 338 were for hematology, 169 were for oncology and 19 were for both hematology and oncology. Follow-up upon discharge was recommended for 429 patients (82%). Out of those 429 patients, 168 patients (39%) were seen in the clinic and 176 patients (41%) were not seen after discharge from the hospital. 85 patients (20%) had a Hematology Oncology provider in a different institution. 118 patients (68%) in this group of 168 patients were seen in less than 30 days. 41% of the patients that were not seen after discharge from the hospital had various reasons, which included 18% of patients who expired, and 10% of patients who chose to be on comfort care. 41% of the patients were lost to follow-up (unable to track after the discharge – data was limited due to this being a retrospective study), 2% of the patients were incarcerated, 23% of the patients had no contact from our office to make a follow-up appointment, 1% of the patients were subsequently hospitalized, and finally, 5% of the patients followed up in a different institution. Conclusions: Hematology was consulted more often than Oncology for the subspecialty in-hospital consultations. 41% of the patients were lost to follow-up due to reasons unknown who should have been seen in the Hematology/Oncology Clinic. Interventions that we recommend in improving this compliance are 1. Formulate a rapid discharge clinic – run by Hematology-Oncology fellows with attending oversight. 2. Involve the Oncology Nurse Navigator to help coordinate patient follow-up. 3. Provide better education for hospital staff about the importance of reviewing discharge instructions with the patients.
Carboplatin beyond 4 cycles during therapy with carboplatin, pemetrexed, and pembrolizumab for advanced non-small cell lung cancer (NSCLC).
Authors: Ahmad Yaser , Chen Dung-Tsa , Gray Jhanelle Elaine , Tanvetyanon Tawee 
Published: June 2023

e13509 Background: Since the publication of KEYNOTE-189 study , carboplatin/pemetrexed/pembrolizumab (carbo/pem/pembro) has become a common frontline regimen for advanced non-small cell lung cancer (NSCLC). In KEYNOTE-189, carboplatin was administered for a maximum of 4 cycles. To date, the number of carboplatin cycles administered in the real-world setting remains unclear. We analyzed factors predicting the receipt of carboplatin beyond 4 cycles (CB4). Methods: We interrogated a population-based, real-world database by Flatiron for NSCLC patients with no actionable EGFR/ALK who received carbo/pem/pembro from March to July 2019 (pre-pandemic period) and from March to July 2020 (pandemic period). Patients were included if they completed the regimen as shown by transitioning to maintenance pem, pembro, or pem/pembro. Primary endpoint was CB4. Secondary endpoint was overall survival. Multivariable logistic regression analyses were performed to identify independent predictors of receiving CB4. Results: Among 2090 patients treated during the study period, 966 patients (46%) started on carbo/pem/pembro and subsequently proceeded to maintenance therapy. Among them, 134 patients (14%) received CB4. Multivariable analysis revealed the following statistically significant predictors of receiving CB4, along with respective odds ratios (95% CI) and p-values: Non-white race 1.67 (1.09-2.57) (p=0.017), ECOG ≥1 1.66 (1.07-2.59) (p= 0.024), pandemic year 2020 1.68 (1.11- 2.52) (p=0.013), and ever-smoking status 0.51 (0.30-0.87) (p=0.013). Survival analysis is ongoing. Conclusions: A significant number of patients received CB4. Since this practice is not considered a standard practice, the benefits and risks of CB4 is unknown. Predictors of receiving CB4 included year of treatment, race, ECOG, and smoking status. Further investigation is needed to understand patient-physician decision making process with regards to the length of carboplatin administration. [Table: see text]
Evaluating the impact of nurse navigation on high-risk breast clinic appointment uptake in a cancer risk assessment program.
Authors: Levin Samantha , Paul Shirlene , McPeek Chelsea , Alvarado Rosalinda , Levy Mia Alyce , Stempel Lisa 
Published: June 2023

e13510 Background: Patients in the breast imaging center are offered comprehensive cancer risk assessment (CRA) using validated risk assessment models (Tyrer-Cuzick 8, GAIL, and NCCN guidelines for genetic testing) at the time of screening mammography. All patients who receive a high-risk breast cancer score are recommended to follow-up at the high-risk breast clinic (HRBC) to determine a personalized management plan including MRI screening, genetic testing, and treatment options. Insufficient communication and patient education regarding breast cancer screening contributes to low HRBC appointment uptake. Nurse navigation (NN) was used to increase the HRBC appointment completion rate. This project aims to assess the effect of NN on HRBC appointment uptake in patients with a high-risk of breast cancer. Methods: Data regarding NN and HRBC appointment uptake for all women at a breast imaging center with a high-risk breast cancer score between July 2021 and January 2022 was extracted from the EMR and grouped into cohorts to assess the impact of NN on HRBC appointment completion. Family history of breast cancer, breast cancer risk model type, and insurance status were also extracted to analyze their relationships with HRBC appointment uptake. A chi-squared analysis was performed to assess the significance of the results. Results: NN contact and HRBC appointment completion of 4090 patients were analyzed. Of the 4090 patients, 1787 (43.7%) were successfully contacted by a nurse navigator. Patients with a family history of breast cancer were more likely to have contact with the nurse navigator (p = 0.022) and complete HRBC appointment (p = 0.017). The distribution of breast cancer risk model and distribution of insurance type were different for patients who completed HRBC appointments and those who did not, (p = 0.0012) and (p = 0.0027), respectively. Of the 4090 total patients, 122 (3.0%) attended the HRBC. Of the 1787 patients contacted by a nurse navigator, 80 (4.5%) completed HRBC appointments (p < 0.0001). Conclusions: Coupling NN with a CRA program at the breast imaging center increased the number of qualified patients who completed HRBC appointments who would not have been identified prior to this program. Patients with a family history of breast cancer, certain types of breast cancer risk model, and certain types of insurance were found to have increased uptake of HRBC appointments. As a result, more patients will receive recommended supplemental screenings and management from a multidisciplinary care team.[Table: see text]
Changes in time to treatment initiation for patients diagnosed with breast, lung, colon, or rectal cancer during the 2020 COVID-19 pandemic in the US.
Authors: Fan Qinjin , Dong Weichuan , Schafer Elizabeth , Wagle Nikita Sandeep , Zhao Jingxuan , Shi Kewei Sylvia , Han Xuesong , Yabroff Robin , Nogueira Leticia M. 
Published: June 2023

e13516 Background: The COVID-19 pandemic resulted in substantial disruptions in health care and declines in cancer diagnoses in the US. We used nationwide data to examine changes in time to first treatment for patients newly diagnosed with cancer during 2020, the first year of the pandemic. Methods: Adults aged ≥18 years newly diagnosed with breast, non-small cell lung cancer (NSCLC), colon, or rectal cancer between January 2019 and November 2020 were identified from the National Cancer Database. Logistic regression was used to calculate crude and adjusted (by age and sex and diagnosis quarter) odds ratios (AOR) of initiating any treatment within 30 days of the diagnosis comparing 2020 vs. 2019 overall and by quarter. Results: A total of 668,229 adults newly diagnosed with cancer were identified, including 358,255 in 2019 and 309,974 in 2020. Individuals diagnosed in 2020 were more likely to initiate treatment ≤ 30 days of breast (AOR = 1.12, 95% confidence interval [95% CI] =1.11-1.14), NSCLC (AOR = 1.09, 95% CI =1.07-1.11), colon (AOR = 1.13, 95% CI =1.09-1.16) or rectal (AOR = 1.08, 95% CI =1.04-1.12) cancer diagnosis, compared to those diagnosed in 2019. Increases in treatment initiation ≤ 30 days were greatest in the second quarter of 2020 for all four cancers. Findings changed little after adjustment for quarter of diagnosis and AORs remained statistically significant. Conclusions: During 2020, there was an increase in treatment initiation within 30 days from diagnosis, especially in the second quarter. The lower volume of diagnoses and efforts by providers to prioritize cancer care may partly explain the observed improvements. Ongoing evaluation of these changes and cancer outcomes is warranted.[Table: see text]