GLORIA

GEOMAR Library Ocean Research Information Access

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 4412-4412
    Abstract: UCBT in adult patients with hematological malignancies has significantly increased over the last 5 years. In addition, the introduction of RIC regimens can allow a decreased incidence of TRM. Thus, the use of UCBT after a RIC regimen can represent an attractive treatment modality for those high risk patients who lack a suitable HLA-matched donor. The aim of this analysis was to assess the outcome of 35 patients who received RIC UCBT in a single centre between 2005 and 2008. All 35 patients had high risk hematological malignancies (AML, n=19; ALL, n=9; NHL, n=5; CML, n=1; and Hodgkin disease, n=1). 27 patients (77%) were in CR (CR1, n=18; CR2, n=8; CR3, n=1), whereas 8 had a more advanced disease (PR, n=2; refractory, n=6) at time of UCBT. Of note, 12 patients (34%) have already received and failed prior autologous transplantation. The median age and weight was 44 (range, 17–62) years and 63 (range, 44–125) kg with 13 patients (37%) older than 50 years (range 51–62). The RIC regimen included Fludarabine 200 mg/m2, Cyclophosphamide 50 mg/kg and low dose TBI (2 Gy). All patients received CSA and MMF for GVHD prophylaxis. 13 patients (37%) received a single CB unit, whereas 22 (63%) received 2 CB units in order to achieve a minimum required cryopreserved cell dose of 3.0×10e7 TNC/kg. For the entire group, the median cryopreserved and infused cell doses were 4.8×10e7 TNC/Kg (range, 3.3–7.0) and 3.7×10e7/Kg (range, 1.9–5.5) respectively. 94% of the patients received 1–2 HLA mismatched grafts. Neutrophil engraftment (ANC & gt;500/μL) occurred in 33 patients (94%) at a median of 20 (range, 6–45) days and a sustained platelets recovery ( & gt;50000/μL) was observed in 25 patients (71%) at a median of 36 (range, 23–136) days after UCBT. Hematological recovery was comparable between single and double CB unit recipients. Primary and secondary graft failure occurred in 4 and 1 patients respectively (AML, n=2; ALL, n=1; CML, n=1; NHL, n=1). Two out of these 5 patients underwent and failed a second UCBT. The overall incidence of grade II–IV acute GVHD was 54% (95%CI, 41–77%; 7 grade II, 10 grade III and 2 grade IV). 19 patients were evaluable for chronic GVHD for an overall incidence of 37% (8 limited and 5 extensive cases). 20 patients (57%; 95%CI, 42–76 %) with experienced at least one episode of a “serious” or “life-threatening” infectious complication (virus other than CMV reactivation, n=11; bacteria, n=10; fungal, n=4) at a median time of 74 (range, 0–595) days after UBCT, requiring long-term hospitalization, and of whom 8 patients were in grade III–IV acute GVHD. 7 patients (20%) experienced severe interstitial pneumonia, with 4 patients (11%) developing ARDS. Most importantly, 5 patients (14%) also required transfer to ICU. With a median follow-up of 468 (range, 105–1170) days, 10 patients (28%) had relapsed or progessed with this being significantly lower in those patients transplanted in CR (P=0.01), but without a significant difference between single and double CB recipients. 14 patients have died (infection, n=5; GVHD, n=3; relapse, n=6; TRM=23%). The KM estimate of OS and DFS was 61% (95%CI, 42–75%) and 52% (95%CI, 34–67%) at 2 years respectively for the entire population. On univariate analysis younger age at transplant and disease status in CR were the only factors associated with significantly better outcome. Although our patients population is small, we conclude that RIC UCBT is an efficient therapy for high risk hematological malignancies. Age and the disease status at transplant are crucial for patients outcome and further efforts are needed to define risk factor specific transplant procedures. Infectious complications and GVHD are still a matter of concern warranting better strategies to provide optimal prophylactic approaches.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 2
    Online Resource
    Online Resource
    Wiley ; 2009
    In:  Statistics in Medicine Vol. 28, No. 21 ( 2009-09-20), p. 2617-2638
    In: Statistics in Medicine, Wiley, Vol. 28, No. 21 ( 2009-09-20), p. 2617-2638
    Type of Medium: Online Resource
    ISSN: 0277-6715
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 1491221-1
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 3
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 193-193
    Abstract: Abstract 193 No definitive data exist defining the optimal myeloablative and/or immunosuppressive association of Reduced Intensity Conditioning (RIC) for allo-SCT. In this perspective, we report the first prospective comparison between 2 widely used conditioning regimens based on reduced intensity or non-myeloablative approaches. Pts were randomized between FBA (Study A) (Fludarabine (30mg/m2/5 days)+Oral Busulfan (4 mg/kg/d over 2 days)+Thymoglobuline (2.5 mg/kg/1day)) (Post graft immunosuppression (IS): CSA) and FTBI (Study B) (Fludarabine (25mg/m2/day over 3 days)+2 Gy TBI) (Post Graft IS: CSA+MMF). Primary endpoint was one-year overall survival (OS). Inclusion criteria were: hematological malignancies, pts non eligible for myeloablative allo SCT, age between 18 and 65, suitable HLA identical sibling, written informed consent. 139 pts were randomized and treated between 2003 and 2008 (Group FBA: N=69; group FTBI: N=70) at 4 transplant centers. The 2 groups were comparable in term of pts characteristics; Median age 54 (21–65); Male gender: 65%; Diagnosis: acute leukemia 18%; NHL 23%; MM 39% others 20%; Disease status: only 32% of the 139 pts were in CR while 68% had measurable disease (PR and stable disease=60%; refractory disease: 8%). Graft failure was documented in 4 pts (6%) in FTBI group. Cumulative incidences (CI) of grade 〉 = 2 aGVHD and cGVHD were respectively: 37% (Group FBA 51%; Group FTBI 26%; p=.003) and 77% (Group FBA 79%; Group FTBI 76%: p=NS). At 1 year, PFS differed (Group FBA 0.68 [0.56 – 0.78]; Group FTBI 0.51 [0.39 – 0.62] ; p=0.048) while OS was similar (Group FBA 0.75 [0.63 – 0.84]; Group FTBI 0.74 [0.62 – 0.83] ; p=NS). With a median follow-up of 39 months (3–71), 72 pts were alive (Group FBA: 35; Group FTBI: 37: p=NS) with a 5 year OS probability estimate of 0.45 [0.31– 0.57] and 0.49 [0.35– 0.61] for groups FBA and FTBI respectively (p=NS). 53 pts were progression free with a 5 year PFS probability estimate of 0.35 [0.22– 0.48] for group FBA ,and 0.23 [0.10– 0.38] for Group FTBI (p=NS). Median PFS were 26.3 (IC95%:13.6 – 47.3) and 13.1 (IC95% : 7.4 – 25.6) months (mths) in groups FBA and FTBI respectively. More relapses/progressions occurred in group FTBI (p=.005) with a 5 year relapse/progression cumulative incidence (CI) of 0.28 [0.16– 0.40] for group FBA and 0.50 [0.39– 0.60] for Group FTBI. Three pts died from secondary cancers (Group FBA: 1; Group FTBI: 2) and 38 from transplant related causes with a 5 year TRM CI of 0.37 [0.25– 0.49] for group FBA and 0.24 [0.14– 0.34] for Group FTBI (p=0.199). QOL was assessed over a 1-year period with the EORTC QLQ-C30 questionnaire. FBA regimen had a stronger negative impact on patients' QOL during the treatment administration which resolved 80 days after the SCT. Detailed economic analysis was included in the clinical trial. Preliminary evaluation of medical direct costs (conditioning regimen, transfusions, hospitalisations and anti-infectious drugs consumption) demonstrated a crude advantage for the FTBI group (66,711€ vs 42,080€ for the FBA and FTBI groups respectively, p 〈 0.001). The cost-effectiveness ratio using PFS as endpoint was 22,392 € per year of life free of relapse gained using FBA conditioning regimen when compared to FTBI. In conclusion, this study establishes that, these 2 regimens produce similar 1 year OS. However, FBA is associated with better 1 year PFS and socially acceptable cost-effectiveness ratio but worse early QOL. FBA is also associated with better long term disease control, whereas FTBI tends to produce lower TRM and higher rejection rates. At 5 years, both OS and PFS appear to be similar in this population of rather old patients with advanced hematological malignancies. Cost-effectiveness analysis using OS as effectiveness criterion and including the cost evaluation of relapse treatment is ongoing. Overall, these results contribute to clarify some previously unanswered issues. Clinical data might help designing individual and optimal strategies for each candidate patient, based on factors that predict the probability of relapse and TRM while economical data may help hospitals to tailor their transplant program, depending on the patient population that they care for. Disclosures: Blaise: Gemzyme: Consultancy, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Pierre-Fabre: Consultancy, Research Funding. Off Label Use: Busulfan, Thymoglobulin, .
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...