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  • 1
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    Trough Plasma Imatinib Levels and ABCG2 Polymorphisms Are Correlated with Optimal Cytogenetic Responses at 6 Months After Treatment with Standard Dose of Imatinib In Newly Diagnosed CML
    American Society of Hematology ; 2010
    In:  Blood Vol. 116, No. 21 ( 2010-11-19), p. 2272-2272
    Details
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 2272-2272
    Abstract: Abstract 2272 To test the correlation of trough plasma Imatinib Mesylate (IM) levels and pharmacogenomic variation with cytogenetic or molecular responses, we measured trough plasma IM levels and analyzed various genetic polymorphisms in newly diagnosed CML patients at 6 months of IM treatment and compared them with the likelihood of achieving cytogenetic complete response (CyCR) or major molecular response to standard dose of IM. Newly diagnosed 94 CML patients were prospectively enrolled in the current study. CyCR was achieved in 71 patients (75.5%). Eighty-four patients (89.4%) showed optimal response (CyCR + cytogenetic partial response CyPR) at 6 months. Trough plasma IM levels were highly variable ranging from 203 to 4980 ng/ml: mean (±SD) was 1392±78.8 ng/ml. Among 47 patients with trough plasma IM level of 〈 1320 ng/ml, 39 patients (83.0%) showed optimal response and 8 (17.0%) suboptimal response. Among 47 patients with trough plasma IM level of ≥1320 ng/ml, 45 patients (95.7%) showed optimal response and 2 (4.3%) suboptimal response (P=0.045). Trough plasma IM level was 1346.0±78.3 ng/ml for the group with non-hematologic toxicity of grade 0 or 1 and 1969.6±365.3 for the group with grade 2–4, which was statistically significant (p=0.038). The impact of single nucleotide polymorphisms (SNPs) in cytochrome P450 (CYP) genes (CYP2D6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2B6, CYP2C8, CYP1A2) and transporter genes (hOCT1, hOCT2, hOCT3, ABCG2, ABCC2, SLCO1B1, ABCB1) potentially associated with IM trough level was also investigated. The AA genotype in CYP2C19*2 (681G 〉 A) was significantly associated with higher IM trough level than dominant genotype (p=0.021), whereas transporter genes did not show any significant results. The CC genotype of ABCG2 (421C 〉 A) gene was related with CCyR (OR 3.47, 95% CI 1.09–11.05; p=0.030). In conclusion, the incidence of optimal responses in newly diagnosed CML patients who had been treated with standard dose of IM for 6 months was significantly higher in the patient group with trough plasma IM level of ≥1320 ng/ml than the group with 〈 1320 ng/ml, and the trough level of IM was influenced by CYP2C19 genotype. Checking trough plasma IM level together with cytogenetic and molecular data at milestone timing may guide the clinicians to adopt dose escalation or 2nd tyrosine kinase inhibitors in CML patients showing suboptimal response or resistance to standard dose of IM. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V116.21.2272.2272
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
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  • 2
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    Ultra-deep sequencing mutation analysis of the BCR/ABL1 kinase domain in newly diagnosed chronic myeloid leukemia patients
    Elsevier BV ; 2021
    In:  Leukemia Research Vol. 111 ( 2021-12), p. 106728-
    Details
    In: Leukemia Research, Elsevier BV, Vol. 111 ( 2021-12), p. 106728-
    Type of Medium: Online Resource
    ISSN: 0145-2126
    URL: Article
    DOI: 10.1016/j.leukres.2021.106728
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 2008028-1
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  • 3
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    Trough plasma imatinib levels are correlated with optimal cytogenetic responses at 6 months after treatment with standard dose of imatinib in newly diagnosed chronic myeloid leukemia
    Informa UK Limited ; 2011
    In:  Leukemia & Lymphoma Vol. 52, No. 6 ( 2011-06), p. 1024-1029
    Details
    In: Leukemia & Lymphoma, Informa UK Limited, Vol. 52, No. 6 ( 2011-06), p. 1024-1029
    Type of Medium: Online Resource
    ISSN: 1042-8194 , 1029-2403
    URL: Article
    DOI: 10.3109/10428194.2011.563885
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2011
    detail.hit.zdb_id: 2030637-4
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  • 4
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    A phase 4 study of nilotinib in Korean patients with Philadelphia chromosome‐positive chronic myeloid leukemia in chronic phase: ENESTK orea
    Wiley ; 2018
    In:  Cancer Medicine Vol. 7, No. 5 ( 2018-05), p. 1814-1823
    Details
    In: Cancer Medicine, Wiley, Vol. 7, No. 5 ( 2018-05), p. 1814-1823
    Abstract: Although nilotinib has improved efficacy compared to imatinib, suboptimal response and intolerable adverse events ( AE s) limit its effectiveness in many patients with chronic myeloid leukemia in chronic phase ( CML ‐ CP ). We investigated the 2‐year efficacy and safety of nilotinib and their relationships with plasma nilotinib concentrations ( PNC s). In this open‐label, multi‐institutional phase 4 study, 110 Philadelphia chromosome‐positive CML ‐ CP patients were treated with nilotinib at a starting dose of 300 mg twice daily. Molecular responses ( MR s) and AE s were monitored for up to 24 months. The 24‐month cumulative MR 4.5 rate was evaluated as the primary endpoint. Plasma samples were collected from 94 patients to determine PNC s, and the per‐patient mean was used to categorize them into four mean PNC ( MPNC ) groups. Cumulative MR rates and safety were compared between groups. With a median follow‐up of 22.2 months, the 24‐month cumulative MR 4.5 rate was 56.2% (95% confidence interval, 44.0%–8.3%), and the median time to MR 4.5 was 23.3 months. There were no significant differences in the cumulative rates of major molecular response, MR 4 , and MR 4.5 between MPNC groups. One patient died due to acute viral hepatitis, and two developed hematological or cytogenetic relapse, while no progression to accelerated or blast phase was observed. Safety results were consistent with previous studies with no new safety signal identified. Across the MPNC groups, there was no significant linear trend in the frequency of AE s. Nilotinib is highly effective for the treatment of CML ‐ CP with manageable AE s. The measurement of PNC has no predictive value for patient outcomes and is thus not found to be clinically useful. This study is registered with clinicaltrials.gov, Number NCT 03332511.
    Type of Medium: Online Resource
    ISSN: 2045-7634 , 2045-7634
    URL: Issue
    URL: Article
    DOI: 10.1002/cam4.2018.7.issue-5
    DOI: 10.1002/cam4.1450
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2659751-2
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  • 5
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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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  • 6
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    Comparison of Molecular Kinetics after the First and Second Imatinib Discontinuation: Results from the KID Study
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 1920-1920
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 1920-1920
    Abstract: Backgroud: Recent reports showing that imatinib (IM) discontinuation can be employed in patients who had enough IM therapy and undetectable molecular residual disease (UMRD) durations prior to IM discontinuation result in treatment-free remission (TFR) as a new therapeutic goal in chronic phase chronic myeloid leukemia (CP CML). Although 50-70% of patients experienced molecular relapse by several TFR studies, the most of patients resumed molecular responses (MR) following restart of IM. Through the Korean multicenter prospective study (Korean Imatinib Discontinuation Study; KID Study), we have identified predictors for sustained UMRD and explored molecular kinetics after the first IM discontinuation. In patients regaining durable UMRD with IM resumption, we tried second IM discontinuation and compared molecular kinetics between the first IM stop and second IM stop. Methods: CP CML patients who were treated with IM for more than 3 years and had undetectable levels of BCR-ABL1 transcripts determined by quantitative reverse transcriptase polymerase chain reaction (PCR) for at least 2 years were eligible for KID study and in cases of MMR loss after 2 consecutive assessments, IM treatment was re-introduced. After IM resumption for MMR loss, the molecular response was evaluated every month until MMR was re-achieved and every 3 months thereafter. The second stop was permitted in the patients who were in second UMRD for at least 2 years. Results: By the data cut-off date of 31 July 2015, among 90 non-transplant UMRD patients with at least 12 months of follow-up, 37 patients lost MMR in 2 consecutive analyses and resumed IM. Among them, 9 patients (5 men and 4 women) with a median age of 54 years (range, 35-59 years) entered into a second IM discontinuation after maintaining UMRD at least 2 years. Prior to first discontinuation, the median duration of IM therapy was 76.8 months (range, 38.5-129.0 months) and the duration of sustained UMRD was 30.1 months (range, 24.4-64.5 months). After first attempt of IM discontinuation, they relapsed after a median duration of 3.7 months (range, 1.9-20.8 months) and re-achieved UMRD at a median of 5.5 months (range, 1.8-9.4 months) after IM resumption. After sustaining a second UMRD for a median of 25.7 months, IM therapy discontinued for a second time. After a median follow-up of 37.4 months (range, 19.7-58.5 months) after second IM discontinuation, 7/9 patients (78%) and 4/9 patients (44%) lost UMRD and MMR, respectively. Among three patients who lost UMRD but not MMR, one patient showed fluctuation of BCR-ABL1 transcript under the level of 0.1% on IS for 19.5 months and two patients has not yet been followed up after a first detection of UMRD loss. Four patients who experienced second relapse (MMR loss) after a median 2.9 months (range, 2.7-3.9 months), which was similar to those of the first IM discontinuation [median 3.75 (range, 1.9-3.9 months)] . The patients who lost MMR were retreated with IM for a median of 13.6 months (range, 0.8-18.6 months); three patients re-achieved MMR at 3.5, 5.5, and 11.5 months, respectively and one re-achieved UMRD at 7.2 months. Conclusion: Our data demonstrated that a second attempt might be possible and the median time to MMR loss after second discontinuation was similar to those of the first discontinuation. But the molecular kinetics after second IM resumption needs longer follow-up with more patients. Further studies on the predictors to select patients for a trial of second TFR and novel strategies such as intermittent therapy will be warranted. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.1920.1920
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 7
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    Low-dose abdominopelvic computed tomography in patients with lymphoma: An image quality and radiation dose reduction study
    Public Library of Science (PLoS) ; 2022
    In:  PLOS ONE Vol. 17, No. 8 ( 2022-8-11), p. e0272356-
    Details
    In: PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 8 ( 2022-8-11), p. e0272356-
    Abstract: This study aimed to evaluate image quality, the detection rate of enlarged lymph nodes, and radiation dose exposure of ultralow-dose and low-dose abdominopelvic computed tomography (CT) in patients with lymphoma. Patients with lymphoma who underwent abdominopelvic CT using dual-source scanner were retrospectively recruited from a single center. CT images were obtained at 90 kVp dual-source mode reformatted in three data sets using the advanced modelled iterative reconstruction algorithm: 100% (standard-dose CT), 66.7% (low-dose CT), and 33.3% (ultralow-dose CT). Two radiologists analyzed subjective image quality and detection of abdominal enlarged lymph nodes on ultralow-dose, low-dose, and standard-dose CT blindly and independently. The results were compared with reference standards. Three readers (two radiologists and one hematologist) reviewed overall image quality and spleen size. In total, 128 consecutive CT scans (77 complete response, 44 partial response, 6 progressive disease, and 1 initial evaluation) from 86 patients (64 B-cell lymphoma, 14 T/NK-cell lymphoma, and 8 Hodgkin’s lymphoma cases) were assessed. The enlarged lymph node-based detection rates for two readers were 97.0% (96/99) and 94.0% (93/99) on standard-dose CT, 97.0% (96/99) and 94.0% (93/99) on low-dose CT, and 94.0% (93/99) and 89.9% (89/99) on ultralow-dose CT. Overall image quality was 3.8 ± 0.5, 3.9 ± 0.5, and 4.1 ± 0.5 on ultralow-dose CT; 4.7 ± 0.4, 4.6 ± 0.5, and 4.8 ± 0.3 on low-dose CT; and 4.8 ± 0.4, 4.7 ± 0.4, and 4.9 ± 0.2 on standard-dose CT, according to two radiologists and one hematologist, respectively. Intraclass correlation coefficients of spleen size were 0.90 (95% confidence interval [CI], 0.87–0.93), 0.91 (95% CI, 0.88–0.93), and 0.91 (95% CI, 0.88–0.93) on ultralow-dose, low-dose, and standard-dose CT, respectively. Mean effective radiation doses of standard-dose, low-dose, and ultralow-dose CT were 5.7 ±1.8 mSv, 3.8 ± 1.2 mSv, and 1.9 ± 0.6 mSv, respectively. Our findings suggest that ultralow-dose and low-dose CT, even with radiation doses reduced by 66.7% and 33.3%, respectively, maintained adequate image quality. These imaging modalities may be employed for follow-up lymphoma evaluation in consideration of the long surveillance periods.
    Type of Medium: Online Resource
    ISSN: 1932-6203
    URL: Article
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    DOI: 10.1371/journal.pone.0272356
    DOI: 10.1371/journal.pone.0272356.g001
    DOI: 10.1371/journal.pone.0272356.g002
    DOI: 10.1371/journal.pone.0272356.g003
    DOI: 10.1371/journal.pone.0272356.t001
    DOI: 10.1371/journal.pone.0272356.t002
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    DOI: 10.1371/journal.pone.0272356.s001
    DOI: 10.1371/journal.pone.0272356.s002
    DOI: 10.1371/journal.pone.0272356.s003
    Language: English
    Publisher: Public Library of Science (PLoS)
    Publication Date: 2022
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  • 8
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    Central Nervous System Relapses in Patients with Diffuse Large B Cell Lymphoma: Multicenter Retrospective Analysis in Korea
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 5314-5314
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 5314-5314
    Abstract: Introduction: Central nervous system (CNS) involvement in patients with diffuse large B-cell lymphoma (DLBCL) is a serious complication with a poor prognosis. Secondary CNS involvements in DLBCL are divided into 2 types as follows: CNS involvement at the time of systemic relapse or progression, and isolated CNS relapse despite systemic remission. The frequency of secondary CNS involvement is reported as variable from 4% to 27% in patients with DLBCL who did not receive CNS prophylaxis. However, there is no clear consensus as to the subset of DLBCL benefits from CNS-directed preventive therapy. Furthermore, there is no general agreement on the intensity and type of therapy against secondary CNS involvement. Thus, we analyzed the clinical features and treatment outcomes of secondary CNS involvement in patients with DLBCL. Patients and methods: We analyzed 59 patients who diagnosed with DLBCL and had secondary CNS involvement. Secondary CNS involvement was defined as a brain parenchyma lesion or leptomeningeal involvement or combined during the follow-up or during the treatment. Results: 35 patients were initially treated with CHOP or CHOP-like regimens, and 24 patients with rituximab-CHOP (R-CHOP). The median age of the patients was 54 years old (range 17–77). 37 patients (62.7%) were presented as advanced stage (7 patients with stage III, 30 patients with stage IV), and 40 patients showed elevated serum LDH. Thus, 27 patients belonged to the high-intermediate or high risk of international prognostic index (IPI). The pattern of CNS involvement was as follows: 21 had lesions of brain parenchyma, 30 leptomeningeal involvements, and 8 combined lesions. There was no clinical variable predicting a pattern of CNS involvement. We dichotomized the patients based on the onset of CNS involvement: early CNS involvement occurred within one year from diagnosis (Early CNS group, 42 patients) and delayed CNS involvement after one year (Delayed CNS group, 17 patients). The early CNS group had more advanced stage of patients (26 patients with stage IV) than delayed CNS group (4 patients with stage IV). The presence of bone marrow invasion was also significantly associated with early CNS involvement: 18 patients in early CNS involvement and 1 patient in delayed CNS involvement. In addition, high or high-intermediate risk of IPI was related with early CNS involvement (P & lt; 0.05). The response to the primary treatment against DLBCL was not related with the onset of CNS involvement, thus 46 patients showed objective response including 33 complete responses (CR). The use of rituximab was not associated with the onset of CNS involvement. However, the number of patients with partial response (PR) was higher in the early group (9/46, 19.6%) than delayed CNS group (2/17, 11.7%). Thus, these findings suggest patients with high tumor burden represented by advanced stage, high IPI, and bone marrow invasion might have CNS involvement at the time of diagnosis. However, the overall survival was not significantly different between these two groups, and the median overall survival of patients with secondary CNS involvement was 5.13 months (95% confidence interval: 3.39–6.87 months). When we compared survival based on the type of therapy in patients with isolated brain parenchyma involvement, combined treatment approach including systemic chemotherapy (high-dosage methotreaxate (MTX) chemotherapy) and localized therapy (intrathecal MTX chemotherapy and/or whole brain radiotherapy) showed a tendency of better survival than localized therapy alone. However, the addition of systemic chemotherapy was not translated into survival benefit in patients with isolated leptomeningeal CNS involvement. Furthermore, the role of systemic chemotherapy using high-dosage MTX was not proved in patients with systemic disease progression and secondary CNS involvement although it showed the tendency of better survival. Conclusions: Patients with advanced stage, high or high-intermediate risk of IPI, and the presence of bone marrow invasion might have a high risk of secondary CNS involvement even during the active treatment. Thus, CNS prophylaxis should be considered. However, further prospective study should be warranted to determine the intensity and type of treatment against secondary CNS involvement in DLBCL.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.5314.5314
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 9
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    Statistical Correlations Between Quantifiable Disease Variables and Prognosis in Hematological Malignancy Patients Treated with Itraconazole as An Empirical Antifungal Therapy: A Prospective Multicenter Observational Study in Korea
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 4028-4028
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 4028-4028
    Abstract: We identified the clinical characteristics including disease status for expecting success outcome of empirical antifungal therapy for invasive fungal infection (IFI) using itraconazole in immunocompromised patients with hematological malignancies. The prospective multicenter observational study was performed at 26 medical centers for 9 months. Three hundred seventy six patients with hematological malignancies (median age 48) had been enrolled and analyzed. The patients with possible and probable categories for IFI according to the EORTC/MSG criteria were included. We excluded the patients with proven IFI. IV itraconazole was administered as routine schedule. Oral itraconazole solution was used after the IV itraconazole. Underlying disease consisted of 61% of AML and 15% of ALL. Overall success rate of empirical antifungal therapy with itraconazole was 196/376 (51%). Acute leukemia in non-CR status and advanced stage of MDS patients showed a lower trend of success rate. Combined co-morbidities, underlying lung disease, poor ECOG performance status (≥2), abnormal chest X-ray at the time of initiation of empirical antifungal therapy, no early initiation of empirical antifungal therapy (the duration of baseline neutropenic fever ≥3 days) and antifungal prophylaxis other than itraconazole were associated with decreased overall success rate. Multivariate analysis revealed that poor ECOG performance status (≥2) (P=0.01, HR = 1.90, 95% CI 1.17–3.06) and abnormal chest X-ray (P=0.02, HR = 2.00, 95% CI 1.12–3.58) were significantly associated with poor outcome of empirical antifungal therapy with itraconazole. Overall success rate of empirical antifungal therapy was not affected by antifungal prophylaxis. Defervescence in setting of neutropenia was 70% (264/276). Higher rate of defervescence was observed in the patients with early stage of MDS (92% vs. 40%, P = 0.02). Median time to defervescence after empirical itraconazole therapy was 3 days. Short mean time to defervescence was observed in the patients with acute leukemia in CR status (P = 0.002) or early stage of lymphoid malignancies (P = 0.03). Baseline fungal infections were diagnosed in 13 patients (3%). Of the patients with baseline fungal infections, 7 patients (54%) had a successful outcome. All 7 patients with successful outcome had baseline fungal infection with candidemia. The rate of breakthrough fungal infection was 4% (16/376). Breakthrough aspergillus infection was documented in the half of theses patients (8/16). The rate of breakthrough fungal infection also was not different according to the different disease status. Premature discontinuation of itraconazole therapy because of toxicity or lack of efficacy occurred in 35% (131/376). The proportion of patients who survived for at least 7 days after completion of itraconazole therapy was 90% (338/376). IV itraconazole followed by oral itraconazole solution is an effective regimen for empirical antifungal therapy in the haematological malignancy patients with persistent neutropenic fever. Poor performance status and abnormal chest X-ray were predictive factors for failure of empirical antifungal therapy with itraconazole in the patients with hematological malignancies. Table 1. Outcomes (overall success rate) according to the clinical characteristics Yes No P Co-morbidities 37/90 (41%) 156/286 (55%) 0.03 Diabetes mellitus 6/20 (30%) 187/356 (53%) 0.07 Lung disease 3/14 (21%) 190/362 (53%) 0.03 ECOG performance status -≥2 (vs. 0 or 1) 45/123 (37%) 148/253 (59%) & lt; 0.001 Galactomannan test – positive 3/9 (33%) 33/74 (45%) 0.73 Abnormal chest X-ray 23/70 (33%) 156/278 (56%) 0.001 Abnormal chest CT 14/51 (28%) 5/8 (63%) 0.10 Duration of baseline neutropenia ≥7 days (vs. & lt;7 days) 101/206 (49%) 92/170 (54%) 0.35 & gt;10 days (vs. ≤10 days) 60/122 (49%) 133/254 (52%) 0.58 Duration of baseline neutropenic fever ≥3 days (vs. & lt;3 days) 89/193 (46%) 104/183 (57%) 0.04 ≥5 days (vs. & lt;5 days) 55/124 (44%) 138/252 (55%) 0.06 Antifungal prophylaxis 95/183 (52%) 98/193 (51%) 0.84 Other drugs (vs. itraconazole) 51/114 (45%) 44/69 (64%) 0.02
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.4028.4028
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 10
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    Predictive Value of 3-Month Early Molecular Response in New Chronic Phase Chronic Myeloid Leukemia Patients Treated with Radotinib
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 4053-4053
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 4053-4053
    Abstract: Background: Recent studies have demonstrated that early molecular milestones were able to identify high-risk chronic myeloid leukemia patients treated with frontline imatinib (IM) and second generation tyrosine kinase inhibitors (2G TKIs) such as nilotinib and dasatinib. However, whether a single measurement of BCR-ABL1 transcripts level after 3 months of treatment is sufficient to define failure necessitating a change of treatment is not confirmed. Radotinib (RAD) is a 2G TKI for BCR-ABL1 tyrosine kinase, which was approved by the Korea FDA for the second-line therapy, and the phase 3 study comparing the efficacy and safety of RAD 300 and 400 mg twice daily and IM 400 mg once daily in patients with newly diagnosed CP CML was performed. The aim of this study was to identify the predictive value of 3-month molecular milestone for an achievement of major molecular response (MMR) by 12 months to RAD therapy. Additionally, in the same population, predictive factors for achieving MMR by 12 months were analyzed. Methods: Among 241 patients who were enrolled in the randomized, open-label, phase 3 study of RAD, 236 patients with available 3-month qRT-PCR on study therapy [RAD 300 mg twice (n = 79), RAD 400 mg twice (n = 79), IM 400 mg once (n = 78)] were evaluated. Molecular responses were monitored using a qRT-PCR assay in 3-month intervals by 12 months. All qRT-PCR were tested with at least 4.5-log sensitivity in the central laboratory (Cancer Research Institute, The Catholic University of Korea, Seoul, Korea) and MMR was defined as a BCR-ABL1 transcript level of 0.1% or lower on the international scale (IS). Results: 236 patients (including 149 men and 87 women) with available 3-month qRT-PCR on study therapy were evaluated. With a median age of 45 years (range, 18-84 years), the distribution of low, intermediate and high Sokal risk scores were 27%, 47% and 26%, respectively. At 3 months, BCR-ABL1 ≤10% [RAD 300 mg twice (n = 68), RAD 400 mg twice (n = 69), IM 400 mg once (n = 55)] and 〉 10% [RAD 300 mg twice (n = 11), RAD 400 mg twice (n = 10), IM 400 mg once (n = 23)] were observed. In the IM 400 mg once group, patients with BCR-ABL1 ≤10% at 3 months showed a significant higher rate of MMR by 12 months compared with that of patients with BCR-ABL1 〉 10% (38.2% vs 13.0%, P = 0.028). In the RAD 300 and 400 mg twice group, an achievement of 3-month EMR was associated with a higher rate of MMR by 12 months [57.4% vs 18.2%, P = 0.016 (RAD 300 mg twice) and 50.7% vs 10.0%, P = 0.018 (RAD 400 mg twice)]. After adjusting for factors affecting achievement of MMR by 12 months on univariate analyses, multivariate analyses showed that b2a2 transcript type (RR of 0.46, P = 0.023), large spleen size (RR of 0.91, P = 0.001), and no achievement of 3-month EMR (RR of 0.24, P = 0.004) were predictor for not achieving MMR by 12 months. Significance of 3-month EMR for achieving MMR by 12 months was observed in the separated treatment groups: RR of 0.24, P = 0.037 in the IM 400 mg once group, RR of 0.17 P = 0.028 in the RAD 300 mg twice group, and RR of 0.11, P = 0.040 in the RAD 400 mg twice group. Conclusions: Our results suggest that 3-month EMR can play key roles for 12-month MMR achievement in CP CML patients treated with IM and RAD. In addition, some factors for achieving 12-month MMR were detected. To evaluate the long-term prognostic value of 3-month EMR, further clinical investigations in a larger patient population with longer follow-up are needed. Disclosures Kim: IL-YANG Pharm.Co.Ltd: Research Funding. Chung:Alexion Pharmaceuticals: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.4053.4053
    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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