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  • 1
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 4497-4497
    Abstract: Abstract 4497 Background: IM 400mg daily is the current standard of treatment of CP CML. Almost 70% of patients achieve complete cytogenetic response (CCR) at 12 months (mo) (IRIS Trial) and the rate of Major Molecular Response (MMR) is 40% with IM 400mg daily (TOPS Trial). On the other hand, low doses of Peg-IFN 2a has the same efficacy and lower toxicity profile and cost as high dose, mainly when it is combined with other drugs (MRC and Hovon groups, Blood 2004; 103:4408). Combination of IM + Peg-IFN 2a or Cytarabine could increase the rate of response in CML. Aims: To evaluate the rates of CCR and MMR at 12 mo in Mexican patients with newly-diagnosed CP-CML treated with IM versus IM + Peg-IFN 2a. Methods: Between 2006 and 2008, 10 patients were randomized 1:1 and stratified by Sokal and Hasford risk groups. Cytogenetic and Molecular assesments were available for all patients. In the arm A of the study IM 400 mg daily was delivered. In the Arm B IM + Peg-IFN 2a was delivered at 400 mg daily + 90 μ g per week respectively. Peg-IFN 2a was started in the 7th week of treatment (Hochhaus A, et al ASCO 2003. Abstract #2287). Results: For this initial report, 10 patients were analyzed, median age was 35 years (25-55), 50% males; Sokal score was: low risk 70%, and high risk 30%. Hasford score was: low risk 40%, intermediate 30% and high risk 30%. All patients are alive with a median follow-up of 41 mo (30-48). CCR at 12 mo was obtained in 80% in both arms of treatment. MMR was obtained in 10% in patients with IM alone and 30% in patients with IM + Peg-IFN 2a. Overall the rate of primary resistance was 10% and the rate of suboptimal response was 10%. IM 400 mg was well tolerated. Peg-IFN 2a was tolerated in most patients, but needed discontinuation because increased cytopenias or other non hematologic toxicities. The median time of duration of treatment with Peg-IFN 2a was 6 mo (3-12). Conclusions: IM 400 mg and IM 400 mg + Peg-IFN 2a obtained similar rates of CCR. IM 400 mg + Peg-IFN 2a obtained a higher rate of MMR. The combination of IM 400 mg + Peg-IFN 2a is feasible. There is a slight increase in toxicity with this combination. Further follow-up is warranted for these patients. 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: 2010
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 2
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 4452-4452
    Abstract: Abstract 4452 Background: Molecular Monitoring of BCR-ABL through standardized qPCR according to the international scale (IS) has been recently included in the follow-up of CML patients treated with tyrosine kinase inhibitors (TKIs) at the IMSS. The Molecular Biology Laboratory of the “Hospital of Specialties” at the “National Medical Center Siglo XXI”, have recently achieved full standardization of the qPCR technique to the international scale (using a conversion factor provided by Adelaide lab). The use of the IS in the molecular monitoring expressed as Bcr-Abl/Abl ratio in percentage is very important, since this is the best way to adopt appropriate strategies with TKI therapy. Objective: To report the evaluation of molecular status of 485 patients with CML attended at the Instituto Mexicano del Seguro Social using the IS in a reference standardized Mexican laboratory. Material and Methods: From August 2011 to May 2012, peripheral blood samples of 485 patients with CML, were sent to our laboratory. We extracted RNA as previously described. A minimum of 5 ml of whole blood was required in order to maximize optimal results. Then we put these results in our database and classified patient samples in five groups according the percentage of Bcr-Abl/Abl in the international scale: The first group were patients with 〉 10% of Bcr-Abl; the second group were patients with 〉 1–10% of Bcr-Abl; the third group were patients with 〉 0.1–1%; the fourth group were patients with ≤0.1% and the fifth group were patients with undetectable Bcr-Abl transcripts. Results: We found the following distribution: Group I ( 〉 10% Bcr-Abl): 91 patients (18.76%); Group II ( 〉 1–10% Bcr-Abl): 65 patients (13.4%); Group III ( 〉 0.1–1% Bcr-Abl) 83 patients (17.11%); Group IV (≤0.1% Bcr-Abl) 122 patients (25.15%); and Group V: undetectable Bcr-Abl: 124 patients (25.56%). Conclusion: Fifty percent of CML patients treated with nilotinib, imatinib or dasatinib, have reached a deep molecular response, that is, Major Molecular response (MMR) or better. Another 17% has reached a molecular response ( 〉 0.1–1%) that is equivalent to Complete Cytogenetic response (CCyR). This information is very useful for clinicians and should be interpreted individually according the lenght of treatment with TKIs, following current CML guidelines and recommendations. Until now, molecular monitoring using the IS was only possible through sending samples to US laboratories. It is important that Mexican clinicians at our institution have now the opportunity to rely on a Mexican validated and standardized laboratory. The results of the molecular response in this cohort of CML patients can be compared to the data of another countries using the IS. Classifying patients according to their molecular status could help to optimized therapies at our institution. Disclosures: Nacho-Vargas: Novartis Oncology: Employment.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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