Prognostic value of response after upfront therapy for acute GVHD Journal Article
| Authors: | Saliba, R. M.; Couriel, D. R.; Giralt, S.; Rondon, G.; Okoroji, G. J.; Rashid, A.; Champlin, R. E.; Alousi, A. M. |
| Article Title: | Prognostic value of response after upfront therapy for acute GVHD |
| Abstract: | One challenge in designing clinical trials for treatment of acute GVHD (aGVHD) is the lack of an established standardized end point to measure the success of therapies. To facilitate assessment of end points in clinical trials for treatment of aGVHD in the current allo-SCT era, a national workshop was recently organized. In this study, which was presented at the workshop, we evaluated the prognostic value of response to upfront therapy in a cohort of 83 patients who had been enrolled on two clinical trials testing novel therapies for aGVHD at our institution. Our results indicate that patients whose aGVHD has a CR or PR by day 28 after initiation of systemic therapy have a significantly lower 6-month cumulative incidence of non-relapse mortality (NRM) (16%) than patients whose aGVHD did not respond to therapy by day 28 (48%, P=0.005). Multivariate analysis based on the Cox proportional hazards regression analysis showed that the impact of response on NRM is independent of patient and aGVHD characteristics. Our data confirm the validity of using day-28 response as a primary end point in clinical trials for upfront therapy for aGVHD. © 2012 Macmillan Publishers Limited All rights reserved. |
| Keywords: | adult; controlled study; treatment outcome; aged; disease-free survival; middle aged; survival rate; transplantation, homologous; major clinical study; overall survival; mortality; systemic therapy; methotrexate; incidence; cohort analysis; stem cell transplantation; prediction; antibodies, monoclonal; acute graft versus host disease; myeloablative conditioning; hematologic neoplasms; drug response; response; remission; liver disease; validity; methylprednisolone; skin disease; tacrolimus; graft vs host disease; gastrointestinal disease; outcomes; pentostatin; acute disease; randomized controlled trial (topic); phase 2 clinical trial (topic); phase 3 clinical trial (topic); anti-inflammatory agents; acute gvhd; non relapse mortality |
| Journal Title: | Bone Marrow Transplantation |
| Volume: | 47 |
| Issue: | 1 |
| ISSN: | 0268-3369 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2012-01-01 |
| Start Page: | 125 |
| End Page: | 131 |
| Language: | English |
| DOI: | 10.1038/bmt.2011.41 |
| PROVIDER: | scopus |
| PUBMED: | 21383686 |
| PMCID: | PMC4114039 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 1 March 2012" - "CODEN: BMTRE" - "Source: Scopus" |
