Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML

Blood

Volumn 121, Issue 19, 2013, Pages 3818-3824

  Branford, Susan ^a,b,c   Yeung, David T ^a,b,d   Ross, David M ^b,d,e   Prime, Jodi A ^a   Field, Chani R ^a   Altamura, Haley K ^a   Yeoman, Alexandra L ^a   Georgievski, Jasmina ^a   Jamison, Bronte A ^a   Phillis, Stuart ^a   Sullivan, Brad ^a   Briggs, Nancy E ^c   Hertzberg, Mark ^f,g,h   Seymour, John F ^f,i   Reynolds, John ^j   Hughes, Timothy P ^b,d,f  

^a University of Adelaide   (Australia)

^b UNIVERSITY OF ADELAIDE   (Australia)

^c UNIVERSITY OF ADELAIDE   (Australia)

^d SA PATHOLOGY   (Australia)

^e FLINDERS UNIVERSITY   (Australia)

^f Australasian Leukaemia and Lymphoma Group   (Australia)

^g WESTMEAD HOSPITAL   (Australia)

^h UNIVERSITY OF SYDNEY   (Australia)

ⁱ UNIVERSITY OF MELBOURNE   (Australia)

^j DEAKIN UNIVERSITY   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BCR ABL PROTEIN; IMATINIB; ANTINEOPLASTIC AGENT; BENZAMIDE DERIVATIVE; PHARMACOLOGICAL BIOMARKER; PIPERAZINE DERIVATIVE; PYRIMIDINE DERIVATIVE;

ADULT; ARTICLE; BCR ABL1 GENE; CANCER REGRESSION; CHRONIC MYELOID LEUKEMIA; COHORT ANALYSIS; CORRELATION ANALYSIS; DRUG DOSE INCREASE; DRUG WITHDRAWAL; FEMALE; GENE; GENE EXPRESSION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; REGRESSION ANALYSIS; SCORING SYSTEM; SEX; SOKA RISK SCORE; STATISTICAL ANALYSIS; TREATMENT OUTCOME; TREATMENT RESPONSE; AGED; BLOOD; CHROMOSOME ANALYSIS; CLINICAL TRIAL (TOPIC); GENETICS; METABOLISM; MIDDLE AGED; MULTICENTER STUDY (TOPIC); PROGNOSIS; REMISSION; SEX DIFFERENCE; STATISTICS; TREATMENT WITHDRAWAL; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BENZAMIDES; BIOMARKERS, PHARMACOLOGICAL; CLINICAL TRIALS AS TOPIC; CYTOGENETIC ANALYSIS; FEMALE; FUSION PROTEINS, BCR-ABL; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; PIPERAZINES; PROGNOSIS; PYRIMIDINES; REMISSION INDUCTION; SEX FACTORS; WITHHOLDING TREATMENT;

MLCS; MLOWN;

EID: 84880496470     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2012-10-462291     Document Type: Article

References (47)

1. Deininger M, O'Brien SG, Guilhot F, et al. International Randomized Study of Interferon Vs STI571 (IRIS) 8-Year Follow up: Sustained Survival and Low Risk for Progression or Events in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Treated with Imatinib. In: Proceedings from the American Society of Hematology; December 5-8, 2009; New Orleans, LA. Abstract 1126.
2. Efficace F, Baccarani M, Breccia M, et al; GIMEMA. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011;118(17):4554-4560.
3. Mahon FX, Réa D, Guilhot J, et al; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010;11(11):1029-1035.
4. Ross DM, Branford S, Seymour JF, et al. Patients with chronic myeloid leukemia who maintain a complete molecular response after stopping imatinib treatment have evidence of persistent leukemia by DNA PCR. Leukemia. 2010;24(10): 1719-1724.
5. Mahon F-X, Rea D, Guilhot J, et al. Discontinuation of Imatinib in Patients with Chronic Myeloid Leukemia Who Have Maintained Complete Molecular Response: Update Results of the STIM Study. In: Proceedings of the American Society of Hematology; December 10-13, 2011; San Diego, CA. Abstract 603.
6. Ross DM, Branford S, Seymour JF, et al. Frequent and sustained drug-free remission in the Australian CML8 trial of imatinib withdrawal. [abstract 0189] Haematologica. 2012;97(suppl 1): 74.
7. Goh HG, Kim YJ, Kim DW, et al. Previous best responses can be re-achieved by resumption after imatinib discontinuation in patients with chronic myeloid leukemia: implication for intermittent imatinib therapy. Leuk Lymphoma. 2009;50(6): 944-951.
8. Kuwabara A, Babb A, Ibrahim A, et al. Poor outcome after reintroduction of imatinib in patients with chronic myeloid leukemia who interrupt therapy on account of pregnancy without having achieved an optimal response. Blood. 2010; 116(6):1014-1016.
9. Branford S, Seymour JF, Grigg A, et al. BCR-ABL messenger RNA levels continue to decline in patients with chronic phase chronic myeloid leukemia treated with imatinib for more than 5 years and approximately half of all first-line treated patients have stable undetectable BCRABL using strict sensitivity criteria. Clin Cancer Res. 2007;13(23):7080-7085.
10. Branford S, Rudzki Z, Harper A, et al. Imatinib produces significantly superior molecular responses compared to interferon alfa plus cytarabine in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Leukemia. 2003;17(12):2401-2409.
11. Cortes JE, Baccarani M, Guilhot F, et al. Phase III, randomized, open-label study of daily imatinib mesylate 400 mg versus 800 mg in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase using molecular end points: tyrosine kinase inhibitor optimization and selectivity study. J Clin Oncol. 2010;28(3):424-430.
12. Hughes TP, Branford S, White DL, et al; Australasian Leukaemia and Lymphoma Group. Impact of early dose intensity on cytogenetic and molecular responses in chronic-phase CML patients receiving 600 mg/day of imatinib as initial therapy. Blood. 2008;112(10):3965-3973.
13. Yeung DT, Osborn M, White DL, et al. Selective Escalation of Imatinib Therapy and Early Switching to Nilotinib In De Novo Chronic Phase CML Patients: Interim Results From the TIDEL-II Trial. In: Proceedings of the American Society of Hematology; December 10-13, 2011; San Diego, CA. Abstract 209.
14. Branford S, Hughes TP, Rudzki Z. Monitoring chronic myeloid leukaemia therapy by real-time quantitative PCR in blood is a reliable alternative to bone marrow cytogenetics. Br J Haematol. 1999;107(3):587-599.
15. Hughes TP, Kaeda J, Branford S, et al; International Randomised Study of Interferon versus STI571 (IRIS) Study Group. Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2003; 349(15):1423-1432.
16. Pfirrmann M, Hochhaus A, Lauseker M, Saussele S, Hehlmann R, Hasford J. Recommendations to meet statistical challenges arising from endpoints beyond overall survival in clinical trials on chronic myeloid leukemia. Leukemia. 2011;25(9): 1433-1438.
17. Guilhot J, Baccarani M, Clark RE, et al. Definitions, methodological and statistical issues for phase 3 clinical trials in chronic myeloid leukemia: a proposal by the European LeukemiaNet. Blood. 2012;119(25):5963-5971.
18. Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16(3):1141-1154.
19. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94(446):496-509.
20. Wang L, Pearson K, Ferguson JE, Clark RE. The early molecular response to imatinib predicts cytogenetic and clinical outcome in chronic myeloid leukaemia. Br J Haematol. 2003;120(6): 990-999.
21. Hughes TP, Hochhaus A, Branford S, et al; IRIS investigators. Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood. 2010; 116(19):3758-3765.
22. Marin D, Ibrahim AR, Lucas C, et al. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. J Clin Oncol. 2012; 30(3):232-238.
23. Hanfstein B, Müller MC, Hehlmann R, et al; SAKK; German CML Study Group. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia. 2012;26(9):2096-2102.
24. Marin D, Hedgley C, Clark RE, et al. Predictive value of early molecular response in patients with chronic myeloid leukemia treated with first-line dasatinib. Blood. 2012;120(2):291-294.
25. Branford S, Kim D-W, Soverini S, et al. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or-intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012;30(35):4323-4329.
26. Marin D, Bazeos A, Mahon F-X, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010;28(14): 2381-2388.
27. Noens L, van Lierde MA, De Bock R, et al. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 2009;113(22):5401-5411.
28. Darkow T, Henk HJ, Thomas SK, et al. Treatment interruptions and non-adherence with imatinib and associated healthcare costs: a retrospective analysis among managed care patients with chronic myelogenous leukaemia. Pharmacoeconomics. 2007;25(6):481-496.
29. Larson RA, Druker BJ, Guilhot F, et al; IRIS (International Randomized Interferon vs STI571) Study Group. Imatinib pharmacokinetics and its correlation with response and safety in chronicphase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008;111(8):4022-4028.
30. Guilhot F, Hughes TP, Cortes J, et al. Plasma exposure of imatinib and its correlation with clinical response in the Tyrosine Kinase Inhibitor Optimization and Selectivity Trial. Haematologica. 2012;97(5):731-738
31. Chen CI, Maecker HT, Lee PP. Development and dynamics of robust T-cell responses to CML under imatinib treatment. Blood. 2008;111(11): 5342-5349.
32. Wodarz D. Heterogeneity in chronic myeloid leukaemia dynamics during imatinib treatment: role of immune responses. Proc Biol Sci. 2010; 277(1689):1875-1880.
33. Catovsky D, Fooks J, Richards S; MRC Working Party on Leukaemia in Adults. Prognostic factors in chronic lymphocytic leukaemia: the importance of age, sex and response to treatment in survival. A report from the MRC CLL 1 trial. Br J Haematol. 1989;72(2):141-149.
34. Jeremic B, Milicic B, Dagovic A, Aleksandrovic J, Nikolic N. Pretreatment clinical prognostic factors in patients with stage IV non-small cell lung cancer (NSCLC) treated with chemotherapy. J Cancer Res Clin Oncol. 2003;129(2):114-122.
35. Gündüz K, Günalp I, Yalç inda?g N, et al. Causes of chemoreduction failure in retinoblastoma and analysis of associated factors leading to eventual treatment with external beam radiotherapy and enucleation. Ophthalmology. 2004;111(10): 1917-1924.
36. Puchner MJ, Herrmann HD, Berger J, Cristante L. Surgery, tamoxifen, carboplatin, and radiotherapy in the treatment of newly diagnosed glioblastoma patients. J Neurooncol. 2000;49(2):147-155.
37. Ganjoo KN, Wakelee H. Review of erlotinib in the treatment of advanced non-small cell lung cancer. Biologics. 2007;1(4):335-346.
38. Michor F, Hughes TP, Iwasa Y, et al. Dynamics of chronic myeloid leukaemia. Nature. 2005; 435(7046):1267-1270.
39. Roeder I, Horn M, Glauche I, Hochhaus A, Mueller MC, Loeffler M. Dynamic modeling of imatinib-treated chronic myeloid leukemia: functional insights and clinical implications. Nat Med. 2006;12(10):1181-1184.
40. Stein AM, Bottino D, Modur V, et al. BCR-ABL transcript dynamics support the hypothesis that leukemic stem cells are reduced during imatinib treatment. Clin Cancer Res. 2011;17(21): 6812-6821.
41. Tang M, Gonen M, Quintas-Cardama A, et al. Dynamics of chronic myeloid leukemia response to long-term targeted therapy reveal treatment effects on leukemic stem cells. Blood. 2011; 118(6):1622-1631.
42. Yhim H-Y, Lee N-R, Song E-K, et al. Imatinib mesylate discontinuation in patients with chronic myeloid leukemia who have received front-line imatinib mesylate therapy and achieved complete molecular response. Leuk Res. 2012;36(6): 689-693.
43. Lee SE, Choi SY, Bang JH, et al. BCR-ABL kinetics after discontinuation of imatinib in CML patients with MR 4.5 or undetectable molecular residual disease. [abstract 0200] Haematologica. 2012;97(suppl 1):80.
44. Cross NCP, White HE, Müller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012;26(10):2172-2175.
45. Kantarjian HM, Hochhaus A, Saglio G, et al. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011;12(9):841-851.
46. Kantarjian HM, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly diagnosed chronicphase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119(5):1123-1129.
47. Rea D, Rousselot P, Nicolini FE, et al. Discontinuation of Dasatinib or Nilotinib in Chronic Myeloid Leukemia (CML) Patients (pts) with Stable Undetectable Bcr-Abl Transcripts: Results From the French CML Group (FILMC). In: Proceedings of the American Society of Hematology; December 10-13, 2011; San Diego, CA. Abstract 604.