bluuebunny/crossref_metadata_2025_split huggingface dataset:
Racial differences in cardiovascular disease mortality among cancer survivors.
Authors: Sung Hyuna , Hyun Noorie , Siegel Rebecca , Jemal Ahmedin 
Published: June 2022

12075 Background: Cancer survivors have an elevated risk of death from cardiovascular disease (CVD). Whether the risk differs by race/ethnicity and cancer type has not been fully explored in the U.S. Methods: Data from survivors of top 23 cancers diagnosed at ages 20 to 64 years during 2000-2018 were obtained from 17 Surveillance, Epidemiology, and End Results registries. Risks for CVD death among survivors relative to the general population were calculated using standardized mortality ratios (SMRs) in each racial/ethnic group: Non-Hispanic White (NHW), Non-Hispanic Black (NHB), Hispanic, Non-Hispanic Asian or Pacific Islander (API), and Non-Hispanic American Indian (AI). Among survivors, the risks were compared by race/ethnicity using cause-specific proportional hazards models for competing risks, controlling for year of diagnosis, age at diagnosis, sex, stage (when appropriate), and the first course of treatment receipt (surgery, radiotherapy, chemotherapy). Results: Among 2,806,515 survivors (NHW, 68%; NHB, 13%; Hispanic, 12%; API, 7%; AI, 0.5%), 57,883 CVD deaths occurred during 6.4 person-years of mean follow-up (32 per 10,000). Cancer survivors overall were at increased risk of CVD death compared to their general population counterpart with an SMR of 1.76 among API (95% CI = 1.69-1.84; 8.7 excess deaths per 10,000), 1.49 among AI (95% CI = 1.33-1.68; 11.9 excess deaths per 10,000), 1.46 among Hispanic (95% CI = 1.41-1.50; 7.4 excess deaths per 10,000), 1.30 among NHB (95% CI = 1281-1.33; 14.9 excess deaths per 10,000), and 1.13 among NHW (95% CI = 1.12-1.14; 3.4 excess deaths per 10,000) survivors. Compared with NHW survivors, the adjusted hazard of CVD death was statistically significantly higher among NHB survivors for 23/23 cancers and among AI survivors for 9/18 cancers but was statistically significantly lower among Hispanic survivors for 5/23 cancers and among API survivors for 10/23 cancers, with no significant difference otherwise. The highest hazards ratios (HRs) were among NHB survivors of melanoma (HR = 3.19, 95% CI = 2.11-4.83); breast (HR = 2.73, 95% CI = 2.57-2.89); pancreatic (HR = 2.63, 95% CI = 2.19-3.16); and testicular (HR = 2.59, 95% CI = 1.62-4.14) cancers, whereas the lowest HRs were among API survivors of head and neck (HR = 0.53, 95% CI = 0.44-0.63) and cervical (HR = 0.57, 95% CI = 0.41-0.80) cancers and Hispanic survivors of cervical cancer (HR = 0.59, 95% CI = 0.46-0.75). Conclusions: The risk of CVD death differs considerably among cancer survivors by race/ethnicity and cancer types, highlighting the need for targeted prevention and surveillance in primary care. Future studies are needed to identify factors that contribute to this variation in order to inform efforts towards mitigating risk.
Body weight (BW) response timing to anamorelin (ANAM) in advanced non–small cell lung cancer (NSCLC)–associated cachexia.
Authors: Skipworth Richard J.E. , Walsh Declan , Rotaru Daniela D. , Ballinari Gianluca , Currow David C. 
Published: June 2022

12110 Background: BW loss and anorexia are key clinical manifestations of cancer cachexia, a multifactorial syndrome affecting around 80% of patients (pts) with advanced cancer. BW loss is associated with reduced tolerance and response to cancer therapy, and shorter survival. ANAM is a novel, oral selective ghrelin receptor agonist. In ROMANA 1 and 2 (NCT01387269, NCT01387282) studies in pts with NSCLC and cachexia, ANAM treatment significantly increased BW and improved anorexia symptoms and concerns compared with placebo (PBO), with rapid responses occurring at wk 3 and sustained at wk 6, 9, and 12. In this post-hoc analysis, we report the timing of BW responses to assess the effects of ANAM treatment at and beyond wk 3. Methods: In ROMANA 1 and 2, pts with advanced NSCLC and BMI <20 kg/m2 or BW loss ≥5% in the past 6 mo received ANAM or PBO for 12 wk. BW responses were grouped on the basis of BW change from baseline (BW gain 0 to <5% or ≥5%, and BW loss); pts were classified according to the timing of first BW response as early responders (at wk 3), late responders (at wk 6, 9, or 12), and non-responders. Missing values were not imputed. Categorical variables are presented as number and percentages, with statistical comparisons performed using the chi-square test. Results: In total, 552 pts in the ANAM arm and 277 in PBO were included in the analysis for all time points; at wk 3/6/9/12, data were available for 534/520/461/412 pts in the ANAM arm and 270/262/229/206 in PBO. The non-cumulative rate of pts with BW gain ≥5% was significantly higher with ANAM compared with PBO at wk 3 (13 vs 6%, p=.0030), wk 6 (26 vs 8%, p<.0001), wk 9 (28 vs 9%, p<.0001), and wk 12 (31 vs 11%, p<.0001); conversely, the rate of BW loss was significantly lower with ANAM at all time points (p<.0001). There were no significant differences between ANAM and PBO in the rate of pts with BW gain 0 to <5% at wk 3, 6, 9, and 12 (p≥.0500). The timing of first occurrence of ≥5% BW gain response is shown in the table. The rates of early and late responders were significantly higher with ANAM compared with PBO, with 28% of ANAM-treated pts first responding beyond wk 3; a larger proportion of responses with ANAM were sustained over time. Conclusions: ANAM significantly increased the rates of ≥5% BW gain and reduced BW loss rates compared with PBO at all time points; the proportion of first responders at wk 3 and beyond wk 3 was higher with ANAM, with the most significant increase seen at wk 6. Continuing ANAM treatment beyond wk 3 results in a clinically significant benefit. Clinical trial information: NCT01387269, NCT01387282. [Table: see text]
Intravenous amisulpride as rescue treatment of postoperative nausea and vomiting in patients undergoing oncologic surgical procedures.
Authors: Elliott Amber , Minkowitz Harold , Ashburn Claudine , Fox Gabriel 
Published: June 2022

12111 Background: Nausea and vomiting or retching after surgery can have significant adverse impacts, including increased length of stay, worse outcomes and patient dissatisfaction. Therefore, effective management remains a high priority. While more aggressive, multimodal prophylaxis has helped, options for treating those patients who fail are limited. Intravenous (IV) amisulpride has been shown to be safe and effective for the rescue treatment of Post-Operative Nausea and Vomiting (PONV) in a large, randomized, double-blind, placebo-controlled trial in a broad surgical population (Habib AS, Kranke P, Bergese SD, Chung F, et al. Anesthesiology 2019;130:203-212). We conducted a post-hoc analysis to investigate the safety and efficacy of amisulpride specifically in those patients undergoing oncologic surgery, predominantly excision of breast, gastrointestinal, or genitourinary malignancies. Methods: This subset analysis includes data from a randomized, double-blind, placebo-controlled, multicenter phase III trial of a single 10 mg dose of IV amisulpride as rescue treatment of PONV occurring in patients failing pre/peri-operative prophylaxis, generally with ondansetron and/or dexamethasone (Habib AS, Kranke P, Bergese SD, Chung F, et al. Anesthesiology 2019;130:203-212). The subset includes only those patients identified as undergoing surgery related to a specified malignancy or a mass considered likely to be malignant. The primary efficacy outcome was complete response (CR), defined as no emetic episodes (vomiting or retching) or administration of antiemetic rescue medication in the 24 hours after dosing. Results: In total, 465 patients were treated with either 10 mg amisulpride or placebo and 112 (56 in each group) underwent oncologic surgery. Of these, 43 (38%) underwent surgery for a pelvic tumor, 37 (33%) had breast or axillary surgery, 13 (12%) had colorectal, hepatic or pancreatic surgery and 19 (17%) underwent procedures for other malignancies, such as nephrectomy or thyroidectomy. The CR rate at 24 hours in the amisulpride group was 38%, compared to 23% with placebo. This was comparable with the success rates for the whole study population (42% vs 29%). The CR rate after 2 hours was 66% in the amisulpride group and 39% in the placebo group, also in line with the overall study results (70% vs 49%). Among those patients whose PONV occurred in the post-anesthesia care unit (PACU), the mean length of PACU stay from treatment to PACU discharge was 156 minutes in the amisulpride group and 230 minutes in the placebo group. Treatment-emergent adverse effects (TEAE) were comparable in nature and incidence between amisulpride and placebo. Conclusions: Amisulpride at 10 mg IV is safe and effective as rescue treatment for PONV in cancer patients undergoing surgery and is associated with a marked reduction in PACU length of stay.
Increasing the use of olanzapine in patients receiving chemotherapy in a community oncology practice.
Authors: Potugari Bindu Rani , Beekman Kathleen W. , Tolkinen Jane , Griggs Jennifer J. 
Published: June 2022

12123 Background: The addition of olanzapine to high emetic risk chemotherapy regimens substantially improves nausea and vomiting within 24 hours and is recommended in the guidelines of both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN). However, the uptake of olanzapine has been low in national and institutional settings. The purpose of this project was to increase guideline-concordant prescribing of olanzapine in eligible patients in a community oncology practice. Methods: We developed a multiphase program to address the barriers to the use of olanzapine in a community oncology practice. Patients’ medical records (N = 423) were reviewed to collect baseline data. Motivational interviewing with prescribing clinicians elicited barriers to prescribing, reinforced clinical guidelines, and elicited and reinforced language that suggested a willingness to change prescribing patterns. Chemotherapy protocols were subsequently updated to include olanzapine for high emetic chemotherapy regimens, and prescriber and nurse education was provided by our pharmacists regarding the most recent ASCO and NCCN guidelines. A fellow-led educational session was provided to the infusion nursing team and care managers. At the end of a seven-month period, prescribing information was identified through a system-generated report followed by a medical record review for validation (N = 136) and was shared monthly with prescribing clinicians. Results: At baseline, the use of olanzapine was zero. Multiple barriers were identified regarding the use of olanzapine during motivational interviewing with clinicians, including lack of knowledge of the guidelines, belief that most patients do not require olanzapine, concerns about sedation with the previously recommended dose of 10 mg, and order sets that did not include olanzapine. After the interventions, there was a statistically significant increase in the use of olanzapine from 0% to 56% (p-value < 0.001). Conclusions: A combination of motivational interviewing, prescriber and nurse information support, and changes to the pre-populated order sets for chemotherapy antiemetics was highly successful in improving the uptake of guideline-concordant prescribing of antiemetics. This model of quality improvement, including motivation interview, may support quality improvement efforts across oncology.[Table: see text]
The impact of an oncology-specific shared savings agreement.
Authors: Thompson Edward , Hospodar Alexa , McLarty Sarah , Pervez Sabah , Yeon Heeseon , Hastings Kevin , Cullum Robert , Junk Christopher , Sapkota Ujwal , Mcgovern-Siembab Allendre , Perez Lady , Angelica Patricia , Jeshang Namrata , Cavers William , Johlie Melissa , Reddy Shirisha , Brito Rogelio A. , Avalos-Reyes Elisea , Johnson Kjel Andrew , Grunsfeld Tracy 
Published: June 2022

1536 Background: In response to rising healthcare costs, several innovative payment strategies have emerged to improve the value and efficiency of healthcare spending. One of these strategies is a shift from volume-based to value-based care (VBC), resulting in the introduction of alternative payment models, innovative provider contracting and new value frameworks. The purpose of this study is to evaluate the impact of a VBC arrangement on total cost of care for chemotherapy patients, specifically cancer-related drug costs, daily hospital inpatient admissions and emergency room visits. Methods: This is a cohort study of chemotherapy patients, in a single state, enrolled in a large national insurer from January 18, 2021, to September 30, 2021. Oncology patients were divided into two groups; the study group consisted of chemotherapy patients receiving care in a VBC arrangement; the control group consisted of chemotherapy patients receiving care at oncology practices not engaged with the insurer in a VBC agreement. The following levers were employed to improve value: digital symptom tracking, biosimilar or lower-cost drug options and NCCN regimen concordance. We defined cancer-related drug costs as the sum of allowed costs paid for medical and pharmacy claims during the study period. Additionally, we averaged the cost per hospital inpatient day and emergency room visit and compared these by group. Results: This study included 1,574 patients, 733 patients in the study group and 841 in the control group. A reduction of 5.1% (a difference of $441) in cancer-related drug costs per member per treatment month (PMPTM) was observed among patients in the study group. Patients in the study group reported 27.8% fewer inpatient days resulting in a savings of $194 PMPTM. Similarly, patients in the study group reported 70.0% fewer emergency room visits resulting in a savings of $59 PMPTM. Conclusions: In this study, chemotherapy patients participating in a shared savings VBC spent less on cancer-related drug costs, hospital inpatient days and emergency room visits through three value levers. Further studies are needed to assess if these results are similar all types of healthcare coverage and to what degree additional value levers further reduce costs. Additionally, the long-term health outcomes of these patients should be assessed.
Does the 4R oncology model improve clinicians’ effectiveness in patient-facing planning of complex cancer care?
Authors: Trosman Julia R. , Kulkarni Swati , Baer Rachel Podrazik , Feldman Lawrence Eric , Pasquinelli Mary , Kircher Sheetal Mehta , Benson Al Bowen , Gradishar William John , Rapkin Bruce , Makower Della F. , Perez Claudia Beth , Boecher Stephanie , Ravelo Mangalindan Arliene , Yu Elaine , Weldon Christine B. 
Published: June 2022

1542 Background: The 4R Oncology model was proposed within the NCI ASCO Teams Project as an approach to facilitate patient-facing care planning, team-based delivery and patient self-management. 4R (Right Info/Care/Patient/Time) enables care teams and patients to manage complex care with a novel 4R Care Sequence plan. We previously reported that 4R significantly improved patient self-management, namely patients’ ability to organize and manage their care (Trosman JCO OP 2021). Here we report the impact of 4R on effectiveness of clinicians to plan and deliver complex multidisciplinary care. Methods: We surveyed clinicians (physicians and nurses) from 8 cancer centers (4 academic, 4 community) participating in a 4R adoption program. The survey was conducted Mar 2019 to Sep 2019 prior to 4R launch (Baseline cohort), and Nov 2021 to Jan 2022 post-4R launch (4R cohort). Baseline cohort included clinicians conducting care planning with patients. 4R cohort included clinicians who used 4R in care planning with new patients. The survey focused on clinicians’ self-reported effectiveness in planning and management of guideline-based care. Descriptive statistics and Fisher’s 2-sided test were used in analyses. Results: Baseline cohort’s response rate was 79% (66/83); 4R cohort’s response rate was 86% (62/72). 4R implementation was associated with significant improvement in all 5 metrics of effective care planning between the baseline and 4R cohorts (Table). Within the 4R cohort, 87% (54/62) clinicians found 4R Care Sequences useful or very useful for care planning and management. The majority, 79% (49/62), spent 10 minutes or less on average developing and administering 4R Care Sequence to a new patient, and 58% (36/62) reported decreased overall volume of post-visit inquiries about care plan from patients who received 4R. When asked about 4R delivery format, 65% (40/62) preferred paper, 23% (14/62) electronic delivery and 12% (8/62) had no preference. Conclusions: The 4R Oncology model is a promising approach to improving clinicians’ effectiveness in patient-facing care planning and reducing the workload associated with patient inquiries. An ongoing 4R research and implementation program continues efforts to identify optimal implementation methods and integrate 4R into clinical practice across the U.S. [Table: see text]
Safety and efficacy of glasdegib in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma: Phase Ib/II GEINO 1602 trial.
Authors: Vaz María Ángeles , Gironés Regina , Del Barco Sonia , Sepulveda Sanchez Juan Manuel , Alonso Miriam , Pineda Estela , Balana Carmen , Martínez-García María 
Published: June 2022

2060 Background: Hedgehog signaling through Smoothened (SMO) protein in gliomas promotes cell cycle progression and leads to glioma stem cells (GSCs) maintenance, which constitutes one of the key hallmarks for glioblastoma (GB) resistance against anticancer therapies. Glasdegib, a SMO inhibitor, may disrupt GSCs and lead to enhanced efficacy of the Stupp scheme. Methods: Newly diagnosed GB pts received glasdegib with standard radiotherapy (RT)/ temozolomide (TMZ) followed by maintenance with glasdegib monotherapy. The primary objective was to determine the recommended phase 2 dose (RP2D) in a 3+3 dose escalation (DE) strategy in phase Ib and overall survival (OS) in phase II. Secondary objectives included progression-free (PFS) according to RANO criteria, safety, changes in performance status, and exploratory biomarker analysis. Results: Between 2018 and 2020, 79 GB pts were enrolled and 78 received at least one dose of glasdegib. In DE, 4 pts received Glasdegib at 100 mg/QD and 6 pts received 75 mg/QD. DLTs were reported in 3/4 pts in 100 mg dose level, and 1/6 pts in 75 mg dose level, declaring 75 mg/QD of glasdegib as RP2D. For phase II, 68 additional pts were treated at 75 mg/QD dose. The median age was 55 years (range: 28-78), 54% were male, 45% were MGMT unmethylated, and 1 pts had an IDH1/2 mutation. Glasdegib treatment lasted a median of 6 m (range: 0.5-21.9). Overall, 72 (97.3%) pts completed concomitant therapy, 65 (87.8%) started adjuvant therapy, 28 (37.8%) completed adjuvant therapy, and 23 (31.1%) continued glasdegib monotherapy. Treatment combination was discontinued due to treatment-related adverse events (TRAEs) in 9 (12.2%) pts. For those pts that received RT/TMZ combined with glasdegib at 75 mg/QD dose, 7 (9.5%) presented grade (G) ≥3 hematological TRAEs during concomitant treatment and 2 (3.1%) during the adjuvant treatment. There were no G≥3 TRAEs of any type during the maintenance phase. Neutrophil count decrease G≥3 was reported in 6 (8.1%) pts and platelet count decrease G≥3 in 7 (9.5%) pts. Cutaneous events G≥3 were reported in 3 (4.1%) pts. ECOG, Minimental and Barthel indexes, were maintained when comparing baseline with end of treatment (p = 0.181, 0.25 and 0.346 respectively). Stabilization was the most common response, reported in 60 (81.1%) pts. After a median follow up of 7.8 m (range 0.7-25.9), median PFS was 6.9 m (95% CI: 6.1-8.5). The 6-m PFS rate was 62.1% (95% CI: 50.9-75.8) and the 18 m OS rate was 63.3% (95% CI: 47.5-84.4). Conclusions: The addition of glasdegib to standard RT and TMZ was safe. Glasdegib monotherapy showed no G ≥3 TRAEs. Most patients had disease stabilization, with a promising preliminary PFS and OS for newly diagnosed GBM. Final survival results are awaited. Clinical trial information: NCT03466450.
Impact of systemic therapy regimen on survival of PCNSL.
Authors: Janopaul-Naylor James , Voloschin Alfredo Daniel , Patel Jimmy S , Rupji Manali , Hoang Kimberly B. , Olson Jeffrey J. , Shu Hui-Kuo George , Zhong Jim , Neill Stewart G. , Eaton Bree R. 
Published: June 2022

2070 Background: Primary CNS Lymphoma (PCNSL) is a rare and often fatal disease. Treatment includes multi-agent systemic therapy with a backbone of high-dose methotrexate (HD-MTX). Despite multiple drug and radiotherapy combinations for induction and consolidation treatment there remains no clear standard of care. The purpose of this analysis is to evaluate how varying treatment approaches impacted clinical outcomes at our institution. Methods: Data retrospectively collected for 95 consecutive patients with PCNSL pathologically confirmed from 2002 to 2021. Primary endpoint was OS with secondary endpoints of PFS and LC. Progression based on RANO criteria. Kaplan-Meier analyses, Log-rank test and Cox proportional hazard models used for time to event endpoints. MVA by backward selection applying an alpha of 0.2 for associations with 1st line chemo agents, number of cycles of HD-MTX (>6 or 0-5), size of enhancing tumor at presentation, CSF cytology, type of surgery (biopsy, STR, or GTR), and use of WBRT. Results: Most patients had KPS >70 (64.2%), were HIV negative (89.5%), and had no history of solid organ transplant (95.8%). Diagnosis was made by biopsy (73.7%) or resection (GTR 13.7%, STR 12.6%). 54.3% had <14 cc contrast-enhancing tumor volume (median 12.6 cc, range 0.5 - 67.8 cc) and 48.6% had single enhancing lesion. Of the 62 patients treated first line with at least 1 cycle of HD-MTX, 61.3% were treated with HD-MTX + Rituximab (R) and 33.9% with HD-MTX + R + temozolomide (TMZ). With or after induction HD-MTX, 1-3 patients received one or a combination of cytarabine, thiotepa, procarbazine, vincristine, carmustine, or ASCT. Of the 60 patients with evaluable CSF, 30.0% had positive cytology. IT chemotherapy (ITc) was administered to 12 patients (5 with + cytology, 4 with - cytology, 3 with unknown cytology). WBRT for consolidation after chemotherapy used for 3 patients and as monotherapy for 9 patients. 2-year OS and PFS rate was 50.1% (95% CI 38.6%-60.5%) and 38.5% (95% CI 27.9%-49.0%). On MVA, > 6 cycles of MTX was associated with superior OS, PFS, and LC. For patients receiving any chemotherapy, addition of R was associated with inferior OS while ITc was associated with improved OS, PFS, and LC (Table). There was no OS association on MVA with TMZ, GTR, consolidation WBRT, or size or number of initial lesions (p>0.05). Conclusions: Completion of induction HD-MTX and use of ITc was associated with better outcomes in this population. Incorporation of R into 1st line therapy was associated with worse OS. Survival remained poor throughout the study period, underscoring importance of further innovation. [Table: see text]