Author: Miller, Jeffrey S ; Heath, Elisabeth I ; Arafa, Ali T ; El-Deiry, Wafik S ; Zorko, Nicholas A ; Zakharia, Yousef ; Felices, Martin ; Stein, Mark N ; Patniak, Akash ; Elliott, Andrew ; Radovich, Milan ; Zarrabi, Kevin K ; Hoon, Dave S B ; Bilen, Mehmet A ; Nabhan, Chadi ; Makovec, Allison ; Barata, Pedro ; Kellen, Samuel ; Narayan, Vivek ; Lozada, John R ; Hwang, Justin H ; Shackelford, Madison ; Sledge, George ; Antonarakis, Emmanuel S

Abstract:

Background:

Natural killer (NK) cells are non-antigen specific innate immune cells that can be redirected to targets of interest using multiple strategies, although none are currently FDA-approved. We sought to evaluate NK cell infiltration into tumors to develop an improved understanding of which histologies may be most amenable to NK cell-based therapies currently in the developmental pipeline.

Methods:

DNA (targeted/whole-exome) and RNA (whole-transcriptome) sequencing was performed from tumors from 45 cancer types (N = 90,916 for all cancers and N = 3365 for prostate cancer) submitted to Caris Life Sciences. NK cell fractions and immune deconvolution were inferred from RNA-seq data using quanTIseq. Real-world overall survival (OS) and treatment status was determined and Kaplan–Meier estimates were calculated. Statistical significance was determined using X2 and Mann–Whitney U tests, with corrections for multiple comparisons where appropriate.

Results:

In both a pan-tumor and prostate cancer (PCa) -specific setting, we demonstrated that NK cells represent a substantial proportion of the total cellular infiltrate (median range 2–9% for all tumors). Higher NK cell infiltration was associated with improved OS in 28 of 45 cancer types, including (PCa). NK cell infiltration was negatively correlated with common driver mutations and androgen receptor variants (AR-V7) in primary prostate biopsies, while positively correlated with negative immune regulators. Higher levels of NK cell infiltration were associated with patterns consistent with a compensatory anti-inflammatory response.

Conclusions:

Using the largest available dataset to date, we demonstrated that NK cells infiltrate a broad range of tumors, including both primary and metastatic PCa. NK cell infiltration is associated with improved PCa patient outcomes. This study demonstrates that NK cells are capable of trafficking to both primary and metastatic PCa and are a viable option for immunotherapy approaches moving forward. Future development of strategies to enhance tumor-infiltrating NK cell-mediated cytolytic activity and activation while limiting inhibitory pathways will be key.

01 Aug 2024·Journal of palliative medicine

Electronic Health Record Tracking of Psychosocial Care in the Context of Serious Illness: A Narrative Review

Review

Author: Cammy, Rebecca

Objective: The electronic health record (EHR) has emerged as a fundamental tool but has focused on physical care delivery. Psychosocial screenings and interventions are central to palliative care that supports whole person care models; however, EHR innovations to capture psychosocial care have not been optimized. Material and Methods: A narrative review was conducted from 2009 to March 2023. EMBASE, PubMed, and PsychINFO were queried to identify articles that discussed EHR tracking of psychosocial care in palliative care. Results: Eight articles met inclusion criteria representing a broad range of works in palliative care. Three themes emerged in the narrative review: (a) quality improvement strategy to support EHR tracking in collaboration with key stakeholders, (b) clarification of psychosocial domains for documentation and measurement, and (c) lack of standardization in data collection tools and processes. Discussion: This narrative review contributes to a limited body of literature on EHR extraction of complex sources of distress in palliative care. The designation of four domains (social history and distress, psychological symptoms, spiritual needs, and patients' goals and preferences) defines psychosocial practice aligned with palliative care quality metrics. Recommendations highlight the importance of shared priorities and collaboration with key stakeholders to fully execute on the clinical utility of EHRs. Future work will continue to evaluate data collection tools and systematic approaches to capture psychological needs and social environment and its impact on health outcomes and quality of life. Conclusion: This review will expand on opportunities for automated reporting of psychosocial care in the context of seriously ill.

01 Aug 2024·European urology oncology

PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy

Article

Author: Cetnar, Jeremy P ; Li-Ning-Tapia, Elsa ; Galsky, Matthew D ; Hahn, Noah M ; Grivas, Petros ; Koshkin, Vadim S ; Carducci, Michael A ; Chu, Xiangying ; Sundi, Debasish ; Gartrell, Benjamin A ; Dreicer, Robert ; Cole, Suzanne ; Jain, Rohit K ; Woo, Brianna

BACKGROUND AND OBJECTIVE:

Neoadjuvant cisplatin-based chemotherapy prior to radical cystectomy (RC) improves overall survival (OS) in muscle-invasive bladder cancer (MIBC). However, many patients are cisplatin ineligible; therefore, new treatment options are needed. Nivolumab without/with lirilumab prior to RC was investigated in cisplatin-ineligible patients in this phase 1b trial (NCT03532451) to determine its safety/feasibility.

METHODS:

Patients with localized MIBC received two doses of nivolumab (480 mg) alone (cohort 1) or with lirilumab (240 mg; cohort 2) prior to RC. Cohorts were enrolled sequentially. The key eligibility criteria were cT2-4aN0-1M0 stage and cisplatin ineligibility/refusal. The primary endpoint was the rate of grade (G) ≥3 treatment-related adverse events (TRAEs) as per Common Terminology Criteria for Adverse Events version 5.0. The key secondary endpoints included the proportion of patients who underwent RC >6 wk after the last dose, CD8+ T-cell density change between pretreatment transurethral resection of bladder tumor (TURBT) and post-treatment RC, ypT0N0,

KEY FINDINGS AND LIMITATIONS:

Among 43 patients enrolled (n = 13, cohort 1; n = 30, cohort 2), 13 and 29 completed intended neoadjuvant therapy, respectively, in cohorts 1 and 2, and 41 underwent RC. The median time from the last dose to RC was 4 wk. The G3 TRAEs occurred in 0% (90% confidence interval [CI] 0-21%) of patients in cohort 1 and 7% (90% CI 1-20%) in cohort 2; all these TRAEs resolved and no G4/5 TRAEs occurred. No patient had delayed RC for >6 wk. In cohorts 1 and 2, ypT0N0 rates for patients with MIBC and RC were 17% and 21%,

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Neoadjuvant nivolumab-based immunotherapy was safe, feasible, and well tolerated in cisplatin-ineligible patients with MIBC. Although ypT0N0 rates were lower than expected, 2-yr survival rates seem to be comparable with those of other neoadjuvant immunotherapy trials. Nivolumab is being evaluated in the CA-017-078 trial (NCT03661320).

PATIENT SUMMARY:

For patients with muscle-invasive bladder cancer unable to receive cisplatin-based chemotherapy, treatment with nivolumab without and with lirilumab prior to radical cystectomy was safe, feasible, and well tolerated. Nivolumab-based immunotherapy showed lower pathologic response rates than but similar survival rates to other neoadjuvant immunotherapy trials.

News (Medical) associated with Sidney Kimmel Cancer Center

27 Apr 2023

·www.prnewswire.com

Susan G. Komen® Welcomes Nine Leaders to Research Advisory Roles

Distinguished Researchers to Influence and Advance Breast Cancer Research DALLAS, April 27, 2023 /PRNewswire/ -- Susan G. Komen®, the world's leading breast cancer organization, has appointed nine world-renowned medical and research experts to serve as advisors to the organization. These breast cancer experts will be part of a distinguished group, known as Komen Scholars, who help guide Komen's research and scientific programs, with a focus on advancing discoveries to improve breast cancer outcomes for everyone. The incoming class of nine Scholars joins an advisory group of nearly 50 world-class leaders in breast cancer research and advocacy, representing about 30 health institutions across the nation. Their expertise spans many areas, including breast cancer biology, genomics, biomarkers, health disparities, therapeutics, clinical trials and imaging. The Komen Scholars contribute to a variety of Komen programs, including leading Komen's scientific peer review process and act as Komen ambassadors in communities around the U.S. and the world. "We're so excited to welcome these incredible individuals as Komen Scholars. Komen is fortunate to have such a tremendous team of experts guiding our work and research priorities: to advance precision medicine, conquer deadly and aggressive breast cancers and achieve health equity," said Kimberly Sabelko, Ph.D., vice president of scientific strategy & programs at Susan G. Komen. The nine clinical oncologists and researchers are: Carlos Arteaga, M.D., University of Texas Southwestern Harold C. Simmons Cancer Center Myles Brown, M.D., Harvard Medical School/Dana-Farber Cancer Institute Susan Domchek, M.D., University of Pennsylvania/Perelman School of Medicine David Mankoff, M.D., Ph.D., University of Pennsylvania Kathy Miller, M.D., Indiana University Melvin and Bren Simon Comprehensive Cancer Center Harikrishna Nakshatri, BVSc, Ph.D., Indiana University Melvin and Bren Simon Comprehensive Cancer Center Jeffrey Rosen, Ph.D., Baylor College of Medicine Bryan Schneider, M.D., Indiana University Melvin and Bren Simon Comprehensive Cancer Center Antonio Wolff, M.D., FACP, FASCO, Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center "The Komen Scholars bring their expertise and experience from laboratories, clinics and as patients. They are incredible assets to the transformative work we're doing at Komen to accelerate research at a time when there is critical need to advance personalized medicine to help everyone impacted by breast cancer live longer, healthier lives," said Jennifer A. Pietenpol, Ph.D., chief scientific advisor at Susan G. Komen, Chief Scientific and Strategy Officer and Executive Vice President for Research at Vanderbilt University Medical Center and Ingram Professor of Cancer Research and Professor of Biochemistry at the Vanderbilt School of Medicine. Komen also expressed its appreciation for the scientific advisors whose terms have come to an end: Nikhil Wagle, M.D. Dana-Farber Cancer Institute Anne Meyn, M.Ed., Advocates in Science, Houston, TX "These leaders are the foremost experts in breast cancer and will make a lasting impact to advance progress against deadly and aggressive breast cancers and achieve health equity to benefit everyone affected by this disease," said Ann Partridge, M.D., MPH, chief scientific advisor for Susan G. Komen and the Eric P. Winer, M.D., Chair in Breast Cancer Research, Vice Chair of the Department of Medical Oncology, Director of the Adult Survivorship Program and Director of the Program for Young Women with Breast Cancer at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "We're grateful for the service of our departing Komen Scholars and appreciate the commitment they, our current, and new Komen Scholars have to ending breast cancer forever." For more information about Komen's research and advocacy scholars go to . About Susan G. Komen ® Susan G. Komen® is the world's leading nonprofit breast cancer organization, working to save lives and end breast cancer forever. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts and supporting millions of people in the U.S. and in countries worldwide. We advocate for patients, drive research breakthroughs, improve access to high-quality care, offer direct patient support and empower people with trustworthy information. Founded by Nancy G. Brinker, who promised her sister, Susan G. Komen, that she would end the disease that claimed Suzy's life, Komen remains committed to supporting those affected by breast cancer today, while tirelessly searching for tomorrow's cures. Visit komen.org or call 1-877 GO KOMEN. Connect with us on social at . SOURCE Susan G. Komen for the Cure

Executive Change

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Drug(Targets)	Indications	Global Highest Phase

K562/GM-CSF vaccine(The Johns Hopkins University) ( CSF-3R )	Philadelphia chromosome positive chronic myelogenous leukemia More	Phase 2
[18F]DCFPyL ( PSMA )	Renal Cell Carcinoma More	Phase 1
NSC-639829 ( Tubulin )	Neoplasms More	Discontinued

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