mimic the role of filgrastim (F), resulting in at least an equivalent shortening of post-PBSCT neutropenia. NHL patients over the age of 18 years who were deemed eligible for PBSCT were identified prior to the administration of high-dose chemotherapy, and following adequate harvest and cryopreservation of peripheral blood progenitor cells (ie, . 2.5 106 CD341 cells/kg). Eligible patients with preserved end organ function received either standard BEAM or BEAC high-dose chemotherapy. Prior to high-dose therapy, patients were randomly assigned to receive either P at a fixed-dose of 6 mg on Day 11(Arm A), or weightbased, dose-adjusted F rounded to the nearest prefilled syringe beginning on Day 11(Arm B) following transplantation. One-hundred one eligible patients were enrolled within US Oncology Transplant Network between July 2003 and April 2007. Three patients were deemed ineligible (CHF death, consent withdrawn, other). The analyses and results presented below outline the remaining 98. The demographic characteristics of both arms were well-balanced with regards to stage at diagnosis and treatment, ECOG Performance Status, histology, and lines of prior therapy. The comparison of P vs F is summarized in the table that follows. Transplant-related mortality and the incidence of Grade 3–4 adverse events were comparable in both arms. In conclusion, administration of pegfilgrastim post-PBSCT appears to be equivalent to multiple daily doses of filgrastim. Such an approach might be considered in lieu of filgrastim thereby obviating the need for multiple daily injections. Comparison of Pegfilgrastim (P) versus Filgrastim (F) Variable
Arm A (Pegfilgrastim)
Arm B (Filgrastim)
No. of Patients Treated (n) Doses Received (mean ± SD) ANC Recovery (days) (mean ± SD) RBC Transfusions (mean ± SD) Platelet Transfusions (mean ± SD) Positive Blood Culture Rate (%) Febrile Neutropenia Rate (FN) (%) Duration of FN (days) (mean ± SD)
50 1.0 ± 0 8.3 ± 1.1 1.7 ± 0.9 3.0 ± 1.9 18.0% 18.0% 5.1 ± 3.4
48 12.7 ± 2.6 8.9 ± 1.5 1.9 ± 1.2 2.8 ± 1.8 29.0% 16.7% 5.5 ± 4.9
80 PRIMARY CMV INFECTION IN CMV SERONEGATIVE RECIPIENTS OF A STEM CELL PRODUCT FROM A SEROPOSITIVE DONOR (D1/R-): FREQUENCY OF AND RISK FACTORS FOR TRANSMISSION Sandhu, R.K., Smith, J., Kirby, K.A., Heimfeld, S., Corey, L., Boeckh, M. Fred Hutchinson Cancer Research Center, Seattle, WA. Background: To evaluate if there is an effect of host and donor factors in developing primary CMV infection in CMV D1/R- hematopoietic stem cell transplant (HCT) recipients. Method: Between 1/1996 and 12/2006, 392 D1/R- patients undergoing 1st allogeneic HCT were evaluated retrospectively for host and donor factors that may affect CMV transmission (recipient and donor age, race, sex, and ABO type, stem cell source, stem cell types [CD14, CD34, mononuclear cells] and overall number, underlying disease risk, conditioning regimen, GVHD prophylaxis, acute GVHD, TBI). Patients were evaluated for CMV antigenemia (AG) and/or DNAemia until day 100 after HCT. Factors associated with CMV transmission were evaluated by Cox regression models. All patients received preemptive antiviral therapy for AG positivity. Results: Of 392 D1/R- patients 383 (97.7%) were monitored regularly (AG: 345, AG and PCR: 29, PCR: 9) while and 9 (2.3%) were not tested because of early death. By day 100, 57 patients (14.5%) became antigenemia or PCR positive (50/345 [14.5%] by AG, 7/ 29 [24.2%] by AG and PCR, and 0% by PCR only); 3 additional patients became positive at sites other than blood. CMV disease occurred in 13 patients (3.3%) at a median of 111 days after HCT (range 19–617 days). Of these, 6 cases occurred before day 100 (incidence 1.5%) and 7 after day 100 (2.2% of patients alive at day 100). Five patients with CMV disease after day 100 had CMV infection diagnosed before day 100, resulting in an incidence of 8.8% among those with early CMV infection. No statistically significant risk factors for CMV transmission via blood or marrow were identified. However, ABO blood group B (hazard ratio 0.2, 95% CI 0.1–1.0,
P 5 0.05, compared to all other groups) and the total number of cells/kg transfused (HR 1.8, 95% 0.9–3.8, P 5 0.09, for values above the 90th percentile) were borderline significant in multivariable models. Conclusions: Transmision of CMV via marrow or stem cells is uncommon. Although no significant risk factors were identified, the observed trends for cell counts and ABO blood groups are interesting and suggest that the inoculum and perhaps genetic factors may be important in determining transmission risk.
81 PERFORMANCE STATUS, BUT NOT THE HEMATOPOIETIC CELL TRANSPLANTATION COMORBIDITY INDEX (HCT-CI), PREDICTS MORTALITY AT A CANADIAN TRANSPLANT CENTRE Guilfoyle, R.1, Demers, A.2, Richardson, E.3, Bredeson, C.4, Seftel, M.1,3. 1 University of Manitoba, Winnipeg, MB, Canada; 2 CancerCare Manitoba, Winnipeg, MB, Canada; 3 CancerCare Manitoba, Winnipeg, MB, Canada; 4 Medical College of Wisconsin, Milwaukee, WI. Introduction: The hematopoietic cell transplantation-specific comorbidity index (HCT-CI) was developed at a single centre in order to predict outcomes for allogeneic transplant recipients who have comorbidities. This index had a higher predictive power for non-relapse mortality (NRM) and overall survival (OS) than other tools such as the Charlson Comorbidity Index. The HCT-CI has, to our knowledge, not been validated in unselected transplant recipients at an institution outside the US. We evaluated whether the HCT-CI predicts NRM and OS at a Canadian institution and whether other readily available pre-transplant variables can predict NRM and OS. Methods: Using a prospective cohort design, we analyzed consecutive adult allogeneic HCT recipients between 01/ 1990 and 12/2005. Comorbidity was scored according to the HCT-CI. Kaplan-Meier survival curves were generated and hazard ratios were calculated using the Cox model. Results: Of 187 patients, 64 had AML or MDS, 40 had CML, and 83 had other diagnoses. Preparative regimens were myeloablative in 177 (95%). Grafts were from related donors in 138 (74%). Stem cell source was marrow in 134 (72%), peripheral blood in 51 (27%), and both in 2 (1%). HCT-CI risk was low in 22 (12%), intermediate in 50 (27%) and high in 104 (55%). Two year OS was 45% (95% CI: 24%-64%), 55% (95% CI: 40%-68%), and 42% (95% CI: 32%-51%) in the low, intermediate and high risk HCT-CI groups respectively. Two year NRM was 40% (95% CI: 21%-65%), 28% (95% CI: 17%-43%), and 34% (95% CI: 25%-44%) in the low, intermediate, and high risk groups, respectively. In both univariate and multivariate analyses, the HCT-CI was not a significant predictor of OS or NRM. In contrast, a KPS of \ 90% at HCT was a strong predictor of post HCT OS and NRM. Conclusions: The HCT-CI failed to predict NRM or OS at a Canadian transplant institution. In contrast, KPS appeared to be a powerful independent indicator of post-transplant survival. We suggest that large, multicentre studies are required before the HCT-CI can be applied in clinical practice.
82 SEVERE HEMORRHAGIC CYSTITIS (HC) AFTER ALLOGENEIC HEMATOPOEITIC STEM CELL TRANSPLANTATION (HSCT): INCIDENCE AND RISK FACTORS Smith, A.R.1, Tolar, J.1, DeFor, T.E.3, Weisdorf, D.J.2, MacMillan, M.L.1. 1 University of Minnesota, Minneapolis, MN; 2 University of Minnesota, Minneapolis, MN; 3 University of Minnesota, Minneapolis, MN. HC is a major source of morbidity after HSCT. Severe HC often results in prolonged hospitalizations, increased health care costs, decreased quality of life and, rarely, death. Further elucidating risk factors may lead to preventive strategies and early treatment. We reviewed 208 cases of HC which occurred in 1353 allogeneic HSCT recipients transplanted at the University of Minnesota from 1995–2006. Severe HC was defined as urinary clots and bladder pain requiring bladder irrigation and/or sequelae such as urethral and/or ureteral obstruction, renal failure and or the need for surgical or chemical bladder cautery or coagulation. A total of 72