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Chronic GVHD Consortium CATCH Study: Incidence, initial presentation and risk factors for chronic GVHD development
Joseph A Pidala1, Betty K Hamilton2, George Liwei Chen3
1H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States.
Insights
Chronic graft-versus-host disease (GVHD) affects many survivors post-transplant. This study identified early signs and risk factors for chronic GVHD, aiding in early intervention strategies.
Area of Science:
- Hematology
- Immunology
- Oncology
Background:
- Chronic graft-versus-host disease (GVHD) remains a significant complication after allogeneic hematopoietic stem cell transplantation (HCT).
- Despite declining incidence, up to 30% of survivors develop chronic GVHD, impacting long-term outcomes.
- Understanding current incidence and early manifestations is crucial for developing effective early treatment strategies.
Purpose of the Study:
- To determine the current incidence of chronic GVHD and its subtypes after allogeneic HCT.
- To identify the earliest presenting signs and symptoms of chronic GVHD across various organs.
- To explore risk predictors and patient-reported outcomes associated with chronic GVHD development and severity.
Main Methods:
- A prospective, multi-center observational study involving 208 subjects undergoing allogeneic HCT.
- Regular assessments including clinician evaluations, patient-reported measures (Lee Symptom Score, PROMIS), and biologic sample collection.
- Data collection occurred pre-HCT, at regular intervals post-HCT, and at the time of chronic GVHD diagnosis.
Main Results:
- The cumulative incidence of any chronic GVHD was 54% by 24 months post-HCT; 38% required systemic immune suppressive therapy (IST).
- Commonly affected organs at onset included mouth (42%), eye (41%), and skin (32%), with predominantly mild to moderate severity.
- Risk factors for requiring IST included baseline donor/recipient CMV positivity, non-PTCY prophylaxis, and changes in specific symptom scores.
Conclusions:
- Current chronic GVHD incidence remains substantial, with significant organ involvement at presentation.
- Early detection of specific symptoms and identification of risk factors like CMV status are key for timely intervention.
- This study provides valuable data for future biomarker research and clinical trials targeting early chronic GVHD therapy.
Abstract:
The incidence of chronic graft-versus-host disease (GVHD) is declining but up to 30% of survivors are still diagnosed with chronic GVHD. We conducted a prospective, multi-center, observational study to understand the incidence and earliest presenting signs and symptoms of chronic graft vs. host disease (GVHD) in the current era to inform trials testing early therapy. Patients were enrolled and assessed prior to allogeneic transplantation (HCT), and approximately every 2 months through the first year post-HCT, and at time of chronic GVHD diagnosis. Clinician assessments, patient-reported measures (Lee Symptom Score (LSS), PROMIS), and biologic samples were collected at each time point. A total of 208 subjects were enrolled across 7 HCT centers. The cumulative incidence of any chronic GVHD was 54% by 24 months post-HCT, while chronic GVHD requiring systemic immune suppressive therapy (IST) was 38%. At onset, organ involvement included skin (32%), eye (41%), mouth (42%), liver (17%), GI (9%), lung (11%), and joint/fascia (5%) with overall severity of mild (or less) in 55%, moderate in 37%, or severe in 8%. Management practices were heterogeneous. Subsequent chronic GVHD requiring IST was significantly associated with baseline donor/recipient CMV positivity and non-PTCY-based acute GVHD prophylaxis, as well as serial changes in skin/mouth/joint (PROM) organ scores and LSS summary score. These data provide current estimates of chronic GVHD incidence and presenting features, new data on risk predictors, and a data resource for future overall and organ-specific biomarker studies.
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