Dasatinib in children and adolescents with relapsed or refractory leukemia: Results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children With Cancer Consortium

Journal of Clinical Oncology

Volumn 31, Issue 19, 2013, Pages 2460-2468

  Zwaan, C Michel ^a   Rizzari, Carmelo ^c   Mechinaud, Francoise ^d   Lancaster, Donna L ^e   Lehrnbecher, Thomas ^g   Van Der Velden, Vincent H J ^b   Beverloo, B Berna ^a   Den Boer, Monique L ^a   Pieters, Rob ^a   Reinhardt, Dirk ^h   Dworzak, Michael ⁱ   Rosenberg, Julie ^j,k   Manos, George ^j   Agrawal, Shruti ^j   Strauss, Lewis ^j   Baruchel, André ^l   Kearns, Pamela R ^f  

^a SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c SAN GERARDO HOSPITAL   (Italy)

^d ROYAL CHILDREN'S HOSPITAL   (Australia)

^e INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^f UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^g GOETHE UNIVERSITY   (Germany)

^h HANNOVER MEDICAL SCHOOL   (Germany)

ⁱ MEDICAL UNIVERSITY OF VIENNA   (Austria)

^j BRISTOL MYERS SQUIBB   (United States)

^k Bayer HealthCare Pharmaceuticals   (United States)

^l HÔPITAL ROBERT DEBRÉ   (France)

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Author keywords

[No Author keywords available]

Indexed keywords

CEFTAZIDIME; DASATINIB; IMATINIB; VANCOMYCIN; ANTINEOPLASTIC AGENT; BENZAMIDE DERIVATIVE; PIPERAZINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRIMIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE MYELOID LEUKEMIA; ADOLESCENT; ADULT; ADVANCED CANCER; ADVERSE OUTCOME; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CHILD; CHILDHOOD CANCER; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; EPISTAXIS; EXPERIMENTAL THERAPY; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HUMAN; KARNOFSKY PERFORMANCE STATUS; LEUKEMIA RELAPSE; LIMB PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MOUTH ULCER; NAUSEA; NEUTROPENIA; OPEN STUDY; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PHILADELPHIA CHROMOSOME NEGATIVE CELL; PHILADELPHIA CHROMOSOME POSITIVE CELL; PLASMA CONCENTRATION-TIME CURVE; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RASH; RHINOPHARYNGITIS; SCHOOL CHILD; SINGLE DRUG DOSE; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; URTICARIA; VOMITING; YOUNG ADULT; ACUTE GRANULOCYTIC LEUKEMIA; CHEMICALLY INDUCED DISORDER; CHRONIC MYELOID LEUKEMIA; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG ANTAGONISM; INFANT; KAPLAN MEIER METHOD; METABOLISM; PATHOLOGY; SAMPLE SIZE; TREATMENT OUTCOME;

ADOLESCENT; ANTINEOPLASTIC AGENTS; BENZAMIDES; CHILD; CHILD, PRESCHOOL; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEADACHE; HUMANS; INFANT; KAPLAN-MEIER ESTIMATE; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; LEUKEMIA, MYELOID, ACUTE; MALE; NAUSEA; PIPERAZINES; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; PYRIMIDINES; SAMPLE SIZE; THERAPIES, INVESTIGATIONAL; THIAZOLES; TREATMENT OUTCOME; VOMITING; YOUNG ADULT;

EID: 84881601575     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.46.8280     Document Type: Article

References (45)

1. Suttorp M, Millot F: Treatment of pediatric chronic myeloid leukemia in the year 2010: Use of tyrosine kinase inhibitors and stem-cell transplantation. Hematology Am Soc Hematol Educ Program 2010:368-376, 2010
2. Barr RD: Imatinib mesylate in children and adolescents with cancer. Pediatr Blood Cancer 55: 18-25, 2010
3. Kolb EA, Pan Q, Ladanyi M, et al: Imatinib mesylate in Philadelphia chromosome-positive leukemia of childhood. Cancer 98:2643-2650, 2003
4. Champagne MA, Capdeville R, Krailo M, et al: Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: Results from a Children’s Oncology Group phase 1 study. Blood 104:2655-2660, 2004
5. Millot F, Guilhot J, Nelken B, et al: Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation. Leukemia 20:187-192, 2006
6. Champagne MA, Fu CH, Chang M, et al: Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: A report from the Children’s Oncology Group. Pediatr Blood Cancer 57:56-62, 2011
7. Millot F, Baruchel A, Guilhot J, et al: Imatinib is effective in children with previously untreated chronic myelogenous leukemia in early chronic phase: Results of the French national phase IV trial. J Clin Oncol 29:2827-2832, 2011
8. Suttorp M, Thiede C, Tauer JT, et al: Chronic myeloid leukemia in pediatrics: First results from study CML-PAED II. Blood 114, 2009 (suppl; abstr 342)
9. Talpaz M, Silver RT, Druker BJ, et al: Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: Results of a phase 2 study. Blood 99:1928-1937, 2002
10. 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 99:3530-3539, 2002
11. Ottmann OG, Druker BJ, Sawyers CL, et al: A phase 2 study of imatinib in patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoid leukemias. Blood 100:1965-1971, 2002
12. Shima H, Tokuyama M, Tanizawa A, et al: Distinct impact of imatinib on growth at prepubertal and pubertal ages of children with chronic myeloid leukemia. J Pediatr 159:676-681, 2011
13. Bansal D, Shava U, Varma N, et al: Imatinib has adverse effect on growth in children with chronic myeloid leukemia. Pediatr Blood Cancer 59:481-484, 2012
14. Berman E, Nicolaides M, Maki RG, et al: Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med 354: 2006-2013, 2006
15. Shah NP, Kim DW, Kantarjian H, et al: 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 95:232-240, 2010
16. 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 113: 6322-6329, 2009
17. 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 116:3852-3861, 2010
18. Lilly MB, Ottmann OG, Shah NP, et al: Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol 85:164-170, 2010
19. Kantarjian H, Shah NP, Hochhaus A, et al: Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 362:2260-2270, 2010
20. Schittenhelm MM, Shiraga S, Schroeder A, et al: Dasatinib (BMS-354825), a dual SRC/ABL kinase inhibitor, inhibits the kinase activity of wild-type, juxtamembrane, and activation loop mutant KIT isoforms associated with human malignancies. Cancer Res 66:473-481, 2006
21. Lombardo LJ, Lee FY, Chen P, 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 47:6658-6661, 2004
22. Graux C, Cools J, Melotte C, et al: Fusion of NUP214 to ABL1 on amplified episomes in T-cell acute lymphoblastic leukemia. Nat Genet 36:1084-1089, 2004
23. Quintás-Cardama A, Tong W, Manshouri T, et al: Activity of tyrosine kinase inhibitors against human NUP214-ABL1-positive T cell malignancies. Leukemia 22:1117-1124, 2008
24. Guerrouahen BS, Futami M, Vaklavas C, et al: Dasatinib inhibits the growth of molecularly heterogeneous myeloid leukemias. Clin Cancer Res 16: 1149-1158, 2010
25. Han L, Schuringa JJ, Mulder A, et al: Dasatinib impairs long-term expansion of leukemic progenitors in a subset of acute myeloid leukemia cases. Ann Hematol 89:861-871, 2010
26. Dos Santos C, Demur C, Bardet V, et al: A critical role for Lyn in acute myeloid leukemia. Blood 111:2269-2279, 2008
27. Talpaz M, Shah NP, Kantarjian H, et al: Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med 354:2531-2541, 2006
28. Shah NP, Kantarjian HM, Kim DW, 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 26: 3204-3212, 2008
29. Zwaan CM, Kearns P, Caron H, et al: The role of the ‘innovative therapies for children with cancer’ (ITCC) European consortium. Cancer Treat Rev 36: 328-334, 2010
30. Gabert J, Beillard E, van der Velden VH, et al: Standardization and quality control studies of ‘real-time’ quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia: A Europe Against Cancer program. Leukemia 17:2318-2357, 2003
31. Beillard E, Pallisgaard N, van der Velden VH, et al: Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using ‘real-time’ quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR): A Europe Against Cancer program. Leukemia 17:2474-2486, 2003
32. Müller MC, Cross NC, Erben P, et al: Harmonization of molecular monitoring of CML therapy in Europe. Leukemia 23:1957-1963, 2009
33. Clopper CJ, Pearson ES: The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26:404-413, 1934
34. Brookmeyer R, Crowley J: A confidence interval for the median survival time. Biometrics 38:29-41, 1982
35. Aplenc R, Blaney SM, Strauss LC, et al: Pediatric phase I trial and pharmacokinetic study of dasatinib: A report from the Children’s Oncology Group phase I consortium. J Clin Oncol 29:839-844, 2011
36. Porkka K, Khoury HJ, Paquette RL, et al: Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer 116:377-386, 2010
37. Quintás-Cardama A, Kantarjian H, O’brien S, et al: Pleural effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol 25:3908-3914, 2007
38. de Lavallade H, Punnialingam S, Milojkovic D, et al: Pleural effusions in patients with chronic myeloid leukaemia treated with dasatinib may have an immune-mediated pathogenesis. Br J Haematol 141:745-747, 2008
39. Goemans BF, Zwaan CM, Miller M, et al: Mutations in KIT and RAS are frequent events in pediatric core-binding factor acute myeloid leukemia. Leukemia 19:1536-1542, 2005
40. Pollard JA, Alonzo TA, Gerbing RB, et al: Prevalence and prognostic significance of KIT mutations in pediatric patients with core binding factor AML enrolled on serial pediatric cooperative trials for de novo AML. Blood 115:2372-2379, 2010
41. Bristol-Myers Squibb: Sprycel prescribing information. http://packageinserts.bms.com/pi/pi_sprycel.pdf
42. Christopher LJ, Cui D, Wu C, et al: Metabolism and disposition of dasatinib after oral administration to humans. Drug Metab Dispos 36:1357-1364, 2008
43. Rosenberg JA, Derreumaux D, Gore L, et al: Phase II study of dasatinib in children and adolescents with newly diagnosed chronic phase chronic myelogenous leukemia (CP-CML) or Philadelphia-positive (Ph+) leukemias resistant or intolerant to imatinib. J Clin Oncol 28:51s, 2010 (suppl; abstr TPS281)
44. ClinicalTrials.gov: A phase 2 multi-center, historically controlled study of dasatinib added to standard chemotherapy in pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (NCT01460160). http://clinicaltrials.gov/show/NCT01460160
45. ClinicalTrials.gov: Dasatinib and combination chemotherapy in treating young patients with newly diagnosed acute lymphoblastic leukemia (NCT00720109). http://clinicaltrials.gov/show/NCT00720109