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Session: Pediatric Oncology II

Type: Oral Abstract Session

Time: Monday June 5, 8:00 AM to 11:00 AM

Location: S504

Phase II trial of dasatinib (DAS) in pediatric patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP).


Pediatric Oncology

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 10511)

Author(s): Lia Gore, Pamela Kearns, Maria Lucia Lee, Carmino Antonio De Souza, Yves Bertrand, Nobuko Hijiya, Linda C. Stork, Nack-Gyun Chung, Rocio Cardenas-Cardos, Tapan Saikia, Franca Fagioli, Jong-Jin Seo, Judith Landman-Parker, Donna Lancaster, Andrew E. Place, Karen R. Rabin, Mariana Sacchi, Rene Swanink, Michel Zwaan; University of Colorado School of Medicine/Children’s Hospital Colorado, Aurora, CO; University of Birmingham, Birmingham, United Kingdom; Support Group for Children and Adolescents with Cancer, Sao Paulo, Brazil; University of Campinas, São Paulo, Brazil; L'Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon, France; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL; Oregon Health & Science University, Portland, OR; The Catholic University of Korea, St. Mary's Hospital, Seoul, Republic of Korea; Instituto Nacional de Pediatria, Mexico City, Mexico; Prince Aly Khan Hospital, Mumbai, India; Regina Margherita Hospital, Turin, Italy; University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea; Hopital Enfants Armand Trousseau, Paris, France; The Royal Marsden Hospital, Surrey, United Kingdom; Dana-Farber Cancer Institute, Boston, MA; Texas Children's Cancer Center, Houston, TX; Bristol-Myers Squibb, Princeton, NJ; Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands

Abstract Disclosures


Background: Safe and effective treatment options for newly diagnosed (ND) or imatinib (IM) resistant/intolerant (R/I) pediatric CML pts are limited, and a large prospective study is needed. DAS has proven safety and efficacy in adults with ND or IM-R/I CML and is now being evaluated in a phase II trial of pediatric pts. Methods: CA180-226/NCT00777036 is an open-label nonrandomized prospective study of pts aged <18 y in 3 cohorts: (1) CML-CP R/I to IM treated with DAS tablets 60 mg/m2 QD, (2) IM-R/I CML-AP/BP or Ph+ ALL (enrollment closed early due to poor response), and (3) ND CML-CP treated with DAS tablets 60 mg/m2 or DAS 72 mg/m2powder for oral suspension (PFOS) QD. Primary objectives were major cytogenetic response (MCyR) for CML-CP R/I to IM and complete cytogenetic response (CCyR) for ND CML-CP (MCyR >30% and CCyR >55% considered of clinical interest). Results: 113 pediatric CML-CP pts were treated. Cumulative rate of MCyR >30% was reached as early as 3 mo (55%; [95% CI 36, 74]) for IM-R/I CML-CP. Cumulative rate of CCyR >55% was reached as early as 6 mo (64% [95% CI 53, 74] for ND CML-CP; 61% [95% CI 46, 74] for pts on tablets and 70% [95% CI 51, 84] for pts on PFOS). Estimated PFS by 48 mo was >75% for CML-CP R/I to IM and >90% for ND CML-CP. One CML-CP pt R/I to IM died 1 y after stopping DAS from gastrointestinal bleeding. AEs were consistent with those observed in adults, except no DAS-related pleural/pericardial effusion or pulmonary arterial hypertension (PAH) were reported here. Conclusions: In the largest prospective trial of pediatric pts with CML-CP, target responses were met early and increased over time with DAS treatment. The efficacy and safety of DAS were consistent with previous reports in adults, except no cases of pleural/pericardial effusion or PAH were observed. These results suggest DAS is safe and highly effective in the first- or second-line treatment of pediatric CML-CP. Clinical trial information: NCT00777036

Pts treated, n295133
Median duration of treatment, mo (range)50 (2-90+)52 (8-75+)27 (<1-42+)
Responses by 24 mo, % (95% CI)
MCyR90 (73, 98)96 (90, 99)
98 (90, 100)94 (80, 99)
CCyR83 (64, 94)94 (87, 98)
96 (87, 100)91 (76, 98)
Major molecular response55 (36, 74)70 (59, 80)
75 (60, 86)64 (45, 80)

Other Abstracts in this Sub-Category:


1. Effect of chimeric antigen receptor-modified T (CAR-T) cells on responses in children with non-CNS extramedullary relapse of CD19+ acute lymphoblastic leukemia (ALL).

Meeting: 2017 ASCO Annual Meeting Abstract No: 10507 First Author: Mala Kiran Talekar
Category: Pediatric Oncology - Leukemia/Lymphoma


2. Inotuzumab ozogamicin in pediatric patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL).

Meeting: 2017 ASCO Annual Meeting Abstract No: 10512 First Author: Deepa Bhojwani
Category: Pediatric Oncology - Leukemia/Lymphoma


3. Measuring mercaptopurine (6MP) adherence using red cell 6MP metabolite levels in children with acute lymphoblastic leukemia (ALL): A COG AALL03N1 study.

Meeting: 2017 ASCO Annual Meeting Abstract No: 10514 First Author: Anna Lynn Hoppmann
Category: Pediatric Oncology - Leukemia/Lymphoma