SUMMARY Defining conditioning regimen intensity has become a critical issue for the hemopoietic stem cell transplant community. In the present report we propose to define conditioning regimens in three categories: (a) myeloablative conditioning (MA) , (b) reduced intensity conditioning (RIC) and (c) non myeloablative conditioning (NMA). Assignment to these categories is based on the duration of cytopenia and on the requirement for stem cell (SC) support: MA regimens cause irreversible cytopenia and SC support is mandatory. NMA regimens cause minimal cytopenia and can be given also without SC support. RIC regimens do not fit criteria for MA or NMA regimens : they cause cytopenia of variable duration and should be given with stem cell support, although cytopenia may not be irreversible. This report also assigns commonly used regimens to one of these categories. based upon the agents, dose or combinations. Standardized classification of conditioning regimen intensities will allow comparison across studies and interpretation of study results.

Chronic graft-versus-host disease (cGVHD) is the leading cause of late treatmentrelated deaths among recipients of allogeneic bone marrow and blood transplants. However, cGVHD is also associated with fewer relapses. We sought to determine whether severity of cGVHD predicts the magnitude of these effects. One impediment to such an analysis is the current limited/extensive grading system for cGVHD because this classification was designed to identify patients likely to benefit from systemic immune suppression and does not capture the severity of multiorgan involvement. We, therefore, first developed a grading system predictive for survival by using data from 1827 HLAmatched sibling allotransplant recipients reported to the International Bone Marrow Transplant Registry (IBMTR). We found Karnofsky performance score, diarrhea, weight loss, and cutaneous and oral involvement to be independent prognostic variables, from which we generated a grading scheme. We tested this scheme, the limited/extensive classification sys-

During the 2006 Tandem BMT Meetings a workshop was convened by the Center for International Blood and Marrow Transplant Research (CIBMTR) to discuss conditioning regimen intensity and define boundaries of “reduced intensity conditioning” (RIC) prior to hematopoietic cell transplantation (HCT). The goal of the workshop was to determine acceptance within the transplant community of available RIC definitions. The participants were surveyed during the workshop to state if they strongly agreed, agreed, disagreed or strongly disagreed with specific statements on conditioning regimen intensity. The questions included the “Champlin criteria” as well as operational definitions used in registries studies exemplified in clinical vignettes. Fifty-six participants including transplant physicians, transplant center directors and transplant nurses with a median of 12 years of experience in HCT answered the survey. Sixty-seven percent agreed with statements that a RIC regimen should cause reversible myelosuppression when administered without stem cell support; result in low non-hematologic toxicity and after transplantation results in mixed donor-recipient chimerism at the time of first assessment in the majority of patients. Likewise the majority (71%) agreed or strongly agreed that regimens with less than 500 cGy of total body irradiation as a single fraction or 800 cGy in fractionated doses, busulfan less than 9 mg/kg, melphalan less than 140 mg/m2 or thiotepa less than 10 mg/kg should be considered RIC regimens. However, only 32% agreed or strongly agreed that the combination of carmustine, etoposide, cytarabine and melphalan (BEAM) be considered a RIC regimen. These results demonstrate that although a consensus of what constitutes a RIC regimen does not exist among HCT professionals, currently used criteria and operational definitions are accepted by a majority of them. These results support the continued use of current criteria for RIC regimens until a consensus statement is developed.

PURPOSE Acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) primarily afflict older individuals. Hematopoietic cell transplantation (HCT) is generally not offered because of concerns of excess morbidity and mortality. Reduced-intensity conditioning (RIC) regimens allow increased use of allogeneic HCT for older patients. To define prognostic factors impacting long-term outcomes of RIC regimens in patients older than age 40 years with AML in first complete remission or MDS and to determine the impact of age, we analyzed data from the Center for International Blood and Marrow Transplant Research (CIBMTR). PATIENTS AND METHODS We reviewed data reported to the CIBMTR (1995 to 2005) on 1,080 patients undergoing RIC HCT. Outcomes analyzed included neutrophil recovery, incidence of acute or chronic graft-versus-host disease (GVHD), nonrelapse mortality (NRM), relapse, disease-free survival (DFS), and overall survival (OS). RESULTS Univariate analyses demonstrated no age group differences in NRM, grade 2 to 4 acute GVHD, chronic GVHD, or relapse. Patients age 40 to 54, 55 to 59, 60 to 64, and > or = 65 years had 2-year survival rates as follows: 44% (95% CI, 37% to 52%), 50% (95% CI, 41% to 59%), 34% (95% CI, 25% to 43%), and 36% (95% CI, 24% to 49%), respectively, for patients with AML (P = .06); and 42% (95% CI, 35% to 49%), 35% (95% CI, 27% to 43%), 45% (95% CI, 36% to 54%), and 38% (95% CI, 25% to 51%), respectively, for patients with MDS (P = .37). Multivariate analysis revealed no significant impact of age on NRM, relapse, DFS, or OS (all P > .3). Greater HLA disparity adversely affected 2-year NRM, DFS, and OS. Unfavorable cytogenetics adversely impacted relapse, DFS, and OS. Better pre-HCT performance status predicted improved 2-year OS. CONCLUSION With these similar outcomes observed in older patients, we conclude that older age alone should not be considered a contraindication to HCT.