AbstractIntroduction:Advocates have been involved in cancer research for several decades, but little is known about their opinions regarding what is satisfying and what is frustrating. This largely qualitative study gathered feedback from a range of advocates regarding their experiences with cancer research to identify common themes and to generate hypotheses for future research.Methods:An online survey with 14 questions about the advocates’ background and experiences with research advocacy was distributed in early 2024 to cancer research advocates through multiple organizations and research advocacy networks. Thirty individuals responded, half of whom were advocates with 10+ years of experience.Results:Breast cancer was the most common cancer site of research activity (n=18/30, 60%), and clinical trials (n=29/30, 97%), and translational research (n=25/30, 83%) were the types of research of greatest interest. Respondents were generally enthused about their work and felt like they were making a meaningful contribution. The greatest frustration was being asked for letters of support at the last minute or otherwise “checking a box” for a researcher applying for a grant. Many respondents expressed difficulty in getting connected with research activities, especially at a local level. The advocates noted that the “career path” to becoming an established advocate is not always clear nor is it easy to find opportunitiesConclusionsand Recommendations: Our survey results demonstrate that research advocates are very engaged and satisfied with their experiences. While excellent training programs provide a solid foundation for new advocates, there should be a greater focus on continued engagement and mentoring for “mid-career” advocates.Citation Format:Bob Riter, Hillary Andrews. Cancer research advocates: satisfaction, frustration, and opportunities [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4024.

15 Nov 2024·Clinical Cancer Research

Plasma ctDNA as a Treatment Response Biomarker in Metastatic Cancers: Evaluation by the RECIST Working Group

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Author: Petrie, Joan ; Dyrskjøt, Lars ; Karlovich, Chris A. ; Litiere, Saskia ; Philip, Reena ; Tolmeijer, Sofie H. ; Laurie, Scott A. ; Seymour, Lesley ; de Vries, Elisabeth G.E. ; Pantel, Klaus ; Alfano, Christian ; Garralda, Elena ; Bogaerts, Jan ; Cabel, Luc ; Villalobos Alberu, Xenia ; Andrews, Hillary S. ; Vellanki, Paz J. ; Wyatt, Alexander W. ; Chen, Alice P. ; Bidard, Francois-Clément ; Calvo, Emiliano ; Toledo, Rodrigo A.

AbstractEarly indicators of metastatic cancer response to therapy are important for evaluating new drugs and stopping ineffective treatment. The RECIST guidelines based on repeat cancer imaging are widely adopted in clinical trials, are used to identify active regimens that may change practice, and contribute to regulatory approvals. However, these criteria do not provide insight before 6 to 12 weeks of treatment and typically require that patients have measurable disease. Recent data suggest that measuring on-treatment changes in the amount or proportion of ctDNA in peripheral blood plasma may accurately identify responding and nonresponding cancers at earlier time points. Over the past year, the RECIST working group has evaluated current evidence for plasma ctDNA kinetics as a treatment response biomarker in metastatic cancers and early endpoint in clinical trials to identify areas of focus for future research and validation. Here, we outline the requirement for large standardized trial datasets, greater scrutiny of optimal ctDNA collection time points and assay thresholds, and consideration of regulatory body guidelines and patient opinions. In particular, clinically meaningful changes in plasma ctDNA abundance are likely to differ by cancer type and therapy class and must be assessed before ctDNA can be considered a potential pan-cancer response evaluation biomarker. Despite the need for additional data, minimally invasive on-treatment ctDNA measurements hold promise to build upon existing response assessments such as RECIST and offer opportunities for developing novel early endpoints for modern clinical trials.

01 Nov 2024·JCO Oncology Advances

Analysis of 20 Independently Performed Assays to Measure Homologous Recombination Deficiency (HRD) in Ovarian Cancer: Findings From the Friends' HRD Harmonization Project

Author: Halford, Zan ; Bi, Shulin ; Zhang, Zhiwei ; Allen, Jeff D. ; Brunner, Lauren ; Li, Wenjie ; Kahn, Andrea G. ; Zou, ShiPing ; McShane, Lisa M. ; Arend, Rebecca ; Oliver, Bailee D. ; McKelvey, Brittany A. ; Zhao, Yingdong ; Kincaid, Kaitlyn ; Kotlov, Nikita ; Stenzinger, Albrecht ; Nam, Hyunjun ; Foxall, McKenzie ; Saul, Daniel ; Starks, Elizabeth R. ; Gupta, Mohit ; Lai, Yi-Hsuan Lucy ; Kohn, Elise C. ; Chapman, Alyssa ; Li, Ming-Chung ; Lazar, Alexander J. ; Karlovich, Chris ; Coletta, Tommaso ; Laird, A. Douglas ; Andrews, Hillary S. ; Safabakhsh, Pegah ; Chen, Li ; Pabla, Sarabjot ; Sokol, Ethan S. ; Taxter, Timothy ; Ding, Yuan ; Stewart, Mark D.

PURPOSEHomologous recombination deficiency (HRD) assays measure DNA damage repair dysfunction to identify patients with high-grade serous ovarian cancer (HGSOC) who may benefit from poly ADP-ribose polymerase inhibitors (PARPis). Numerous assays are available, but only two have undergone prospective clinical validation. Assay variability can affect patient and provider treatment choices; however, the level of assay variability across laboratory developed tests is unknown.METHODSFriends of Cancer Research initiated a research partnership, inviting HRD assay developers to participate in two blinded analyses. In the first, 11 assay developers reported HRD status for the Cancer Genome Atlas HGSOC data set (In Silico; n = 348) and then 17 assay developers reported HRD status for nucleic acids freshly extracted from archival specimens (n = 90) from patients with advanced HGSOC (clinical). HRD status was compared for each analysis.RESULTS The median (IQR) pairwise positive percent agreement (PPA) for the in silico analysis was 74% (51%-89%) and 81% (64%-92%) for pairwise negative percent agreement (NPA); for the clinical analysis PPA was 83% (70%-91%) and NPA was 80% (62%-91%). There was higher positive agreement on HRD status calls among those with a BRCA1 or BRCA2 mutation and a higher negative agreement in CCNE1 -amplified cases. Sample characteristics like tissue block age were not observed to be associated with agreement. A subgroup of tumors largely called HRD across assays with no BRCA1 or BRCA2 mutations was associated with better outcomes on standard platinum-based therapy compared with not HRD; however, the subgroup was small, and further research is warranted. CONCLUSIONThis analysis demonstrates how results from 20 HRD assays compare when assessing HGSOC. The results set the stage to improve alignment and establish standards for acceptable levels of agreement moving forward.

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