Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase: results from a phase II trial

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Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase : results from a phase II trial. / Gore, Lia; Kearns, Pamela; de Martino Lee, Maria Lucia; De Souza, Carmino Antonio; Bertrand, Yves; Hijiya, Nobuko; Stork, Linda C.; Chung, Nack-Gyun; Cardos, Rocio Cardenas; Saikia, Tapan; Fagioli, Franca ; Seo, Jong Jin; Landman-Parker, Judith; Lancaster, Donna L.; Place, Andrew E.; Rabin, Karen R.; Sacchi, Mariana; Swanink, Rene; Zwaan, C. Michel.

In: Journal of Clinical Oncology , Vol. 36, No. 13, 01.05.2018, p. 1330-1338.

Research output: Contribution to journalArticlepeer-review

Harvard

Gore, L, Kearns, P, de Martino Lee, ML, De Souza, CA, Bertrand, Y, Hijiya, N, Stork, LC, Chung, N-G, Cardos, RC, Saikia, T, Fagioli, F, Seo, JJ, Landman-Parker, J, Lancaster, DL, Place, AE, Rabin, KR, Sacchi, M, Swanink, R & Zwaan, CM 2018, 'Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase: results from a phase II trial', Journal of Clinical Oncology , vol. 36, no. 13, pp. 1330-1338. https://doi.org/10.1200/JCO.2017.75.9597

APA

Gore, L., Kearns, P., de Martino Lee, M. L., De Souza, C. A., Bertrand, Y., Hijiya, N., Stork, L. C., Chung, N-G., Cardos, R. C., Saikia, T., Fagioli, F., Seo, J. J., Landman-Parker, J., Lancaster, D. L., Place, A. E., Rabin, K. R., Sacchi, M., Swanink, R., & Zwaan, C. M. (2018). Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase: results from a phase II trial. Journal of Clinical Oncology , 36(13), 1330-1338. https://doi.org/10.1200/JCO.2017.75.9597

Vancouver

Author

Gore, Lia ; Kearns, Pamela ; de Martino Lee, Maria Lucia ; De Souza, Carmino Antonio ; Bertrand, Yves ; Hijiya, Nobuko ; Stork, Linda C. ; Chung, Nack-Gyun ; Cardos, Rocio Cardenas ; Saikia, Tapan ; Fagioli, Franca ; Seo, Jong Jin ; Landman-Parker, Judith ; Lancaster, Donna L. ; Place, Andrew E. ; Rabin, Karen R. ; Sacchi, Mariana ; Swanink, Rene ; Zwaan, C. Michel. / Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase : results from a phase II trial. In: Journal of Clinical Oncology . 2018 ; Vol. 36, No. 13. pp. 1330-1338.

Bibtex

@article{c927d3c82cf3435998b80e4f722b8d86,
title = "Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase: results from a phase II trial",
abstract = "Purpose: Safe, effective treatments are needed for pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP). Dasatinib is approved for treatment of adults and children with CML-CP. A phase I study determined suitable dosing for children with Philadelphia chromosome–positive (Ph+) leukemias.Methods: CA180-226/NCT00777036 is a phase II, open-label, nonrandomized prospective trial of patients < 18 years of age receiving dasatinib. There are three cohorts: (1) imatinib-resistant/intolerant CML-CP, (2) imatinib-resistant/intolerant CML in accelerated/blast phase or Ph+ acute lymphoblastic leukemia (n = 17), and (3) newly diagnosed CML-CP treated with tablets or powder for oral suspension. Major cytogenetic response > 30% for imatinib-resistant/intolerant patients and complete cytogenetic response (CCyR) > 55% for newly diagnosed patients were of clinical interest.Results: Of 113 patients with CML-CP, 14 (48%) who were imatinib-resistant/intolerant and 61 (73%) who were newly diagnosed remained on treatment at time of analysis. Major cytogenetic response > 30% was reached by 3 months in the imatinib-resistant/intolerant group and CCyR > 55% was reached by 6 months in the newly diagnosed CML-CP group. CCyR and major molecular response by 12 months, respectively, were 76% and 41% in the imatinib-resistant/intolerant group and 92% and 52% in newly diagnosed CML-CP group. Progression-free survival by 48 months was 78% and 93% in the imatinib-resistant/intolerant and newly diagnosed CML-CP groups, respectively. No dasatinib-related pleural or pericardial effusion, pulmonary edema, or pulmonary arterial hypertension were reported. Bone growth and development events were reported in 4% of patients.Conclusion: In the largest prospective trial to date in children with CML-CP, we demonstrate that dasatinib is a safe, effective treatment of pediatric CML-CP. Target responses to first- or second-line dasatinib were met early, and deep molecular responses were observed. Safety of dasatinib in pediatric patients was similar to that observed in adults; however, no cases of pleural or pericardial effusion or pulmonary arterial hypertension were reported.",
author = "Lia Gore and Pamela Kearns and {de Martino Lee}, {Maria Lucia} and {De Souza}, {Carmino Antonio} and Yves Bertrand and Nobuko Hijiya and Stork, {Linda C.} and Nack-Gyun Chung and Cardos, {Rocio Cardenas} and Tapan Saikia and Franca Fagioli and Seo, {Jong Jin} and Judith Landman-Parker and Lancaster, {Donna L.} and Place, {Andrew E.} and Rabin, {Karen R.} and Mariana Sacchi and Rene Swanink and Zwaan, {C. Michel}",
year = "2018",
month = may,
day = "1",
doi = "10.1200/JCO.2017.75.9597",
language = "English",
volume = "36",
pages = "1330--1338",
journal = "Journal of Clinical Oncology ",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "13",

}

RIS

TY - JOUR

T1 - Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase

T2 - results from a phase II trial

AU - Gore, Lia

AU - Kearns, Pamela

AU - de Martino Lee, Maria Lucia

AU - De Souza, Carmino Antonio

AU - Bertrand, Yves

AU - Hijiya, Nobuko

AU - Stork, Linda C.

AU - Chung, Nack-Gyun

AU - Cardos, Rocio Cardenas

AU - Saikia, Tapan

AU - Fagioli, Franca

AU - Seo, Jong Jin

AU - Landman-Parker, Judith

AU - Lancaster, Donna L.

AU - Place, Andrew E.

AU - Rabin, Karen R.

AU - Sacchi, Mariana

AU - Swanink, Rene

AU - Zwaan, C. Michel

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Purpose: Safe, effective treatments are needed for pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP). Dasatinib is approved for treatment of adults and children with CML-CP. A phase I study determined suitable dosing for children with Philadelphia chromosome–positive (Ph+) leukemias.Methods: CA180-226/NCT00777036 is a phase II, open-label, nonrandomized prospective trial of patients < 18 years of age receiving dasatinib. There are three cohorts: (1) imatinib-resistant/intolerant CML-CP, (2) imatinib-resistant/intolerant CML in accelerated/blast phase or Ph+ acute lymphoblastic leukemia (n = 17), and (3) newly diagnosed CML-CP treated with tablets or powder for oral suspension. Major cytogenetic response > 30% for imatinib-resistant/intolerant patients and complete cytogenetic response (CCyR) > 55% for newly diagnosed patients were of clinical interest.Results: Of 113 patients with CML-CP, 14 (48%) who were imatinib-resistant/intolerant and 61 (73%) who were newly diagnosed remained on treatment at time of analysis. Major cytogenetic response > 30% was reached by 3 months in the imatinib-resistant/intolerant group and CCyR > 55% was reached by 6 months in the newly diagnosed CML-CP group. CCyR and major molecular response by 12 months, respectively, were 76% and 41% in the imatinib-resistant/intolerant group and 92% and 52% in newly diagnosed CML-CP group. Progression-free survival by 48 months was 78% and 93% in the imatinib-resistant/intolerant and newly diagnosed CML-CP groups, respectively. No dasatinib-related pleural or pericardial effusion, pulmonary edema, or pulmonary arterial hypertension were reported. Bone growth and development events were reported in 4% of patients.Conclusion: In the largest prospective trial to date in children with CML-CP, we demonstrate that dasatinib is a safe, effective treatment of pediatric CML-CP. Target responses to first- or second-line dasatinib were met early, and deep molecular responses were observed. Safety of dasatinib in pediatric patients was similar to that observed in adults; however, no cases of pleural or pericardial effusion or pulmonary arterial hypertension were reported.

AB - Purpose: Safe, effective treatments are needed for pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP). Dasatinib is approved for treatment of adults and children with CML-CP. A phase I study determined suitable dosing for children with Philadelphia chromosome–positive (Ph+) leukemias.Methods: CA180-226/NCT00777036 is a phase II, open-label, nonrandomized prospective trial of patients < 18 years of age receiving dasatinib. There are three cohorts: (1) imatinib-resistant/intolerant CML-CP, (2) imatinib-resistant/intolerant CML in accelerated/blast phase or Ph+ acute lymphoblastic leukemia (n = 17), and (3) newly diagnosed CML-CP treated with tablets or powder for oral suspension. Major cytogenetic response > 30% for imatinib-resistant/intolerant patients and complete cytogenetic response (CCyR) > 55% for newly diagnosed patients were of clinical interest.Results: Of 113 patients with CML-CP, 14 (48%) who were imatinib-resistant/intolerant and 61 (73%) who were newly diagnosed remained on treatment at time of analysis. Major cytogenetic response > 30% was reached by 3 months in the imatinib-resistant/intolerant group and CCyR > 55% was reached by 6 months in the newly diagnosed CML-CP group. CCyR and major molecular response by 12 months, respectively, were 76% and 41% in the imatinib-resistant/intolerant group and 92% and 52% in newly diagnosed CML-CP group. Progression-free survival by 48 months was 78% and 93% in the imatinib-resistant/intolerant and newly diagnosed CML-CP groups, respectively. No dasatinib-related pleural or pericardial effusion, pulmonary edema, or pulmonary arterial hypertension were reported. Bone growth and development events were reported in 4% of patients.Conclusion: In the largest prospective trial to date in children with CML-CP, we demonstrate that dasatinib is a safe, effective treatment of pediatric CML-CP. Target responses to first- or second-line dasatinib were met early, and deep molecular responses were observed. Safety of dasatinib in pediatric patients was similar to that observed in adults; however, no cases of pleural or pericardial effusion or pulmonary arterial hypertension were reported.

U2 - 10.1200/JCO.2017.75.9597

DO - 10.1200/JCO.2017.75.9597

M3 - Article

C2 - 29498925

VL - 36

SP - 1330

EP - 1338

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 13

ER -