Case Studies To Define Serious GvHD
ASBMT members are invited to participate in a CIBMTR-sponsored online survey to test the feasibility of new approaches for evaluating GvHD. The survey is available online.
“The current criteria for assessment of acute and chronic GvHD were first developed in the 1970s,” said Paul Martin, MD, of Fred Hutchinson Cancer Research Center who is directing the project. “Changes in clinical practice since then have altered the presentation and natural history of GvHD. A single outcome measure encompassing both acute and chronic GvHD would be highly desirable as a way of summarizing the overall incidence of major complications caused by allogeneic donor T-cells. Major complications caused by ‘serious’ GVHD include death or threat to life, prolonged hospitalization or significant disability or incapacity as consequences of GVHD.”
Discussion and Debate
There is considerable room for discussion and debate concerning elements in any definition of “serious” GvHD, Dr. Martin said. Flowers et al. (Bone Marrow Transplant 2005;35:277-82) developed a definition of “serious” GvHD to analyze outcomes among 171 patients who received allogeneic hematopoietic cell transplant after a non-myeloablative conditioning regimen. This definition was reached by categorizing cases according to general criteria and then by developing rules to define the boundary between serious and non-serious GvHD through a series of iterative refinements.
“Given the breadth and diversity of the transplant community today, investigators are not likely to adopt the definition of serious acute or chronic GvHD offered by Flowers et al. in the same way that the much smaller transplant community in 1974 adopted the Glucksberg grading system for acute GvHD," Dr. Martin said. “Although investigators could modify the definition of ‘serious’ GvHD according to their own preferences, a single consensus definition would have the obvious advantage of allowing valid comparisons among different studies.”
First Step
As a first step toward a consensus definition, a workshop has been planned for the 2006 BMT Tandem Meetings. In preparation for this workshop, 10 cases histories representing patients with GvHD have been abstracted for evaluation. Each case history ends with two questions:
- Does this case represent “serious” GvHD?
- If so, at what point in time did the transition from “not-serious” to “serious” GvHD occur?
Responses to these questions will then be used to assess the feasibility of reaching a consensus definition and to identify more specific criteria that could be used in deciding whether a case of GvHD is serious or not.
The 10 case histories are posted online where they will be available through Dec. 31.