Format

Send to

Choose Destination
Biol Blood Marrow Transplant. 2017 Sep;23(9):1491-1497. doi: 10.1016/j.bbmt.2017.05.014. Epub 2017 May 17.

Long-Term Follow-Up and Impact of Comorbidity before Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Relapsed or Refractory Acute Myeloid Leukemia-Lessons Learned from the Prospective BRIDGE Trial.

Author information

1
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany. Electronic address: moritz.middeke@uniklinikum-dresden.de.
2
Medizinische Klinik III, Klinikum Chemnitz, Chemnitz, Germany.
3
Klinik für Hämatologie, Onkologie und Palliativmedizin, Rems-Murr-Klinikum Winnenden, Winnenden, Germany.
4
Klinikum der Johann Wolfgang Goethe Universität Frankfurt am Main, Medizinische Klinik II, Frankfurt, Germany.
5
Zentrum für Blutstammzell- und Knochenmarktransplantation, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.
6
Städtisches Klinikum Nord, 5. Medizinische Klinik, Nürnberg, Germany.
7
Universitätsklinikum Erlangen, Medizinische Klinik 5, Erlangen, Germany.
8
III. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim, Germany.
9
Abteilung für Hämatologie, Onkologie, Immunologie, Rheumatologie und Pulmologie, Medizinische Universitätsklinik Tübingen, Tübingen, Germany.
10
Klinik für Hämatologie, Onkologie und Palliativmedizin, HELIOS Klinikum Bad Saarow, Bad Saarow, Germany.
11
Klinikapotheke, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany.
12
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany.
13
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany; German Cancer Consortium (DKTK), Heidelberg, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.
14
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany; DKMS German Bone Marrow Donor Center, Dresden, Germany.

Abstract

In patients with relapsed or refractory (r/r) acute myeloid leukemia (AML), allogeneic hematopoietic stem cell transplantation (HSCT) is considered to be the only treatment providing long-term disease control. The BRIDGE trial studied the safety and efficacy of a clofarabine-based salvage therapy before HSCT in patients with r/r AML. Here, we report the long-term follow-up of this phase II multicenter trial and exploratory analyses on the impact of comorbidity on outcome. Eighty-four patients with a median age of 61 years (range, 40 to 75) were enrolled. Patients were scheduled for at least 1 cycle of salvage therapy with CLARA (clofarabine 30 mg/m2; cytarabine 1 g/m2, days 1 to 5). Chemo-responsive patients with a donor received HSCT after first CLARA. The conditioning regimen consisted of clofarabine 30 mg/m2, day -6 to -3, and melphalan 140 mg/m2 day -2. The Eastern Cooperative Oncology Group (ECOG) score, the hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and the Cumulative Illness Rating Scale were obtained at study enrollment as well as before HSCT. Sixty-seven percent of the patients received HSCT within the trial. After a median follow up of 40 months, the estimated 3-year overall survival (OS) for all enrolled patients and those with HSCT within the trial was 40% and 55%, respectively. Relapse-free survival for patients who underwent transplantation with a complete remission afterwards (n = 50) was 48%, calculated from the day of transplantation. In multivariate analysis, both the HCT-CI and ECOG score had a statistically significant impact on OS with a hazard ratio of 1.22 (P = .025)and 1.72 (P = .001), respectively. Using a clofarabine-based salvage therapy combined with early allogeneic HSCT, we were able to achieve good long-term results for patients with r/r AML. In this cohort, both the HCT-CI and the ECOG scores gave prognostic information on OS, showing the feasibility and clinical relevance of comorbidity evaluation at the time of diagnosis of r/r AML patients.

KEYWORDS:

Acute myeloid leukemia; Clofarabine; Comorbidity; Hematopoietic stem cell transplantation

PMID:
28527985
DOI:
10.1016/j.bbmt.2017.05.014
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center