bluuebunny/crossref_metadata_2025_split huggingface dataset:
Stereotactic radiosurgery (SRS) for brain metastasis (BM) in hormone receptor positive (HR+) HER2 negative breast cancer (BC).
Authors: Singareeka Raghavendra Akshara , Gao Chao , Wang Fuchenchu , An Ran , Wang Yan , Suki Dima , Heimberger Amy B. , Tripathy Debu , Li Jing , Ibrahim Nuhad K. 
Published: June 2021

1069 Background: With the increase of the utilization of SRS for the treatment of oligometastatic BM over surgical reaction or whole brain radiation therapy (WBRT), we sought to evaluate the impact of SRS on overall survival in HR+Her2- BC and prognostic factors associated with SRS. Methods: We reviewed prospectively collected data in the electronic data bases of the breast medical, surgical and radiation oncology departments at MD Anderson cancer center. We aimed at identifying HR+HER2- BC patients who received upfront SRS for BM’s between 08/10/2009 and 02/27/2018.Overall survival was defined as the time from the first SRS to last follow-up/death. Multivariate analysis by the Cox proportional hazards regression analysis was performed to evaluate the prognostic factors (age at BM, stage, Karnofsky performance score (KPS), symptomatic BM, BM at 1stdistant metastatic presentation, extracranial Disease, treatment history, salvage therapy, number of brain lesion treated) of SRS that influenced survival. Results: A total of 125 patients were identified, and we are reporting on 68 with completed analysis. Median age at time of first SRS was 53.86 years. 51 patients of the 68 were deceased at the time of this analysis and 17 patients were alive at the time of last follow-up. 49 patients (72.06 %) presented with radiation necrosis after SRS; 36 patients (52.94 %) presented with BM as 1st distant metastasis including metastasis to other sites. Number of BM’s lesions <4 was 60 (88.2%) and >=4 was 7 (10.3%). The median follow-up from time of first SRS for survivors was 10.84 months. 24 (35.29%) received two or more sessions of SRS and the mean time between first and second SRS sessions for these patients was 14.24 months. Median time from first SRS to second SRS for ER+HER2− patients was 10.84 months (n = 24); on multivariable analysis, higher Karnofsky performance score (KPS) was associated with better survival compared to no salvage therapy. Patients with KPS>90 (p=0.005) had better survival and reduced the hazard by a factor of 0.33 (or 67%). Receiving SRS (p=0.0003) or SRS+WBRT (0.0001) as salvage therapy reduced the hazard (risk of death) by 86% and 85%, respectively. Conclusions: SRS is an effective treatment modality for HR+HER2- BM from BC. Patients who received SRS or SRS and WBRT, KPS >90 had better survival than patients who didn’t receive any salvage therapy. Updated data will be available at the time of the presentation.[Table: see text]
Decreased enrollment of patients with advanced lobular breast cancer compared to ductal breast cancer in interventional clinical trials.
Authors: Abel Mary Kathryn , Melisko Michelle E. , Rugo Hope S. , Chien Amy Jo , Diaz Italia , Levine Julia K. , Griffin Ann , McGuire Joseph , Esserman Laura , Borno Hala , Mukhtar Rita A. 
Published: June 2021

1092 Background: Response Evaluation Criteria in Solid Tumors (RECIST) criteria are often used to measure tumor response in cancer trials, especially in the stage IV setting. However, RECIST requires measurable disease, which is less common in invasive lobular breast carcinoma (ILC) of the breast, a diffusely growing tumor type, compared to invasive ductal carcinoma (IDC). We examined the prevalence of RECIST in breast cancer clinical trials, and whether there are differential trial enrollment rates by histology and stage. Methods: We analyzed the clinicaltrials.gov database to evaluate the proportion of interventional, stage IV clinical trials that require measurable disease as inclusion criteria or outcome measures. We then performed an institutional cohort study comparing the proportion of patients in the University of California, San Francisco (UCSF) OnCore clinical trials management system (CTMS) to the UCSF Cancer Registry between 2000-2018, stratified by histology and stage. We hypothesized that the proportion of patients with ILC in the CTMS would be significantly lower than in the cancer registry. Results: There were 146 actively-recruiting, interventional clinical trials for stage IV breast cancer that were identified in our search on clinicaltrials.gov. Overall, 108 (74%) required measurable disease for study participation. The UCSF Cancer Registry included 8,679 patients, while the UCSF OnCore CTMS included 1,511 patients (Table). In those with early stage disease, where RECIST is not typically used, there was no difference in the proportion of ILC patients enrolled in clinical trials versus in the cancer registry. However, among those with stage IV disease, there was a significantly lower proportion of patients with ILC in the CTMS than in the cancer registry (9.2% versus 17.9%, p = 0.005). In contrast, patients with stage IV IDC were overrepresented in the clinical trials database compared to the cancer registry. Conclusions: Patients with metastatic ILC were significantly less likely to be enrolled in clinical trials than those with metastatic IDC. This decreased enrollment may be due to the widespread use of RECIST, and further investigation is needed to ensure equity in access to clinical trials.[Table: see text]
Efficacy of a fully remote primary lecture series at an academic hematology and oncology fellowship program.
Authors: Ghanem Sassine , Harewood Janine Claudia Khadija , Yee Jia-Llon , Campbell Jimenez Brian , Gonsky Jason Parker 
Published: June 2021

11031 Background: 615 fellows began training in American combined hematology/oncology fellowship programs in July 2020. These new fellows face a steep learning curve. The coronavirus pandemic has significantly affected how we learn, with programs having to convert most collective learning to a completely virtual format. Research on the efficacy of introductory lecture series in academic hematology/oncology programs is limited especially regarding virtual formats. We introduced a virtual introductory lecture series with the goal of increasing the clinical confidence and knowledge base of first-year fellows. Methods: A once weekly remotely-delivered two-hour primer series was designed with lectures given by both third-year fellows and faculty from July-August 2020. Fellows were asked to complete pre & post-test evaluations of each lecture. Evaluations included a combination of knowledge-based questions & self-reported confidence assessment. Results: 14 fellows were assigned pre- and post-tests in the study. 1 fellow was excluded due to lack of participation. A total of 123 paired pre and post-tests were compared. Data analysis was performed with SPSS v 24.0 using the paired samples t-test. Pre and post-tests were graded on a scale of 0-100. The pre to post mean difference compares the mean test result of the post tests to that of the corresponding pretests. Questions were divided into 2 groups. The 1st group tested the fellow’s medical knowledge regarding the pathology while the 2nd group tested the comfort in the management, diagnosis and treatment. In the statistical analysis, these questions were defined as “Knowledge” and “Comfort” accordingly, the sum as “Complete”. A statistically significant improvement in post-test knowledge for fellows of all years was noted with a pre to post test mean difference of 12.52, P <.0001. The difference was more pronounced among 1st year fellows with a pre to post test mean difference of 16.84, P <.0001. A similar improvement was seen for the comfort in management questions. The post-test comfort pre to post test mean difference was 10.48, P <.0001 for fellows of all years and 6.70, P <.0001 for first year fellows. Conclusions: A remotely-delivered introductory lecture series for fellows in a hematology/oncology training program increases both clinical knowledge and clinical confidence in fellows of all years of training.[Table: see text]
NCI protocol 10250: A phase II study of temozolomide and olaparib for the treatment of advanced uterine leiomyosarcoma.
Authors: Ingham Matthew , Allred Jacob B. , Gano Katherine , George Suzanne , Attia Steven , Burgess Melissa Amber , Seetharam Mahesh , Boikos Sosipatros Alexandros , Bui Nam , Chen James Lin , Close Julia Lee , Cote Gregory Michael , Thaker Premal H. , Ivy S. Percy , Das Biswajit , Shapiro Geoffrey , Kochupurakkal Bose , Trepel Jane B. , Pommier Yves , Schwartz Gary K. 
Published: June 2021

11506 Background: Uterine leiomyosarcoma (uLMS) is an aggressive sarcoma subtype with frequent metastatic relapse. After failure of front-line chemotherapy, remaining options provide limited benefit (trabectedin: ORR 11%, mPFS 4.0 mos; pazopanib: ORR 11%, median PFS 2.9 mos; dacarbazine: ORR 9%, mPFS 1.5 mos). Recent molecular studies suggest uLMS harbors characteristic defects in the homologous recombination (HR) DNA repair pathway, including somatic biallelic BRCA2 deletion in 10%, implicating potential sensitivity to PARP-inhibitor based treatment approaches. In preclinical uLMS models in which temozolomide (T, an oral equivalent to dacarbazine) or the PARP inhibitor olaparib (O) showed limited single agent activity, the combination of T + O was highly effective in inhibiting uLMS tumor growth and promoting apoptosis. Methods: NCI protocol #10250 is a single-arm, open-label, multi-center phase II study evaluating T + O in advanced uLMS. Pts had progression on ≥ 1 prior line and ECOG PS ≤ 2. Pts received T 75 mg/m2 PO daily + O 200 mg PO BID days 1-7 in 21-day cycles. Primary endpoint was ORR. A one-stage binomial design was used. If ≥ 5/22 responded, the treatment was considered promising (95% power; α = 0.06). All pts underwent paired tumor biopsies. Correlative assays to evaluate for HR deficiency (whole exome sequencing/RNAseq, RAD51 foci formation) and for intrinsic PARP inhibitor resistance (SLFN11 expression) will be correlated with response. Results: 22 patients were evaluable (median age 55, median prior treatment lines 3). Median follow-up was 10.8 mos. Primary endpoint, ORR within 6 mos of initiating treatment, was 23% (5/22). Overall ORR was 27% (6/22). Median PFS was 6.9 mos (95% CI: 5.4 mos – not estimable (NE)). Median duration of response (DOR) was 12.0 mos (95% CI: 9.5 mos – NE). Hematologic toxicity was common (grade 3/4 neutropenia, 77%; thrombocytopenia 32%) but manageable with dose modification. Correlative assays are ongoing with plans to present at the meeting. An immunohistochemical assay for RAD51 foci has been adapted for uLMS samples and clearly distinguishes BRCA2- deleted and wild-type tumors. Conclusions: NCI 10250 met the prespecified primary efficacy endpoint of ORR in a population of patients with heavily pre-treated uLMS. Responses are durable (median DOR 12 mos). Correlative assays are being completed to evaluate whether uLMS tumors with HR deficiency or with preserved SLFN11 expression are most sensitive to T + O and may underlie durable responses. A randomized study of the combination is planned. Clinical trial information: NCT03880019.
Updated results of European Organization for Research and Treatment of Cancer (EORTC) phase 2 trial 1202 cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma.
Authors: Sanfilippo Roberta , Hayward Richard L , Musoro Jammbe , Benson Charlotte , Leahy Michael Gordon , Brunello Antonella , Blay Jean-Yves , Steeghs Neeltje , Desar Ingrid , Ali Nasim , Hervieu Alice , Thway Khin , Marreaud Sandrine , Litiere Saskia , Kasper Bernd 
Published: June 2021

11518 Background: Treatment options for patients with unresectable and/or metastatic dedifferentiated liposarcoma (DDLPS) are limited. The most effective agents include doxorubicin, ifosfamide, trabectedin and eribulin, but, in general, objective response rates (ORR) and progression free survival (PFS) are modest. Cabazitaxel exerts its effect through inhibition of microtubular disassembly and has been shown to be relatively safe, effective and well-tolerated. EORTC 1202 assessed whether cabazitaxel demonstrated sufficient antitumor activity in patients with metastatic or inoperable locally advanced DD LPS to justify further investigation in a phase III setting. Methods: This was an international multi-center, open label single arm phase II trial. The clinical cut-off date for the primary analysis was performed on August 31, 2020. Data base lock was performed on February 2, 2021. Eligible patients with metastatic or inoperable locally advanced DD LPS, after a centralized pathological review, were treated with cabazitaxel 25mg/m² IV infusion over 1 hour every 21 days. Primary endpoint was PFS rate at 12 weeks assessed by local investigator per RECIST 1.1. Based on a Simon two-stage design, at least 4 out of 17 (Stage 1) and 11 out of 37 (Stage 2) eligible and evaluable patients who are progression-free at 12 weeks were needed. Currently, a centralized radiological assessment is ongoing. Results: Forty patients were registered by 10 institutions in 4 countries between March 2015 and March 2019, with 2 patients being ineligible. One patient was still on treatment at the clinical cut-off date. The number of cycles ranged from 1 to 30, with a median of 5; 26 patients (65%) received at least 4 cycles of cabazitaxel. PFS at 12 weeks was 55% (conditional 1-sided 95% CI 40.8-100), achieving the primary study endpoint. The median FU was 21.6 months, median PFS was 6 months and median OS 21 months. RR was 8% with one CR and two PR. Twenty-three(60.5%) pts had a SD. Disease control (PR+SD) was achieved in 26 patients (68%). The most common cabazitaxel -related grade >3 adverse events in all 40 registered patients were Neutrophil count decreased (50%), febrile neutropenia (25%), fatigue (12.5%), and anemia (10%). There were no cabazitaxel-related deaths. Conclusions: EORTC 1202 met its primary endpoint, with 21/38 pts (55%) being progression-free at 12 weeks. Results of this trial confirm activity of cabazitaxel in patients with metastatic or inoperable locally advanced DD LPS and looks interesting if compared to the other available options and experimental drugs recently reported in this patient population. Clinical trial information: NCT01913652.
Efficacy and safety of anlotinib plus TQB2450 in patients with advanced soft tissue sarcoma: A multicenter, single armed, phase 1b trial.
Authors: Liu Jiayong , Fan Zhengfu , Guo Wei , Gao Tian , Li Shu , Xu Jie , Bai Chujie , Xue Ruifeng , Zhang Lu , Xie Lu , Tan Zhichao 
Published: June 2021

11547 Background: Anlotinib, a multitargeted tyrosine kinase inhibitor, had been prove to be effective for the treatment of advanced or metastatic soft tissue sarcoma(STS) faild anthracycline chemotherapy. With the lack of prospective data of combination of PDL-1 inhibitor and antiangiogenic agent, we designed a phase 1b study to investigated the efficacy and safety of anlotinib plus TQB2450 in patients with STS. Methods: Eligible patients (age 18-70, ECOG 0-1, with histopathologically confirmed advanced STS, at least one measurable lesion according to RECIST 1.1, and previously received front-line anthracycline chemotherapy) were included and received anlotinib (12mg qd, D1-14, 21d/cycle) plus TQB2450 (1200 mg, IV, D1, 21d/cycle) until disease progression or intolerable toxicities.The primary endpoint was objective response rate (ORR), secondary endpoints included safety, overall survival (OS), progression-free survival (PFS), disease control rate (DCR). Results: From January 2019 to January 2021, 30 pts were enrolled1, 12 alveolar soft part sarcoma and 18 others (7 synovial sarcoma, 4 leiomyosarcoma, 5 undifferentiated pleomorphic sarcoma, 1 fibrosarcoma and 1 epithelioid sarcoma). ORR by RECIST was 36.7%, DCR was 83.3%, 11/30 pts had PR, 14/30 (46.7%) had SD, 5/30 (16.7%) PD. Median PFS was 9.6 m in all pts and 4.9m. in non-ASPS, respectively. Median OS in non-ASPS was 10.27m, while mOS in all pts and both mPFS and mOS in ASPS had not been reached. Notably, to ASPS pts, ORR was 75%, and DCR was 100%. The most common 1-2 grade treatment-related adverse reaction (TRAE) was hypothyroidism (19/30,63.3%)，hypercholesterolemia (16/30, 53.3%) and hypertriglyceridemia (16/30, 53.3%), the most common ≥3 grade TRAEs were hypertriglyceridemia (3/30, 10%). 6 SAE (20%) occurred, including 2 pneumothorax, 1 Immune associated hapatic injury, 1 hypotension, 1 Immune myocarditis and 1 diabetic ketoacidosis. Conclusions: The combination of anlotinib and TQB2450 showed promising activity in second-line treatment of advanced STS, especially in ASPS, with well tolerance and acceptable toxicity.
A pilot study of the feasibility and utility of a fitness tracker to correlate activity level with patient reported outcomes (PROs) in sarcoma patients undergoing systemic therapy.
Authors: Davis Elizabeth J. , Ayers G. Dan , Wallace Deborah , Kaiser Elizabeth , Keedy Vicki Leigh , Agarwal Rajiv 
Published: June 2021

11559 Background: The feasibility and utility of wearable devices is unknown in sarcoma patients (pts). Objective assessment of activity level, body composition, and PROs facilitate understanding of the tolerability and toxicity of cancer treatment. Methods: From 6/11-10/12/2020, we enrolled sarcoma pts receiving systemic therapy to a prospective study evaluating activity levels and sleep via a Fitbit Charge 3, body composition with the Inbody 570, and PROs using NIH PROMIS short forms (fatigue, pain, physical function, and sleep disturbance), the Generalized Anxiety Disorder Scale, and the Patient Health Questionnaire Depression Scale. Time on study was 12-16 weeks depending upon treatment. The Fitbit was worn continuously. Body composition and PROs were assessed every 3-4 weeks. Feasibility was defined as successful device wearing and data syncing. Data was collected through a cloud-based application, Fitabase. Results: 22 pts were approached and enrolled. Two pts did not complete the first study assessment due to disease progression and were excluded from analysis. 50% of pts were female. 90% of pts were white. Median age was 47 yrs (range 20-81). The most common histologies were Ewing sarcoma and leiomyosarcoma. 89.5% (17/19) of pts wore the Fibit for >3 weeks; median time was 68 days (5-112). 95% (19/20) of pts were able to sync data. Median step count was 2614 steps (376-19806). High step counts, defined as greater than the median, were associated with improved sleep (p=0.14) and physical function (p=0.22), and decreased pain (p=0.15), but these associations were not statistically significant. Low step counts, defined as lower than the median, were associated with skeletal muscle mass loss (p=0.22), but this was not statistically significant. Conclusions: Incorporating a fitness tracker is feasible in sarcoma pts receiving systemic therapy. It provides longitudinal, objective evaluation of activity levels and sleep patterns. Correlation of activity level with sleep, body composition, and PROs was limited due to small numbers; however, a larger prospective pilot study is ongoing.[Table: see text]
A patient reported outcomes of treatments for desmoid tumors: An international natural history study.
Authors: Braggio Danielle , Lucas Amanda , Hernandez Lynne , Mercier Kelly 
Published: June 2021

11560 Background: The Desmoid Tumor Research Foundation (DTRF) launched the natural history study (NHS) in 2017. At this time, there are no standard-of-care options for this rare sarcoma. The treatments, clinical descriptors, and the patient reported outcomes to pharmacologic agents are described here within. Methods: The web-based natural history study launched September 2017 in collaboration with the National Organization of Rare Disorders. It contains 15 surveys covering diagnostics, disease, treatment, care management, and quality of life. Treatment types included in the DTRF NHS were pharmacology, surgery, radiation, high-intensity focused ultrasound (HiFU), and active surveillance (watch and wait). Results: While surgery was once the primary intervention for desmoid tumor patients, the NHS participants reported that 47.6% had received active surveillance or no systemic treatment at diagnosis. This is most common for desmoid tumors located in abdominal wall (54/103; 52.4%). There were 87 reported cases of complete surgical resection, 38 incomplete resections, and 23 bowel resections. 9 amputations were reported; 8 participants reported recurrent disease following the removal of the limb. The non-surgical interventions, such as radiation and HiFU, were mostly described for participants with chest wall tumors (15 pts) and joints/extremities (10 pts). Many options for systemic therapies were described including sorafenib (44/284; 15.5%), sulindac (36/284; 12.7%), and anti-hormonal agents tamoxifen and toremifene (34/285; 10.9%) were described. Targeted agents, such as gamma secretase inhibitor, pazopanib, and sorafenib, were greater in the United States than the non-US country participants (21% vs 9%). Multiple lines of treatments were reported by 81 participants, surgery is greatest as the first intervention for all tumor locations (49/81, 60%), with the exception of those with head/neck tumors who received chemotherapy (6/11, 55%). Analysis has started to evaluate the efficacy of systemic treatments from these NHS data. The table describes the participant reported outcomes of anti-hormonal agents, chemotherapeutics, non-steroidal anti-inflammatories, and targeted agents. Both chemotherapies and targeted agents were reported to have 38.1% response rates from the participants with 34.3% and 23.8% of participants reported progressive disease on therapy, respectively. Conclusions: Desmoid tumor NHS study participants reported the use of many treatment modalities demonstrating a range of frequency of use by tumor location and efficacy. Data collection through the DTRF NHS is ongoing.[Table: see text]