bluuebunny/crossref_metadata_2025 huggingface dataset:
Use of adjuvant bisphosphonate therapy in breast cancer by Indian oncologists: An implementation science study.
Authors: Davis Sissmol , John Dr Serene Sara , Davichan Dr Anjali , Santoki Aditya , Mathew Aju
Published: June 2023

e13667

Background: Several clinical trials, expert consensus and guidelines have recommended the use of bisphosphonates (BP) in reducing the breast cancer recurrence risk in postmenopausal women. The 2019 St. Gallen Panel voted 83.7% in favour of the routine use of bisphosphonates in postmenopausal women. Similarly, the 2022 ASCO-Ontario Health guidelines for breast cancer supports the recommendation. However, the uptake of these recommendations in routine clinical practice is poorly studied. We aimed to investigate the use of adjuvant BP therapy by Indian oncologists (implementation science study). Methods: A cross sectional survey study design was used to investigate our research question. Physicians in India who treat patients with breast cancer were presented with a clinical vignette of a young woman with postmenopausal (induced) non-metastatic high risk hormone receptor-positive breast cancer. A snowball sampling strategy was employed to avoid sampling bias. Participants were requested to state their gender, primary qualification, practice setting, number of years of practice as an oncologist and proportion of patients with breast cancer in their practice. Instead of providing the option of BP therapy, we asked an open-ended question whether they would recommend any additional therapy other than surgery, radiation, chemotherapy and anti-estrogen therapy. We asked them to write in the name or class of drug if they would prescribe an additional therapy to the patient. Results: The survey was completed by 74 Oncologists. The response rate is unknown as a snowball sampling strategy was employed. Majority of the respondents were male (74%), were non-teaching private practitioners (42%), medical oncologists (62%) with up to 10 years of experience (65%), and breast cancer patients make up to 50% of their patients (84%). Most of the oncologists responded no to our question on additional therapy (76%). Of those who responded yes, only 8 suggested BP therapy (11%). Conclusions: Despite strong evidence and guidelines, adjuvant BP therapy in high-risk early breast cancer was only recommended by very few oncologists in our survey study. Steps to bridge this gap between academic research and clinical application is urgently warranted. Implementation of clinical guidelines has to be monitored routinely which may be facilitated by provider and patient surveys. This can also assist in identifying and addressing the concerns with newer recommendations.
Knowledge and use of different breast cancer screening tools among primary care physicians: A cross-sectional study.
Authors: Camejo Natalia , Amarillo Dahiana , Bernate Moira , Burguez Florencia , Darino Eliana , Deleon Adrian , Milwa Tatiana , Barcia Maria , Krygier Gabriel David
Published: June 2023

e13673

Background: In Uruguay, breast cancer (BC) is the leading cause of cancer incidence and mortality in women. Objective: To understand the implementation of BC screening among primary care physicians in routine clinical practice and the degree of adherence to the recommendations put forward in 2015 by the Ministry of Public Health (MPH) for the early detection of BC. Methods: This was a descriptive, cross-sectional, observational study. An anonymous survey was administered to physicians working in primary care. Results: 169 physicians were included, 89.4% (151) consider the use of screening mammography decreases mortality from BC, 54.4% (92) indicate mammography from 40 years of age and 38.5% (65) from 50 years of age. The majority (56.8%, 96) indicate mammography every 2 years in the population of women aged 50-69 years. Of the respondents, 65.7% (111) were aware of the national guidelines and 47.9% (81) followed them, while 18.9% (32) followed recommendations from other scientific bodies. Conclusions: This study showed that primary care physicians make correct use of the different BC screening tools. Active measures are needed to develop educational programs for healthcare personnel, which may enable them to disseminate knowledge and positively influence patients' attitudes.
Fertility preservation in women with cancer in Brazil: Infertility specialists' perceptions and attitudes.
Authors: Andrade Warne Pedro , Lamaita Rivia Mara , Rannige Renata Lack , Rodrigues Angelica Nogueira , silva-Filho Agnaldo Lopes
Published: June 2023

e13676

Background: Oncofertility is a universal right and a global oncology priority. However, there is a lack of communication between infertility specialists and their clinical oncologists on topics relating to fertility preservation. The present study aims to evaluate the perceptions and attitudes of infertility specialists regarding fertility preservation in women with cancer in Brazil. Methods: An online questionnaire was sent to infertility specialists affiliated to the Brazilian Federation of Associations of Gynecology and Obstetrics (FEBRASGO, in the Portuguese acronym). Results: A total of 100 (30.9%) of 323 FEBRASGO infertility specialists responded, most located in the southern and southeastern Brazilian states. Experience in Human Reproduction ranged from one to 40 years (mean ± standard deviation: 15.5 ±10.2 years). Considering women with cancer in reproductive age in whom fertility preservation was indicated, 60.3% ±28.8% of them performed the procedure (ranging from 10 to 100%). Three main barriers to fertility preservation were appointed: cost (41%), knowledge and acceptance of medical oncologists (35%) and accessibility (9%). Most infertility specialists (58%) considered age above 40 years as the limit for fertility preservation in women with cancer. Breast and ovarian cancers, leukemia, and lymphoma were considered the most relevant types to be considered for fertility preservation, while lung, thyroid, gastric and brain. Conclusions: This is the first Brazilian study on specialists' impressions on cancer patient's access to fertility preservation. While most Brazilian cancer patients are treated in the public health system, most fertility specialists are in the private sector. Currently, the model of care is fragmented and a more integrated workflow between cancer and fertility experts is fundamental to improve fertility sparing access. Further studies are needed on the topic, also including clinical oncologists, hematologists, breast cancer specialists, and patients.
Telemedicine services in community oncology practices.
Authors: Loh Kah Poh , Wang Ying , Nightingale Chandylen L. , Parsons Susan K. , Braun-Inglis Christa M. , Gada Umang , Montes Alexander , Culakova Eva , Magnuson Allison , Yilmaz Sule , Strause Sarah , Kamen Charles Stewart , Mustian Karen Michelle , Morrow Gary R. , Mohile Supriya Gupta ,   Landscape Committee
Published: June 2023

e13678

Background: Telemedicine services have grown tremendously due to the COVID-19 pandemic. We described the use of telemedicine for research purposes at community oncology practices. Methods: We utilized results from the National Cancer Institute Community Oncology Research Program 2017 and 2022 Landscape Surveys, which were designed to understand cancer delivery research capacity in community oncology practices. We used multivariable logistic regression to examine factors associated use of telemedicine for research purpose in 2022, adjusting for region, practice ownership type, and number of oncology providers. Results: Information was available from 504 and 685 discrete practices in 2017 and 2022, respectively. These represent 210 and 259 practice groups; practice groups serving only pediatric patients were excluded. Mean numbers of oncology providers at the practice group level were 18 (IQR 5-21) and 20 (IQR 7-22) in 2017 and 2022, respectively. Over 90% of practice groups reported having outpatient electronic health records and patient portal in both years. In 2022, IT service was available onsite in 71%. In 2017, 31% of practice groups utilized telemedicine for delivery of cancer care and 15% can utilize telemedicine for research purposes. In 2022, telemedicine was used for research purposes in 73% of practice groups. Specifically, telemedicine was used for collection of patient-reported outcomes (54%), delivery of health care interventions (47%), consent (39%), conduct of qualitative interviews (32%), delivery of behavioral interventions (30%), collection of biometric data (e.g., weight, blood pressure) (14%), and collection of neurocognitive testing data (12%). One-third of all practice groups (35%) did not have internet-abled devices available for patients, 53% had them onsite, and 2% had them on site and for patients to take home. On multivariable analysis, a greater number of oncology providers was associated with greater use of telemedicine for research purposes (every 10-unit increase, AOR 1.31, 95% CI 1.04-1.64). Conclusions: From 2017 to 2022, there has been an increased use of telemedicine for research purposes, though its use varies across practices. Bigger practice groups were more likely to use telemedicine for research purpose. Cancer care delivery research that incorporates telemedicine should consider implementing site-specific and standardized resources. [Table: see text]
Telemedicine and cancer care in Syria: A promising initiative during the war and COVID-19 era.
Authors: Saifo Maher , Alali Mousa
Published: June 2023

e13680

Background: Telemedicine (TM) is the practice of medicine using technology to deliver care to patients at their locations. One of the major difficulties that cancer patients in Syria face is the ability to frequently visit Albairouni University Cancer Center (ABUH) in Damascus. The travel-related barriers to reach ABUH have increased due to the war, unsafe road, shortage of fuel, and high travel costs. Moreover, in response to the COVID-19 pandemic in the country, healthcare providers reduced unnecessary visits. Here, we present an initiative illustrating our Syrian experience of TM in cancer care. Methods: The initiative began on 2 January 2021 to serve cancer patients near to Salamyieh (a rural area, 3-hour drive to ABUH). We satellite a clinic located near to patients’ homes, and we provide it with the necessary telecommunication infrastructure to virtually contact me at ABUH. The team, consisting of physicians and volunteers, meet patients and help me gather the history, symptoms and all relevant documents to set up and complete the care plan. Patients who need to receive treatment present to ABUH where the cancer therapies are completely free of charge. The whole services of this initiative are free including the E-consults, follow-ups, and auto transportation back and forth to ABUH. The volunteers accompany and help patients in their trips to AHBU, as many of them lost their beloved caregivers due to the war. Results: Throughout the last 2 years, we served 500 new patients. The numbers of E-consults were 920 and 800 in 2021 and 2022, respectively. Few patients were uncomfortable with it due to the lack of in-person interaction. Thus, it was a challenge to build connection and trust with patients virtually. Conclusions: Collectively, despite of the limited resources, TM initiatives have a lot to offer for patients with cancer and present a great solution to follow up with them. This experience shows that TM works especially in low-income countries, during the pandemic, and in a war-affected setting, all of which are associated with poor socioeconomic status and insecurity.
Tele-oncology implementation logic model.
Authors: Alishahi Tabriz Amir , Turner Kea , Naso Cristina , Gonzalez Brian D. , Oswald Laura B. , Nguyen Oliver , Hallanger-Johnson Julie E. , Patel Krupal , Hong Young-Rock , Powell Byron J , Spiess Philippe E.
Published: June 2023

e13681

Background: The onset of the coronavirus disease 2019 (COVID-19) pandemic changed the landscape of oncology practice and placed tele-oncology at the center of cancer care delivery. As tele-oncology will likely remain a key part of cancer care delivery, healthcare organizations need to determine how to implement tele-oncology programs. We conducted an instrumental case study at a National Cancer Institutes -designated comprehensive cancer center that successfully implemented tele-oncology. Methods: Data were collected from three sources between June 2020–February 2022. We conducted semi-structured interviews among stakeholders directly involved in implementing and/or managing tele-oncology and surveys of administrators of the center’s tele-oncology and clinicians who used the program. Document analysis of implementation deliverables were also analyzed. Data collection and analyses were guided by the Consolidated Framework for Implementation Research, and Clinical Transformation in Technology. We used the Implementation Research Logic Model (IRLM) to develop a framework depicting determinants and key steps for implementing tele-oncology. Results: We interviewed 40 clinicians. We also invited 364 employees to complete online surveys, of which 151 (41.5%) responded. Most respondents were physicians (41.7%), nurse practitioners (26.5%), or physician assistants (26.5%). To implement tele-oncology program, three elements should be considered: (1) platform, (2) people, and (3) process. We found hospitals should: 1) adopt a safe and adaptable platform to deliver tele-oncology; 2) build a multidisciplinary tele-oncology team to provide the administrative, legal, workflow, and clinical support; 3) provide training and resources to make sure all the team members can deliver their responsibilities; 4) identify and appreciate early adopters, departments, and clinicians with successful experiences; 5) frequently evaluate the clinical and implementation outcomes; 6) secure reimbursement comparable with in-person rate and ; 7) advocate for policies that are supportive of tele-oncology in the future. Conclusions: Using IRLM we presented the tele-oncology implementation framework that can be used by hospitals around the world to implement their own tele-oncology.
Cost of care associated with utilization of telehealth in clinical trials.
Authors: Gleason Emily , Tubridy Elizabeth , Andriani Leslie , Uwawuike Destiny , Gunter Simon , Koelper Nathanael , Harvie Heidi , Ko Emily Meichun
Published: June 2023

e13682

Background: Due to COVID-19 pandemic restrictions, telehealth was incorporated into standard oncologic care and clinical trials. Existing data show that telehealth in clinical trials is safe, feasible, and reduces barriers to participation. We sought to analyze whether telehealth changed the cost of care compared to traditional clinical trial operations. Methods: We conducted a retrospective cohort study of gynecologic oncology patients enrolled in therapeutic clinical trials at a NCCN designated cancer center, comparing health care reimbursement cost of care on trial pre-TELEhealth (9/30/2019 to 3/15/2020) with those during TELEhealth (3/16/2020 to 8/20/2020). Inclusion required trial enrollment during both study periods, at least 1 telehealth visit, and identifiable billing records. Health care costs were collected. Cost data included: 2020 Medicare reimbursements for procedures, provider billing, DRG for hospital admissions, drug average sales price, and GoodRx for outpatient prescriptions. Encounters unrelated to cancer care were excluded. Overall cost per patient and patient-per-month on trial were calculated for scheduled (per protocol) and unscheduled (non-protocol) encounters. Pairwise t-tests between pre-TELE and TELE periods were performed. Results: 28 patients were included (86% White, 7% Black, 6% other) with 26 (93%) ovarian, 1 (4%) uterine, and 1 (4%) concurrent ovarian/uterine cancer. The majority (89%) had stage 3 or 4 cancer at diagnosis. Overall care utilization was similar in pre-TELE and TELE periods, with 292 vs. 321 scheduled visits, and 31 vs. 37 unscheduled visits. Mean total cost per patient was similar in pre-TELE and TELE periods, including scheduled encounters ($15794.58 (SD 17719.92) vs. $20714.47 (SD 25338), p= 0.118) and unscheduled encounters ($759.96 (SD 2066.72) vs. $2911.71 (SD 6060.18), p=0.080). Per month on trial, mean cost per patient did not differ. No differences were seen in total scheduled or total unscheduled encounters, nor office visits, admissions, ED visits and outpatient procedures. Conclusions: Incorporation of telehealth in gynecologic cancer clinical trials did not increase cost of scheduled or unscheduled care. Telehealth is a critical component to decentralizing clinical trials, reducing barriers to trial participation and improving the value of cancer care. [Table: see text]
Geographic disparities in Medicare telehealth utilization and access to specialized cancer care in the United States.
Authors: Goel Utkarsh , Gautam Misha , Gandhi Shipra , Roy Arya Mariam
Published: June 2023

e13683

Background: Access to specialized cancer care varies by place of residence, partly due to differences in geographic proximity to designated cancer centers. Telehealth services can help alleviate some of these geographic disparities. In response to the COVID-19 pandemic, Medicare telehealth services were expanded rapidly. In this study, we sought to describe the geographic variations in Medicare telehealth utilization and their relationship with locations of designated cancer centers in the United States. We hypothesized that differences in telehealth utilization might be reflective of barriers to telehealth access for Medicare beneficiaries in these regions. Methods: We used the Medicare Telehealth Trends data file and calculated the proportion of Medicare users who used a telehealth service (% Telehealth Users) across all quarters of 2021. To obtain % Telehealth Users in a state, the number of telehealth users were divided by the total number of telehealth-eligible users. Then, using % Telehealth Users as a metric of telehealth utilization, we ranked all US states by overall % Telehealth Users, and % Telehealth Users in rural and urban locations. Finally, we correlated these ranks with the presence of an NCI (National Cancer Institute) Designated Cancer Center within the states. Results: The % Telehealth Users ranged from 15%-53% overall, 16%-54% for rural locations, and 14%-54% for urban locations, across lowest ranked to highest ranked states. The 5 lowest ranking states and their respective % Telehealth Users overall were- Wyoming (20%), Montana (20%), Iowa (20%), South Dakota (18%), Nebraska (17%), and North Dakota (15%). The lowest ranking states in terms of rural % Telehealth Users were Montana, Kansas, Iowa, Tennessee, Wyoming (19% each), and South Dakota and Nebraska (16% each). The lowest ranking states in terms of urban % Telehealth Users were Montana (20%), Wyoming (20%), Nebraska (19%), South Dakota (16%), and North Dakota (14%). 4 out of 6 states overall, 3 out of 7 in the rural category, and 4 out of 5 states in the urban category that were ranked the lowest in telehealth utilization did not have an in-state NCI designated cancer center. Conclusions: Telehealth services can bridge gaps in access to specialty cancer care for patients that do not live in geographic proximity of cancer centers. However, regions lacking geographic proximity to cancer centers were also regions with poorest telehealth utilization. Advocacy and policy efforts directed towards increasing access to telehealth can ensure equitable and timely access to specialized cancer care in these regions of need.
Rural disparities in telemedicine use among cancer survivors during the COVID-19 pandemic.
Authors: Lee Min Jee , Tsai Meng-Han
Published: June 2023

e13686

Background: The COVID-19 pandemic has led to significant changes in the delivery of healthcare across the world, including the widespread adoption of telemedicine. This study examined the prevalence of telemedicine use by rurality and determined whether rurality was associated with its use among cancer survivors in the United States (US). Methods: The 2021 National Health Interview Survey (NHIS) was used to examine the use of telemedicine among cancer survivors during the pandemic. Our primary outcome is telemedicine use and rurality is our main exposure of interest. Other covariates of interest include demographics, health-related factors (# of comorbidities, self-rated health), and types of cancer history. Descriptive statistics and multiple logistic regression models were used to examine the mentioned association. Results: Among 27,500 eligible cancer survivors, 51.6% (14,140 participants) of them reported telemedicine use. The use of telemedicine varied by rurality, with 41.4% of rural cancer survivors using telemedicine compared to 58.4% of cancer survivors in large central metropolitan areas (p < 0.001). Rural cancer survivors had significantly lower odds of using telemedicine during the pandemic compared to metropolitan cancer survivors. Cancer survivors residing in rural were 0.58 times less likely (95% CI, 0.43 to 0.78) and cancer survivors residing in medium and small metropolitan areas were 0.72 times less likely (95% CI, 0.56 to 0.93) to report telemedicine use compared to cancer survivors residing in large central metropolitan areas. Conclusions: Significant rural disparities in telemedicine use were evident among cancer survivors. Rural cancer survivors were less likely to use telemedicine during the COVID-19 pandemic. To ensure equitable access to telemedicine, continued reimbursement for telemedicine services, but additional efforts are needed to improve access to and utilization of healthcare for rural cancer survivors.
Current trends in oncology-related utilization of digital health (telemedicine, RPM, and asynchronous messaging).
Authors: Revol Cindy , Miller Austin , Jain Sanjula , Oakes Allison H.
Published: June 2023

e13688

Background: It is well established that digital health (particularly telehealth) utilization increased in response to the COVID-19 pandemic; however, the extent to which digital health is used in oncology care is unknown. Conceptually, telehealth and other digital health solutions may alleviate some of the emotional, financial, and physical burdens associated with receiving oncology care. The objective of this study was to examine trends in the utilization of digital health (telehealth, remote patient monitoring (RPM), and asynchronous messaging (AM)) among cancer patients and the demographics of those patients relative to digital health and oncology patients writ large. Methods: We used the Trilliant Health national all-payer claims database to analyze digital health interactions for both oncology and non-oncology patients from Jan 2020 - Jun 2022. We defined a digital health visit as any visit with a procedure code for telehealth, RPM, or AM. An oncology care visit (digital or in-person) was defined as any visit with a primary diagnosis of cancer. An oncology digital health visit was defined as a visit with one of the digital health procedure codes coupled with a primary diagnosis of cancer. Results: Digital health represented 3.19% of total oncology care volume, a majority of which was telehealth (3.18%). Among all telehealth visits, 0.9% of visits were for oncology-related care. Additionally, a majority (72.8%) of these oncology-related telehealth visits were for E&M encounters related to ongoing cancer care. By payer type, telehealth visits were more common among commercially insured patients (56.1%) compared to commercially insured patients’ share of all oncology care (39.8%). While overall telehealth utilization is disproportionately female (62.2%), women comprised 51.2% of all oncology care volume and 52.5% of all oncology-related telehealth volume. While the 65+ population accounts for just 19.3% of all telehealth volume, they are responsible for 61.1% of telehealth oncology-related volume–more closely resembling that age group’s 73.5% share of total oncology care volume. Oncology care represented 0.2% and 0.5% of total RPM and AM volume, respectively. Conclusions: Oncology digital health visits remain a very small portion of overall digital health utilization and total oncology care. Prior research found that the share of younger patients seeing oncology providers is increasing over time, signaling worsening patient acuity. Given the demand for digital health overall skews younger, it is likely that demand for more virtual cancer care services will increase. While research suggests digital health yields cost savings, more needs to be understood about the quality implications of virtual versus in-person visits. While virtual care increases access to those with time and travel constraints, providers need to ensure equal access to these services for all patients.
Tp53 as a potential therapeutic biomarker in patients with recurrent high-grade glioma treated with anlotinib and temozolomide.
Authors: Wang Chao-Jie , Yin Ming-Mei , Zhao Zheng , Zhang Meng-Yi , Zhao Wei-Feng
Published: June 2023

e14000

Background: Patients with recurrent high-grade glioma (rHGG) had a dismal prognosis. Previous studies have found that anlotinib is effective in treating rHGG, but there are no predictive biomarkers to select potential beneficiaries. Methods: The clinical and pathological data of patients with rHGG treated with anlotinib and temozolomide (TMZ) in our hospital were collected and analyzed. Treatment response was assessed according to Response Assessment in Neuro-Oncology criteria. Survival was estimated using the Kaplan-Meier curve with the log-rank test. Tumor protein 53 ( TP53), O-6-methylguanine-DNA methyltransferase, and pre-treatment peripheral blood index were evaluated for potential therapeutic biomarkers. Results: From August 2017 to February 2022, 23 eligible patients with rHGG were included in this study. The objective response rate was 52.2% (95% confidence intervals [CI]: 30.6-73.2%), and the disease control rate was 91.3% (95% CI: 72.0-98.9%). The median progress-free survival (PFS) for all patients was 5.3 months (95% CI: 4.9-5.7 months), with a 6-month PFS rate of 30.4% (95% CI: 13.2-52.9%). The median overall survival (OS) and the 12-month OS rate were 11.0 months (95% CI: 9.7-12.3) and 39.1% (95% CI: 19.7-61.5%), respectively. Patients with TP53 wild-type had significantly higher OS than those with TP53 mutant-type (13.0 months [95% CI: 10.5-15.5 months] vs. 9.0 months [95% CI: 7.4-10.6 months], p= 0.009). Multivariate cox proportional hazards analysis showed that TP53 was an independent prognostic biomarker for OS. Conclusions: The present study showed that anlotinib combined with TMZ had a promising efficacy in treating rHGG and TP53 was a potential biomarker to predict prognosis.
Cytology-histology correlation, time to diagnosis and time to therapy when cytology is performed in addition to biopsies in malignant spinal lesions of previously unknown malignant disease.
Authors: Asemissen Anne Marie , Köpke Leon-Gordian , Heuer Annika , Welker Lutz , Stangenberg Martin , Lübke Andreas , Schröder Malte , Dreimann Marc , Bokemeyer Carsten , Viezens Lennart , Krüger Lara
Published: June 2023

e14007

Background: Metastatic spinal lesions are the first manifestation of malignant disease in up to 30% of patients (pts). Spinal care, diagnostic evaluation and initiation of systemic therapy are crucial for outcome in pts with advanced cancer. Histopathology (HP) from bone specimens is time consuming and decalcification procedure can hamper diagnostic information. The additional evaluation of spinal lesions by cytopathology (CP) has the potential to reduce time to diagnosis (TTD) and time to therapy (TTT). Therefore, we performed simultaneous analysis of CP and HP specimens from suspected malignant spinal lesions to evaluate the diagnostic value of additional CP. This work was supported by the German Society for Spine Surgery (DWG). Methods: We obtained CP specimens by transpedicular, intralesional aspiration through a Yamshidi needle or touch preparation from solid tissue samples. CP and HP specimens from spinal lesions were evaluated in parallel in 54 pts (CP/HP group). We analyzed sensitivity and specificity of CP in reference to HP. Furthermore, we compared the TTD and TTT of CP/HP group with a retrospective cohort of 103 patients in whom only HP was performed (HP group). Results: The collection of CP samples was feasible without elongation of surgery time or any complications for the pts. In 52/54 (96%) pts a CP-specimen was successfully obtained. Of the 52 pts analyzed, multiple myeloma was diagnosed in 10 pts, solid malignancy in 34, 1 pt had lymphoma and 7 did not show malignancy. The most common solid malignancies were prostate cancer (n=9), breast cancer (n=5) and adenocarcinoma of the lung (n=5). The sensitivity and specificity of CP in reference to HP is 98% and 71%, respectively. The concordance of CP and HP in differentiating between hematologic or solid neoplastic lesions is 94.2%. TTD in the CP/HP group was significantly shorter compared to HP group (1.7±1.8 and 8.6±3.6 d, respectively; p<0.001). In addition, TTT in the CP/HP group was significantly shorter than in the HP group (19.3±14.4 d and 31.4±24.7 d; p=0.003). In 24.1% of pts a specific tumor therapy was initiated based on CP diagnosis before obtaining the results of HP. Conclusions: The evaluation of CP from malignant spinal lesions shows high sensitivity and concordance with HP and reduced TTD and TTT. Therefore, CP in addition to HP from spinal lesions of suspected malignancy has the potential to improve quality of life and prognosis in pts with advanced cancer. We therefore recommend the implementation of additional CP to HP in previously undiagnosed malignant spinal lesions.
Combination beta-adrenergic blockade and immunotherapy for the treatment of primary and metastatic brain cancer.
Authors: Lorrey Selena , Wachsmuth Lucas P , Ostrom Quinn T , Fecci Peter E.
Published: June 2023

e14017

Background: Brain tumors present a unique challenge to immunotherapeutic success, as immune responses in patients with brain tumors are suppressed both within the tumor microenvironment and peripherally. The systemic immunosuppression observed in brain tumor patients limits the capacity of the immune system to respond to immunotherapy. Brain tumor patients, particularly those with primary brain tumors like glioblastoma, represent a population in dire need of more thoughtful, targeted treatment approaches. Through this work we present an immunosuppressive axis specifically activated in the context of intracranial malignancies that inhibits immunotherapeutic success in these patients. We demonstrate that overactive adrenergic signaling is a major barrier to immunotherapeutic success. More specifically, beta-adrenergic signaling is known to suppress immune responses in various contexts. Our data indicate that combining beta-adrenergic blockade with immunotherapy provides a survival benefit in the setting of brain tumors, where immunotherapy alone has proven ineffective. Methods: Using the SEER Medicaid database, we retrospectively examined outcomes in patients with melanoma and lung adenocarcinoma brain metastasis who received checkpoint blockade therapy alone vs those concurrently on beta-blocker therapy. Results: We found that patients receiving combination therapy showed increased overall survival compared to those receiving checkpoint blockade alone. We then validated these findings in preclinical models of both glioma and melanoma brain metastases, demonstrating that combining immunotherapy and propranolol, a highly-prescribed FDA-approved beta-blocker, extended survival. Conclusions: Moving forward, we suggest that combination therapy with propranolol and immunotherapy, particularly checkpoint blockade, represents a promising translational treatment platform for patients with primary or metastatic intracranial malignancies.
A demographic and socioeconomic analysis of risk factors in meningeal melanomatosis.
Authors: Jacobs Evan J , Cook Madison , Wu Xinxin , Keirns Darby , Silberstein Peter T. , Hsia Beau
Published: June 2023

e14019

Background: Meningeal melanomatosis (MM) is a rare and aggressive central nervous system neoplasm that normally occurs in the leptomeningeal melanocytes. Meningeal melanomatosis represents only 0.06% to 0.1% of all primary brain tumors, but it is accompanied with a very poor prognosis with data showing a mean survival of 10 weeks after diagnosis. Despite intrathecal chemotherapy treatment, only a modest positive effect on survival was observed. Limited research has been done. In this study, demographic factors in patients diagnosed with MM from the National Cancer Database (NCDB) were analyzed to elucidate potentially valuable insights regarding its epidemiology. Methods: A retrospective cohort study using data collected between 2004–2020 from the NCDB included 137 patients with a histologically confirmed diagnosis of MN. The descriptive analysis included an examination of demographic factors such as sex, age, race, Hispanic status, insurance coverage, type of medical facility, and Charleson-Deyo score. Primary site was also analyzed. Results: A total of 137 patients were identified with a diagnosis of MM between 2004 – 2020. The most common primary sites of MM were the meninges, not otherwise specified (NOS) (43.8%), spinal meninges (29.2%) and cerebral meninges (19.0%). In the dataset, 50.4% of diagnosed patients were male. The average age of diagnosis was 51.4 years (SD = 21.5, range = 0 – 90 years). The majority of the individuals (73.7%) had a Charlson-Deyo comorbidity score of 0. Most of the individuals diagnosed with MM were non-Hispanic (83.9%) and 87.6% of patients with diagnosed MM were White. Among the 115 patients with available data for median household income, 37.4% were in the top income quartile. A greater proportion of patients, 54.7%, had private insurance compared to those without insurance or those insured through Medicare or Medicaid. The majority of patients resided in metropolitan counties with a population exceeding 250,000 (71.8%) For patients with documented treatment facility type (N = 99), 56.6% of patients were treated in an academic/research program. Conclusions: This first NCDB analysis fills a crucial void in the existing knowledge on MM. MM affected males and females equally, contrary to published literature which suggested a slight predominance in males. The most common primary sites of diagnosis were the meninges NOS, spinal meninges and cerebral meninges, which supports findings in the literature. This is a novel description of the socioeconomic factors of MM patients in the literature, showing that these patients tend to have higher incomes and reside in densely populated metropolitan areas, and are more likely to receive treatment in an academic medical facility. Additional research is imperative to elucidate the influence of demographic and socioeconomic factors on the diagnosis, treatment options, and overall survival outcomes for patients with MM.
Ivosidenib off-label use for IDH mutant gliomas: The MD Anderson Cancer Center real life experience.
Authors: Lam Keng , Lin Heather Y. , Williford Garret , Wathoo Chetna , Majd Nazanin
Published: June 2023

e14022

Background: Ivosidenib, a small-molecule IDH inhibitor is FDA approved for relapsed or refractory acute myeloid leukemia and cholangiocarcinoma with IDH1 mutation. Early phase clinical trials have shown promising findings for IDH mutant gliomas and results of larger studies of IDH inhibitors in gliomas are still pending. Meanwhile, neuro-oncologists continue to encounter patients with IDH mutant gliomas with limited treatment options. Here, we describe our experience with off-label use of ivosidenib in IDH mutant gliomas. Methods: This is a retrospective case series study in a single cancer care institute. Data points collected include but not limited to patient demographics, type of IDH mutation, treatment history prior to starting ivosidenib, duration of treatment, and progression-free survival. Descriptive statistics were used to summarize patient’s characteristics. The distribution of median progression-free survival (mPFS) was estimated by the Kaplan-Meier method. Results: From August 2018 to December 2022, we identified 13 patients with IDH-mutant glioma prescribed ivosidenib 500mg daily off-label. Four patients did not receive treatment: two were too sick soon after ivosidenib prescribed, and two were not able to get financial coverage. For the nine patients that were treated, median age was 37 (range 25-44). 8 were males and 1 was female. Five have IDH1 R132H mutations, 1p19q intact and four have IDH mutation and 1p19q co-deletion. The highest grade for the tumor is grade 3. Four have non-enhancing disease only. The median lines of therapy prior to starting ivosidenib was 2 (range 0-5). Three patients did not have radiation by the time they started ivosidenib, including two who received this drug as first-line treatment initiated by providers outside of MD Anderson. All patients are still alive as of January 11th, 2023. Disease control rate (all stable disease) was 78%. After a median follow-up of 17.8 (range 15-29) months, mPFS was 3.81 (95% CI: 1.25, 12.78) months. Patients with non-enhancing disease had better PFS than those with enhancing disease, but this was not statistically significant (median PFS: 8.28 vs 3.81 months, p-value = 0.42). Two patients had adverse events: one with grade 1 lethargy, and another patient had a grade 3 surgical wound infection unrelated to the drug requiring a pause in treatment. Conclusions: Ivosidenib was successfully approved by third party payers for treatment of nine patients with IDH mutant gliomas. Ivosidenib was well-tolerated with a modest PFS. Patients with non-enhancing disease may trend toward better PFS than those with enhancing disease. The updated survival data and potential correlation with clinical, molecular, and radiographic data will be presented at the conference.
Prevalence and characteristics analysis of CDKN2A/B deletion in glioma.
Authors: Zhuang Dongxiao , Han Tiantian , Guo Didi , Kong Rongrong , Chen Siqi , Dong Yuwei , Wang Mengjuan , Ding Ran , Deng Wanglong , Bu Fanfeng
Published: June 2023

e14026

Background: Glioma is the most common type of brain malignancy in adults. The 5th edition of the World Health Organization (WHO) highlighted the homozygous deletion of the CDKN2A/2B as a clinically important molecular alteration in IDH-mutant glioma. In the study, we reported the prevalence and characteristics analysis of CDKN2A/B deletion in glioma. Methods: This study retrospectively analyzed the genomic alteration of 2390 Chinese glioma patients during 2019-2022. Next-generation sequencing (NGS) of 131-gene profiling was performed to detect gene mutations in tumors of the patients. Patients were divided into two groups for copy number (CN) variation set, as heterozygous deletion (CN> 0.5, HET-del) or homozygous deletion (CN≤ 0.5, HOM-del) group. Results: A total of 743 (31%) cases were detected with CDKN2A/B deletion, 21 cases were children (< 18 years old), and 722 cases were adults, with a mean age of 53 years (0-85 years). CDKN2A/B deletion showed a higher frequency in the subgroup of IDH-wildtype glioma compared with IDH-mutant glioma in adults (39% vs. 15%, p<0.005). The age showed no significant difference between CDKN2A/B HET-del (n=420) and HOM-del (n=323) patients (average age: 53, p = 0.74). In both of the two groups, the most frequently somatic mutated genes were TERT, EGFR, PTEN. However, NF1 mutations were significantly enriched in the HET-del group (21% vs. 12%，p<0.005). Conclusions: Taken together, CDKN2A/B deletion were found in 31% glioma patients and showed higher frequency in IDH-wildtype glioma. NF1 mutations were significantly enriched in the HET-del group, which may reveal distinct prognosis and pathogenic mechanisms in glioma.
The efficacy and safety of anlotinib combined with bevacizumab in treatment of recurrent isocitrate dehydrogenase wildtype glioblastoma: A retrospective analysis.
Authors: Li Shuo , Lai Long , Hou Zhiwei , Tao Rongjie , Qu Bing , Zhang Hui , Yu Jinming
Published: June 2023

e14028

Background: Glioblastoma (GBM) is the most common and aggressive malignant primary brain tumor with a 5-year survival rate of 5%. There is no standard and effective treatment for recurrent GBM. Angiogenesis is recognized as a key event in the progression of GBM. Bevacizumab as an anti-angiogenic monoclonal antibody has been recommended by NCCN guidelines for recurrent GBM. Anlotinib is a small-molecule multi-target tyrosine kinase inhibitor (TKI) which has different function mechanisms and targets with bevacizumab. Therefore, we investigated the clinical efficacy and safety of anlotinib combined with bevacizumab in patients with recurrent IDH-wide type (wt) GBM on the basis of TMZ treatment. Methods: We retrospectively analyzed the clinical data of 18 patients with IDH-wt GBM in Shandong Cancer Hospital and Institute from 2019 to 2022. The primary endpoint was progression-free survival (PFS) and overall survival (OS) for combination treatment. The secondary endpoint was 6-months PFS rate, 1-year OS rate, objective response rate (ORR), disease control rate (DCR), OS and safety and toxicity profile. Results: All patients were diagnosed as WHO grade IV IDH-wt GBM and the median age of all patients was 55 years (range 39-76). Patients with recurrent GBM were first treated with anlotinib, followed by bevacizumab when patients developed progression or cerebral edema. In the overall population, the median OS for overall patients is 27 months, and the median survival time after first recurrence is 13.3 months. The median survival time of anlotinib treatment and combination treatment is 15.6 months and 12 months, respectively and the median PFS is 14.3 months and 9.1 months, respectively. The ORR for combination treatment was 27.8%, and 6-months DCR was 77.8%. The last follow-up date was October 15, 2022. By the last follow-up date, 3 patients were continuing anlotinib combined with bevacizumab treatment with no disease progression. The 6-months PFS rate was 78.9%, and the 1-year OS rate was 44.4%. The treatment-related adverse events (AEs) were shown in Table 3. The main AEs was bone marrow suppression (83.3%, 15/18), most of which were grade I and II (50%, 9). The AEs were relieved by adjusting the drug dose and symptomatic treatment. There were no treatment related deaths. Conclusions: Our study reported the clinical effect of anlotinib combined with bevacizumab treatment in recurrent GBM patients on the basis of TMZ treatment in a real-world setting. This is the first attempt to conduct dual antiangiogenic treatment in GBM patients. We demonstrate a promising result and suggest that this combination treatment may be a novel and safety treatment option for recurrent IDH-wt GBM patients.
Tumor treating fields (TTFields) therapy skin safety and prevention strategy using a fractionated schema protocol (3-days on/1-day off), effect on skin adverse events.
Authors: Gatson Na Tosha N. , Ornelas Sara , Manikowski Jesse , Toms Steven A , Leese Erika
Published: June 2023

e14030

Background: Tumor Treating Fields (TTFields) therapy is a locoregional, noninvasive modality currently approved for newly diagnosed (nd) and recurrent (r) CNS WHO grade 4 astrocytomas and glioblastoma (GBM), as well as pleural mesothelioma. TTFields are electric fields that disrupt cellular processes critical for cancer cell viability and tumor progression, and are generated by a portable device, delivered by skin-placed arrays. TTFields therapy is not associated with systemic toxicities, nor significant toxicities to healthy tissues or organs within the body; the most commonly associated adverse event (AE) is mild-to-moderate skin irritation beneath arrays, which can typically be managed with appropriate prophylaxis and timely intervention strategies (Lacouture et al 2014 and 2020). Here we report safety outcomes with a novel 3-day on/1-day off protocol strategy that aims to prevent and minimize skin irritation and limit treatment interruptions. Methods: In this dual center, retrospective analysis, adult patients with grade 4 ndGBM or rGBM followed a 3 days-on (72-80 h) and 1 day-off (16–24 h) TTFields therapy use schedule, with skin specific wound prevention guidance (barrier forming moisturizing topical creams and selenium-based shampoos) during the ‘off day’. Information on the presence and severity of skin AEs was collected from patient charts. Results: Adult patients (N = 76) received TTFields therapy with the 3-on/1-off protocol between 2015 and 2021 at 2 healthcare centers in the United States. Median age was 57 years (range 25–81 years) and mean time on TTFields therapy was 73 weeks. Skin AEs occurred in 5% of patients on the 3-day on/1-day off protocol, as compared to 16% and 52% reported in the randomized, phase 3 EF-11 (NCT00379470) and EF-14 (NCT00916409) studies in patients with rGBM and ndGBM, respectively. As in the clinical studies, most AEs were mild in nature. All patients who had a skin AE, prior to starting the 3-days on/1-day off protocol, received treatment to resolve the AE. In addition, no patients had to discontinue TTFields therapy or modify array placement due to skin AEs while on the 3-on/1-off protocol. Conclusions: These real-world clinical practice data confirm the positive known safety profile of TTFields therapy and are consistent with findings from clinical studies. Mild-to-moderate skin irritation is the AE most commonly associated with TTFields therapy, which is mostly manageable and resoluble. These data suggest that skin irritation could be further reduced with active preventative approaches, as described in the fractionated schema (3-days on/1-day off) protocol.