Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib

Haematologica

Volumn 95, Issue 2, 2010, Pages 232-240

  Shah, Neil P ^a   Kim, Dong Wook ^b   Kantarjian, Hagop ^c   Rousselot, Philippe ^d   Llacer, Pedro Enrique Dorlhiac ^e   Enrico, Alicia ^f   Vela Ojeda, Jorge ^g   Silver, Richard T ^h   Khoury, Hanna Jean ⁱ   Müller, Martin C ^j   Lambert, Alexandre ^k   Matloub, Yousif ^k   Hochhaus, Andreas ^l  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b The Catholic University of Korea   (South Korea)

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

^d SAINT LOUIS HOSPITAL   (France)

^e UNIVERSITY OF SÃO PAULO   (Brazil)

^f Instituto de Trasplante de Medula Osea   (Argentina)

^g INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^h NEW YORK PRESBYTERIAN HOSPITAL   (United States)

ⁱ EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j UNIVERSITY OF HEIDELBERG   (Germany)

^k BRISTOL MYERS SQUIBB   (United States)

^l JENA UNIVERSITY HOSPITAL   (Germany)

more..

Author keywords

Chronic myeloid leukemia; Chronic phase; Cytogenetic response; Dasatinib; Inhibition

Indexed keywords

BCR ABL PROTEIN; DASATINIB; IMATINIB;

ARTICLE; CANCER SURVIVAL; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; CYTOPENIA; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FLUID RETENTION; HUMAN; MAJOR CLINICAL STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; PHILADELPHIA CHROMOSOME NEGATIVE CELL; PLEURA EFFUSION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT RESPONSE;

CYTOGENETIC ANALYSIS; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE; FOLLOW-UP STUDIES; FUSION PROTEINS, BCR-ABL; HUMANS; LEUKEMIA, MYELOID, CHRONIC-PHASE; PIPERAZINES; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; PYRIMIDINES; THIAZOLES;

EID: 76549116248     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2009.011452     Document Type: Article

References (33)

1. Schiffer CA. BCR-ABL tyrosine kinase inhibitors for chronic myelogenous leukemia. N Engl J Med. 2007;357(3):258-65.
2. Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, L, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001; 344(14):1031-7.
3. GLEEVEC (imatinib mesylate) tablets. Imatinib prescribing information. East Hanover, New Jersey, Novartis Pharmaceuticals Corporation, Revised November. 2007.
4. Peng B, Hayes M, Resta D, Racine-Poon A, Druker BJ, Talpaz M, et al. Pharmacokinetics and pharmacodynamics of imatinib in a phase I trial with chronic myeloid leukemia patients. J Clin Oncol. 2004;22(5):935-42.
5. Peng B, Capdeville R. In Reply. J Clin Oncol. 2005;23:3857-8.
6. Lu JF, Eppler SM, Wolf J, Hamilton M, Rakhit A, Bruno R, et al. Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Clin Pharmacol Ther. 2006;80(2):136-45.
7. Motzer RJ, Hoosen S, Bello CL, Christensen JG. Sunitinib malate for the treatment of solid tumours: a review of current clinical data. Expert Opin Investig Drugs. 2006;15(5):553-61.
8. Ranson M, Hammond LA, Ferry D, Kris M, Tullo A, Murray PI, et al. ZD1839, a selective oral epidermal growth factor receptortyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial. J Clin Oncol. 2002;20(9):2240-50.
9. Strumberg D, Clark JW, Awada A, Moore MJ, Richly H, Hendlisz A, et al. Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: a review of four phase I trials in patients with advanced refractory solid tumors. Oncologist. 2007; 12(4):426-37.
10. SPRYCEL (dasatinib). Dasatinib prescribing information. New York, NY, Bristol-Myers Squibb, Revised November. 2007.
11. Shah NP, Kasap C, Weier C, Balbas M, Nicoll JM, Bleickardt E, et al. Transient potent BCR-ABL inhibition is sufficient to commit chronic myeloid leukemia cells irreversibly to apoptosis. Cancer Cell. 2008;14(6):485-93.
12. Shah NP, Kantarjian HM, Kim DW, Réa D, Dorlhiac-Llacer PE, Milone JH, et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008; 26(19):3204-12.
13. Brave M, Goodman V, Kaminskas E Farrell A, Timmer W, Pope S, et al. Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate. Clin Cancer Res. 2008; 14(2):352-9.
14. Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, et al. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinibresistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007;109(8): 3207-13.
15. Guilhot F, Apperley J, Kim DW, Bullorsky EO, Baccarani M, Roboz GJ, et al. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007;109(10):4143-50.
16. Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, et al. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007;109(6):2303-9.
17. Druker BJ, Guilhot F, O'Brien SG, Gathmann I, Kantarjian H, Gattermann N, et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006;355(23):2408-17.
18. Baccarani M, Saglio G, Goldman J, Hochhaus A, Simonsson B, Appelbaum F, F, 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(6):1809-20.
19. Kantarjian HM, Smith TL, O'Brien S, Beran M, Pierce S, Talpaz M. Prolonged survival in chronic myelogenous leukemia after cytogenetic response to interferon-alpha therapy. The Leukemia Service. Ann Intern Med. 1995;122(4):254-61.
20. Kloke O, Niederle N, Opalka B, Hawig I, Seeber S, Becher R. Prognostic impact of interferon alpha-induced cytogenetic remission in chronic myelogenous leukaemia: long-term follow-up. Eur J Haematol. 1996; 56(1-2):78-81.
21. Mahon FX, Fabères C, Pueyo S, Cony-Makhoul P, Salmi R, Boiron JM, et al. Response at three months is a good predictive factor for newly diagnosed chronic myeloid leukemia patients treated by recombinant interferon-alpha. Blood. 1998; 92(11):4059-65.
22. Tasigna (nilotinib). Nilotinib prescribing information. East Hanover, Novartis Pharmaceuticals Corporation, Revised October. 2007.
23. Tam CS, Kantarjian H, Garcia-Manero G, Borthakur G, O'Brien S, Ravandi F, et al. Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia. Blood. 2008;112(3):516-8.
24. Hughes T, Deininger M, Hochhaus A, Branford S, Radich J, Kaeda J, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood. 2006;108(1):28-37.
25. Hughes TP, Kaeda J, Branford S, Rudzki Z, Hochhaus A, Hensley ML, et al. 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):1423-32.
26. Shah NP, Tran C, Lee FY, Chen P, Norris D, Sawyers CL. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science. 2004;305(5682):399-401.
27. Mauro MJ, Baccarani M, Cervantes F, Lipton JH, Matloub Y, Sinha R, et al. Dasatinib 2-year efficacy in patients with chronic-phase chronic myelogenous leukemia (CML-CP) with resistance or intolerance to imatinib (START-C). J Clin Oncol. 2008;26:374s[Abstract].
28. Rousselot PH, Facon T, Paquette R, et al. Dasatinib or high-dose imatinib for patients with chronic myelogenous leukemia chronic-phase (CML-CP) resistant to standard-dose imatinib: 2-year follow-up data from START-R. J Clin Oncol 2008;26:375s[Abstract].
29. Wang X, Hochhaus A, Kantarjian HM, et al. Dasatinib pharmacokinetics and exposureresponse (E-R): relationship to safety and efficacy in patients (pts) with chronic myeloid leukemia (CML). J Clin Oncol. 2008;26:175s[Abstract].
30. Lombardo LJ, Lee FY, Chen P, Norris D, Barrish JC, Behnia K, et al. Discovery of N-(2-chloro-6-methyl-phenyl)-2-(6-(4-(2-hydroxyethyl)- piperazin-1-yl)-2-methylpyrimidin-4-ylamino) thiazole-5-carboxamide (BMS-354825), a dual Src/Abl kinase inhibitor with potent antitumor activity in preclinical assays. J Med Chem. 2004; 47(27):6658-61.
31. Quintas-Cardama A, Kantarjian H, O'brien S, Borthakur G, Bruzzi J, Munden R, et al. Pleural effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol. 2007;25(25):3908-14.
32. Gorre ME, Mohammed M, Ellwood K, Hsu N, Paquette R, Rao PN, et al. Clinical resistance to STI-571 cancer therapy caused by BCR-ABL gene mutation or amplification. Science. 2001;293(5531):876-80.
33. le Coutre P, Tassi E, Varella-Garcia M, Barni