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THE HODGKIN LYMPHOMA INTERNATIONAL STUDY FOR INDIVIDUAL CARE (HOLISTIC): A MULTI-NATIONAL COLLABORATIVE TO ENHANCE DECISION MAKING FOR PEDIATRIC AND ADULT HODGKIN LYMPHOMA (HL)
Author(s): ,
Andrew Evens
Affiliations:
Rutgers Cancer Institute New Jersey,New Brunswick,United States
,
Ranjana Advani
Affiliations:
Stanford Cancer Institute,Stanford,United States
,
Berthe Aleman
Affiliations:
The Netherlands Cancer Institute,Den Haag,Netherlands
,
Marc Andre
Affiliations:
CHU UCL Namur,Yvoir,Belgium
,
Nickhill Bhakta
Affiliations:
St. Jude Children's Research Hospital ,Memphis,United States
,
Megan Cardoso
Affiliations:
Stakeholder, Patient Advocate,Chelmsford Pediatrics,Chelmsford,United States
,
Sharon Castellino
Affiliations:
Aflac Cancer & Blood Disorders Center of Children's Healthcare,Atlanta,United States
,
James Cerhan
Affiliations:
The Mayo Clinic,Rochester,United States
,
Chun Chao
Affiliations:
Division of Epidemiologic Research,Kaiser Permanente Southern California,Pasadena,United States
,
Joshua Cohen
Affiliations:
Tufts Medical Center,Boston,United States
,
Peter Cole
Affiliations:
Department of Pediatrics,Rutgers Cancer Institute of New Jersey,New Brunswick,United States
,
Andreas Engert
Affiliations:
University Hospital of Cologne,Cologne,Germany
,
Massimo Federico
Affiliations:
Università degli Studi di Modena e Reggio Emilia,Modena,Italy
,
Lizette Figueroa
Affiliations:
Leukemia and Lymphoma Society,Rye Brook,United States
,
Jamie Flerlage
Affiliations:
St. Jude Children's Research Hospital ,Memphis,United States
,
Christopher Flowers
Affiliations:
MD Anderson Cancer Center,Houston,United States
,
Catherine Fortpied
Affiliations:
EORTC,Brussels,Belgium
,
Jonathan Friedberg
Affiliations:
University of Rochester and the Wilmot Cancer Institute,Rochester,United States
,
Debra Friedman
Affiliations:
Vanderbilt-Ingram Cancer Center Cancer,Nashville,United States
,
Andrea Gallamini
Affiliations:
Antoine Lacassagne Cancer Center,Nice,France
,
Meghan Gutierrez
Affiliations:
Lymphoma Research Foundation,New York,United States
,
Theresa Hahn
Affiliations:
Clinical Epidemiology,Roswell Park Comprehensive Cancer Center,Buffalo,United States
,
Annette Hay
Affiliations:
Queen's University,Kingston,Canada
,
Tara Henderson
Affiliations:
The University of Chicago,Chicago,United States
,
David Hodgson
Affiliations:
Department of Radiation Oncology,Princess Margaret Hospital/University Health Network,Toronto,Canada
,
Brad Hoppe
Affiliations:
Radiation Oncology,The Mayo Clinic,Jacksonville,United States
,
Richard Hoppe
Affiliations:
Stanford Cancer Institute,Stanford,United States
,
Peter Hoskin
Affiliations:
University of Manchester,Manchester,United Kingdom
,
Melissa Hudson
Affiliations:
St. Jude Children's Research Hospital,Memphis,United States
,
Martin Hutchings
Affiliations:
Copenhagen University Hospital,Copenhagen,Denmark
,
Peter Johnson
Affiliations:
University of Southampton,Southampton,United Kingdom
,
Frank Keller
Affiliations:
Aflac Cancer and Blood Disorders Center,Atlanta,United States
,
Kara Kelly
Affiliations:
Roswell Park Comprehensive Cancer Center,Buffalo,United States
,
Lale Kostakoglu
Affiliations:
Mount Sinai ,New York,United States
,
Anita Kumar
Affiliations:
Tufts Medical Center,Boston,United States
,
Brian Link
Affiliations:
University of Iowa Hospitals and Clinics,Iowa City,United States
,
Michael Link
Affiliations:
Pediatric Hematology and Oncology,Stanford University,Palo Alto,United States
,
Raymond Mailhot
Affiliations:
Proton Therapy Institute,University of Florida ,Jacksonville,United States
,
Ralph Meyer
Affiliations:
McMaster University,Hamilton,Canada
,
Lindsay Morton
Affiliations:
National Cancer Institute,Rockville,United States
,
Andrea Ng
Affiliations:
Dana-Farber Cancer Institute,Boston,United States
,
John Radford
Affiliations:
University of Manchester,Manchester,United Kingdom
,
John Raemaekers
Affiliations:
EORTC,Brussels,Belgium
,
Les Robison
Affiliations:
St. Jude Children's Research Hospital,Memphis,United States
,
Angie Mae Rodday
Affiliations:
Tufts Medical Center,Boston,United States
,
Kerry Savage
Affiliations:
BC Cancer,Vancouver,Canada
,
Cindy Schwartz
Affiliations:
Medical College of Wisconsin,Milwaukee,United States
,
Lena Specht
Affiliations:
University of Copenhagen,Copenhagen,Denmark
,
David Straus
Affiliations:
Memorial Sloan Kettering Cancer Center,New York,United States
,
Jenica Upshaw
Affiliations:
Cardiology,Tufts Medical Center,Boston,United States
,
Flora van Leeuwen
Affiliations:
Netherlands Cancer Institute,Amsterdam,Netherlands
,
Samuel Volchenboum
Affiliations:
The University of Chicago,Chicago,United States
,
Lorna Warwick
Affiliations:
Lymphoma Coalition,Mississauga,Canada
,
John Wong
Affiliations:
Division of Clinical Decision Making,Tufts Medical Center,Boston,United States
,
Lennie Wong
Affiliations:
Division Of Biostatistics,City of Hope,Duarte,United States
,
Pier Luigi Zinzani
Affiliations:
Università di Bologna ,Bologna ,Italy
Susan Parsons
Affiliations:
Tufts Medical Center,Boston,United States
(Abstract release date: 05/14/20) EHA Library. Evens A. 06/12/20; 293638; EP1149
Dr. Andrew Evens
Dr. Andrew Evens
Contributions
Abstract

Abstract: EP1149

Type: e-Poster

Background
Although HL has good overall disease control, its treatment is associated with an increased risk of late effects (LE), premature mortality, and compromised health-related quality of life (HRQL). Decision making is further complicated by clinical trial results that differ; a growing range of treatment options; and the absence of ideal, objective information on long-term outcomes with modern therapy.


Aims
To develop methods for a large multi-national collaborative to assemble the best available evidence, including detailed information extracted from prominent HL clinical trials, “real world” HL registries & ongoing HL survivorship cohorts in order to establish dynamic HL decision models (DM) to calculate individualized short-term disease outcomes, estimate impact on HRQL, and to project long-term risks (i.e., 30+ years) with modern therapy.


Methods
We formed an international consortium, HoLISTIC (www.hodgkinconsortium.com), consisting of 50+ pediatric & adult HL providers, decision scientists, statisticians, epidemiologists & patient (pt) advocates. We are creating a data repository of individual pt data (IPD) from 16 large contemporary pediatric & adult clinical trials for newly diagnosed HL pts & 6 HL survivorship/registry cohorts (Table), the latter enriched with LE data. We will enhance our prior DM from group level data (Parsons S et al. Brit J Haem 2018) to establish a dynamic DM from IPD. Using statistical & simulation modeling, the enhanced DM will project outcomes of interest including quality-adjusted life years (QALYs) reflecting both morbidity & mortality (early & late). Results will be validated & calibrated against prominent external cohorts (e.g., St. Jude LIFE Cohort & Dutch Hodgkin LE Cohort).


Results
Applying established data science methods, we created a common data model with a data dictionary across all sources resulting in creation of an annotated database. To date, we have fully harmonized IPD from 10 clinical trials (~8,000 HL pts) ranging in size from 165 to 1925 HL pts. At diagnosis, median age was 26 years (IQR 18-38); 52% were male; 43% had B symptoms, 34% had mediastinal bulk and 79% had nodular sclerosis histology. Median follow up was 5.0 years (IQR 3.5-7.4) for clinical trial pts. In addition, we have assembled “real world” data on >600 HL pts from a large community oncology system (Kaiser Permanente Southern California, KPSC) and created a unified data dictionary of the KPSC data and the Mayo/Iowa Molecular Epidemiology Resource HL cohort. Trial IPD harmonization is ongoing in order to create an enhanced DM that includes ‘linkage’ of survivorship/registry pts combined into the same model to help estimate LEs, including pre-mature mortality.


Conclusion
HoLISTIC capitalizes on a new multidisciplinary, International pediatric & adult oncology collaborative that has successfully harmonized extensive IPD, integrated from both clinical trials & HL survivorship/registry cohorts. Furthermore, we developed methods to combine IPD from clinical trials & survivorship cohorts into the same DM to provide objective data delineating the influence that pt (and disease) characteristics and alternative treatment options have on acute outcomes for individual HL pts as well as simulating/estimating future LEs (prior to therapy). The model will also allow for incorporation of updated information as new therapies & knowledge emerge and it will be open source. Additionally, the DM will be converted to a web-based platform to test & evaluate among HL providers & pts at the point of care in order to identify the options best aligned with pts values & preferences.  

Session topic: 17. Hodgkin lymphoma - Clinical

Abstract: EP1149

Type: e-Poster

Background
Although HL has good overall disease control, its treatment is associated with an increased risk of late effects (LE), premature mortality, and compromised health-related quality of life (HRQL). Decision making is further complicated by clinical trial results that differ; a growing range of treatment options; and the absence of ideal, objective information on long-term outcomes with modern therapy.


Aims
To develop methods for a large multi-national collaborative to assemble the best available evidence, including detailed information extracted from prominent HL clinical trials, “real world” HL registries & ongoing HL survivorship cohorts in order to establish dynamic HL decision models (DM) to calculate individualized short-term disease outcomes, estimate impact on HRQL, and to project long-term risks (i.e., 30+ years) with modern therapy.


Methods
We formed an international consortium, HoLISTIC (www.hodgkinconsortium.com), consisting of 50+ pediatric & adult HL providers, decision scientists, statisticians, epidemiologists & patient (pt) advocates. We are creating a data repository of individual pt data (IPD) from 16 large contemporary pediatric & adult clinical trials for newly diagnosed HL pts & 6 HL survivorship/registry cohorts (Table), the latter enriched with LE data. We will enhance our prior DM from group level data (Parsons S et al. Brit J Haem 2018) to establish a dynamic DM from IPD. Using statistical & simulation modeling, the enhanced DM will project outcomes of interest including quality-adjusted life years (QALYs) reflecting both morbidity & mortality (early & late). Results will be validated & calibrated against prominent external cohorts (e.g., St. Jude LIFE Cohort & Dutch Hodgkin LE Cohort).


Results
Applying established data science methods, we created a common data model with a data dictionary across all sources resulting in creation of an annotated database. To date, we have fully harmonized IPD from 10 clinical trials (~8,000 HL pts) ranging in size from 165 to 1925 HL pts. At diagnosis, median age was 26 years (IQR 18-38); 52% were male; 43% had B symptoms, 34% had mediastinal bulk and 79% had nodular sclerosis histology. Median follow up was 5.0 years (IQR 3.5-7.4) for clinical trial pts. In addition, we have assembled “real world” data on >600 HL pts from a large community oncology system (Kaiser Permanente Southern California, KPSC) and created a unified data dictionary of the KPSC data and the Mayo/Iowa Molecular Epidemiology Resource HL cohort. Trial IPD harmonization is ongoing in order to create an enhanced DM that includes ‘linkage’ of survivorship/registry pts combined into the same model to help estimate LEs, including pre-mature mortality.


Conclusion
HoLISTIC capitalizes on a new multidisciplinary, International pediatric & adult oncology collaborative that has successfully harmonized extensive IPD, integrated from both clinical trials & HL survivorship/registry cohorts. Furthermore, we developed methods to combine IPD from clinical trials & survivorship cohorts into the same DM to provide objective data delineating the influence that pt (and disease) characteristics and alternative treatment options have on acute outcomes for individual HL pts as well as simulating/estimating future LEs (prior to therapy). The model will also allow for incorporation of updated information as new therapies & knowledge emerge and it will be open source. Additionally, the DM will be converted to a web-based platform to test & evaluate among HL providers & pts at the point of care in order to identify the options best aligned with pts values & preferences.  

Session topic: 17. Hodgkin lymphoma - Clinical

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