bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ki67 and PR to predict sensitivity of palbociclib: A real-world study.
Authors: Shao Xi-Ying , Shen Xia-Bo , Li Guang-Liang , Zheng Ya-Bing , Cao Wen-Ming , Chen Zhan-Hong , Wang Xiao-Jia 
Published: June 2021

e13032 Background: Palbociclib combined with endocrine therapy are approved as a front-line treatment for hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC). A key challenge remains to uncover biomarkers to identify those patients who may benefit from palbociclib treatment. Methods: We retrospectively analyzed the values of Ki67 and progesterone receptor (PR), detected by immunohistochemistry, in 81 ABC patients with palbociclib and hormone therapy treatment, and evaluated the impact on progression-free survival (PFS). Results: In total population, women with Ki67≥14% had marginal significant shorter PFS than those with Ki67<14%. Patients with Ki67≥30% had significant shorter PFS than those with Ki67<30% ( P=0.048). While PR≥ 20% was associated with longer PFS. And what’s more, the change trend of Ki67 or PR from primary tissue to metastatic lesions was related to PFS. In regard with hormone therapy subgroup, there were significant association between Ki67 and PR levels and PFS in aromatase inhibitors (AIs) subgroup. Patients with Ki67≥14% or Ki67≥ 30% had shorter PFS than those with Ki67<14% or Ki67<30%, respectively ( P=0.024, P <0.001). Additionally, the change trend of Ki67 or PR from primary tissue to metastatic lesions was related to PFS. When both Ki67 and PR are considered, there were significant differences between different cohort. Compared with those with Ki67≥14% and PR <20%, patients with Ki67<14% and PR≥20% had significant longer PFS. In addition, patients with Ki67<30% and PR≥20% had significant longer PFS than those with Ki67≥30% and PR<20%. Besides, in AIs cohort, patients with Ki67<14% and PR≥20% had significant longer PFS than those with Ki67≥14% and PR <20%. Women with Ki67<30% and PR≥20% had significant longer PFS than those with Ki67≥30% and PR<20%. Conclusions: The present study indicates that both Ki67 and PR have a greater impact on palbociclib and hormone therapy and may help selecting a more effective partner of palbociclib.
Relative risk of hepatotoxicity associated with cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials.
Authors: Jahan Nusrat , Wongsaengsak Sariya , Rehman Shabnam , Adhikari Nimesh , Tijani Lukman Aderoju , Raghunath Arrvind 
Published: June 2021

e13037 Background: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) such as palbociclib, abemaciclib, and ribociclib have changed the landscape of management of estrogen receptor-positive and HER2-negative breast cancer in recent years. We conducted a systematic review and meta-analysis of phase 3 randomized controlled trials (RCTs) to determine the relative risk of hepatic dysfunction associated with the use of CDK4/6i. Methods: We conducted a systematic search using PRISMA guidelines in PubMed, EMBASE, American Society of Clinical Oncology (ASCO) and San Antonio Breast Cancer Symposium meeting abstracts from inception through Jan 30, 2021. Phase 3 RCTs using CDK4/6i in the intervention arm and reporting the number of events for elevation of liver enzymes were included in the analysis. The Cochran-Mantel-Haenszel method and random effects model were used to calculate the pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was tested by Cochran’s Q test and I2 value. Results: Nine phase 3 RCTs — MONALEESA-2, MONALEESA-3, MONALEESA-7, MONARCH 2, MONARCH 3, MONARCH plus, monarchE, PALOMA-2, and PALOMA-3 — randomizing 5,809 patients in the CDK4/6i arms and 4,638 patients in the control arms were included in the analysis. The CDK4/6i arms used CDK4/6i such as palbociclib, abemaciclib, or ribociclib in combination with one of the standard-of-care endocrine therapies such as letrozole, anastrozole, tamoxifen, or fulvestrant. The control arms received placebo along with respective endocrine therapies. The incidence of any grade alanine aminotransferase (ALT) elevation was 13.1% in the CDK4/6i arm and 5.4% in the control arm, pooled RR: 2.18, 95% CI: 1.74-2.72, P < 0.00001, I2 = 45%. The incidence of any grade aspartate aminotransferase (AST) elevation was 12.5% in the CDK4/6i arm and 5.3% in the control arm, pooled RR: 2.00, 95% CI: 1.57-2.54, P < 0.00001, I2 = 57%. The incidence of grade 3/4 ALT elevation was 4.1% in the CDK4/6i arm and 0.8% in the control arm, pooled RR: 4.43, 95% CI: 3.08-6.37, P < 0.00001, I2 = 0%. The incidence of grade 3/4 AST elevation was 2.9% in the CDK4/6i arm and 0.9% in the control arm, pooled RR: 2.70, 95% CI: 1.75-4.19, P < 0.00001, I2 = 29%. No fatal case of hepatotoxicity has been reported. Conclusions: Cyclin-dependent kinase 4/6 inhibitors are associated with significant risk of any grade and grade 3/4 hepatic enzymes elevation. Regular monitoring of liver function is a key to early detection and initiation of appropriate management.
Telemedicine use and satisfaction amongst radiation oncologists during the COVID-19 pandemic: Evaluation of current trends and future opportunities.
Authors: Deshane Alok , Damico Nicholas , Kharouta Michael , Wu Anna , WANG GI-Ming , Machtay Mitchell , Kumar Aryavarta M. S. , Choi Serah , Bhatt Aashish D. 
Published: June 2021

e13503 Background: During the COVID-19 pandemic telemedicine became an attractive alternative to in person appointments. The role of telemedicine in patients who undergo frequent on site treatment, such as radiation therapy, is unclear. The purpose of this study was to examine telemedicine use, physician satisfaction and barriers to continued use in radiation oncology. Methods: An anonymous, electronic survey was distributed to radiation oncologists internationally. Participants described demographic and practice characteristics and a 5 point Likert scale assessed provider satisfaction, ease of use and overall utility of telemedicine. Analyses include descriptive statistics and subgroup comparisons using Chi-square and Fisher’s exact test. Results: 232/5343 (4.3%) completed the survey, 63.8% of whom were male, 52.6% age 50 or younger and 78.0% from the United States (U.S.). Only 14.2% used Telemedicine previously, which increased to 93.1% during COVID-19. Amongst all telemedicine users, usage rates were 77.9% for initial consultations, 97.2% for follow-up visits, and 35.9% for on-treatment visits. 69.8% report that <25% of patients requiring treatment experienced delays due to COVID-19. Most conducted appointments from the workplace, with 40.1% also doing so from home. Satisfaction was high at 73.8%, perceived usefulness was 76.9% and 81.5% hope to continue using telemedicine after the pandemic. However, 82.4% had concerns with the inability to examine patients. Although 82.1 % believed that telemedicine would improve patient access to health care services overall, 63.0% were concerned with patient ability to access required technology. 49.5% had concerns regarding continued billing/reimbursement; less commonly at government centers (18.8%) compared to academic/satellite facilities (52.7%) and free-standing centers/community hospitals (50.7%), p=0.039 for both comparisons. These concerns were also significantly higher amongst US physicians (53.2% vs 34.9%, p=0.048). Conclusions: Widespread adoption of telemedicine by radiation oncologists occurred during COVID-19 with high rates of satisfaction and interest in continued use. Sustained reimbursement for telemedicine services is a significant concern, particularly in the US and outside of government facilities. [Table: see text]
Evaluation of patient navigation and delivery of head and neck cancer therapy during COVID-19 pandemic: A single institution experience.
Authors: Cervantez Sherri Rauenzahn , Mesa Ruben A. , Viles Jeremy , Salazar Mary , Villarreal Leslie , Bonnen Mark , Asper Joshua 
Published: June 2021

e13510 Background: The COVID-19 (COVID) pandemic presents many challenges to cancer patient treatment. Care coordination pathways are more complex to ensure safe screening and monitoring for COVID while reducing person-to-person interaction. The oncologic management of head and neck cancer (HNC) involves an interdisciplinary workflow. Time from diagnosis/specialized oncologic referral to initiation of treatment is critical for optimal outcomes. The insertion of any additional rate limiting factor could drastically increase the timeliness to care. Our study evaluates the effectiveness of patient navigation and the impact of institutional COVID process on timeliness to treatment. Methods: Operational workflow changes were set in place with goal of obtaining COVID testing prior to initiation of therapy. Patients with COVID symptoms after initial clearance were subjected to additional COVID testing. COVID screening was obtained in a single location when feasible. COVID positive or patients with pending results were triaged to determine risk/benefits of delaying treatment initiation and CDC guidelines for safe administration of therapy were considered. Patients with pending or positive results, but acute situation, were treated after hours in full PPE gear in order to reduce exposure risks. Results: Navigation information for 88 HNC patients were collected from 1/1/20 to 1/1/21. All patients were treated with curative intent. COVID testing data were collected contemporaneously with the pandemic from 4/1/20 to 1/31/21. Thirty patients with HNC required coordination of CMT and completed COVID screening test an average of 19 days prior to the start of therapy (29 negative; 1 positive). Two (6%) patients received their screening results after therapy initiation. Four patients did not complete therapy (13%); 26 completed (86%). Patients treated with radiation averaged 31 treatments (range 30-35) each treatment indicative of an aerosolized risk exposure. Each infusion representing and aerosolized and IV risk exposure. During the course of care we experienced zero patient-to-staff contracted COVID positives. Five staff members tested positive for COVID however contact tracing indicated outside source. Prior to the pandemic, average time from referral to appointment (TRA) with oncology specialist was 14.62 days, time from first appointment with oncology specialist to first treatment modality (TAT) was 46.29 days, and time from referral to our center and initiation of first treatment (TRT) was 60.91 days. During the pandemic, from March 2020 to May 2020, average TRA was 10.51 days, TAT was 24.09 days, and TRT was 34.6 days. Conclusions: Appropriate navigation, protocols and team vigilance resulted in improved timeliness to treatment. Continued delivery of oncologic care to HNC patients can be achieved without increased patient or staff risk for contraction of COVID.
Can acute care utilization be reduced by a risk score-based intervention alone?
Authors: Csik Valerie Pracilio , Binder Adam F , Handley Nathan , Li Michael , Croyle Megan , Waldman Lauren , Worster Brooke 
Published: June 2021

e13523 Background: Acute care utilization (ACU), encompassing both emergency department visits and hospitalizations, is common in patients with cancer, with nearly three quarters of patients with advanced disease hospitalized at least once in the year after their diagnosis. From a population health perspective, focusing on the highest risk patients is likely to identify the top 5% while the next 30% can be considered rising risk and are likely to need care management support. Many risk scoring systems have been developed, but few have demonstrated effective integration in clinical practice. We sought to evaluate if a risk assessment tool alone was adequate to determine an appropriate patient outreach strategy that results in reduced ACU. Methods: We utilized the REDUCE score (Reducing ED Utilization in the Cancer Experience - see 2020 ASCO Quality Abstract 208) to develop an intervention conducted in two phases. Phase I included a chart review and targeted outreach to high risk patients identified by REDUCE by a nurse navigator. Outreach resulted in communication of patient needs to the care team. Phase II involved initial identification by REDUCE followed by further screening assessment with a distress screen. Those who were high risk and had high distress (score ≥4) were discussed by an interdisciplinary team (supportive medicine physicians, social work, nurses, nurse practitioners) to determine an intervention. Results: Of the patients in phase I (N = 138), 26.1% had ACU afterward, while in phase II (N = 169) 7.1% had ACU. The average distress score among all patients in the phase II group was 6.0 and the REDUCE score was 2.87, while the subset of patients who experienced ACU had an average distress score of 6.4 and a REDUCE score of 3.22. These findings indicate that there is a directional correlation between REDUCE score and distress screening results. Conclusions: The REDUCE score may be a valuable tool to assist in identifying patients at risk for ACU, but the significantly less ACU in phase II compared to phase I suggests that the risk score combined with a biopsychosocial screening, such as distress as required by the Commission on Cancer, may prove more valuable than the risk score alone. To identify the most impactful intervention, and to fully understand the implications of a patient’s specific REDUCE score within the high risk category, additional assessment would be beneficial. These preliminary results highlight that directionally correlated measures obtained from a biopsychosocial screening in combination with a risk score gives a more complete picture of patient’s overall risk of ACU.
Geolocation of uterine cervical neoplasms (UCN) in the context of a prevention program in Tucumán, Argentina.
Authors: Holgado Silvia Victoria , Vinuales Ana , Goroso Daniel Gustavo , Watanabe William Tsutomu , Zarba Juan Jose , Gonzalez Adriana , Bliss Natalia , Vega Italia 
Published: June 2021

e13535 Background: : UCN is one of the major public health problems in Tucumán, that must be related to the type of population to which it belongs (Rural or Urban). Geolocation allows the processing and analysis of geographic information whose results support decision-making in solving complex planning and management problems on the territory. The objective of this study is to carry out management quality controls of the PPCCUT (Programa de Prevención de Cáncer Cervical Uterino-Tucumán) to achieve adequate prevention and detection of uterine cervical lesions in the province. Methods: An observational cross-sectional study of 1343 women, (16-90 years), with a biopsy diagnosis UCN, under PPCCUT (years 2013-2020). Preanalytical work: allowed the review quality the registries and the diagnoses follow-up. Data recollection from SITAM (Online Information System for Screening), population registry database. Variables: Address: registered in SITAM, joined by information from the provincial female electoral roll 2019. Histological Diagnosis: High grade squamous intraepithelial lesion (HSIL), Invasive Squamous Carcinoma (ISC), Adenocarcinoma In situ (AIS), Invasive Adenocarcinoma (IDA). Analytical work: The conversion from address to latitude and longitude was performed by programming Google Sheet. This data was segmented by hospital center and opened in layers inside QGIS, as well as the map of Argentina. Results: Preanalytical. Register showed from 1343 patients received 1748 biopsies, were excluded 160 without address (incomplete data loading by the effectors). Lack of coordination in diagnosis area: 33 patients received first “in situ diagnosis” and in a short time later were consider “invasive lesions”. Some Patients had 2 bis 6 biopsies with same diagnosis. Analytical (geolocation): showed the influence of PPCCUT outside the province, including living abroad. It was found correlation between patients’ distribution with the population density. Conclusions: The importance of the work lays in the lack of antecedents in the application of the geolocation tool in programs of UCN in Tucumán and in other regions of Argentina. This allowed monitoring in different aspects of the programmatic management.
Cancer patients diagnosed with COVID-19 infection: A multicenter retrospective cohort of nine Brazilian cancer centers.
Authors: Padua Tiago Costa de , Monteiro Mariana Ribeiro , Almeida Kaique , Souza Camila Brambilla , Pezzutti Daniela , Borges De Andrade Maria Clara , Maiolino Angelo , do Carmo Rafael Luis Moura Lima , Freitas Tuane Borges do Livramento , Longo Cecilia , Perdigao Maria Carolina Lopes , Ferreira Cynthia Lemos , Sousa Tercia Tarciane Soares de , Cruz Sueli Monterroso da , Kinupe Abrahao Ana Beatriz , Piotto Gustavo Henrique Munhoz , Vieira Fernando Meton de Alencar Camara , Araujo Luiz H. 
Published: June 2021

e13600 Background: The COVID-19 infection was declared pandemic in March 2020. Since then, multiple studies have attempted to correlate clinical factors with risk of complications from COVID-19, including cancer. However, cancer patients are underrepresented in clinical trials and the results vary between different cohorts. Methods: We conducted a multicentre retrospective study, based on systematic review of medical records, including nine cancer centers, located in five different Brazilian cities. Patients were diagnosed with COVID-19 through RT-PCR between March 15, 2020 and August 13 , 2020. Poisson regression models were then used to test for an association between clinical characteristics and severity of COVID-19 infections. Results: 102 patients had data collected for analysis, 85 (83.3%) of whom were hospitalized due to complications from COVID-19 infection. The median age was 65.8 years, most were female patients (61.8%) and white (73,5%). 78.4% had a performance status of 0-1, and the most common cancer subtypes were gastrointestinal (30.4%), breast (22.6%) and hematological (13.7%). Almost 40% of population had stage IV disease. Mortality rate for all hospitalized patients was 36.5%, while for those admitted to the ICU it was 68.4%. Key univariable risk factors for mortality included age (RR 1.03), ECOG ≥ 2 (RR 1.83), hypertension (RR 1.72), lung metastasis (RR 1.67), and lymphocytes ≤ 1000 admission (RR 2.40). At the multivariable analysis, the risk factors were also age (RR 1.02), primary lung cancer (RR 2.61), lung metastasis (RR 2.86), and coronary disease (RR 3.76). Conclusions: Despite the high mortality of patients hospitalized with COVID-19, our data are compatible with other cohorts. Cancer patients must be carefully monitored in pandemic periods of infectious diseases.
Association of serum brain-specific protein fragments and brain metastases in patients with metastatic breast cancer.
Authors: Damaso Sara , Willumsen Nicholas , Cavaco Ana C. Martins , Corredeira Patrícia , Pacheco Teresa Raquel Duarte , Costa Ana Lucia , Faria Claudia C , Tzara Ourania , Henriksen Kim , Karsdal Morten A. , Ali Suhail M. , Leitzel Kim , Lipton Allan , Costa Luis 
Published: June 2021

e14007 Background: Brain metastases (BrMs) occur frequently in patients with breast cancer (BC) and represent one of the most difficult-to-treat events. Novel clinical tools are needed to identify BC patients at high risk of developing BrMs. Blood-based liquid biopsies represent a minimally invasive procedure that may detect surrogate markers of pathological changes occuring in the brain as a result of BrMs. Here we evaluated serum levels of a panel of brain-specific protein fragments in metastatic BC patients with BrMs, with no-BrMs and controls. Methods: Our cohort includes stage IV BC patients with BrMs (n= 27; median age 51 y.o.) and no-BrMs (n=50; median age 53.5 y.o.), and healthy controls (H) (n=23, median age 50 y.o.). Serum levels of 5 brain-specific protein fragments were measured by immunoassays and compared between groups. No-BrMs samples were collected at the time of metastatic disease diagnosis; BrMs samples were collected at BrMs diagnosis and before local treatment. Association with overall survival (OS) was evaluated by univariate Cox regression analysis. Results: All markers were significantly higher in patients with no-BrMs compared to H. Only Neurocan, Tenascin-R and GFAP were significantly higher in patients with BrMs compared to H. When comparing metastatic BC patients, significantly higher levels of Tau-A, Tau-C, Neurocan and GFAP were found in no-BrMs patients versus BrMs (Table). Association with OS was not found in BrMs patients, although a trend for high Tau-A levels to predict poor OS was detected in the no-BrMs group (HR 4.4, 95%CI 0.9-21.3, p=0.068). Conclusions: Protein fragments expected to be derived from brain remodeling consequent to BrMs were elevated in BC patients both with BrMs and no-BrMs at the time of sampling, with an overall trend for the highest levels to be found in patients with no-BrMs. This may suggest that brain remodeling processes are associated with BC and could partly explain the relatively high incidence of BrMs relapse in BC. Further studies requiring samples collected pre- and post-treatment are needed to further validate the diagnostic and prognostic value of these non-invasive biomarkers in BC BrMs setting. [Table: see text]
Prognostic value of methylation status of MGMT gene promoter in patients with glioblastoma after combination treatment.
Authors: Vlasov Stanislav G. , Gvaldin Dmitry Yu. , Pushkin Anton A. , Kit Oleg I. , Engibaryan Marina A. , Sakun Pavel G. , Voshedskiy Vitaliy I. , Gusareva Marina A. , Komandirov Maksim A. , Kultysheva Yulia A. , Solntseva Anna A. , Rodionova Olga G. , Karnaukhova Elena A. , Khatyushin Vladislav E. , Teplyakova Maria A. , Kecheryukova Takhmina M. , Zbrailova Ekaterina S. , Rogova Tatiana S. 
Published: June 2021

e14025 Background: The effectiveness of radiation therapy in the classical and stereotactic treatment regimens of the primary glioblastoma multiforme was analyzed and compared. Methods: 87 patients with primary glioblastoma multiforme were hospitalized during the study period. 17 patients of them were in the treatment group (stereotactic radiotherapy, dose per fraction 2 Gy, 60 Gy total dose, CTV 2.0 cm, PTV 0.1 cm - group 1), and 70 patients were in the control group (conventionally fractionated radiotherapy, dose per fraction 2 Gy, 60 Gy total dose, CTV 2.0 cm, PTV 0.5 cm - group 2). Patients of both groups were treated with alkylating agents as the third stage of complex treatment. MGMT methylation was evaluated by pyrosequencing. Results: The use of stereotactic radiation therapy allowed to conduct a full course of treatment without interruption, whereas in the second group, due to the development of adverse reactions, the course was interrupted for 7 patients (10%). The advantage of stereotactic radiation therapy was a less pronounced increase and rapid regression of neurological deficits during treatment, manifested by better local control for 6 months. Hypermethylation of MGMT was detected in 39% of glioblastoma cases and was not detected in non-tumor tissue. The presence of promoter methylation disrupts DNA repair and is associated with longer survival in glioblastoma patients receiving alkylating agents. Note that the median survival of patients with MGMT hypermethylation in the group 1 was 285 days (IQR = 323.75), and in the group without hypermethylation was significantly more than 338.5 days (IQR = 476) (p = 0.045). A similar trend was observed in the second group: in patients with hypermethylated MGMT, the median survival was 271 days (IQR = 337), the result is different from patients without hypermethylated MGMT – 342 days (IQR = 493) (p = 0.039). Conclusions: As a result, the application of the stereotactic approach of radiation therapy in the complex treatment of patients with glioblastoma and their classification by the MGMT methylation status with a cut-off point of 10% has the basis for improving the effectiveness and tolerability of radiation therapy and contributes to the overall survival of patients.