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  • American Society of Clinical Oncology (ASCO)  (10)
  • Agarwal, Parul  (10)
Materialart
Verlag/Herausgeber
  • American Society of Clinical Oncology (ASCO)  (10)
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Sprache
Erscheinungszeitraum
Fachgebiete(RVK)
  • 1
    Online-Ressource
    Online-Ressource
    Adaptive expertise for medical oncology fellows: How to foster evidence-based medicine mastery.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e23015-e23015
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e23015-e23015
    Kurzfassung: e23015 Background: Adaptive expertise (AE) describes a physician’s ability to effectively apply pre-existing knowledge to unfamiliar clinical situations. This skill relies on understanding not just “how” solutions work, but instead developing a framework of “why” a specific decision is correct for a particular situation. Acquiring this skillset enables one to rely on foundational knowledge, while simultaneously reaching for novel information in order to make the best clinical decision. Given the expansion of primary literature and evolving treatment options in oncology, development of AE is critical for fellows to provide high level patient care. There is limited research focused on oncology trainee development of AE and evidence-based medicine (EBM) mastery. Methods: We designed an observational cohort study of ten first-year medical oncology fellows at Johns Hopkins during the 2021-2022 academic year (IRB00293232). Fellows were required to attend a case-based, faculty moderated EBM peer-teaching curriculum. A validated, ten question Likert scale AE questionnaire (Carbonell instrument) was administered to each fellow at baseline. Data collection from weekly questionnaires measuring efficiency and innovation in case preparation and presentation is ongoing. These data will be quantitatively summarized and correlated with the baseline AE instrument to evaluate change and development of AE over the academic year. Results: Ten learners have participated in the curriculum as of February 2022. All questions in the baseline AE instrument had a 100% response rate. Selected results are presented in Table.While all participants “strongly agree” that knowledge in their discipline keeps on developing, only 50% “strongly agree” that they are able to apply knowledge in new and unfamiliar situations with a degree of success, highlighting the need for a curriculum focused on AE for trainees. Conclusions: AE utilizing EBM in medical oncology is an essential skill for trainees to acquire. Next steps will include moderated focus groups at the 6 month and 10-month time point, followed by analysis of the weekly questionnaires, which will allow for formal assessment of this curriculum. Future directions will include expansion to include other institutions and adaption for different learner levels.[Table: see text]
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e23015
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2022
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 2
    Online-Ressource
    Online-Ressource
    Improving resident education on the inpatient solid tumor oncology rotation through development of an asynchronous video curriculum.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e23014-e23014
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e23014-e23014
    Kurzfassung: e23014 Background: As the oncology patient population grows, continued recruitment of talented individuals is essential. Meaningful and highly educational clinical exposures play a crucial role in a resident’s decision to pursue fellowship in oncology. Currently, the majority of oncology exposure occurs in the inpatient setting, where trainees are confronted with many competing clinical demands, leaving minimal time for teaching. Prior work has demonstrated that dedicated time for teaching supplemented with high-yield educational material improves trainee satisfaction and interest in a particular field. We hypothesize that implementing an asynchronous inpatient video oncology curriculum will improve resident clinical competency and satisfaction. Methods: This is an ongoing, single institution educational intervention using the Kern method for curriculum development in the Johns Hopkins Osler Internal Medicine Residency (IRB00307077). A targeted needs assessment has been developed to identify gaps in medical knowledge, assess preparedness in managing common solid tumor inpatient diagnoses, and explore satisfaction with prior educational experiences on this service. Based on these results, ten educational videos will be created by content experts and aligned with the learning objectives of the Osler residency program and ABIM blueprint. Trainees will have dedicated time to watch the videos during their solid tumor rotation. We plan to evaluate effectiveness of our curriculum by measuring completion rates and pre- and post-video multiple choice responses. We will also assess knowledge retention and resident satisfaction at three and six months post-rotation with online questionnaires. Results: Annual Osler program ACGME survey data review revealed a high level of resident dissatisfaction with the oncology clinical experience compared with other rotations. While 83.3% of residents rated their general internal medicine experience as “excellent,” only 52.4% rated their oncology experience as “excellent.” Needs assessment data collection has been delayed by the COVID-19 pandemic but is ongoing. Following topic selection, videos will be created in April 2022 with plans for video curriculum implementation in July 2022. Conclusions: In order to attract and retain trainees in the field of oncology, it is imperative that educational curricula adapts to meet learners’ needs. Efficient, evidence-based instructional strategies designed to promote clinical competency for internal medicine residents on an inpatient solid tumor service may foster engagement and rotation satisfaction. We are currently evaluating how an asynchronous video inpatient oncology curriculum may significantly improve the inpatient internal medicine trainee experience. If successful, this curriculum can be adapted for other trainees and practitioners new to the field of oncology.
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e23014
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2022
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 3
    Online-Ressource
    Online-Ressource
    Geographic disparities in breast cancer mortality and place of death in the United States from 2003 to 2019.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 12034-12034
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 12034-12034
    Kurzfassung: 12034 Background: Breast cancer is the 2nd leading cause of cancer-related death in women with existing barriers in preventive services, access to treatment, and end-of-life care. There are unique sociopolitical challenges to rural healthcare with gaps in national health funding and hospice infrastructure. We investigated rural-urban disparities in age-adjusted mortality rates (AAMRs) and place of death in individuals dying from breast cancer. Methods: CDC WONDER database was utilized to analyze deaths from breast cancer from 2003 to 2019 using population classification per 2013 US Census: large metropolitan (≥1 million), small- or medium-sized metropolitan (50,000-999,999), and rural areas ( 〈 50,000). We extracted AAMRs by geographic area, age, and race/ethnicity. We estimated annual percentage changes (APC) in AAMR using robust linear regression models of the log-scale AAMR, including population size as weights, and assessed differential changes over time by geographic area with interaction tests. We estimated the percent of all deaths occurring in medical, hospice, and nursing facilities, and home. Odds ratios (OR) for the association between each place of death and individual-level characteristics were calculated using logistic regression, adjusting for year of death. Differential changes in place of death over time by geographic region were assessed with interaction tests. Results: From 2003 to 2019, there were 676,532 breast cancer-related deaths (52.9% large metro, medium/small metro 30.3%, rural 16.8%). Total AAMR declined from 39.8 to 30.9 during this period with rural areas noting least improvement (APC -1.24, 95% CI [-1.39, -1.09], p 〈 0.001 for time trend) compared to large metropolitan (APC -1.74, 95% CI [-1.63, -1.46]). Non-Hispanic Black women had higher AAMRs among all racial/ethnic groups. Across all years, women in large metropolitan (OR 2.02, 95% CI [1.96, 2.07] ) and medium/small metropolitan (OR 2.19, 95% CI [2.12, 2.25]) had higher odds of dying in a hospice facility compared to rural areas. Rural women died least often in a hospice facility (9.7% vs 14.5% large metropolitan vs 16.9% medium/small metropolitan in 2019), more often in a nursing facility (19.2% vs 12% large metropolitan vs 13.9% medium/small metropolitan) and slightly more often at home (44.6% vs 41.7% large metropolitan vs 43.4% medium/small metropolitan). Women in large metropolitan areas were most likely to die in a medical facility. Conclusions: Rural women with breast cancer experienced greater mortality and least annual improvement, with notable disparities in place of death. Our findings support interventions to improve access across cancer care continuum and congressional policy to urgently re-invest in cancer care access in rural areas.
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.12034
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2022
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 4
    Online-Ressource
    Online-Ressource
    Retrospective Survival Analysis of Patients With Resected Pancreatic Ductal Adenocarcinoma and a Germline BRCA or PALB2 Mutation
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  JCO Precision Oncology , No. 3 ( 2019-12), p. 1-11
    Details
    In: JCO Precision Oncology, American Society of Clinical Oncology (ASCO), , No. 3 ( 2019-12), p. 1-11
    Kurzfassung: Germline mutations in the homologous recombination genes BRCA1, BRCA2, and PALB2 confer an increased risk for pancreatic ductal adenocarcinoma (PDAC). Tumors associated with mutations in homologous recombination genes are sensitive to DNA-damaging agents. We retrospectively studied patients with resected PDAC and a pathogenic germline mutation in one of these three genes. The planned analyses included overall survival (OS) and changes therein when platinum chemotherapy was used in the perioperative setting. MATERIALS AND METHODS Thirty-two individuals with pathogenic germline mutations in BRCA1, BRCA2, or PALB2 and resected PDAC (mutation positive) were matched in a 1:2 fashion to patients who were noncarriers or untested (mutation negative) by age, year of diagnosis, stage, and sex. Patients were identified via one of two available databases at University of Pennsylvania: the Basser Center for BRCA Registry or the electronic medical record. The primary outcome was OS. RESULTS Patients in the mutation-positive group had a median OS (mOS) of 46.6 months; those in the mutation-negative group had an mOS of 23.2 months (hazard ratio [HR], 0.49; 95% CI, 0.27 to 0.88). With platinum exposure in the perioperative setting, mOS in the mutation-positive group had not yet been met versus a mOS of 23.1 months in the mutation-negative group (HR, 0.12; 95% CI, 0.01 to 1.00). When neither group was treated with platinum, there was no significant OS difference between groups (HR, 0.52; 95% CI 0.12 to 2.24). Patients in the mutation-positive group who received perioperative treatment with platinum had a trend toward improved mOS compared with those who did not (HR, 0.15; 95% CI, 0.02 to 1.23; P = .07). CONCLUSION Platinum-based chemotherapy may confer a survival benefit in patients with resected PDAC and a pathogenic germline BRCA1, BRCA2, or PALB2 mutation. Knowledge of a germline mutation may be important to determine best choice of perioperative chemotherapy.
    Materialart: Online-Ressource
    ISSN: 2473-4284
    URL: Article
    DOI: 10.1200/PO.18.00271
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2019
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 5
    Online-Ressource
    Online-Ressource
    Resident Inpatient Curriculum for Oncology (RICO): Results of a targeted needs assessment performed in the Osler Internal Medicine Residency Program.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 365-365
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 365-365
    Kurzfassung: 365 Background: An important factor contributing to a resident’s interest in oncology training is early and consistent exposure to the field. Currently, completing an inpatient oncology rotation is associated with a decreased interest in pursuing a career in oncology and low resident satisfaction. The reasons for this are multi-factorial, including high task burden and limited dedicated teaching time. Fortunately, prior work has revealed that interest in oncology fellowship training increases when residents receive targeted educational material during their oncology rotations. As part of a multifaceted approach to improve the inpatient curriculum, we conducted a targeted needs assessment at our institution. Our goal is to improve resident satisfaction, clinical competency, and interest in pursuing subspecialty training in oncology by implementing a focused educational intervention. Methods: The Johns Hopkins Hospital is an urban academic medical center where the Osler Internal Medicine Residency Program of approximately 156 housestaff complete their training. A majority of these residents rotate through the inpatient solid tumor service. We performed a targeted needs assessment designed with the ABIM Blueprint, the solid tumor service learning objectives, and ACGME data specific to our program. The survey was created using Qualtrics software and distributed via email to all PGY-1, PGY-2, and PGY-3 residents. Results: 42.9% of residents participated in the survey. 79% of participants indicated they planned to pursue subspecialty training after residency with 21% of those in oncology. Approximately half of participants (45%) had rotated on the solid tumor service. 51% of participants reported barriers to education; the most common barriers identified were patient census and high resident task burden. “On the fly teaching” was the preferred instructional strategy by 70% of participants, followed by in-person didactics and asynchronous videos. The top three areas of interest for content creation were: basics of antineoplastic therapy, tumor lysis syndrome, and immune checkpoint inhibitor toxicities. Conclusions: Resident educational experiences on subspecialty rotations plays a strong role in the ultimate decision to pursue further training. Given the rising need for oncologists nationally, it is imperative that programs identify and address gaps in the educational experience on oncology rotations. Our needs assessment identified several concrete ways to improve resident experience on the Johns Hopkins inpatient solid tumor service. Next steps will include development and implementation of a high-yield resident inpatient curriculum for oncology (RICO), with focused assessments planned throughout the academic year to measure clinical competency, resident satisfaction and ultimately identify areas for further improvement.
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.28_suppl.365
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2022
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 6
    Online-Ressource
    Online-Ressource
    Cancer beliefs and screening across three NYC neighborhoods.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e22512-e22512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e22512-e22512
    Kurzfassung: e22512 Background: Differences in breast cancer screening exist between the NYC neighborhoods of East Harlem (EH) and Central Harlem (CH), and the Upper East Side (UES). Here we assess the relationship between six cancer beliefs and breast cancer screening among women in these neighborhoods. Methods: We include women aged ≥40 who responded to the Community Cancer Needs Survey between 2018-2019 and were eligible to undergo screening mammography within 2 years (“recommended screening”). All estimates use weighted data generated using raking techniques. We compared categorical variables using Chi-square tests & estimated odds ratios (OR) and 95% confidence intervals (CI) from logistic regression model associating beliefs and reported mammography receipt (results and covariates listed in Table). For each belief, we compared women who reported “agree” (combined strongly or somewhat agree) to those who “disagree” (combined strongly or somewhat disagree). Results: Of the weighted sample of 76,610 (41.3% CH, 34.4% EH, and 24.3% UES) women eligible to undergo screening mammography, 75.1%, 81.2%, and 90.3% of women in CH, EH, and UES, respectively reported recommended screening. There was no difference by neighborhood in prolonged ( 〉 2 years ago) screening intervals: 10.6% in CH, 7.9% in EH, and 9.8% in the UES, while never use was reported by 11.3% in CH, 7.6% in EH, and none in the UES (p= 〈 0.0001). The table summarizes agreement between cancer beliefs and timely receipt of mammography. Conclusions: In this study, cancer beliefs are inconsistently associated with use of breast cancer screening across three NYC neighborhoods. Assessment of beliefs reveal important opportunities for breast cancer (and other cancer) prevention by promoting awareness of risk factors and screening in these communities.[Table: see text]
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e22512
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2021
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 7
    Online-Ressource
    Online-Ressource
    Socioeconomic disparities in supportive therapy use and tolerance of aromatase inhibitors in patients with early-stage, hormone-positive breast cancer.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 523-523
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 523-523
    Kurzfassung: 523 Background: Socioeconomic disparities impact breast cancer survival with significantly higher mortality among women of lower socioeconomic status. Little is known about how disparities affect patients with early-stage hormone receptor positive (HR+) breast cancer (BC) and patients’ tolerance and adherence to standard of care adjuvant aromatase inhibitor (AI) therapy. AI-related adverse effects are common and can cause therapy intolerance and early discontinuation. Supportive therapies have been shown to improve symptom tolerability when utilized by patients. This study assessed socioeconomic disparities in utilization of supportive therapies and adherence to initial AI therapy. Methods: We performed a retrospective chart review of all female patients at our academic institution with early-stage, HR+, BC who were initiated on adjuvant AI between 2011-2020. We collected information on side effects, duration of first AI and use of supportive therapies. We linked median family income with zip codes based on national census data and sorted them based on the Pew Research Center categorization. Primary endpoints were the rate of discontinuation of AI at 1-year and utilization of supportive therapies in relation to income, insurance coverage and primary language. The Fisher's exact test, Pearson's Chi-squared test, and Wald test methods were used to compare rates of discontinuation of front-line AI therapy and use of supportive therapies for each group. Results: We identified 1006 patients of whom 95% (n = 954) had AI related side effects yet only 31% (n = 311) received supportive therapies in the first year of AI treatment. The majority (59%) of patients were in the middle-income range ($52,200-$156,000), followed by upper (24%) and lower (17%) income. Upper-income was associated with higher use of supportive therapies (OR 1.46, p = 0.031) but was not associated with lower 1-year discontinuation rate. Medicare was the most common insurance coverage (45%), followed by Commercial (32%) and Medicaid (23%). English was the primary language for 86% of patients. Neither insurance coverage nor primary language was associated with either endpoint. In evaluating race, Black patients had the least use of supportive therapies (p 〈 0.001), yet this group had the lowest 1-year discontinuation rate (p = 0.005). Conclusions: Our results demonstrate that income and race were associated with use of crucial supportive therapies that are proven to help patients mitigate AI toxicities. The etiology of these disparities is likely multifactorial and requires further study to ensure equitable care and access for all patients.
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.523
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2022
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 8
    Online-Ressource
    Online-Ressource
    Phase II trial of XmAb20717 (vudalimab) in patients with advanced biliary tract cancers.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS4184-TPS4184
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS4184-TPS4184
    Kurzfassung: TPS4184 Background: For patients with advanced biliary tract cancers (BTCs), gemcitabine and cisplatin has been the standard-of-care first-line therapy, with a median overall survival (OS) of 11.7 months. More recently, TOPAZ-1 demonstrated a modest, but significant overall survival benefit (HR 0.80; 95% CI 0.66 – 0.97) to the addition of durvalumab to gemcitabine and cisplatin with a median OS of 12.8 months. However, for patients without targetable molecular variants, second-line and beyond options are limited, with FOLFOX demonstrating an overall response rate (ORR) of 5% and increase in median overall survival by 0.9 months compared to active symptom control. In patients with advanced BTCs, combination immunotherapy approaches with PD-1 or PD-L1 plus CTLA-4 inhibitors have been associated with improved ORRs of 10.8% - 23% compared to ORRs of 3 – 7% observed with single agent PD-1 or PD-L1 inhibitors. XmAb20717 (vudalimab) is a novel, bispecific antibody targeting PD-1 and CTLA-4 which demonstrated an ORR of 14.1% in a phase I dose expansion cohort of patients with advanced malignancies, including patients that had experienced disease progression on prior immune checkpoint inhibitors. Methods: We initiated a single-arm, phase II clinical trial with a Simon two-stage mini-max design to evaluate the efficacy of XmAb20717, in terms of ORR, in patients with advanced biliary tract cancers previously treated with gemcitabine-based chemotherapy. In the first stage, 13 patients evaluable for efficacy will be accrued. If no responses are observed in these 13 patients, the study will be stopped for futility. Otherwise, 14 additional patients evaluable for efficacy will be accrued to total 27 evaluable patients. If 4 or more responses are observed in these 27 patients, then the null hypothesis will be rejected. XmAb20717 (10 mg/kg) is administered intravenously on days 1 and 15 of a 28-day cycle. Important inclusion criteria include that patients with FGFR2 fusions, NTRK fusions, or IDH1 mutations must have received molecularly targeted therapy unless contraindicated or refused. Patients are not eligible if they have received prior immune checkpoint inhibitor therapy. Correlative studies will include longitudinal peripheral blood collection for circulating immune cell profiling. As of January, 2023, 8 patients have been enrolled with enrollment ongoing. Clinical trial information: NCT05297903 .
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.TPS4184
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2023
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 9
    Online-Ressource
    Online-Ressource
    Overall survival (OS) and pathologic response rate from a phase II clinical trial of neoadjuvant GVAX pancreas vaccine (with cyclophosphamide) in combination with nivolumab and stereotactic body radiation therapy (SBRT) followed by definitive resection for patients with borderline resectable pancreatic adenocarcinoma (BR-PDAC).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e16309-e16309
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e16309-e16309
    Kurzfassung: e16309 Background: The optimal management of BR-PDAC remains undefined due to the high rate of local progression and/or metastasis with upfront surgery alone. Given the limited activity of single agent PD-1 blockade in PDAC, combination strategies aimed at increasing high-avidity T-cells in the tumor microenvironment (TME) are under investigation. GVAX is an allogenic, whole cell, GM-CSF-secreting vaccine that activates T-cell immunity against tumor-associated antigens. Prior work has shown that GVAX in combination with low-dose cyclophosphamide (Cy) can inhibit T-regulatory cells and induce both PD-L1 expression and the formation of tertiary lymphoid aggregates. This multi-center phase II clinical trial evaluates the safety and clinical efficacy of the addition of GVAX/Cy/nivolumab and SBRT to neoadjuvant chemotherapy in patients with BR-PDAC. Methods: Patients received neoadjuvant mFOLFIRINOX or gemcitabine/abraxane if intolerant to mFOLFIRINOX. Two to six weeks after chemotherapy, the first dose combination immunotherapy with Cy (200 mg/m2), nivolumab (240mg) and GVAX (5 x 10 8 vaccine cells) was given. Three weeks later, patients received the second dose of combined immunotherapy concurrently with SBRT (6.6 Gy x 5 days) prior to surgical resection. The primary endpoint is CD8 + T-cell density (CD8) in surgical specimens compared with CD8 in historical control samples treated with neoadjuvant mFOLFIRINOX and SBRT only. Additional endpoints include pathologic response rates, adverse events (AEs) as graded by NCI CTCAE version 4.03, OS, and evaluation of immune changes to the TME. Results: 31 patients were enrolled from 2/2/2018 to 7/27/2021. Of these, 18 patients received at least one dose of combination immunotherapy. Following study treatment, one patient had progressive disease, three had occult intra-operative metastatic disease and 14 underwent definitive surgical resection (13 R0 resections and one R1 resection). The major pathologic response rate was 35% (defined as 〈 10% residual viable tumor), including one pathologic complete response (pCR). At a median follow-up of 20.5 months, median OS was 20.4 months (95% CI 18.2, NA). There were two grade 3 or higher AEs (one case of nivolumab-related autoimmune hepatitis and one case of SBRT-related pancytopenia). Conclusions: The addition of combined immunotherapy and SBRT to chemotherapy was safe and feasible in BR-PDAC. Observed median OS, pCR and R0 resection rates were comparable to contemporary studies administering neoadjuvant mFOLFIRINOX and SBRT. Additional immune correlative data will be available and reported at the time of the conference, guiding future applications of novel vaccine approaches. Clinical trial information: NCT03161379 .
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e16309
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2023
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 10
    Online-Ressource
    Online-Ressource
    Prevalence of germline variants in patients with pancreatic neuroendocrine tumors.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4135-4135
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4135-4135
    Kurzfassung: 4135 Background: About 10% of pancreatic neuroendocrine tumors (pNETs) are thought to be related to inherited syndromes, including multiple endocrine neoplasia type 1 (MEN1), multiple endocrine neoplasia type 4 (MEN4), von Hippel-Lindau disease (VHL), neurofibromatosis type 1 (NF1), and tuberous sclerosis complex (TSC). Here, we report the prevalence of pathological/likely pathological germline variants (PV/LPV) in 2 cohorts: 1) High-risk and 2) Unselected. Methods: We retrospectively collected clinical data of patients with biopsy proven pNETs seen at MD Anderson Cancer Center (MDACC) and Johns Hopkins Hospital (JHH). Cohort 1 (high risk cohort) included 132 patients seen at MDACC, who underwent germline testing based on high-risk criteria such as early onset, personal or family history of cancer and syndromic features between 2013 -2019. Cohort 2 (unselected cohort) included 106 patients seen at JHH, who underwent germline testing following their diagnosis of pNETs between 2020 to 2022. Results: In the high-risk cohort (n = 132), 33% (n = 44) had PV/LPV, and 17 % (n = 22) had a variant of unknown significance (VUS). Amongst the 132 patients, 35% underwent multigene panel testing, 53% had targeted germline testing and 12% had a physician documented outside test diagnosis. The demographics consisted of 52%(n = 69) females, 67% (n = 88) white, 54%(n = 71) had metastatic disease, 58%(n = 76) underwent surgical resection. WHO grading (n = 77) is as follows G1 (39%), G2 (59%), G3 (2%). In the unselected cohort (n = 106), 21% (n = 22) had PV/LPV, 28 % (n = 30) had a VUS. Of these, 93% of the patients underwent multigene panel testing. The demographics consisted of 42% (n = 44) females, 67% (n = 88) white, 48% (n = 51) had metastatic disease, 60% (n = 64) underwent surgical resection, WHO grading (n = 93) is as follows G1 (37%), G2 (49%), G3 (14%). Conclusions: PV/LPV are prevalent in patients with sporadic pNET irrespective of high-risk features or family history. While in the high-risk patients there is a higher prevalence, we also identified a 21% prevalence of PV/LPV with universal germline testing in the unselected cohort. In both cohorts, we identified a high number of mutations in the DNA repair pathway not previously described, which could affect subsequent therapies and surveillance for patients and their family members. The findings support upfront universal germline testing in all patients with diagnosis of pNETs. [Table: see text]
    Materialart: Online-Ressource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4135
    RVK:
    XA 52760
    RVK:
    XA 10000
    Sprache: Englisch
    Verlag: American Society of Clinical Oncology (ASCO)
    Publikationsdatum: 2023
    ZDB Id: 2005181-5
    Standort Signatur Einschränkungen Verfügbarkeit
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