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Non-Myeloablative (NMA) Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients with Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation (Bu/Flu/TBI) Conditioining: Results of a Phase II Trial

Track: Poster Abstracts
Saturday, March 1, 2014, 6:45 PM-7:45 PM
Longhorn Hall E (Exhibit Level 1) (Gaylord Texan)
Jonathan E Brammer, MD , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Alex Stentz, MPH , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
James Dibb , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Rachel Frires, BA , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Gabrielle Meyers, MD , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Peter Curtin, MD , Medicine, University of California, San Diego, La Jolla, CA
Tibor Kovacsovics, MD , Hematology and Hematologic Malignancies, University of Utah Huntsman Cancer Institute, Salt Lake City, UT
Jose Leis, MD, PhD , Hematology Oncology/Blood and Marrow Transplant, Mayo Clinic Arizona, Phoenix, AZ
Gundula R Palmbach , Center for Hematologic Malignancies, Oregon Health and Sciences University, Portland, OR
James Gajewski, MD, FACP , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Richard T. Maziarz, MD , Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland, OR

Introduction:

Non-myeloablative (NMA) allogeneic transplant for the treatment of hematologic malignancies has become the standard of care for patients unable to tolerate myeloablative conditioning. The BuFluTBI transplant regimen was designed with the primary goal of reducing non-relapse mortality (NRM) while maximizing primary disease control in older and infirm patients.

Methods:

Patients with high-risk hematologic malignancies were given an outpatient conditioning regimen of busulfan 3.2 mg/kg IV on day -5, fludarabine 30 mg/m2 IV on days -4, -3, -2, and 200 cGy of total body irradiation (TBI). Sources of hematopoietic stem cells were either from related or unrelated donors (at least 7/8 antigen match). GVHD prophylaxis was given with cyclosporine and mycophenolate mofetil. Clinical predictors of response were evaluated utilizing Cox Proportional Hazards Model.

Results:

147 patients were enrolled from 2005-2011; 86 (59%) with myeloid disease and 61 (41%) with lymphoid disease. The median age was 64, and the median comorbidity index (HCT-CI) score was 3. The overall survival (OS), with 2 years median follow-up, was 60% at 1 year and 48% at 2 years, with projected OS 37% at 5 years. Relapse rates were 29% at 1 year and 33% at 2 years, with relapse mortality of 13% at 1 year, and 20% at 2 years. NRM at 1 year was 27% and 33% at 2 years. 54% of patients developed early or late grade II-IV acute GVHD (aGVHD), and 67% of patients developed cGVHD within 2 years. On multivariate analysis, amongst 92 evaluable patients, HCT-CI score greater than 4, pre-transplant KPS <90, delayed platelet engraftment >15 days, and aGVHD were found to be independent predictors of poor survival as demonstrated in the table.

Conclusions:

In an infirm elderly population with a high HCT-CI, BuFluTBI is an effective regimen with favorable OS with acceptable levels of NRM.

Multivariate Analysis of Clinical Predictors of Overall Survival (n=92)

Characteristic

HR (95% CI)

P-Value

KPS <90

2.08 (1.10-3.92)

0.023

HCT-CI 4+

2.77 (1.44-5.32)

0.002

Not in CR

1.16 (0.59-2.32)

0.664

Age >65

1.32 (0.70-2.51)

0.393

Plt Engraftment >15 Days

2.48 (1.21-5.08)

0.013

ANC Engraftnent >14 Days

1.58 (0.84-3.00)

0.156

+ aGVHD

4.31 (1.80-10.33)

0.001

+ cGVHD

1.24 (0.53-2.95)

0.618

Risk Score: High/Very High

1.40 (0.67-2.90)

0.371

*All variables were normalized to HR=1

Disclosures:
Nothing To Disclose
See more of: Poster Session 2: Allogeneic Transplants
See more of: Poster Abstracts
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