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  • 1
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    Nilotinib Combined With Multi-Agent Chemotherapy For Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Final Results Of Prospective Multicenter Phase 2 Study
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 55-55
    Details
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 55-55
    Abstract: We previously reported the interim analysis on the clinical outcome of nilotinib (Tasigna®, Novartis Pharma, Basel, Switzerland), when combined with multi-agent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) in adults. Herein, we reported the final results of the multicenter prospective phase2 trial of Adult Acute Lymphoblastic Leukemia Working Party, the Korean Society of Hematology. Newly diagnosed Ph+ALL patients aged 18 years old or more were eligible when they had adequate organ function. Diagnosis of Ph+ALL was performed via confirmation of the presence of Ph chromosome by conventional GTL-band technique, and/or positive molecular analysis with nested RT PCR for detection of BCR-ABL fusion transcripts. Written informed consent was obtained from all subjects. All patients received induction treatment consisting of vincristine, daunorubicin, oral or parenteral prednisolone, and nilotinib. After achieving complete remission (CR), subjects received either 5 courses of consolidation followed by 2-year maintenance with nilotinib, or allogeneic hematopoietic cell transplantation (alloHCT) depending on the donor availability, his/her tolerability, and patient’s wish. Nilotinib was administered twice a day with a single dose of 400mg (800mg per day) from day8 of induction until the initiation of conditioning for alloHCT or the end of maintenance therapy. Minimal residual disease (MRD) monitoring was performed at the central lab with quantitative RT-PCR assays for peripheral blood BCR-ABL RNA using LightCycler® Technology in serial; at the time of diagnosis, at hematologic CR(HCR), and every 3 months thereafter. BCR-ABL quantification was expressed relative to the amount of glucose-6-phosphate dehydrogenase (G6PDH) mRNA. The molecular response was defined as complete (MCR, MRD-negative) if the BCR-ABL/G6PDH ratio was less than 1x10-6. Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (version 2.0). Subjects had been followed up for 2 years after alloHCT or during maintenance therapy. Data were frozen up in June, 2013. A total of 91 subjects (male: female = 45: 46) were enrolled onto the study between January 2009 and May 2012. The median age was 47 (range 18-71) years old. Type of BCR breakpoint was minor (e1a2) in 71% of patients. The median BCR-ABL/G6PDH ratio was 6.09 (bone marrow) and 3.28 (peripheral blood) at diagnosis. During induction, all subjects required blood product transfusion, and incidence of nonhematologic adverse events (AE) over grade 3 was 17% (jaundice), 18% (ALT elevation), 13% (lipase elevation), and 2% (pancreatitis). Neither QTc prolongation over 500ms nor significant arrhythmia happened among any subject and any cycle. HCR rate was 90% and median time to HCR was 27 days (range, 13-72); most of failure was due to death in aplasia (n=8). MCR rate at HCR was 55%, Cumulative MCR rate was 84%, and median time to MCR was 1.1 months (range, 0.6-15.8). Most common cause of dropout from study was treatment-related death (n=22; during induction/consolidation vs. after alloHCT = 12 vs. 10), and HREL (n=15). Nilotinib was interrupted 75 times among 64 subjects, reduced 14 times among 12 subjects, and discontinued permanently due to hematologic relapse (HREL, n=14), AE (n=6, over gr3:3), and other cause (n=2). Fifty nine patients underwent alloHCT, 34 with myeloablative and 25 with reduced-intensity conditioning. Incidences of acute graft-versus-host disease (GVHD) and chronic GVHD were 41% and 29%, respectively. With a median follow-up of 20.7 months of surviving subjects, estimated hematologic relapse-free survival (RFS), and overall survival (OS) rate at 2 years were 74% and 70%, respectively. Among subject achieving MCR, 2-year molecular RFS rate was 56%. When events were defined as ‘dropout due to AE, isolated molecular / extramedullary relapse, HREL, and death from any cause’, median event-free survival was 12.5 months. In this prospective study, nilotinib was shown to be effective for adult Ph+ALL, and concurrent administration of nilotinib with cytotoxic drug was well-tolerable, although death in aplasia during induction was the most common cause of failure of achieving HCR. In terms of MRD, potential of nilotinib to achieve and maintain MRD negativity were satisfactory (Clinicaltrials.gov NCT00844298). Disclosures: Off Label Use: Nilotinib for Ph+ALL-sientific and academic purpose.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V122.21.55.55
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
    detail.hit.zdb_id: 1468538-3
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  • 2
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    Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 6 ( 2015-08-06), p. 746-756
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 6 ( 2015-08-06), p. 746-756
    Abstract: Nilotinib plus multiagent chemotherapy was feasible and showed a comparable outcome to previous results with imatinib for Ph-pos ALL. The achievement of deep MR with nilotinib at postremission correlated well with the clinical outcomes for Ph-pos ALL.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2015-03-636548
    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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  • 3
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    Pegfilgrastim Prophylaxis Is Effective in the Prevention of Febrile Neutropenia and Reduces Mortality in Patients Aged ≥ 75 Years with Diffuse Large B-Cell Lymphoma Treated with R-CHOP: A Prospective Cohort Study
    Korean Cancer Association ; 2022
    In:  Cancer Research and Treatment Vol. 54, No. 4 ( 2022-10-15), p. 1268-1277
    Details
    In: Cancer Research and Treatment, Korean Cancer Association, Vol. 54, No. 4 ( 2022-10-15), p. 1268-1277
    Abstract: PurposeFebrile neutropenia (FN) can cause suboptimal treatment and treatment-related mortality (TRM) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). Materials and methodsWe conducted a prospective cohort study to evaluate the effectiveness of pegfilgrastim prophylaxis in DLBCL patients receiving R-CHOP, and we compared them with the PROCESS cohort (n=485). ResultsSince January 2015, 986 patients with DLBCL were enrolled. Pegfilgrastim was administered at least once in 930 patients (94.3%), covering 90.3% of all cycles. FN developed in 137 patients (13.9%) in this cohort (23.7% in the PROCESS cohort, p 〈 0.001), and 4.2% of all cycles (10.2% in the PROCESS cohort, p 〈 0.001). Dose delay was less common (≥3 days: 18.1% vs. 23.7%, p=0.015; ≥5 days: 12.0% vs. 18.3%, p=0.023) in this cohort than in the PROCESS cohort. The incidence of TRM (3.2% vs. 5.6%, p=0.047) and infection-related death (1.8% vs. 4.5%, p=0.004) was lower in this cohort than in the PROCESS cohort. The 4-year overall survival (OS) and progression-free survival (PFS) rates of the two cohorts were not different (OS: 73.0% vs. 71.9%, p=0.545; PFS: 69.5% vs. 68.8%, p=0.616). However, in patients aged ≥75 years, the 4-year OS and PFS rates were higher in this cohort than in the PROCESS cohort (OS: 49.6% vs. 33.7%, p=0.032; PFS: 44.2% vs. 30.3% p=0.047). Conclusion Pegfilgrastim prophylaxis is effective in the prevention of FN and infection-related death in DLBCL patients receiving R-CHOP, and it also improves OS in patients aged ≥75 years.
    Type of Medium: Online Resource
    ISSN: 1598-2998 , 2005-9256
    URL: Article
    DOI: 10.4143/crt.2021.1168
    Language: English
    Publisher: Korean Cancer Association
    Publication Date: 2022
    detail.hit.zdb_id: 2514151-X
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  • 4
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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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  • 5
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    Clinical Significance Of SF3B1, U2AF1 and SRSF2 Spliceosomal Gene Mutations For The Treatment Of Hypomethylating Agents In Myelodysplastic Syndrome
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 2802-2802
    Details
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 2802-2802
    Abstract: Many reports state that hematopoietic malignancies mostly result from somatic mutations in HSCs in the bone marrow. Somatic mutations of spliceosomal gene such as SF3B1, U2AF1 and SRSF2 have been widely described in myelodysplastic syndrome (MDS). Some studies presented that MDS patient with splicing factor mutations influence the clinical outcomes. However, the clinical significances for the treatment of hypomethylating agents (HMA) in splicing factor mutation were not reported. Therefore, this study investigated the influences of the SF3B1, U2AF1 and SRSF2 splice gene mutation in MDS patients who received the HMAs. Materials and Methods MDS harboring ring sideroblast and association with somatic spliceosomal gene mutation was well demonstrated but, comparatively rare and showed good prognosis. So, we excluded MDS harboring ring sideroblast in this study. The study cohort of 133 MDS patients without harboring ring sideroblast was examined for somatic mutations in SF3B1, U2AF1 and SRSF2 splicing gene using direct sequencing method and 59 out of 133 patients received the treatment of HMAs (43 of Azacitidine and 16 of decitabine) for the treatment of MDS. Using the international prognostic scoring system(IPSS), the treatment indications for the HMA were as follows, 1) inermediate-1 with anemia and no response for the treatment of erythropoietin, 2) intermediate-1 with anemia accompanying other cytopenia ( neutrophil 〈 1,000/uL or PLT 〈 100,000/uL), 3) intermediate-2 or high risk. The response analysis was followed the modified IWG MDS response criteria. Results In 59 patients, mutations in K700E of SF3B1; S34T, S34P or Q157P of U2AF1; P95H or P95R of SRSF2 were found in 6 (10.2%), 7 (11.8%), and 4 (6.8%) patients, respectively. The 17 patients were observed any mutation (SF3B1, U2AF1 or SRSF2) in 59 patients. We compared the clinical features, treatment responses and survivals according to the somatic mutations of spliceosomal gene vs wild type (WT) in each mutation. The disease composition of 59 patients was like as follows; 1 of MDS with del(5q), 6 of RCUD, 24 of RCMD, 9 of RAEB-1, 19 of RAEB-2. In the clinical features, lower risk (according to IPSS, WPSS and revised-IPSS) patients was included in the group with SF3B1 mutation (P 〈 0.05). The hematologic improvement or more response for the HMA was observed in 33% vs 47% in SF3B1 mutation vs WT, 29% vs 48% in U2AF1 and 75% vs 44% in SRSF2, respectively. There was no difference in the response rates for the HMA therapy according to the mutation or wild type (P 〉 0.05). Overall survival did not show the statistical differences in each mutation (P 〉 0.05). The leukemia free survival in patients with SRSF2 mutation was inferior to the WT (p=0.001). However, anyone showed the leukemic transformation in the patients with SF3B1 mutation without statistical significance (p=0.247) (Fig. 1). Conclusion Our results show that mutation of SF3B1, U2AF1 and SRSF2 spliceosomal gene in MDS patients without harboring ring sideroblast did not influence the treatment response and overall survival for the HMAs. However, alteration of SRSF2 splice gene may be regarded as a risk factor of leukemic transformation. So, the patients with SRSF2 mutation treated with HMA have to consider the aggressive therapy such as allogeneic stem cell transplantation before leukemic transformation. To confirm this result, it will be needed more study for large number of patients. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V122.21.2802.2802
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
    detail.hit.zdb_id: 1468538-3
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  • 6
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    Serum Level Of Parathyroid Hormone Is Associated With Risk Factors and Clinical Outcomes In Multiple Myeloma
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 5365-5365
    Details
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 5365-5365
    Abstract: Parathyroid hormone (PTH) is synthesized and secreted by the chief cells of the parathyroid gland. PTH has a positive impact on hematopoietic stem cells by indirectly decreasing hematopoietic cell apoptosis, and is currently being investigated as a potential therapeutic to stimulate hematopoiesis and enhance bone marrow engraftment. According to previous study, it was hypothesized that elevated PTH may mediate the induction of multiple myeloma (MM) through the biologic effects of IL-6. However, there was no comprehensive study regarding clinicopathological implications of PTH in MM. This study investigated the pathological and clinical implications of serum PTH in MM patients and relationship with other risk factors of MM. Patients and Methods A total of 115 patients who were newly diagnosed with MM were enrolled between 2006 and 2012. Serum PTH level was measured by automated 2-site chemiluminescent sandwich assay (Abbott Diagnostics). The medical parameters were reviewed for age, sex, PTH, plasma cell percentage in bone marrow, serum M protein, immunoglobulin level, free light chain (FLC) - kappa and lambda, FLC ratio, calcium, creatinine, hemoglobin, albumin, beta-2 microglobulin, lactate dehydrogenase (LDH), international staging system (ISS) stage, international myeloma working group (IMWG) response, chromosome abnormality, bone lesion, treatment outcome, and so on. The collected data was analyzed by PASW 18.0. We performed Spearman’s correlation analysis, Mann Whitney U-test, Kruskall Wallis test, time dependent Cox regression analysis, survival analysis by Kaplan-Meier method, etc. Results Serum PTH level of 115 myeloma patients was 24.7±34.9 (ranged 0.0-284.1) pg/mL. Serum level of IgG, IgM, FLC-lambda, albumin, and LDH was in positive correlation with serum PTH. Age, plasma cell percentage, M protein, IgA, FLC-kappa, FLC ratio, calcium, creatinine, hemoglobin, and beta-2 microglobulin showed negative correlation with PTH. Among those above, IgM (rho=0.190, p=0.045) and calcium (rho=-0.220, p=0.043) revealed statistically significant correlation with serum PTH. Serum PTH level in MM patients was not significantly different according to the group of IMWG response (p=0.450) and ISS stage (p=0.414). Meanwhile, there was no significant difference of PTH according to chromosomal abnormality (p=0.353), bone lesion (p=0.207), and disease progression (p=0.322). Besides, only calcium level was meaningfully different (p=0.016) by the comparison of clinical parameters between MM patient’s group with high PTH level and non-high PTH group (cut-off PTH level=68.3 pg/mL, Mann Whitney U-test). Relative to non-high PTH ( 〈 68.3 pg/mL) group, the hazard ratio was higher for group with high PTH level (≥68.3 pg/ml) ([HR] 3.037; p=0.524; 95% CI, 0.100∼92.586; Table 1). With regard to the prognostic implication of serum PTH value, the patient group with above 68.3 pg/mL showed moderate, inferior progression free survival (PFS) than non-high PTH group (median, 5 months vs. 13 months, p=0.056, Fig.1B). However, no overall survival (OS) differences were found between high PTH group and non-high PTH group (Fig. 1A). Interestingly, subgroup analysis showed that patients with high PTH level significantly had an inferior PFS than those with non-high PTH level. In detail, the subgroup were as follows; patients who reached the complete remission (CR) state (N=25) defined by IMWG response criteria at the end of follow up period (median, 3 months vs. 41 months, p=0.001, Fig.1C), patients (N=41) who belonged to ISS stage II (median, 1 months vs. 15 months, p=0.006, Fig.1D), patients (N=97) with no chromosome abnormality (median, 4 months vs. 15 months, p=0.034, Fig.1E), patients (N=28) who have undergone transplantation (median, 3 months vs. 18 months, p=0.009, Fig.1F). Conclusion This study showed that blood PTH level in MM at diagnosis was associated with risk factors and clinical outcome in MM patients. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V122.21.5365.5365
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
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  • 7
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    Normal karyotype acute myeloid leukemia patients with CEBPA double mutation have a favorable prognosis but no survival benefit from allogeneic stem cell transplant
    Springer Science and Business Media LLC ; 2016
    In:  Annals of Hematology Vol. 95, No. 2 ( 2016-1), p. 301-310
    Details
    In: Annals of Hematology, Springer Science and Business Media LLC, Vol. 95, No. 2 ( 2016-1), p. 301-310
    Type of Medium: Online Resource
    ISSN: 0939-5555 , 1432-0584
    URL: Article
    DOI: 10.1007/s00277-015-2540-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2016
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  • 8
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    Comparison of first-line treatment with CHOP versus ICED in patients with peripheral T-cell lymphoma eligible for upfront autologous stem cell transplantation
    Frontiers Media SA ; 2023
    In:  Frontiers in Oncology Vol. 13 ( 2023-8-22)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 13 ( 2023-8-22)
    Abstract: Upfront autologous stem cell transplantation (ASCT) has been recommended for patients who are newly diagnosed with peripheral T-cell lymphoma (PTCL), and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), an anthracycline-based chemotherapy has been the frontline chemotherapy for PTCL. However, it is not clear whether anthracycline-based chemotherapies such as CHOP could be standard induction therapy for PTCL. Methods We conducted a randomized phase II study to compare CHOP with fractionated ifosfamide, carboplatin, etoposide, and dexamethasone (ICED) for patients eligible for ASCT. The primary endpoint was progression-free survival (PFS) and secondary endpoints included objective response rate, overall survival (OS), and safety profiles. Results Patients were randomized into either CHOP (n = 69) or ICED (n = 66), and the characteristics of both arms were not different. PTCL-not otherwise specified (NOS, n = 60) and angioimmunoblastic T-cell lymphoma (AITL, n = 53) were dominant. The objective response rate was not different between CHOP (59.4%) and ICED (56.1%), and the 3-year PFS was not different between CHOP (36.7%) and ICED (33.1%). In AITL patients, CHOP was favored over ICED whereas ICED was associated with more cytopenia and reduced dose intensity. Patients who received upfront ASCT after achieving complete response to CHOP or ICED showed 80% of 3-year OS. Discussion In summary, our study showed no therapeutic difference between CHOP and ICED in terms of response and PFS. Thus, CHOP might remain the reference regimen especially for AITL based on its better outcome in AITL, and upfront ASCT could be recommended as a consolidation of complete response in patients with PTCL.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    DOI: 10.3389/fonc.2023.1230629
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
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  • 9
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    A Prospective Study of Preemptive Tenofovir Disoproxil Fumarate Therapy in HBsAg-Positive Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  American Journal of Gastroenterology Vol. 118, No. 8 ( 2023-08), p. 1373-1380
    Details
    In: American Journal of Gastroenterology, Ovid Technologies (Wolters Kluwer Health), Vol. 118, No. 8 ( 2023-08), p. 1373-1380
    Abstract: This prospective study aimed to investigate the efficacy and safety of preemptive antiviral therapy with tenofovir disoproxil fumarate (TDF) for HBsAg-positive patients with newly diagnosed diffuse large B-cell lymphoma receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy. METHODS: We enrolled 73 patients from 20 institutions. The primary end point was the absolute risk of hepatitis B virus (HBV)-related hepatitis during preemptive TDF therapy and for 24 weeks after withdrawal from TDF. Hepatitis was defined as a more than 3-fold increase in serum alanine aminotransferase from baseline or an alanine aminotransferase level of ≥100 U/L. HBV-related hepatitis was defined as hepatitis with an increase in serum HBV-DNA to 〉 10 times that of the pre-exacerbation baseline or an absolute increase of ≥20,000 IU/mL compared with the baseline. RESULTS: No patient developed HBV reactivation or HBV-related hepatitis during preemptive antiviral therapy (until 48 weeks after completion of R-CHOP chemotherapy) with TDF. All adverse events were grade 1 or 2. HBV reactivation was reported in 17 (23.3%) patients. All HBV reactivation was developed at a median of 90 days after withdrawal from TDF (range, 37–214 days). Six (8.2%) patients developed HBV-related hepatitis at a median of 88 days after withdrawal from TDF (range, 37–183 days). DISCUSSION: Preemptive TDF therapy in HBsAg-positive patients with diffuse large B-cell lymphoma receiving R-CHOP chemotherapy was safe and effective for preventing HBV-related hepatitis. However, a long-term maintenance strategy of preemptive TDF therapy should be recommended because of the relatively high rate of HBV-related hepatitis after withdrawal from TDF (ClinicalTrials.gov ID: NCT02354846).
    Type of Medium: Online Resource
    ISSN: 0002-9270 , 1572-0241
    URL: Article
    DOI: 10.14309/ajg.0000000000002185
    RVK:
    XA 18920
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 10
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    Discrepancy of Interim PET/CT Responses Based on Visual and Quantitative SUV-Based Assessments in the Patients with Diffuse Large B-Cell Lymphoma and Extranodal Involvements
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 1446-1446
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 1446-1446
    Abstract: Background 18 F-FDG PET is currently used in diffuse large B-cell lymphoma (DLBCL) for staging and evaluation of therapeutic efficacy at various time points. Nevertheless, the predictive value of interim PET/CT (iPET/CT) has not been consistent throughout the studies. Since FDG is not a tumor-specific substance, it may accumulate to the point of being detected in a variety of benign conditions or infectious lesions, which may give rise to false positive interpretation. Particularly, iPET/CT assessment in patients with multifocal, non-contiguous involvement at extranodal (EN) sites may result in a false determination of prognosis due to tracer uptake of inflammatory or physiologic anatomic sites, which could contribute to the variability in outcomes and the poor reproducibility. Therefore, the purpose of this study is to investigate the predictive accuracy of iPET/CT response based on visual and quantitative SUV-based assessments in patients with DLBCL and EN involvements. Methods iPET/CT responses for 163 patients with newly diagnosed DLBCL and EN involvements were investigated retrospectively. iPET/CT responses were based on the visual and quantitative SUV-based assessments. Briefly, the assessment of PET/CT was performed at the time of diagnosis, at the third or fourth cycles and at the completion of R-CHOP. For visual assessment, the five-point scale (5-PS) based on the Deauville criteria was used and graded as negative or positive by comparison with initial PET/CT scan and grade 1-3 were considered as negative and grade 4-5 were considered the residual metabolic response. Second, we classified patients using the quantitative analysis of 18 F-FDG uptake changes based on the percentage of SUVmax reduction (DSUVmax) between initial and interim PET/CT scans. The cutoff points of DSUVmax were 65.7% based on previous reports. Results Median age was 61 years (range 18-83 years) and 88 patients (54.0%) in advanced disease (III/IV). Patients were classified according to the IPI risk with 95 patients (58.3%) being classified as low or low-intermediate and 68 patients (41.7%) as high-intermediate or high risk. Number of extranodal site(s) were 1 site in 102 patients (62.6%), 2 sites in 39 (23.9), 3 sites in 18 (11.0), and 4 sites in 4 (2.5%). iPET/CT responses based on visual analysis were classified into grade 1-3 of 5-PS in 99 patients (60.7%) and grade 4-5 in 64 (39.3%), and based on SUV-based, classified into higher the cutoff of DSUVmax ( 〉 65.7%) in 140 patients (85.9%) and lower ( 〈 65.7%) in 23 patients (14.1%), respectively. On visual assessment, iPET/CT-positive patients had no difference of relapse rates (28.3±5.4%) compared to those of iPET/CT-negative patients (23.1±4.5%) (p=0.419). Among the patients with 5-PS grade 4-5, 46 patients (71.9%) achieved higher the optimal cutoff of DSUVmax ( 〉 67.5%). The 5-year overall survival (OS) rates and progression free survival (PFS) rates were 75.6±3.8% vs 60.6±11.7% (p=0.056), and 77.9±3.7% vs 55.9±12.1% (p=0.007) depending on the cutoff of DSUVmax, respectively. Among the patients with 1 EN involvement, DSUVmax successfully predict the long-term outcomes in terms of 5yr-OS (83.2±4.3% vs 62.1±14.6%, p=0.012) and PFS (86.9±3.9% vs 41.3±16.6%, p 〈 0.001), while for those with more than 1 EN involvements, DSUVmax failed to predict long-term outcomes. In the multivariate analysis, DSUVmax 〈 65.7% (HR=2.675, 95% CI 1.304-5.486, p=0.007), ECOG 2-3 (HR=2.553, 95% CI 1.228-5.309, p=0.012), and the involvement of more than 1 EN sites (HR=2.370, 95% CI 1.247-4.504, p=0.008) were unfavorable factors for PFS. Visual assessments based on Deauville 5-PS score could not predict the disease progression or long-term outcomes regardless of the number of extranodal involvements or IPI risk groups. Conclusion The quantitative SUV-based assessments in iPET/CT could have significant potential as a prognostic predictor of PFS and OS, especially in the patients with 1 EN site involvement. However, the visual assessments have the limitations to predict long-term outcomes with high false positive rates at EN involvements. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.1446.1446
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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