Long-term efficacy and safety of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors

American Journal of Hematology

Volumn 90, Issue 9, 2015, Pages 755-768

  Gambacorti Passerini, Carlo ^a   Kantarjian, Hagop M ^b   Kim, Dong Wook ^c   Khoury, Hanna J ^d   Turkina, Anna G ^e   Brümmendorf, Tim H ^f,g   Matczak, Ewa ^h   Bardy Bouxin, Nathalie ^h   Shapiro, Mark ^h   Turnbull, Kathleen ^h   Leip, Eric ^h   Cortes, Jorge E ^b  

^a UNIVERSITY OF MILANO BICOCCA   (Italy)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c The Catholic University of Korea   (South Korea)

^d EMORY UNIVERSITY   (United States)

^e NATIONAL RESEARCH CENTER FOR HEMATOLOGY   (Russian Federation)

^f UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^g UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^h PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BOSUTINIB; CREATININE; DASATINIB; IMATINIB; NILOTINIB; PROTEIN TYROSINE KINASE INHIBITOR; ANILINE DERIVATIVE; ANTINEOPLASTIC AGENT; BENZAMIDE DERIVATIVE; NITRILE; PIPERAZINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE; QUINOLINE DERIVATIVE;

ABDOMINAL PAIN; ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; BONE PAIN; BRAIN HEMORRHAGE; BRAIN INFARCTION; BRAIN ISCHEMIA; CANCER PATIENT; CANCER RESISTANCE; CEREBROVASCULAR ACCIDENT; CHILL; CHRONIC MYELOID LEUKEMIA; CONSTIPATION; COUGHING; CYTOGENETICS; DECREASED APPETITE; DIARRHEA; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; EDEMA; ELEVATED BLOOD PRESSURE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMATOMA; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; INSOMNIA; KAPLAN MEIER METHOD; LEUKOCYTOSIS; LEUKOPENIA; LIMB PAIN; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUTROPENIA; OCCLUSIVE CEREBROVASCULAR DISEASE; OROPHARYNX PAIN; PERIPHERAL EDEMA; PETECHIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; RASH; RAYNAUD PHENOMENON; RESPIRATORY FAILURE; SIDE EFFECT; SUBARACHNOID HEMORRHAGE; THORAX PAIN; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VOMITING; ADOLESCENT; BLAST CRISIS; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG RESISTANCE; FOLLOW UP; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; SURVIVAL; VERY ELDERLY;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANILINE COMPOUNDS; ANTINEOPLASTIC AGENTS; BENZAMIDES; BLAST CRISIS; DIARRHEA; DRUG RESISTANCE, NEOPLASM; FEMALE; FEVER; FOLLOW-UP STUDIES; HUMANS; IMATINIB MESYLATE; MALE; MIDDLE AGED; NITRILES; PIPERAZINES; PNEUMONIA; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROTEIN KINASE INHIBITORS; PYRIMIDINES; QUINOLINES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84939565243     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.24034     Document Type: Article

References (41)

1. Faderl S, Talpaz M, Estrov Z, et al. Chronic myelogenous leukemia: Biology and therapy. Ann Intern Med 1999;131:207-219.
2. Kantarjian HM, Dixon D, Keating MJ, et al. Characteristics of accelerated disease in chronic myelogenous leukemia. Cancer 1988;61:1441-1446.
3. Cortes J, Kantarjian H. Advanced-phase chronic myeloid leukemia. Semin Hematol 2003;40:79-86.
4. Kantarjian HM, Talpaz M, O'Brien S, et al. Survival benefit with imatinib mesylate versus interferon-alpha-based regimens in newly diagnosed chronic-phase chronic myelogenous leukemia. Blood 2006;108:1835-1840.
5. Kantarjian H, Talpaz M, O'Brien S, et al. Survival benefit with imatinib mesylate therapy in patients with accelerated-phase chronic myelogenous leukemia-comparison with historic experience. Cancer 2005;103:2099-2108.
6. Sawyers CL, Hochhaus A, Feldman E, et al. Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: Results of a phase II study. Blood 2002;99:3530-3539.
7. Kantarjian HM, Cortes J, O'Brien S, et al. Imatinib mesylate (sti571) therapy for Philadelphia chromosome-positive chronic myelogenous leukemia in blast phase. Blood 2002;99:3547-3553.
8. Saglio G, Hochhaus A, Goh YT, et al. Dasatinib in imatinib-resistant or imatinib-intolerant chronic myeloid leukemia in blast phase after 2 years of follow-up in a phase 3 study: Efficacy and tolerability of 140 milligrams once daily and 70 milligrams twice daily. Cancer 2010;116:3852-3861.
9. Kurzrock R, Kantarjian HM, Druker BJ, et al. Philadelphia chromosome-positive leukemias: From basic mechanisms to molecular therapeutics. Ann Intern Med 2003;138:819-830.
10. Kantarjian HM, Giles F, Gattermann N, et al. Nilotinib (formerly amn107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood 2007;110:3540-3546.
11. Hochhaus A, Baccarani M, Deininger M, et al. Dasatinib induces durable cytogenetic responses in patients with chronic myelogenous leukemia in chronic phase with resistance or intolerance to imatinib. Leukemia 2008;22:1200-1206.
12. de Lavallade H, Apperley JF, Khorashad JS, et al. Imatinib for newly diagnosed patients with chronic myeloid leukemia: Incidence of sustained responses in an intention-to-treat analysis. J Clin Oncol 2008;26:3358-3363.
13. Apperley JF, Cortes JE, Kim DW, et al. Dasatinib in the treatment of chronic myeloid leukemia in accelerated phase after imatinib failure: The START a trial. J Clin Oncol 2009;27:3472-3479.
14. Kantarjian H, Cortes J, Kim DW, et al. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-Month median follow-up. Blood 2009;113:6322-6329.
15. le Coutre P, Ottmann OG, Giles F, et al. Nilotinib (formerly amn107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia. Blood 2008;111:1834-1839.
16. Lee S, Kim YJ, Min CK, et al. The effect of first-line imatinib interim therapy on the outcome of allogeneic stem cell transplantation in adults with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia. Blood 2005;105:3449-3457.
17. Ravandi F, O'Brien S, Thomas D, et al. First report of phase 2 study of dasatinib with hyper-CVAD for the frontline treatment of patients with philadelphia chromosome-positive (ph+) acute lymphoblastic leukemia. Blood 2010;116:2070-2077.
18. Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013;122:872-884.
19. Jain P, Kantarjian H, Cortes J. Chronic myeloid leukemia: Overview of new agents and comparative analysis. Curr Treat Options Oncol 2013;14:127-143.
20. Liu-Dumlao T, Kantarjian H, Thomas DA, et al. Philadelphia-positive acute lymphoblastic leukemia: Current treatment options. Curr Oncol Rep 2012;14:387-394.
21. NCCN Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia. Version 3. 2013. Fort Washington, PA: National Comprehensive Cancer Network.
22. NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia. Version 2.2014. Fort Washington, PA. National Comprehensive Cancer Network.
23. Bosulif: EPAR Product Information. London, United Kingdom: European Medicines Agency.
24. ®. New York, NY: Pfizer Inc.; 2014.
25. Cortes JE, Kantarjian HM, Brummendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood 2011;118:4567-4576.
26. Gambacorti-Passerini C, Brummendorf TH, Kim DW, et al. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up. Am J Hematol 2014;89:732-742.
27. Kantarjian HM, Cortes JE, Kim DW, et al. Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors. Blood 2014;123:1309-1318.
28. Khoury HJ, Cortes JE, Kantarjian HM, et al. Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood 2012;119:3403-3412.
29. Baccarani M, Saglio G, Goldman J, et al. Evolving concepts in the management of chronic myeloid leukemia: Recommendations from an expert panel on behalf of the European LeukemiaNet. Blood 2006;108:1809-1820.
30. Cortes J, Rousselot P, Kim DW, et al. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood 2007;109:3207-3213.
31. le Coutre PD, Giles FJ, Hochhaus A, et al. Nilotinib in patients with ph+ chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results. Leukemia 2012;26:1189-1194.
32. Cortes J, Kim DW, Raffoux E, et al. Efficacy and safety of dasatinib in imatinib-resistant or -intolerant patients with chronic myeloid leukemia in blast phase. Leukemia 2008;22:2176-2183.
33. Redaelli S, Piazza R, Rostagno R, et al. Activity of bosutinib, dasatinib, and nilotinib against 18 imatinib-resistant BCR/ABL mutants. J Clin Oncol 2009;27:469-471.
34. Redaelli S, Mologni L, Rostagno R, et al. Three novel patient-derived BCR/ABL mutants show different sensitivity to second and third generation tyrosine kinase inhibitors. Am J Hematol 2012;87:E125-E128.
35. Soverini S, Colarossi S, Gnani A, et al. Resistance to dasatinib in Philadelphia-positive leukemia patients and the presence or the selection of mutations at residues 315 and 317 in the BCR-ABL kinase domain. Haematologica 2007;92:401-404.
36. Deininger MW, O'Brien SG, Ford JM, et al. Practical management of patients with chronic myeloid leukemia receiving imatinib. J Clin Oncol 2003;21:1637-1647.
37. Sneed TB, Kantarjian HM, Talpaz M, et al. The significance of myelosuppression during therapy with imatinib mesylate in patients with chronic myelogenous leukemia in chronic phase. Cancer 2004;100:116-121.
38. Singer JB, Shou Y, Giles F, et al. UGT1A1 promoter polymorphism increases risk of nilotinib-induced hyperbilirubinemia. Leukemia 2007;21:2311-2315.
39. Szczepanski T. Why and how to quantify minimal residual disease in acute lymphoblastic leukemia? Leukemia 2007;21:622-626.
40. Liu-Dumlao T, Kantarjian H, Thomas DA, et al. Philadelphia-positive acute lymphoblastic leukemia: Current treatment options. Curr Oncol Rep 2012;14:387-394.
41. Shimoni A, Leiba M, Schleuning M, et al. Prior treatment with the tyrosine kinase inhibitors dasatinib and nilotinib allows stem cell transplantation (SCT) in a less advanced disease phase and does not increase SCT toxicity in patients with chronic myelogenous leukemia and philadelphia positive acute lymphoblastic leukemia. Leukemia 2009;23:190-194.