Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia

International Journal of Hematology

Volumn 89, Issue 3, 2009, Pages 332-341

  Sakamaki, Hisashi ^a   Ishizawa, Ken Ichi ^b   Taniwaki, Masafumi ^c   Fujisawa, Shin ^d   Morishima, Yasuo ^e   Tobinai, Kensei ^f   Okada, Masaya ^g   Ando, Kiyoshi ^h   Usui, Noriko ⁱ   Miyawaki, Shuichi ^j   Utsunomiya, Atae ^k   Uoshima, Nobuhiko ^l   Nagai, Tadashi ^m   Naoe, Tomoki ⁿ   Motoji, Toshiko ^o   Jinnai, Itsuro ^p   Tanimoto, Mitsune ^q   Miyazaki, Yasushi ^r   Ohnishi, Kazunori ^s   Iida, Shinsuke ^t   Okamoto, Shinichiro ^u   Seriu, Taku ^v   Ohno, Ryuzo ^w   more..

^a TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^b TOHOKU UNIVERSITY   (Japan)

^c KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^d YOKOHAMA CITY UNIVERSITY MEDICAL CENTER   (Japan)

^e AICHI CANCER CENTER HOSPITAL   (Japan)

^f NATIONAL CANCER CENTER   (Japan)

^g HYOGO COLLEGE OF MEDICINE   (Japan)

^h TOKAI UNIVERSITY   (Japan)

ⁱ JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j SAISEIKAI MAEBASHI HOSPITAL   (Japan)

^k Jiaikai Imamura Hospital   (Japan)

^l MATSUSHITA MEMORIAL HOSPITAL   (Japan)

^m JICHI MEDICAL UNIVERSITY   (Japan)

ⁿ NAGOYA UNIVERSITY   (Japan)

^o TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^p SAITAMA MEDICAL UNIVERSITY   (Japan)

^q OKAYAMA UNIVERSITY   (Japan)

^r NAGASAKI UNIVERSITY   (Japan)

^s HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^t NAGOYA CITY UNIVERSITY   (Japan)

^u KEIO UNIVERSITY   (Japan)

^v Bristol Myers KK   (Japan)

^w AICHI SHUKUTOKU UNIVERSITY   (Japan)

more..

Author keywords

CML; Dasatinib; Imatinib intolerant; Imatinib resistant; Ph+ ALL

Indexed keywords

DASATINIB; IMATINIB; ANTINEOPLASTIC AGENT; BCR ABL PROTEIN; PYRIMIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; AGED; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; CHROMOSOME ANALYSIS; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FEMALE; HEADACHE; HEART ARRHYTHMIA; HEART FAILURE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; JAPAN; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NAUSEA; NEUTROPENIA; PAIN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHILADELPHIA CHROMOSOME POSITIVE CELL; PLEURA EFFUSION; PNEUMONIA; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; ASIAN; GENETICS; METABOLISM; MIDDLE AGED; MUTATION; MYELOID LEUKEMIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; FUSION PROTEINS, BCR-ABL; HUMANS; LEUKEMIA, MYELOID, CHRONIC-PHASE; MIDDLE AGED; MUTATION; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PYRIMIDINES; THIAZOLES;

EID: 67649203120     PISSN: 09255710     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12185-009-0260-2     Document Type: Article

References (32)

1. S Wong ON Witte 2004 The BCR-ABL story: bench to bedside and back Annu Rev Immunol 22 247 306 10.1146/annurev.immunol.22.012703.104753 (Pubitemid 38680424)
2. BJ Druker CL Sawyers H Kantarjian 2001 Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome N Engl J Med 344 1038 42 10.1056/NEJM200104053441402 (Pubitemid 32267973)
3. BJ Druker M Talpaz DJ Resta 2001 Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia N Engl J Med 344 1031 7 10.1056/NEJM200104053441401 (Pubitemid 32267972)
4. HM Kantarjian S O'Brien JE Cortes 2002 Treatment of Philadelphia chromosome-positive, accelerated-phase chronic myelogenous leukemia with imatinib mesylate Clin Cancer Res 8 2167 76
5. BJ Druker F Guilhot SG O'Brien 2006 Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia N Engl J Med 355 2408 17 10.1056/NEJMoa062867 (Pubitemid 44903745)
6. ME Gorre M Mohammed K Ellwood 2001 Clinical resistance to STI-571 cancer therapy caused by BCR-ABL gene mutation or amplification Science 293 876 80 10.1126/science.1062538 (Pubitemid 32743979)
7. NP Shah JM Nicoll B Nagar 2002 Multiple BCR-ABL kinase domain mutations confer polyclonal resistance to the tyrosine kinase inhibitor imatinib (STI571) in chronic phase and blast crisis chronic myeloid leukemia Cancer Cell 2 117 25 10.1016/S1535-6108(02)00096-X (Pubitemid 41039112)
8. A Hochhaus T Hughes 2004 Clinical resistance to imatinib: mechanisms and implications Hematol Oncol Clin North Am 18 641 56 10.1016/j.hoc.2004.03.001 (Pubitemid 38969136)
9. A Hochhaus S Kreil AS Corbin 2002 Molecular and chromosomal mechanisms of resistance to imatinib (STI571) therapy Leukemia 16 2190 6 10.1038/sj.leu. 2402741 (Pubitemid 35331833)
10. T Illmer M Schaich U Platzbecker 2004 P-glycoprotein-mediated drug efflux is a resistance mechanism of chronic myelogenous leukemia cells to treatment with imatinib mesylate Leukemia 18 401 8 10.1038/sj.leu.2403257 (Pubitemid 38425851)
11. J Thomas L Wang RE Clark M Pirmohamed 2004 Active transport of imatinib into and out of cells: implications for drug resistance Blood 104 3739 45 10.1182/blood-2003-12-4276 (Pubitemid 39564452)
12. Y Dai M Rahmani SJ Corey P Dent SA Grant 2004 Bcr/Abl-independent, Lyn-dependent form of imatinib mesylate (STI-571) resistance is associated with altered expression of Bcl-2 J Biol Chem 279 34227 39 10.1074/jbc.M402290200 (Pubitemid 39318046)
13. NJ Donato JY Wu J Stapley 2003 BCR-ABL independence and LYN kinase overexpression in chronic myelogenous leukemia cells selected for resistance to STI571 Blood 101 690 8 10.1182/blood.V101.2.690 (Pubitemid 36077594)
14. T O'Hare DK Walters EP Stoffregen 2005 In vitro activity of Bcr-Abl inhibitors AMN107 and BMS-354825 against clinically relevant imatinib-resistant Abl kinase domain mutants Cancer Res 65 4500 5 10.1158/0008-5472.CAN-05-0259 (Pubitemid 40740783)
15. NP Shah C Tran FY Lee P Chen D Norris CL Sawyers 2004 Overriding imatinib resistance with a novel ABL kinase inhibitor Science 305 399 401 10.1126/science.1099480 (Pubitemid 38938156)
16. MR Burgess BJ Skaggs NP Shah FY Lee CL Sawyers 2005 Comparative analysis of two clinically active BCR-ABL kinase inhibitors reveals the role of conformation-specific binding in resistance Proc Natl Acad Sci USA 102 3395 3400 10.1073/pnas.0409770102 (Pubitemid 40328056)
17. M Talpaz NP Shah H Kantarjian 2006 Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias N Engl J Med 354 2531 41 10.1056/NEJMoa055229 (Pubitemid 43882349)
18. H Kantarjian R Pasquini N Hamerschlak 2007 Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib: a randomized phase 2 trial Blood 109 5143 50 10.1182/blood-2006-11- 056028 (Pubitemid 46890528)
19. A Hochhaus HM Kantarjian M Baccarani 2007 Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy Blood 109 2303 9 10.1182/blood-2006-09-047266 (Pubitemid 46425867)
20. F Guilhot J Apperley DW Kim 2007 Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase Blood 109 4143 50 10.1182/blood-2006-09-046839 (Pubitemid 46743375)
21. J Cortes P Rousselot DW Kim 2007 Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis Blood 109 3207 13 10.1182/blood-2006- 09-046888 (Pubitemid 46572505)
22. O Ottmann H Dombret G Martinelli 2007 Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study Blood 110 2309 15 10.1182/blood-2007-02-073528 (Pubitemid 47523149)
23. MJ Mauro M Baccarani F Cervantes 2008 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 26 Suppl 18 7009a
24. F Guilhot C Chastang M Michallet 1997 Interferon alfa-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia. French Chronic Myeloid Leukemia Study Group N Engl J Med 337 223 9 10.1056/ NEJM199707243370402 (Pubitemid 27310437)
25. The Italian Cooperative Study Group on Chronic Myeloid Leukemia 1994 Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia N Engl J Med 330 820 5 10.1056/NEJM199403243301204 (Pubitemid 24083561)
26. M Baccarani G Saglio J Goldman 2006 Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet Blood 108 1809 20 10.1182/blood-2006-02-005686 (Pubitemid 44394987)
27. LJ Lombardo FY Lee P Chen 2004 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 47 6658 61 10.1021/jm049486a (Pubitemid 40053752)
28. Y Morishima M Ogura M Nishimura 2004 Efficacy and safety of imatinib mesylate for patients in the first chronic phase of chronic myeloid leukemia: results of a Japanese phase II clinical study Int J Hematol 80 261 6 10.1532/IJH97.04074 (Pubitemid 39410934)
29. E Matsuo Y Miyazaki C Tsutsumi 2007 Imatinib provides durable molecular and cytogenetic responses in a practical setting for both newly diagnosed and previously treated chronic myelogenous leukemia: a study in Nagasaki prefecture, Japan Int J Hematol 85 132 9 10.1532/IJH97.06157 (Pubitemid 46365550)
30. J Sugita J Tanaka M Kurosawa 2008 Effects of the mean daily doses of imatinib during the first year on survival of patients with chronic myeloid leukemia in Japan: a study of the Hokkaido Hematology Study Group Eur J Haematol 80 160 3
31. K Miyazawa J Nishimaki T Katagiri 2003 Thrombocytopenia induced by imatinib mesylate (Glivec) in patients with chronic myelogenous leukemia: is 400 mg daily of imatinib mesylate an optimal starting dose for Japanese patients? Int J Hematol 77 93 5 10.1007/BF02982610
32. NP Shah HM Kantarjian DW Kim 2008 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 26 3204 12 10.1200/JCO.2007.14.9260