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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 3_suppl ( 2014-01-20), p. 141-141
    Abstract: 141 Background: Cbz showed antitumor activity in a CT-resistant human gastric cancer xenograft model. The Phase I GASTANA study aimed to determine the safety profile of Cbz in pts with advanced gastric adenocarcinoma who failed prior CT regimens. Methods: Asian pts with metastatic gastric adenocarcinoma failing 2 prior CT regimens received Cbz (single agent, Day 1 of every 3-week cycle) in a standard 3+3 dose escalation design. Dose levels (DL) were 20 mg/m 2 (DL 1), 25 mg/m 2 (DL 2) and 15 mg/m 2 (DL -1). Treatment continued until disease progression or unacceptable toxicity. Prophylactic G-CSF was not permitted at cycle 1. Results: Fifteen pts were evaluable for dose-limiting toxicities (DLTs) at cycle 1. All pts were heavily pretreated (median of 2 prior anticancer regimens), and 11 had prior taxane exposure.At DL 1, no DLTs occurred in any of the first 3 pts. At DL 2, 4 pts were enrolled as 1 pt discontinued prematurely, with only 1 DLT (Grade [Gr] 4 febrile neutropenia [FN]) observed. However, all 4 pts at DL 2 experienced FN, and so 3 more pts were enrolled at DL 1 to further explore safety at this lower DL. Two DLTs (Gr 4 neutropenia 〉 7 days) occurred in these additional 3 pts. In response, DL -1 was opened, with no DLTs observed in the 6 pts enrolled. The median numbers of cycles were 5 (DL 1), 1.5 (DL 2) and 3 (DL -1). Frequent Gr 3/4 toxicities (safety population, N = 16) included neutropenia (63%) and FN (38%). Best overall responses included 1 partial response (6.3%; DL -1) and 8 stable disease (50%). Conclusions: Due to the unexpectedly high incidence of neutropenia-related complications compared with pts with other cancer types, a further Phase II study of Cbz was put on hold pending further data in pts with gastric cancer. The frequent occurrence of neutropenic complications with Cbz in this study may be attributed in part to the heavily pretreated nature of the pts and the accumulated toxicity of prior taxane therapy. Also, prophylactic G-CSF use after cycle 1 was not mandatory in pts with dose interruptions due to neutropenia, which may have increased the rate of neutropenic complications in subsequent cycles. Clinical trial information: NCT01497964.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Korean Medical Science, XMLink, Vol. 28, No. 8 ( 2013), p. 1248-
    Type of Medium: Online Resource
    ISSN: 1011-8934 , 1598-6357
    Language: English
    Publisher: XMLink
    Publication Date: 2013
    detail.hit.zdb_id: 2056822-8
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  • 3
    In: Annals of Hematology, Springer Science and Business Media LLC, Vol. 91, No. 12 ( 2012-12), p. 1917-1922
    Type of Medium: Online Resource
    ISSN: 0939-5555 , 1432-0584
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2012
    detail.hit.zdb_id: 1458429-3
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 10550-10550
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 4997-4997
    Abstract: Abstract 4997 Purpose This analysis was aimed to compare clinical features in different age cohorts of multiple myeloma (MM) patients and to identify the impact of the clinical characteristics on survival in the patients in a single center. Patients and Methods We retrospectively analyzed data from 513 patients between Sep 1995 and Feb 2010 in the Asan Medical Center. Correlation of baseline characteristics with survival was made by the following age strata: 〈 45, 45–54, 55–64, and ≥65 years of age. Results Median observed overall survival (OS) in the entire cohort was 3.20 years (95% confidence interval: 2.71–3.68). Observed survival decreased steadily with ages from 4.56 years in patients younger than age 45 years to 2.50 years in patients ≥65 years (P=0.003). The patients in the oldest group (age 65 years or older) were more likely to have International Staging System (ISS) stage II or III than others (P=0.007). There were no significant differences in hypercalcemia (≥10 mg/dL), elevated serum creatinine (≥2 mg/dL), anemia (Hb 〈 10 g/dL) and osteolytic bone lesion, so called CRAB among the different age cohorts. Prognostic factors including elevated C-reactive protein (CRP) (≥ 0.8mg/dL), lactate dehydrogenase (LDH), bone marrow plasma cell infiltration also did not differ significantly among 10-year age cohorts. However, hypoalbuminemia ( 〈 3.5 g/dL) and high serum β2-microglobulin (≥3.5 mg/dL) level were more frequent in patients ≥65 years of age (P=0.001 and P=0.046, respectively). Furthermore, higher proportion of patients underwent ASCT in the younger 10-year age cohorts (71.4%, 53.7%, 43.4%, 2.5% in 〈 45, 45–54, 55–64, and ≥ 65 years of age, respectively, P 〈 0.001). Conclusion No significant differences in the myeloma related organ or tissue impairment and prognostic markers including CRP, LDH and bone marrow infiltration of myeloma cells were noted among different age groups. However, survival significantly declined in the higher age group, which might be related to higher ISS stage associated with hypoalbuminemia, high serum β2-microglobulin level and lower proportion of patients receiving ASCT. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 6
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 1668-1668
    Abstract: Background The International Prognostic Index (IPI) has been useful prognostic tool to predict prognosis of aggressive non-Hodgkin lymphoma in the last 20 years. Since the advent of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy for diffuse large B-cell lymphoma (DLBCL), its utility has been challenged and other prognostic index including revised IPI and National Comprehensive Cancer Network (NCCN)-IPI were proposed, which are not popularly used yet. We aimed to develop new prognostic model for DLBCL in rituximab era. Method Between March 2004 and June 2012, patients with DLBCL treated with R-CHOP were identified in the database of the Asan Medical Center (AMC) Lymphoma Registry. Primary end point was to devise a new prognostic index for DLBCL. Secondary end point was to validate the NCCN-IPI in our cohort. We tested new prognostic index model in the training set of AMC cohort consisted of randomly selected 80% of the sample (503 patients). The remaining 20% (118 patients) was used as an internal validations set. Results The AMC cohort consisted of 621 patients. Median follow-up duration was 43.3 months (6.2-122.5 months). Baseline characteristics of AMC cohort are presented in table 1. Median age was 57 years (range, 16-85 years). Median ϐ-2 microglobulin (ϐ-2 MG) was 2.10 mg/L (range, 1.0-66.0 mg/L). The univariate analysis of baseline characteristics revealed that age (≦60 vs. 〉 60 years), LDH (within normal vs. increased), ECOG performance (0 or 1 vs. ≧2), advanced stage (Ann Arbor stage I/II vs. III/IV), extra-nodal involvement (≦1 vs. 〉 1), B symptoms (no vs. yes), and ϐ-2 MG (≦2.5 vs. 〉 2.5) could predict overall survival (OS), whereas bulky disease and gender did not (p value 0.140, 0.621, respectively). In the multivariate analysis, age, LDH, ECOG performance status, and ϐ-2 MG were significantly associated with OS (p value 0.001, 〈 0.001, 0.004, and 0.019, respectively), while stage, extra-nodal involvement, and B symptom did not (p value 0.057, 0.233, and 0.577, respectively). We developed a new prognostic model with these 4 significant factors in the multivariate analysis. One point is assigned for each of the risk factors without refined categorization. Four risk groups were composed as followings: low (0 point), low-intermediate (1 point), high-intermediate (2-3 points), and high (4 points). The new prognostic model showed better discriminative power compared with classic IPI (Figure 1A). Five-year OS of low- and high-risk subgroup in new scoring model and classic IPI model in AMC cohort were 95% and 32% versus 89% and 45%, respectively. Our model was validated in an internal validation set (Figure 1B). NCCN-IPI also could stratify four risk groups (Figure 1 A and B). Conclusion We propose a new prognostic index model for DLBCL in rituximab era with age, LDH, ECOG performance and ϐ-2 MG, which has good discriminative power and convenient to apply. It warrants further validation using an independent cohort. Table 1. Baseline Characteristics Characteristics Total N=621 % Training set N=503 % Validation set N=118 % Age, years Median, range ≦ 60 years 〉 60 years 57.0 377 244 16-85 60.7 39.3 57.0 300 203 16-84 59.6 40.4 57.0 77 41 17-85 65.3 34.7 Sex Male Female 343 278 55.2 44.8 273 230 54.3 45.7 70 48 59.3 40.7 ECOG PS 0 or 1 ≧ 2 569 52 91.6 8.4 462 41 91.8 8.2 107 11 90.7 9.3 Serum lactate dehydrogenase levels Normal Elevated 334 287 53.8 46.2 279 224 55.5 44.4 55 63 46.6 53.4 Ann Arbor stage I and II III and IV 293 328 47.2 52.8 236 267 46.9 53.1 57 61 48.3 51.7 Number of extranodal sites 〈 2 ≧ 2 403 218 64.9 35.1 329 174 65.4 34.6 74 44 62.7 37.3 B symptoms No Yes 549 72 88.4 11.6 447 56 88.9 11.1 102 16 86.4 13.6 International prognostic index Low/ low-intermediate High-intermediate/high 404 217 65.1 34.9 327 176 65.0 35.0 77 41 65.3 34.7 ¥Â -2 microglobulin, mg/L Median, range ≦ 2.5 mg/L 〉 2.5 mg/L 2.1 422 199 1.0-66.0 68.0 32.0 2.1 339 164 1.0-29.6 67.4 32.6 2.1 83 35 1.0-66.0 70.3 28.7 Table 2. Multivariate Analysis for Factors Associated with Overall Survival Factors HR 95% CI P value Score Age, years ≦ 60 years 〉 60 years 1.000 2.051 1.362-3.090 0.001 1 Serum lactate dehydrogenase levels Normal Elevated 1.000 3.165 1.951-5.135 〈 0.001 1 ECOG PS 0 or 1 ≧ 2 1.000 2.073 1.261-3.407 0.004 1 ϐ -2 microglobulin, mg/L ≦ 2.5 mg/L 〉 2.5 mg/L 1.000 1.691 1.0391-2.622 0.019 1 Figure 1. IPI versus NCCN IPI versus new prognostic index model in Asan Medical Center training set (A) and internal validation set (B) Figure 1. IPI versus NCCN IPI versus new prognostic index model in Asan Medical Center training set (A) and internal validation set (B) Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 7
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2014
    In:  Annals of Hematology Vol. 93, No. 6 ( 2014-6), p. 995-1000
    In: Annals of Hematology, Springer Science and Business Media LLC, Vol. 93, No. 6 ( 2014-6), p. 995-1000
    Type of Medium: Online Resource
    ISSN: 0939-5555 , 1432-0584
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2014
    detail.hit.zdb_id: 1458429-3
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  • 8
    In: Infection & Chemotherapy, XMLink, Vol. 44, No. 2 ( 2012), p. 71-
    Type of Medium: Online Resource
    ISSN: 2093-2340 , 2092-6448
    Language: Korean
    Publisher: XMLink
    Publication Date: 2012
    detail.hit.zdb_id: 2538318-8
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