Imatinib discontinuation in chronic myeloid leukaemia patients with undetectable BCR-ABL transcript level: A systematic review and a meta-analysis

European Journal of Cancer

Volumn 77, Issue , 2017, Pages 48-56

  Campiotti, Leonardo ^a   Suter, Matteo Basilio ^b   Guasti, Luigina ^a   Piazza, Rocco ^c   Gambacorti Passerini, Carlo ^c   Grandi, Anna Maria ^a   Squizzato, Alessandro ^a  

^a UNIVERSITY OF INSUBRIA   (Italy)

^b OSPEDALE DI CIRCOLO   (Italy)

^c SAN GERARDO HOSPITAL   (Italy)

Author keywords

Chronic myeloid leukaemia; Discontinuation; Imatinib; Review; Tyrosine kinase inhibitors

Indexed keywords

BCR ABL PROTEIN; IMATINIB; INTERFERON; ANTINEOPLASTIC AGENT;

CHRONIC MYELOID LEUKEMIA; DRUG SAFETY; DRUG WITHDRAWAL; EMBASE; FOLLOW UP; HUMAN; LEUKEMIA RELAPSE; MEDLINE; META ANALYSIS; PRIORITY JOURNAL; RECURRENCE RISK; REVIEW; RISK FACTOR; SIDE EFFECT; SYSTEMATIC REVIEW; AGED; DRUG SUBSTITUTION; FEASIBILITY STUDY; FEMALE; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MALE; MIDDLE AGED; REMISSION; TUMOR RECURRENCE;

AGED; ANTINEOPLASTIC AGENTS; DRUG SUBSTITUTION; FEASIBILITY STUDIES; FEMALE; HUMANS; IMATINIB MESYLATE; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; REMISSION INDUCTION;

EID: 85016455652     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2017.02.028     Document Type: Review

References (46)

1. [1] National Comprehensive Cancer Network, Chronic myelogenous leukemia. 2015, NCCN Clinical Practice Guidelines in Oncology.
2. [2] Baccarani, M., Deininger, M.V., Rosti, G., Hochhaus, A., Soverini, S., Apperley, J.F., et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia. Blood 122 (2013), 872–884.
3. [3] Talpaz, M., Silver, R.T., Druker, B.J., Goldman, J.M., Gambacorti-Passerini, C., Guilhot, F., et al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study. Blood 99 (2002), 1928–1937.
4. [4] Saglio, G., Kim, D.W., Issaragrisil, S., le Coutre, P., Etienne, G., Lobo, C., et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 362 (2010), 2251–2259.
5. [5] Kantarjian, H.M., Shah, N.P., Cortes, J.E., Baccarani, M., Agarwal, M.B., Undurraga, M.S., et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood 119 (2012), 1123–1129.
6. [6] Gambacorti-Passerini, C., Antolini, L., Mahon, F.X., Guilhot, F., Deininger, M., Fava, C., et al. Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib. J Natl Cancer Inst 103 (2011), 553–561.
7. [7] Phillips, K.M., Pinilla-Ibarz, J., Sotomayor, E., Lee, M.R., Jim, H.S., Small, B.L., et al. Quality of life outcome in patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors: a controlled comparison. Support Care Cancer 21:4 (2013), 1097–1103.
8. [8] Noens, L., van Lierde, M.A., De Bock, R., Verhoef, G., Zachée, P., Berneman, Z., et al. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood 113 (2009), 5401–5411.
9. [9] Experts in Chronic Myeloid Leukemia, Price of drugs for chronic myeloid leukemia (CML), reflections on the unsustainable cancer drug prices: perspective of CML experts. Blood 121:22 (2013), 4439–4442.
10. [10] Mahon, F.X., Discontinuation of tyrosine kinase therapy in CML. Ann Hematol 94 (2015), S187–S193.
11. [11] Moher, D., Liberati, A., Tetzlaff, J., Altman, D.G., Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 151 (2009), 264–269.
12. [12] Stroup, D.F., Berlin, J.A., Morton, S.C., Olkin, I., Williamson, G.D., Rennie, D., et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 283 (2000), 2008–2012.
13. [13] Bland, J.M., Kerry, S.M., Statistics notes. Weighted comparison of means. Br Med J, 316, 1998, 129.
14. [14] Mantel, N., Haenszel, W., Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 22 (1959), 719–748.
15. [15] Higgins, J.P., Thompson, S.G., Deeks, J.J., Altman, D.G., Measuring inconsistency in meta-analyses. Br Med J 327 (2003), 557–560.
16. [16] Sterne, J.A., Egger, M., Smith, G.D., Systematic reviews in health care: investigating and dealing with publication and other biases in meta-analysis. Br Med J 323 (2001), 101–105.
17. [17] Mahon, F.X., Réa, D., Guilhot, J., Guilhot, F., Huquet, F., Nicolini, F., et al. 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 11 (2010), 1029–1035.
18. [18] Koskenvesa, P., Kreutzman, A., Rohon, P., Pihlman, M., Vakkila, E., Räsänen, A., et al. Imatinib and pegylated IFN-α2b discontinuation in first-line chronic myeloid leukemia patients following a major molecular response. Eur J Haematol 92:5 (2014), 413–420.
19. [19] Rousselot, P., Charbonnier, A., Cony-Makhoul, P., Agape, P., Nicolini, F.E., Varet, B., et al. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol 32:5 (2014), 424–430.
20. [20] Benjamini, O., Kantarjian, H., Rios, M.B., Jabbour, E., O'Brien, S., Jain, P., et al. Patient-driven discontinuation of tyrosine kinase inhibitors: single institution experience. Leuk Lymphoma, 55(12), 2014 287–286.
21. [21] Thielen, N., van der Holt, B., Cornelissen, J.J., Verhoef, G.E., Giussinklo, T., Biemond, B.J., et al. Imatinib discontinuation in chronic phase myeloid leukaemia patients in sustained complete molecular response: a randomised trial of the Dutch-Belgian Cooperative Trial for Haemato-Oncology (HOVON). Eur J Cancer 49:15 (2013), 3242–3246.
22. [22] Lee, S.E., Choi, S.Y., Bang, J.H., Kim, S.H., Jang, E.J., Byeun, J.Y., et al. Predictive factors for successful imatinib cessation in chronic myeloid leukemia patients treated with imatinib. Am J Hematol 88:6 (2013), 449–454.
23. [23] Takahashi, N., Kyo, T., Maeda, Y., Sugihara, T., Usuki, K., Kawaguchi, K., et al. Discontinuation of imatinib in Japanese patients with chronic myeloid leukemia. Haematologica 97:6 (2012), 903–906.
24. [24] Hardan, I., Stanevsky, A., Volchek, Y., Tohami, T., Amariglio, N., Trakhtenbrot, L., et al. Treatment with interferon alpha prior to discontinuation of imatinib in patients with chronic myeloid leukemia. Cytokine 57:2 (2012), 290–293.
25. [25] Ross, D.M., Branford, S., Seymour, J.F., Schwarer, A.P., Arthur, C., Bartley, P.A., 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 24:10 (2010), 1719–1724.
26. [26] Burchert, A., Müller, M.C., Kostrewa, P., Erben, P., Bostel, T., Liebler, S., et al. Sustained molecular response with interferon alfa maintenance after induction therapy with imatinib plus interferon alfa in patients with chronic myeloid leukemia. J Clin Oncol 28:8 (2010), 1429–1435.
27. [27] Yhim, H.Y., Lee, N.R., Song, E.K., Yim, C.Y., Jeon, S.Y., Shin, S., 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 36 (2012), 689–693.
28. [28] Legros, L., Rousselot, P., Giraudier, S., Tulliez, M., Huguet, F., Nicolini, F.E., et al. Second attempt to discontinue imatinib in CP-CML patients with a second sustained complete molecular response. Blood 120:9 (2012), 1959–1960.
29. [29] Giona, F., Putti, M.C., Micalizzi, C., Menna, G., Moleti, M.L., Santoro, N., et al. Long term results of high dose imatinib in children and adolescence with chronic myeloid leukaemia in chronic phase: the Italian experience. Br J Haematol 170:3 (2015), 398–407.
30. [30] Rousselot, P., Huguet, F., Rea, D., Legros, L., Cayuela, J.M., Maarek, O., et al. Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years. Blood 109 (2007), 58–60.
31. [31] Mori, S., Vagge, E., le Coutre, P., Abruzzese, E., Martino, B., Pungolino, E., et al. Age and dPCR can predict relapse in CML patients who discontinued imatinib: the ISAV trial. Am J Hematol 90:10 (2015), 910–914.
32. [32] Ross, D.M., Branford, S., Seymour, J.F., Schwarer, A.P., Arthur, C., Yeung, D.T., et al. Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study. Blood 122:4 (2013), 515–522.
33. [33] Hehlmann, R., Müller, M.C., Lauseker, M., Hanfstein, B., Fabarius, A., Schreiber, A., et al. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. J Clin Oncol 32 (2014), 415–423.
34. [34] Tang, M., Foo, J., Gonen, J., Guilhot, J., Mahon, F.X., Michor, F., Selection pressure exerted by imatinib therapy leads to disparate outcomes of imatinib discontinuation trials. Haematologica 97:10 (2012), 1553–1561.
35. [35] Gallipoli, P., Abraham, S.A., Holyoake, T.L., Hurdles toward a cure for CML: the CML stem cell. Hematol Oncol Clin N Am 25 (2011), 951–966.
36. [36] Rea, D., Rousselot, P., Guilhot, J., Guilhot, F., Mahon, F.X., Curing chronic myeloid leukemia. Curr Hematol Malignancy Rep 7 (2012), 103–108.
37. [37] Chen, Y., Peng, C., Sullivan, C., Dongguan, L., Shaoguang, L., Novel therapeutic agents against cancer stem cell of chronic myeloid leukemia. Anti Cancer Agents Med Chem 10 (2011), 111–115.
38. [38] Bonifazi, F., De Vivo, A., Rosti, G., Tiribelli, M., Russo, D., Trabacchi, E., et al. Testing Sokal's and the new prognostic score for chronic myeloid leukaemia treated with alpha-interferon. Italian Cooperative Study Group on Chronic Myeloid Leukaemia. Br J Haematol 111 (2000), 587–595.
39. [39] Pfirrmann, M., Baccarani, M., Saussele, S., Guilhot, J., Cervantes, F., Ossenkoppele, G., et al. Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia. Leukemia 30 (2016), 48–56.
40. [40] Hoffmann, V.S., Baccarani, M., Lindoerfer, D., Castagnetti, F., Turkina, A., Zaritsky, A., et al. The EUTOS prognostic score: review and validation in 1288 patients with CML treated frontline with imatinib. Leukemia 27 (2013), 2016–2022.
41. [41] Hoffmann, V.S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., et al. The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries. Leukemia 29 (2015), 1336–1343.
42. [42] Müller, M.C., Cross, N.C., Erben, P., Harmonization of molecular monitoring of CML therapy in Europe. Leukemia 23 (2009), 1957–1963.
43. [43] Treatment-free remission accomplished with dasatinib in patients with CML (TRAD), NCT02268370. https://clinicaltrials.gov/ct2/show/NCT02268370.
44. [44] Nilotinib treatment-free remission study in CML patients (ENESTFreedom), NCT01784068. https://clinicaltrials.gov/ct2/show/NCT01784068.
45. [45] Treatment-free remission after sustained MR4.5 on nilotinib (ENESTop), NCT01698905. https://clinicaltrials.gov/ct2/show/NCT01698905.
46. [46] Sustained treatment-free remission in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing nilotinib versus imatinib with switch to nilotinib in absence of optimal response. NCT02602314. https://clinicaltrials.gov/ct2/show/NCT02602314.