(P 69) DEVELOPMENT AND MISSION OF THE HARMONIZATION INTERNATIONAL BONE SARCOMA CONSORTIUM (HIBISCUS)

Objective: Osteosarcoma and Ewing sarcoma are rare malignancies with only about 3 cases/million/year and 1.5 cases/million/year, respectively (1,2). International efforts to aggregate data in other rare cancers has facilitated refinement of risk stratification and study of rare subtypes. We established the Harmonization International Bone Sarcoma Consortium (HIBiSCus) in May of 2019. The goal of HIBiSCus is to increase understanding and accelerate progress through larger analytic patient populations in osteosarcoma and Ewing Sarcoma. This report describes the establishment of this new data resource for the field.

Methods: The founding members of HIBiSCus partnered with the Pediatric Cancer Data Commons group, now called Data for the Common Good, at the University of Chicago who had experience and expertise in launching consortia for other disease groups and facilitating data dictionary work (3, 4, 5, 6). A memorandum of understanding governs the Consortium. Consortium decisions are managed by an executive committee consisting of one member from each group and representatives from multiple disciplines including pathology, radiation oncology, radiology, surgery, and biostatistics. The executive committee has three Co-Chairs (Figure 1). Data dictionaries are created by assimilation, clarification, and balloting of clinical trial case report forms. Data are shared under data sharing agreements and will be accessed through a data portal by project proposal application to and approval from the executive committee.

Results: There are ten cooperative group members participating in HIBiSCus, including Children’s Oncology Group (COG), Euro Ewing Consortium (EEC), National Cancer Research Institute Sarcoma Clinical Studies Group (NCRI), Cooperative German-Austrian-Swiss Osteosarcoma Study Group (COSS) of the German Pediatric Oncology-Hematology Society (GPOH), Cooperative Ewing Sarcoma Study Group (CESS) of the GPOH, French Bone Sarcoma Group GROUPOS (SFCE, GSF-GETO, UNICANCER), Spanish Sarcoma Group (GEIS), Italian Sarcoma Group (ISG), Scandinavian Sarcoma Group (SSG), and Grupo Latino Americano Oncología Pediátrica (GALOP). The memorandum of understanding was signed on April 23, 2021. Two data dictionaries have been finalized by assessing prior clinical trials and working group discussion. Data dictionaries are available at: https://commons.cri.uchicago.edu/data-dictionaries/. One data contributor agreement is signed and another nine are in progress. Finalizing data transfer agreements is anticipated to take time, especially since it includes international partnership in the context of varying regulations regarding use and sharing of patient data for research (7). Data from the first cooperative group are expected to be available in late fall 2023. Although data import is still pending, it is projected that there will be over 9500 Ewing sarcoma patients and 6800 Osteosarcoma patients in the database (Figure 2). Multidisciplinary workgroups have been devised to continue the momentum of the HIBiSCus consortium formation while awaiting data, maximize productivity as well as anticipate and address issues that arise during data harmonization. The first workgroup to be launched is the bone tumor clinical trial standards workgroup focused on guidelines for molecular assessments, staging and risk classification, data collection, and response criteria for clinical trials.

Conclusion: With our new international partnerships, HIBiSCus provides a platform to access data for research. It also provides for wider global discussions and consensus, with data expected to be deposited over the next years.