bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multidisciplinary consensus recommendations for the management of non-spine bone metastases: Results of a modified Delphi process in a community-academic partnership.
Authors: Mathis Noah J , Yang Jonathan T. , Vaynrub Maksim , Santos Martin Ernesto , Kotecha Rupesh , Panoff Joseph , Salner Andrew L. , McIntosh Alyson F , Gupta Ranju , Gulati Amitabh , Yerramilli Divya , Xu Amy , Bartelstein Meredith , Guttmann David , Yamada Yoshiya , Pfister David G. , Lin Diana , Lapen Kaitlyn , Lipitz-Snyderman Allison , Gillespie Erin F. 
Published: June 2021

e24092 Background: Local therapy for bone metastases is becoming increasingly complex, but national guidelines remain limited. We leveraged a community-academic partnership to develop consensus recommendations for multidisciplinary treatment of non-spine bone metastases which are generalizable to diverse practice settings. Methods: We convened a group of 15 physicians (9 radiation oncologists, 2 orthopaedic surgeons, 2 medical oncologists, 1 interventional radiologist, 1 interventional pain specialist) treating bone metastases across 4 institutions from Apr 2020-Feb 2021. We distributed a survey to identify questions warranting consensus development in the treatment of non-spine bone metastases. A literature review was conducted to inform answer statements, and evidence was rated using the Strength of Recommendation Taxonomy. A modified Delphi process was employed to reach consensus defined (a priori) as ³75% of respondents indicating “agree” or “strongly agree”. Results: A total of 16 questions were identified, including indications for multidisciplinary discussion or referral (n=4), appropriate use and duration of RT (n=4), and handling of systemic therapies during RT (n=5). After 2 rounds of modified Delphi process, consensus has been reached on 9 questions (see Table). Strength of Recommendation was rated A (1/9, 11%), B (5/9, 56%), or C (3/9, 33%). Conclusions: Our consensus process provides guidance for management of non-spine bone metastases that expands upon current guidelines. We also highlight areas where prospective trials are needed, including the role of RT prior to stabilization surgery and the selection of patients for ablative treatment. [Table: see text]
Breaking bad news in the oncologic population: Residents' perspective.
Authors: Thota Vihitha , Paravathaneni Mahati , Konduru Sudheer , Baralo Bohdan , Mulla Sana , Thirumaran Rajesh 
Published: June 2021

e24113 Background: Delivering bad news to patients is a delicate but required skill for doctors as part of patient care. There has been evidence that good communication from health care providers can improve patients' compliance to treatment as well as be beneficial emotionally. While many studies have been done in regards to patients' perceptions of receiving bad news, there are limited studies looking at a physicians' perspective, and even more so concerning residents' perceptions. In community hospitals, many patients are diagnosed with cancer, and resident physicians are often responsible for informing the patients and their families regarding the diagnosis. The manner in which the news is delivered is important, however it is unclear how much training is provided to residents before they are required to break bad news to patients. The lack of training can often result in improper delivery and poor patient care. Methods: We surveyed Internal Medicine and General Surgery residents at Mercy Catholic Medical Center, a conglomeration of two community teaching hospitals in Philadelphia, about prior training, confidence level, attitudes, and need for further education on delivering bad news to oncologic patients using a survey created after extensive research. The factors associated with confidence level were analyzed using paired T-test and ANOVA methods. Results: A total of 65 residents (72%) participated. No statistical significance was seen between American versus foreign medical graduates, MD vs. DO residents, or among those in different specialties when assessing their confidence in delivering bad news. Though only 62% of participants reported having had prior training in delivering bad news, residents with previous training (p1) or who have had to deliver bad news previously (p2) reported higher confidence when it came to delivering a new diagnosis of cancer (p1 0.03, p2 0.001), delivering news regarding the progression of cancer (p1 0.03, p2 0.02), delivering news regarding the recurrence of cancer (p1 0.04, p2 0.002), and delivering news regarding end-stage cancer with little to no treatment options left (p1 0.04, p2 0.003). 100% of participants thought communicating bad news is an important skill for a physician, and 92% of participants thought further education would help prepare them for similar scenarios in the future. Simulated patient scenarios (64%), grand rounds lectures/presentations (59%), and feedback from faculty after actual patient scenarios (57%) were the most requested whereas pamphlets/brochures (17%) and online training courses (20%) were less popular. Conclusions: Our study highlights the importance of prior training or exposure among residents in being able to deliver bad news to patients effectively. We propose that implementing further training in the form of simulated scenarios and lectures can improve residents' confidence at delivering bad news and result in a better physician-patient relationship.
Evaluating the dyadic management of sexuality-related parameters in women with early breast cancer (EBC): The emergence of “partner reported outcome measurements” (pROMs).
Authors: Sapir Eli , Corn Benjamin W. , Hasid Lior , Deutsch Irad , Vorobiof Daniel A. 
Published: June 2021

e24118 Background: Patient-centered healthcare has focused on incorporating the values of patients (Pts) during clinical decision-making. Accordingly, assessments are often executed with patient reported outcome measurements (PROMs). In the context of tumors located in a sexual organ, life quality may be predicated on the perception of the patient’s partner when such a relational dyad exists. Therefore, we created a “partner” reported outcome measurements (pROMs). Accordingly, we sought to query the interconnection of PROMs and pROMs in the setting of early breast cancer (EBC) by using a digital health technology application. Methods: In this ongoing study, 93 EBC Pts and 18 partners, active members of Belong.life, a social engagement platform for cancer Pts and caregivers, replied anonymously and voluntarily to a targeted survey related to sexuality and intimacy parameters in the Pts and their partners. 72% of the partners were 50-69 years of age (yoa), 61% were Caucasian. 70% of the Pts were 50-69 yoa and 72% Caucasian. 72% of the Pts and 78% of the partners had college and university degrees. At diagnosis 78% of the Pts had Stages 1-2, 44% had breast conserving surgery, and most (78%) received chemotherapy. Results: We report the interim results of the first 14 patients-partner dyads. At the time of diagnosis, 86% of partners and 50% of Pts were very or extremely concerned about the patient’s health. Of note, 43% of Pts were not concerned at all or slightly concerned about their own health. With the passage of time, the concern about the patient’s health had decreased to 50% among the partners and 28% among the Pts. Regarding intimacy and sexuality issues prior to the EBC diagnosis, 64% of the Pts didn’t have any complaints but it changed dramatically after diagnosis with 50% mentioning less sex drive and 40% less intimacy. In the partners group 67% didn’t have complaints before the diagnosis but 28% voiced complaints after the diagnosis. Only half of Pts and partners felt they could speak freely about their mutual feelings. Only 23% of Pts and 11% of partners indicated they would agree to seek professional help for issues related to sexuality and intimacy. Ultimately, 71% of Pts and 79% of partners felt happy with each other. Conclusions: Partners were very concerned about the health of Pts; however, the dyad was not always synchronized. Notwithstanding it, the dyad adjusted their concerns during the course of treatment. Body changes had modest effect on the relationship. While dissatisfaction of sexual activity was evident it did not significantly affect the feelings of patients and partners towards each other. The development of pROMs could re-synchronize the dyad thereby creating a more meaningful cancer journey.
Adaptive and maladaptive coping strategies among patients with advanced cancer.
Authors: Dev Rony , Reddy Akhila Sunkepally , Arthur Joseph Anthony , Haider Ali , Subbiah Ishwaria Mohan , Delgado-Guay Marvin Omar , Carmack Cindy L. , Bruera Eduardo , Hui David 
Published: June 2021

e24129 Background: Few studies have examined the coping mechanisms among patients with advanced cancer seen by palliative care. The objective of the study was to evaluate coping strategies in advanced cancer patients and identity risk factors for maladaptive coping. Methods: The authors conducted a secondary analysis of a cross-sectional survey on chemical coping. We prospectively enrolled patients with advanced cancer from a Supportive Care Clinic and documented the patient demographics, symptom expression (Edmonton Symptom Assessment System), Zubrod performance status, substance use history including tobacco, and coping strategies (the Brief COPE Questionnaire). Univariate and multivariate analyses were performed to identify risk factors for the use of maladaptive coping strategies. Results: Among 399 patients, the most common malignancies were gastrointestinal (21%) and breast (19%). Cancer patients frequently incorporated adaptive coping strategies including acceptance (86.7%), emotional support (79.9%), religion (69.4%), active coping (62.4%), instrumental support (48.4%), positive reframing (48.6%), planning (49.6%), and infrequently, humor (18.5%). Common maladaptive strategies included self-distraction (36.6%) and venting (14.5%), while self-blame (6.3%), denial (4.5%), behavioral disengagement (1.8%), and substance use (1.0%) were infrequently reported. On univariate analysis, venting was significantly associated with anxiety and depression, female gender, and tobacco use; and self-distraction was significantly associated with younger age, gender, depression, dyspnea, and a post-secondary education (P<0.05 for all). On multivariate analysis, male gender (OR -1.22, p<0.0001) and smoking (non-smoker vs everyday OR -1.9, P=0.008 ) remained significant for maladaptive venting; and age (HR -0.026, p=0.005), male gender (OR -0.65, p=0.004), dyspnea (OR -0.12, p=0.01) and post-secondary education (OR 0.596, p=0.022) remained significant for self-distraction. Conclusions: The vast majority of patients with advanced cancer seen by palliative care reported using adaptive coping strategies. We identified subgroup of patients who may be more likely to use maladapative coping strategies and may benefit from further psychological support.
Saci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC).
Authors: Garrido-Castro Ana Christina , Keenan Tanya Elizabeth , Li Tianyu , Lange Paulina , Callahan Catherine , Guerriero Jennifer , Tayob Nabihah , Anderson Leilani , Yam Clinton , Daniel Brooke R. , Carey Lisa A. , Nanda Rita , Winer Eric P. , Mittendorf Elizabeth A. , Tolaney Sara M. 
Published: June 2021

TPS1106 Background: Immune checkpoint inhibitors (ICIs) have not yet benefited most patients with breast cancer. In mTNBC, ICIs combined with chemotherapy have improved survival only in PD-L1+ mTNBC. The optimal ICI combination agent to overcome primary resistance in PD-L1– mTNBC is unknown. One promising agent is the anti-Trop-2-SN-38 antibody drug conjugate (ADC) SG, which led to median progression-free survival (PFS) of 5.6 months in mTNBC with ≥2 prior lines of chemotherapy.1 This ADC may boost anticancer immunity by binding immune cell receptors to promote antibody-dependent cellular cytotoxicity.2 In addition, the SN-38 payload of SG is the active metabolite of irinotecan, which depletes regulatory T cells, upregulates MHC class I and PD-L1 expression, and augments the antitumor activity of anti-PD-1/L1 antibodies in murine tumor models.3 The irinotecan analogue camptothecin also enhances CD8+ cytotoxic T cell effector functions and antitumor immune responses by inhibiting NR4A transcription factors,4 which have recently been shown to play a central role in inducing the T cell dysfunction associated with chronic antigen stimulation in solid tumors. Methods: This is a multi-center 1:1 randomized phase II trial to investigate whether the addition of pembrolizumab (200 mg IV every 3 weeks) to SG (10 mg/kg IV days 1+8 every 21 days) improves PFS compared to SG alone in mTNBC that is PD-L1– by standard of care testing with 22C3 CPS < 10 or SP142 immune cells < 1% (NCT04468061). Key eligibility criteria include no prior systemic therapy for mTNBC and evaluable disease. Previously treated brain metastases are permitted. Exclusion criteria include prior treatment with SG, irinotecan, and PD-1/L1 inhibitors. Based on a sample size of 110 patients per arm, the trial has 80% power to detect a 3-month difference in median PFS from 5.5 months in the SG-alone cohort to 8.5 months in the SG + pembrolizumab cohort with a one-sided alpha of 0.1. Participants undergo mandatory baseline and on-treatment research biopsies if their disease is safely accessible. Tumor biopsies will be evaluated for Trop-2, immune cells, inhibitory checkpoints, transcriptomic signatures, and genomic alterations. Stool specimens will be submitted for microbiome analyses, and health-related quality of life will be assessed. The trial is currently open and enrolling patients. References: 1) Bardia A et al. Ann Oncol 31, S1142-S1215 (2020). 2) Cardillo TM et al. Bioconjug Chem 26, 919-931 (2015). 3) Iwai T et al. Oncotarget 9, 31411-31421 (2018). 4) Hibino S et al. Cancer Res 78, 3027-3040 (2018). Clinical trial information: NCT04468061 .
A phase III multicenter randomized controlled trial of postsurgical stereotactic radiotherapy versus surgically targeted radiation therapy (STaRT) for the treatment of large (>2.5cm) newly diagnosed brain metastases: Trial in progress.
Authors: Weinberg Jeffrey , McAleer Mary Frances , Johnson Jason Michael , Kudchadker Rajat , Wefel Jeffrey Scott , Yuan Ying , Lin Heather Y. 
Published: June 2021

TPS2067 Background: Resection (R) followed by single or multi-fraction stereotactic radiosurgery (SRT) of brain metastases lowers resection bed recurrence compared to R alone. Nevertheless, for larger (>2.5cm) brain metastasis, 12-month recurrence rates after R+SRT can exceed 20–30%. Aiming to improve outcomes, a permanently implanted collagen tile brachytherapy device (GammaTile or GT, GT Medical Technologies, Tempe, AZ) utilizing Cs-131 seeds embedded within a bioresorbable collagen tile was developed and is described as Surgically Targeted Radiation Therapy (STaRT) to distinguish it from external beam radiation therapy. It is hypothesized that immediate adjuvant radiotherapy (RT) and/or RT dose intensification could improve outcomes. The device is FDA-cleared for this indication and early commercial use is demonstrating favorable safety and efficacy outcomes. STaRT allows rapid dose delivery of radiation therapy directly to the tumor bed with predictable dosimetry immediately at the time of resection, and an intense but localized radiation treatment, which may confer a reduced risk for radiation necrosis compared to other therapies. The device is easily placed with minimal additional operative time and limited staff radiation exposure. It is hypothesized that R+ STaRT will increase the surgical bed recurrence-free survival, while reducing the impact on functional and neurocognitive status compared to R+SRT. Methods: Multicenter, randomized, comparison trial of patients with resectable, previously untreated “index” brain metastases measuring ≥2.5–5 cm, and 0–3 other tumors, will be preoperatively randomized 1:1 to undergo either R+ SRT or R+STaRT to the index lesion; unresected tumors in both groups will receive SRT. Planned sample size is 180 from 13 sites. Enrollment will open in Q1. Primary endpoint is surgical bed-recurrence free survival. Secondary endpoints include overall survival, quality of life (Functional Assessment of Cancer Therapy-Brain, Linear Analog Self-Assessment), neurocognition (Hopkins Verbal Learning Test, Trail Making Tests, Controlled Oral Word Association), functional status (Karnofsky Performance Scale, Barthel-ADL), and adverse events. Follow-up will be at 1,3,6,9, and 12 months, then every 6 months through 24 months. This will be the first randomized trial comparing R+SRT versus R+STaRT delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. Primary and secondary outcome measures will be captured to elucidate the potential risks and benefits of these two differing post-operative RT delivery methods in the setting of newly diagnosed metastatic brain tumors. Clinical trial information: NCT04365374.
A multicenter observational study of cs-131 seeds embedded in a collagen carrier tile in intracranial brain neoplasms: Trial in progress.
Authors: Lee K. Stuart , Peach Matthew , Chen Clark C , Dusenbery Kathryn , Ferreira Clara , Shen Colette , Jaikumar Sivakumar , McDermott Michael W , Kotecha Rupesh , McCracken David J , Nowlan Adam W , Dunbar Erin M. , Trusheim John E , Monyak David James , Wanebo John , Choi Mehee , Brachman David , Misell Lisa 
Published: June 2021

TPS2073 Background: Brachytherapy is an efficacious means for radiation delivery in the treatment of a spectrum of central nervous system tumors. Traditional brachytherapy methods have been limited by uneven dose distribution, complicated workflow, extended procedural times, the cost of dedicated equipment, and frequent adverse events. To address these issues, a permanently implanted device with Cs-131 radiation seeds embedded in a bioresorbable collagen carrier tile (GammaTile [GT], GT Medical Technologies, Tempe, AZ USA) was developed. Described as surgically targeted radiation therapy (STaRT) to distinguish it from external beam radiation therapy, the device is FDA-cleared for use in newly diagnosed malignant intracranial neoplasms and recurrent intracranial tumors, and has demonstrated excellent safety and local control outcomes in early commercial use. Methods: The overarching primary objectives of this multicenter, prospective, observational (phase IV) registry study are to evaluate “real-world” clinical outcomes and patient reported outcomes that measure the safety and efficacy of STaRT using the GT device. The registry is planned for 600 prospectively enrolled subjects at up to 50 enrolling sites. All adult patients undergoing surgical resection of brain tumors of any pathology with intra-operative GT placement are eligible for enrollment, upon consent. Information on patient demographics, tumor pathology, overall survival, adverse events related to radiation or surgery, and quality of life (FACT-Br and LASA) will be collected. Serial MRIs will be collected, and timing of surgical bed recurrence and/or distant recurrence will be collected. Data will be collected at 1-, 3-, 6-, 9-, 12-, 18-, and 24-months, then every 6 months through 5 years. Results will be used to benchmark clinical outcomes of GT therapy, allow for comparisons to other existing treatments, and facilitate the design of future clinical trials. Enrollment opened on November 15, 2020, and seven subjects have been enrolled to date at three centers. This study will be the first observational study of resection plus STaRT, delivered by Cs-131 sources in permanently implanted bioresorbable collagen tile carriers, and will allow for evaluation of this treatment approach in a real world setting, as well as provide an information platform for cross-comparison of results obtained from ongoing GT clinical trials. Clinical trial information: NCT04427384.
GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma.
Authors: Wen Patrick Y. , Mellinghoff Ingo K. , Buxton Meredith Becker , Cavenee Webster K. , Colman Howard , De Groot John Frederick , Ellingson Benjamin M. , Gordon Gary B. , Khasraw Mustafa , Lassman Andrew B. , Lim Michael , Perry James R. , Tanner Kirk , Weller Michael , Yung W. K. Alfred Alfred , Cloughesy Timothy Francis ,   GBM AGILE Investigators
Published: June 2021

TPS2074 Background: GBM AGILE, Glioblastoma Adaptive, Global, Innovative Learning Environment, is an international, multi-arm, seamless phase 2/3 response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent glioblastoma (GBM) with the goal of identifying effective therapies matching them accurately to different patient subtypes in an accelerated manner. It is a collaboration between academic investigators, patient organizations and industry to support new drug applications for newly diagnosed and recurrent GBM. Methods: The primary objective of GBM AGILE is to identify therapies that effectively improve overall survival in patients with ND or recurrent GBM. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to investigational arms based on their performance. Operating under a Master Protocol, GBM AGILE allows multiple drugs from different pharmaceutical companies to be evaluated simultaneously and/or over time against a common standard of care control. Based on performance, a drug may graduate and move to a rapid stage 2 (phase 3) within the trial, and the totality of the data can be used for a new drug application. An active pipeline is critical to the ongoing success of GBM AGILE. With the leadership of the trial’s Arm Selection Committee, uniform processes for including new drugs have been established to ensure a consistent review of drugs/drug combinations over the course of the trial. Factors considered include relevant pre-clinical data, preliminary evidence for antitumor activity. pharmacokinetic data to support proposed drug dosing and administration, and potential biomarkers helpful for the development of a drug. GBM AGILE provides an efficient mechanism to screen and develop robust information regarding the efficacy of proposed novel therapeutics and associated biomarkers for GBM and to quickly move therapies and biomarkers into clinic. GBM AGILE received IND approval from the FDA in April 2019, screening its first patient in June 2019. Site activation is ongoing in the US, with over 35 active sites and over 425 patients screened (as of February 2021). Expansion to Canada, Europe and China are under progress. Clinical trial information: NCT03970447.