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  • American Society of Hematology  (20)
  • 1
    Online Resource
    Online Resource
    A Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in the Induction Chemotherapy for Acute Myeloid Leukemia
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2535-2535
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2535-2535
    Abstract: Introduction: We conducted a randomized trial comparing two different doses of daunorubicin as induction chemotherapy in young adults with acute myeloid leukemia (AML) and showed intensification of induction therapy using a high daily dose of daunorubicin (90 mg/m2/d x 3d) improved both complete remission (CR) rate and survival duration compared to standard daunorubicin dose (45 mg/m2/d x 3d) (Lee JH et al. Blood 2011;118:3832). As it is necessary to compare the effects of high-dose daunorubicin with that of other agents, especially idarubicin, we performed another randomized trial comparing two induction regimens in young adults with AML: idarubicin vs. high-dose daunorubicin (ClinicalTrials.gov #NCT01145846). Here, we present final results of the study. Methods: Between May 2010 and March 2014, a total of 316 patients (65 years or younger) with newly diagnosed AML except acute promyelocytic leukemia were registered in this study. Seventeen patients were removed from the study (change of diagnosis in 11, patient's refusal to be randomized in 3 and other in 3) and the remaining 299 patients were analyzed. After random assignments, 149 patients received idarubicin (AI, 12 mg/m2/d x 3d) and 150 patients received high-dose daunorubicin (AD, 90 mg/m2/d x 3d) in addition to cytarabine (200 mg/m2/d x 7d) for induction of CR. Patients with persistent leukemia received the second attempt of induction chemotherapy, consisting of idarubicin (AI, 12 mg/m2/d x 2d) or daunorubicin (AD, 45 mg/m2/d x 2d) plus cytarabine (5d). Patients who attained CR received 4 cycles of high-dose cytarabine (3 g/m2 x 6 doses) in patients with good- or intermediate-risk cytogenetics and 4 cycles of cytarabine (1 g/m2 x 6d) plus etoposide (150 mg/m2 x 3d) in those with high-risk cytogenetics. Hematopoietic cell transplantation (HCT) was performed according to attending physician's discretion after one or two cycles of consolidation chemotherapy in most transplant cases. Results: CR was induced in 232 (77.6%) of 299 patients. Reasons for induction failure were resistant disease in 50, hypoplastic death in 5, and indeterminate cause in 12. As postremission therapy, 3 patients received no further treatment, 71 received consolidation chemotherapy without HCT, 137 underwent allogeneic HCT, and 21 underwent autologous HCT. The CR rates were not significantly different between two arms: 80.5% (120 of 149, AI) vs. 74.7% (112 of 150, AD) (P=0.224). With a median follow-up of 1046 days, overall survival probabilities at 4 years were 51.1% in AI vs. 54.7% in AD (P=0.756). The probabilities at 4 years for relapse-free survival were 63.5% in AI vs. 74.2% in AD (P=0.181) and those for event-free survival were 44.8% in AI vs. 50.7% in AD (P=0.738). Toxicity profiles were similar between two arms. Interestingly, overall and event-free survivals of 44 patients with FLT-ITD mutants (27 in AI and 17 in AD) were significantly different according to the induction regimens (AI vs AD; overall survival, 30.8% vs. 61.9%, P=0.030; event-free survival, 31.4% vs. 61.9%, P=0.025). Conclusions: The results of this phase 3 trial, which compared idarubicin (12 mg/m2/d x 3d) with high-dose daunorubicin (90 mg/m2/d x 3d), did not show significant differences between two arms in the outcomes of patients in terms of CR rates and overall, relapse-free or event-free survivals. In subset analysis, high-dose daunorubicin seems to be more effective than idarubicin in patients with FLT-ITD mutants. Disclosures Kim: Celgene: Research Funding; Alexion Pharmaceuticals: Research Funding; Il-Yang: Research Funding; Novartis: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2535.2535
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
    detail.hit.zdb_id: 1468538-3
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  • 2
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    Long-Term Follow-up of Continuous Imatinib Plus Combination Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
    American Society of Hematology ; 2014
    In:  Blood Vol. 124, No. 21 ( 2014-12-06), p. 3654-3654
    Details
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 3654-3654
    Abstract: Introduction: The effect of imatinib plus combination chemotherapy were assessed in 87 patients, aged 16-71 years, with newly diagnosed Philadelphia Chromosome-Positive (Ph+) acute lymphoblastic leukemia (ALL). Methods: Imatinib (600 mg/day orally) was administered continuously with combination chemotherapy, starting from eighth day of remission induction treatment, then through 5 courses of consolidation or until allogeneic hematopoietic cell transplantation (HCT). Patients who were not transplanted were maintained on imatinib for 2 years. Molecular response monitoring was performed at the central lab (Asan Medical Center) with quantitative RT-PCR assays for peripheral blood or bone marrow BCR-ABL RNA in serial; at the time of diagnosis, at hematologic complete remission (HCR), and every 3 months thereafter. The molecular response was defined as complete (MCR) if the BCR-ABL/G6PDH ratio was less than 1x10-5. Results: Between October 2005 and February 2009, total 89 patients with newly diagnosed Ph+ALL were enrolled. With median follow-up of 5 years among survivors (range: 2.6-8.9 years) and data were frozen up in July, 2014. Two patients were not assessed, one due to a final diagnosis of CML blastic phase and one for refusal of the protocol treatment 4 months after enrollment. Eighty-two patients (94%) achieved HCR at a median 25 days (range, 14-69 days). Among these 82 HCR patients, 40 experienced recurrence of leukemia and 5-year relapse free survival (RFS) rate was 36.8%. Median time of RFS was 33 months (95% CI 20-46 months). In all, 24 patients died without leukemia progression or recurrence. Causes of treatment related morality were infection (n=5), bleeding (n=2), and HCT related complication (n=17). The 5-year overall survival (OS) rate was 33.4% and the median time of OS was 22.9 months (95% CI, 7.95-37.97 months). In total, 56 patients (68%) underwent allogeneic HCT in first HCR and had received a median 2 courses (range, 0-5 courses) of consolidation prior to HCT. At a median follow-up of 5-years (range, 2.1-8.4 years) after HCT, 23 patients experienced leukemia recurrence (cumulative incidence, 59.1%; 95% CI, 49.7%-68.5%). Of these 23 patients, 17 showed new molecular evidence of disease recurrence before hematologic relapse. Six patients, however, experienced hematologic recurrence without preceding molecular evidence of leukemia recurrence. The 5-year OS rate of patient underwent allogeneic HCT at first HCR was 52.6% and the median time of OS was 72.0 months (95% CI, 17.49-126.50 months). In the patients who completed the five cycles of consolidation, 7 patients were maintained on imatinib. Among these 7 patients, four patients finished 2-year imatinib maintenance. At median follow-up of 4 years (range, 1.9-7.4 years) after maintenance, 6 patients relapsed. The median time of RFS of patient who received maintain therapy was 40.7 months (95% CI, 24.38-57.19 months). One patient with relapse received HCT at second HCR after salvage therapy and two patients died with leukemia recurrence. Cumulative MCR rate was 88.5%, and median time to MCR was 54 days (range, 13-384 days). Median time of MCR duration was 13 months (range, 0.9-60.3 months). MCR achievement within 3months after remission induction was significant predictor of RFS (P=0.004) and OS (P=0.003). Thirty two patients who lost of MCR had significantly inferior RFS (P 〈 0.0001) and OS (P=0.001) then 41 who maintained MCR. Total mean imatinib dose intensity over the entire treatment period was 80% (range, 22-110%) and mean imatinib dose intensity during remission induction was 85% (range, 22-131%). Imatinib dose intensity during remission induction; 〉 90% vs. ¡Â90%; was significantly associated with median HCR duration (44 vs. 13 months, P=0.001, Fig. 1), median overall survival (39 vs. 10 months, P 〈 0.0001, Fig. 2), and 3-year MCR rate (61% vs. 19%, P=0.001, Fig. 3). The probability for maintaining MCR at 3 years according to total imatinib dose intensity; 〉 80% vs. ¡Â80%; was 57% (95% CI, 43.0-75.5%) and 33% (95% CI, 12.3-55.4%), respectively (P=0.05). Conclusions: The higher imatinib dose intensity is correlated with the better molecular response and the superior overall outcome. The quantitative monitoring of BCR-ABL transcript levels is useful in identifying subgroups of Ph+ALL patients at a high risk of relapse. Figure 1 Figure 1. Figure 2 Figure 2. Figure 3 Figure 3. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V124.21.3654.3654
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 3
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    Retrospective Comparison of Azacitidine and Decitabine in the Treatment of Myleodysplastic Syndrome,
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 3809-3809
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 3809-3809
    Abstract: Abstract 3809 Introduction: Two DNA methyltransferase inhibitors, azacitidine and decitabine, are currently approved for the treatment of myleodysplastic syndrome (MDS) according to the results of several Phase II and III trials, which have demonstrated the efficacy of the agents. Despite widespread clinical use of DNA methyltransferase inhibitors, one of important practical issues is which drug should be chosen. In this retrospective study, we tried to compare azacitidine and decitabine for the treatment of MDS in regards to treatment response, toxicities, and survival. Methods: Between September 2006 and October 2010, a total of 149 patients were treated with either azacitidine (n=75) or decitabine (n=74) for MDS defined by the WHO classification and chronic myelomonocytic leukemia (CMML) in 3 Korean institutes; all are included in this analysis. Azacitidine 75 mg/m2/day was administered as a subcutaneous injection for 7 consecutive days and decitabine 20 mg/m2/day as a 1-hour intravenous infusion for 5 consecutive days. Both agents were repeated every 4 weeks. Treatment response was evaluated using modified International Working Group response criteria. Results: Median age of the patients, 100 males and 49 females, was 60 years (range, 23–83). WHO subtype at the time of decitabine treatment was RA in 18, RARS in 2, RCMD in 28, RCRS in 5, RAEB-1 in 46, RAEB-2 in 39, unclassified in 2, and CMML in 9. IPSS risk category was low/intermediate-1 in 72 and intermediate-2/high in 72. Median number of courses delivered to each patient was 5 (range, 1–31) for azacitidine and 4 (range, 1–24) for decitabine (P=0.033). Hematologic responses (CR/PR/mCR) were induced in 9 patients (12.0%) with azacitidine and in 22 (29.7%) with decitabine (P=0.008). The rates of overall response (CR/PR/mCR/HI) was not significantly different between azacitidine (52.0%) and decitabine (63.5%) (P=0.155). Median number of treatment courses to achieve any response was 2 (range, 1–6) for azacitidine and 1 (range, 1–5) for decitabine (P=0.269). Adverse events were evaluated for the first 6 courses for all patients, for a total of 584 courses. Major adverse events were cytopenia and cytopenia-related infection. Grade 3 or higher neutropenia was more frequent with decitabine (79.6%) than with azacitidine (72.2%) (P=0.040), but incidence of febrile episode requiring intravenous antibiotics was similar (12.4% with decitabine vs. 15.4% with azacitidine, P=0.298). Grade 3 or higher non-hematologic toxicities were infrequent and reversible with both agents. Median follow-up duration of surviving patients was 46.9 months (range, 11.8–55.5) for azacitidine and 22.7 months (range 3.3–33.3) for decitabine. Probabilities of overall survival (OS) at 2 years were 43.5% for azacitidine, and 55.5% for decitabine. The difference of OS in favor of decitabine over azacitidine was significant after adjustment for other variables (HR, 0.539; 95% CI, 0.325–0.895; P=0.017). Subgroup analysis showed that the survival superiority of decitabine over azacitidine was evident principally in patients with IPSS low/intermediate-1 (HR, 0.131; P=0.006), MDS duration of 1 year or less (HR, 0.534; P=0.022), or ECOG performance scale of 0–1 (HR, 0.589; P=0.060). In contrast, a tendency was noted for survival superiority of azacitidine over decitabine in patients with MDS duration over 1 year (HR, 2.107; P=0.235) or ECOG scale of 2–3 (HR, 2.492; P=0.074). Conclusions: Although both azacitidine and decitabine were effective in the treatment of patients with MDS, there were some differences between two agents in regards to response patterns, toxicities, and type of subgroups that showed more beneficial effects with the hypomethylating agent. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.3809.3809
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 4
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    A Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in the Induction Chemotherapy for Acute Myeloid Leukemia: An Interim Analysis
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 3628-3628
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3628-3628
    Abstract: Abstract 3628 Introduction: We conducted a randomized trial comparing two different doses of daunorubicin as induction chemotherapy in young adults with acute myeloid leukemia (AML) and showed intensification of induction therapy using a high daily dose of daunorubicin (90 mg/m2/d × 3d) improved both complete remission (CR) rate and survival duration compared to standard daunorubicin dose (45 mg/m2/d × 3d) (Lee JH et al. Blood 2011;118:3832). Our results confirmed the ECOG work (Fernandez HF et al. N Engl J Med 2009;361:1249). Thus, high-dose daunorubicin (90 mg/m2/d) for 3 days should be the future standard of care for induction of patients with AML. However, it is not known whether a dose of 90 mg/m2/d is superior to a dose of 45–90 mg/m2/d. It is also necessary to compare the effects of high-dose daunorubicin with that of other agents, especially idarubicin. For these reasons, we began another randomized trial comparing two induction regimens in young adults with AML: idarubicin vs. high-dose daunorubicin. This study is now recruiting patients (ClinicalTrials.gov #NCT01145846). Here, we present the results of interim analysis of the study. Methods: This study began on May 2010 and target number of patient's accrual is 300. A total of 161 patients (65 years or younger) with newly diagnosed AML except acute promyelocytic leukemia were registered in this study as of March 22, 2012. Four patients were removed from the study (patient's refusal to be randomized in 2 and change of diagnosis in 2) and the remaining 157 patients were analyzed. After random assignments, 81 patients received idarubicin (AI, 12 mg/m2/d × 3d) and 76 patients received high-dose daunorubicin (AD, 90 mg/m2/d × 3d) in addition to cytarabine (200 mg/m2/d × 7d) for induction of CR. Patients with persistent leukemia received the second attempt of induction chemotherapy, consisting of idarubicin (AI, 12 mg/m2/d × 2d) or daunorubicin (AD, 45 mg/m2/d × 2d) plus cytarabine (5d). Patients who attained CR received 4 cycles of high-dose cytarabine (3 g/m2 × 6 doses) in patients with good- or intermediate-risk cytogenetics and 4 cycles of cytarabine (1 g/m2 × 6d) plus etoposide (150 mg/m2 × 3d) in those with high-risk cytogenetics. Hematopoietic cell transplantation (HCT) was performed according to attending physician's discretion. Results: CR was induced in 123 (78.3%) of 157 patients. Reasons for induction failure were resistant disease in 26, hypoplastic death in 2, and indeterminate cause in 6. As postremission therapy, 3 patients received no further treatment, 35 received consolidation chemotherapy without HCT, 73 underwent allogeneic HCT, and 12 underwent autologous HCT. The CR rates were not significantly different between two arms: 77.8% (63 of 81, AI) vs. 78.9% (60 of 76, AD) (P=0.859). With a median follow-up of 285 days, overall survival probabilities at 18 months were 65.6% in AI vs. 72.6% in AD (P=0.278). The probabilities at 18 months for relapse-free survival were 78.5% in AI vs. 86.2% in AD (P=0.563) and those for event-free survival were 61.5% in AI vs. 67.7% in AD (P=0.078). Toxicity profiles were similar between two arms. Conclusions: The results of interim analysis of this ongoing phase 3 trial, which compares idarubicin (12 mg/m2/d × 3d) with high-dose daunorubicin (90 mg/m2/d × 3d), did not show significant differences in the outcomes of patients. It appears that the effects of two drugs with the doses in current study are equivalent as an induction chemotherapeutic agent in regards to CR rates and overall, relapse-free or event-free survivals. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.3628.3628
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 5
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    A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 14 ( 2011-10-06), p. 3832-3841
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 14 ( 2011-10-06), p. 3832-3841
    Abstract: We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m2 per day times 3 days) in addition to cytarabine (200 mg/m2 per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2011-06-361410
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
    detail.hit.zdb_id: 1468538-3
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  • 6
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    Preliminary Results of a Prospective Multicenter Phase III Trial Comparing High-Dose and Standard-Dose Daunorubicin for Induction of Complete Remission (CR) in Acute Myeloid Leukemia (AML).
    American Society of Hematology ; 2007
    In:  Blood Vol. 110, No. 11 ( 2007-11-16), p. 1833-1833
    Details
    In: Blood, American Society of Hematology, Vol. 110, No. 11 ( 2007-11-16), p. 1833-1833
    Abstract: The effectiveness of anthracycline dose intensification for induction of CR in AML has not been studied in a randomized fashion. We conducted a prospective randomized trial to compare the therapeutic efficacy and toxicity of two different doses of daunorubicin in combination with cytarabine in AML. This study began on August 2001 and 293 adult patients (younger than 60 years) with newly diagnosed AML except M3 have been enrolled. Fourteen patients were removed from the study and the remaining 279 patients were analyzed. After random assignments, 135 patients received standard-dose daunorubicin (SD-DN, 45 mg/m2/d × 3 d) and 144 patients received high-dose daunorubicin (HD-DN, 90 mg/m2/d × 3 d) in addition to cytarabine (200 mg/m2/d × 7 d) for induction of CR. Patients with persistent leukemia received the second attempt of induction chemotherapy, consisting of standard-dose daunorubicin (2 d) plus cytarabine (5 d). Patients who attained CR received 4 cycles of high-dose cytarabine (3 g/m2 × 6 doses) and 2 cycles of daunorubicin (1 d) plus cytarabine (5 d). For patients in intermediate- or high-risk cytogenetic groups, allogeneic hematopoietic cell transplantation was performed if there was a suitable donor. CR was induced in 98 of 135 patients (72.6%) in SD-DN arm and 119 of 144 (82.6%) in HD-DN arm (P = 0.044). The impact of daunorubicin dose intensification on the CR rates were different by cytogenetic risk group: the CR rates for SD-DN vs. HD-DN arm were 24/25 (96.0%) vs. 35/36 (97.2%) for good-risk group, 63/88 (71.6%) vs. 64/83 (77.1%) for intermediate-risk group, and 10/20 (50.0%) vs. 19/24 (79.2%) for poor-risk group. With a median follow-up of 596 days for surviving patients, the 4-year probabilities of overall survival, disease-free survival, and relapse-free survival were similar between SD-DN and HD-DN arm. Two different doses of daunorubicin (SD-DN vs. HD-DN) showed similar toxicity profiles regarding recovery times from myelosuppression, transfusion requirements, severe toxicities (grades III to IV) classified by NCI-CTC ver 2.0 including cardiac toxicities, and duration of antibiotics administration. In conclusion, high-dose daunorubicin showed higher CR rates in AML patients of intermediate- and poor- cytogenetic risk groups without increase of toxicities compared to standard-dose daunorubicin.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V110.11.1833.1833
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
    detail.hit.zdb_id: 1468538-3
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  • 7
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    Clinical Significance of PML/RAR Isoform in Patients of Acute Promyelocytic Leukemia.
    American Society of Hematology ; 2007
    In:  Blood Vol. 110, No. 11 ( 2007-11-16), p. 4218-4218
    Details
    In: Blood, American Society of Hematology, Vol. 110, No. 11 ( 2007-11-16), p. 4218-4218
    Abstract: Background: Three types of PML-RARα mRNA fusion transcripts in acute promyelocytic leukemia (APL) could be existed: a short (S)-form type, a long (L)-form type or a variable (V)-form type. Whether 3 types of PML-RARα mRNA fusion transcripts associated with different manifestations and outcomes in individual APL cases are unclear. Recently, some studies reported the controversial results for the relationship between the types of PML-RARα mRNA fusion transcripts and clinical outcomes. But, there was no data about the types of PML-RARα mRNA fusion transcripts especially for the APL patients who were received remission induction therapy with AIDA. Methods: We performed a retrospective analysis for the data of 94 patients with APL, whose isoform data was available. We evaluated the differences of therapeutic outcome of remission induction chemotherapy in terms of response rate, relapse-free survival (RFS), overall survival (OS) and the association of pretreatment clinical parameter characteristics according to the PML-RARα isoforms. Results: The median age of the patients was 41 years (15–85). CR rate following remission induction treatment was 84.9% (AIDA 87.0% vs. non-AIDA 80.0%). Among 94 patients, there were 58 L-form cases (62.1%), 32 S-form cases (34.0%), 4 V-form cases (4.3%). There was no significant difference at any patient’s pretreatment characteristic according to PML-RARα isoform type. CR rate was higher in the group of initial WBC 〈 10,000/ul (93.5% vs. 65.4%, p=0.001). But there was no difference within the isoform L/S subgroup (84.2% vs. 87.2%). And OS and RFS were not different between isoform L/S subgroup (5yr 74.3% vs. 83.1%, 84.2% vs. 85.1%). AIDA induction group was better than non-AIDA induction group regarding OS and RFS (5yr 84.4% vs 55.7%, p=0.026, 90.0% vs 65.7%, p=0.007), but not significant in the multivariate analysis. And also, it was not significantly different in the OS and RFS between isoform L/S subgroup of the AIDA induction group (5yr 80.5% vs. 92.0%, 95.7% vs. 97.0%). Conclusion: This study suggests that high initial WBC count is associated with low CR rate, AIDA induction group has a trend of better OS and RFS, treatment outcomes according to PML-RARα isoform type are not different. Prospective study will be needed to confirm the meaningful significance of PML-RARα isoform type.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V110.11.4218.4218
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
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  • 8
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    Validation of New Prognostic Model Including Comorbidities in Patients with Myleodysplastic Syndrome Receiving Hypomethylating Therapy
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 1708-1708
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 1708-1708
    Abstract: Abstract 1708 Introduction: A new prognostic model including comorbidities, which are assessed using the Adult Comorbidity Evaluation-27 (ACE-27), was proposed for the patients with MDS by researchers from MD Anderson Cancer Center, Houston, TX (J Clin Oncol 2011;29: 2240). The model was developed after analysis of 600 patients who presented to the center. We aimed to validate the new prognostic model for the Korean patients with MDS who were treated with hypomethylating agents. Methods: Between September 2006 and October 2010, 149 patients were treated with either azacitidine or decitabine for MDS defined by the WHO classification and chronic myelomonocytic leukemia (CMML) in 3 Korean institutes. The new prognostic model included age ( 〉 65 years, 2 score points), comorbidity assessed by ACE-27 (mild/moderate, 1 point; severe, 3 points), and IPSS (intermediate-2, 2 points; high, 3 points). Patients were divided into one of 3 risk groups: low (score 0–1), intermediate (scores 2–4), and high (scored 5–8). Risk group by the new prognostic model could not be assigned in 10 patients, thus a total of 139 patients were included in this analysis. Azacitidine 75 mg/m2/day was administered as a subcutaneous injection for 7 consecutive days (n=68) and decitabine 20 mg/m2/day as a 1-hour intravenous infusion for 5 consecutive days (n=71). Both agents were repeated every 4 weeks. Clinico-patholoical data including comorbidities were collected at time of hypomethylating therapy. Treatment response was evaluated using modified International Working Group response criteria. Results: Median age was 61 years (range, 23–83); 47 patients were over 65 years old. Overall comorbidity score assessed by ACE-27 was as follows: none (n=65), mild (n=53), moderate (n=15), and severe (n=6). IPSS risk category was low/intermediate-1 in 72, intermediate-2 in 55, and high in 12. Risk group measured by the prognostic model was low in 42 (30.2%), intermediate in 79 (56.8%), and high in 18 (12.9%). Hypomethylating therapy induced hematologic responses (CR/PR/mCR) in 28 patients (20.1%) and rate for overall responses (CR/CR/mCR/HI) was 57.6% (80/139). The treatment responses were not significantly different between 3 risk groups. At a median follow-up time of 27.0 months (range, 3.3–55.5) among surviving patients, 70 patients died and overall survival (OS) probability was 49.5% at 2 years; median OS was 24.1 months (95% CI, 11.7–36.5). OS was significantly different according to the presence of comorbidities (OS at 2 years, none vs. mild/moderate vs. severe, 63.4% vs. 37.5% vs. 33.3%, P=0.006) or risk groups by the prognostic model (OS at 2 years, low vs. intermediate vs. high, 71.1% vs. 46.1% vs. 18.5%, P 〈 0.001). The survival differences by the prognostic model were maintained after adjustment for other variables (low vs. intermediate, HR, 2.810, 95% CI, 1.444–5.468, P=0.002; low vs. high, HR, 6.037, 95% CI, 2.708–13.459, P 〈 0.001). Conclusions: The new prognostic model including comorbidities assessed by ACE-27 was useful to predict overall survival in patients with MDS receiving azacitidine or decitabine, although the model could not predict response to the hypomethylating agents. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.1708.1708
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 9
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    The Equal Activity of Azacytidine in 4 Risk Groups of IPSS in MDS.
    American Society of Hematology ; 2007
    In:  Blood Vol. 110, No. 11 ( 2007-11-16), p. 4615-4615
    Details
    In: Blood, American Society of Hematology, Vol. 110, No. 11 ( 2007-11-16), p. 4615-4615
    Abstract: Introduction: The methylated proportion of the gene, turning on the cell cycle, increases with a progression of MDS. Newly introduced demethylaing agent, azacytidine (AZA) may be more active in advanced cases of MDS. Early data for the hematologic responses in several stages of MDS supported this. The powerful tool predicting the outcome of MDS is international prognostic scoring system (IPSS). Our study is to compare the response to AZA among the IPSS risk groups using international working group criteria. Methods: One hundres five patients with MDS were treated with AZA from May 2006 till August 2007. Seven patients had insufficient data. Finally, 108 patients were enrolled. Results: Their median age was 59 years-old (range; 20∼83), and male to female ratio was 2.09. The previous hematologic diseases documented in 8 patients; apalastic anemia (7), and megaloblstic anemia (1). The secondary MDS occurred in 3 patients; after the chemotherapy (2) and radiotherapy (1). A median time from the diagnosis to treatment was 3 months (0∼183). The previous treatment (percentage of patients given) was the transfusion of RBC (74%) and PLT (35%), oxymetholone (17%), steroid (13%), erythropoietin (7%), cyclosporine (7%), ATG (5%), valproic acid (5%), chemotherapy (3%), and allogeneic SCT (2%). Their ECOG performance scale was 0 (58 patients), 1 (45) and 2 (5), respectively. Their diagnoses just before the AZA were RA (20 patients), RARS (5), RCMD (27), RCMD-RS (6), RAEB-1 (27), RAEB-2 (20), MDS-U (1), MDS with isolated 5q− (1) and CMMoL (1). A number of patients with a LOW, INT-1, INT-2, and HIGH risk was 4 (4%). 70 (65%) 23 (21%) and 11 (10%), respectively. The rate of hematologic response (CR+PR+marrow CR+HI) and cytogenetic response (continued normal karyotype and CR) were similar; 100%/75%/93%/67% and 100%/59%/50%/50% in LOW/INT-1/INT-2/HIGH risk groups, respectively. There were 6 treat-related mortalities, and their causes of death were infection in 4 patients and bleeding in 2 patients. Two patients stopped after one cycle of treatment because of grade 4 hepatoxicity and pulmonary toxicity, respectively. During a median follow-up of 9 months, 4 patients were confirmed as transformation to AML and 1 patient suffered from persistent marrow aplasia. One-year expected overall and failure-free survival was 82 ± 5% and 79 ± 6%, respectively in 108 patients. Conclusion: AZA showed the equal activity in 4 risk groups on IPSS in patients with MDS. Not only the hematologic response but the cytogenetic response was similar between 4 groups.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V110.11.4615.4615
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
    detail.hit.zdb_id: 1468538-3
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  • 10
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    Prognostic Implications of CD14 Positivity in Acute Myeloid Leukemia Arising From Myleodysplastic Syndrome,
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 3523-3523
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 3523-3523
    Abstract: Abstract 3523 Introduction: Secondary AML that has evolved from MDS shows different clinical features and outcomes compared to de novo AML. Prognostic implications of immunophenotypes have been studied in de novo AML, whereas those have not well been defined in secondary AML from MDS. Methods: This retrospective study involved analysis of data from 65 adult patients, 37 males and 28 females, who were diagnosed with AML arising from MDS at a single institute. Data for baseline clinico-pathological features, treatments, and outcomes were collected from medical records of each patient. Immunophenotyping was performed for the markers including TdT, CD34, CD13, CD33, CD117, CD14, CD56, HLA-DR, CD3, CD7, CD10, and CD19 using flow cytometry. Results: At the time of MDS diagnosis, the WHO subtype was RA/RARS in 5, RCMD in 10, RAEB-1 in 17, RAEB-2 in 29, and unknown in 4. For the treatment of MDS, hypomethylating agents were given to 17 patients and 2 patients underwent allogeneic hematopoietic cell transplantation (HCT). Median duration of MDS prior to diagnosis of AML was 4.9 months (range, 0.3–91.1). At the time of AML evolution, median age was 50.7 years (range, 18–80), and cytogenetic risk group was good-risk in 1, intermediate-risk in 45, and poor-risk in 18. Proportion of positivity of each immunophenotype marker was as follows: TdT (5%), CD34 (65%), CD13 (98%), CD33 (97%), CD117 (90%), CD14 (22%), CD56 (10%), HLA-DR (93%), CD3 (2%), CD7 (35%), CD10 (8%), and CD19 (2%). After the evolution to AML, 52 patients received induction chemotherapy consisted of cytarabine plus idarubicin or daunorubicin and 8 patients underwent allogeneic HCT as initial treatment of AML. Complete remission (CR) was induced in 27 patients after treatment. At a median follow-up time of 29.2 months (range, 2.6–116.2) among surviving patients, 49 patients died, 13 relapsed, and 53 died or relapsed. Median overall survival (OS), relapse-free survival (RFS), and event-free survival (EFS) were 7.6, 26.1, and 5.4 months, respectively. Of immunophenotype markers, CD14 positivity only showed prognostic implications at the univariate analyses: lower CR rate after induction chemotherapy (P=0.034) and shorter survivals (OS, P 〈 0.001; RFS, P=0.078, and EFS, P 〈 0.001). Differences in OS and EFS remained significant after adjustment for other variables (OS, HR, 4.49, 95% CI, 2.16–9.87, P 〈 0.001; EFS, HR, 4.06, 95% CI, 2.03–8.13, P 〈 0.001). Other prognostic variables included age of 60 years or older (shorter OS [P=0.003] and EFS [P=0.020] ), WBC over 60,000/mcl (shorter OS [P 〈 0.001] and EFS [P=0.001] ), and poor cytogenetic risk group (shorter OS [P=0.005]). Conclusions: Surface expression of CD14 on leukemic blasts was an independent prognostic factor for survivals in the patients with AML arising from MDS. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.3523.3523
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
    detail.hit.zdb_id: 1468538-3
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