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380

Blood. 2017:129(14):1919-1926.DOI: 10.1182/blood-2016-07-726893

Comparison of self-report and electronic monitoring of 6MP intake in childhood ALL: A Children's Oncology Group study

Landier, Wendy; Chen, Yanjun; Hageman, Lindsey; Kim, Heeyoung; Bostrom, Bruce C; Casillas, Jacqueline N; Dickens, David S; Evans, William E; Maloney, Kelly W; Mascarenhas, Leo; Ritchey, A Kim; Termuhlen, Amanda M; Carroll, William L; Relling, Mary V; Wong, F Lennie; Bhatia, Smita
Adequate exposure to oral 6-mercaptopurine (6MP) during maintenance therapy for childhood acute lymphoblastic leukemia (ALL) is critical for sustaining durable remissions; the accuracy of self-reported 6MP intake is unknown. We aimed to directly compare self-report to electronic monitoring (Medication Event Monitoring System [MEMS]), and identify predictors of over-reporting in a cohort of 416 children with ALL in first remission over 4 study months per patient (1,344 patient-months for the cohort) during maintenance therapy. Patients were classified as "perfect reporters" (self-report=MEMS), "over reporters" (self-report>MEMS by >/=5 days/month for >/=50% of study months), and "others" (all patients not meeting criteria for perfect- or over-reporter). Multivariable logistic regression examined sociodemographic and clinical characteristics, 6MP dose-intensity, TPMT genotype, TGN levels, and 6MP non-adherence (MEMs-based adherence rate <95%) associated with the over-reporter phenotype; generalized estimating equations (GEE) compared 6MP intake by self-report and MEMS over the study period. Self-reported 6MP intake exceeded MEMS at least some of the time in 84% of patients. Fifty (12%) patients were classified as perfect reporters, 98 (23.6%) as over-reporters, 2 (0.5%) as under-reporters, and 266 (63.9%) as others. Multivariable logistic regression technique identified the following variables associated with the over-reporter phenotype: i) non-white race: Hispanic, odds ratio (OR)=2.4, 95%CI, 1.1-5.1, p=0.02; Asian, OR=3.1, 95%CI, 1.2-8.3, p=0.02; African-American, OR=5.4, 95%CI, 2.3-12.8, p=0.0001; ii) paternal education
PMCID:5383868
PMID: 28153823
ISSN: 1528-0020
CID: 2437172
Haemophila. 2017:23(2):e138-e140.DOI: 10.1111/hae.13138

Splice site mutation in factor X gene manifesting as severe intracranial haemorrhage in neonatal period with a challenging treatment course [Letter]

Madhusoodhan, P P; Lu, B Y; Chen, J; Jones, C L; Meyer, J A; Roman, E A; Nardi, M; Carroll, W L; Bhatla, T
PMID: 27995737
ISSN: 1365-2516
CID: 2374292
Clinical cancer research. 2017:23(4):873-875.DOI: 10.1158/1078-0432.CCR-16-2825

Beating the Clock in T-Cell Acute Lymphoblastic Leukemia

Carroll, William L; Aifantis, Iannis; Raetz, Elizabeth A
CDK4/6 inhibition was synergistic with dexmethasome and everolimus but antagonistic with conventional chemotherapy in T-cell acute lymphoblastic leukemia (T-ALL) pre-clinical models. Cyclin dependent kinase inhibition in combination with glucocorticoids and mTOR inhibition offers a unique therapeutic opportunity in T-ALL.
PMID: 28007775
ISSN: 1078-0432
CID: 2374552
Blood. 2017:130(Suppl 1):2479-2479.DOI:

Genomic and Epigenetic Effects of DNA Methyltransferase Inhibition in Acute Lymphoblastic Leukemia [Meeting Abstract]

Saint Fleur-Lominy, Shella; Bhatla, Teena; Kelly, Stephen; Vasudevaraja, Varshini; Tsirigos, Aristotelis; Carroll, William L
ORIGINAL:0012451
ISSN: 1528-0020
CID: 2914662
Pediatric blood & cancer. 2016:63:S15-S15.DOI:

The Genomic Landscape of T-Lineage Acute Lymphoblastic Leukemia [Meeting Abstract]

Liu, Y; Easton, J; Shao, Y; Wilkinson, M; Edmonson, M; Ma, X; Auvil, JGuidry; Gerhard, D; Winick, N; Raetz, E; Willman, C; Carroll, W; Dunsmore, K; Winter, S; Wood, B; Downing, J; Loh, M; Hunger, S; Zhang, J; Mullighan, C
ISI:000384818800370
ISSN: 1545-5017
CID: 2385902
Pediatric blood & cancer. 2016:63:S26-S26.DOI:

Epigenetic Landscape of Relapsed Childhood Acute Lymphoblastic Leukemia [Meeting Abstract]

Bhatla, T; Wang, J; Saint Fleur, S; Hunger, S; Loh, M; Brown, P; Carroll, WL
ISI:000384818800420
ISSN: 1545-5017
CID: 2385932
Leukemia. 2016:30(9):1909-12.DOI: 10.1038/leu.2016.60

MLL rearrangements impact outcome in HOXA-deregulated T-lineage acute lymphoblastic leukemia: a Children's Oncology Group Study

Matlawska-Wasowska, K; Kang, H; Devidas, M; Wen, J; Harvey, R C; Nickl, C K; Ness, S A; Rusch, M; Li, Y; Onozawa, M; Martinez, C; Wood, B L; Asselin, B L; Chen, I-M; Roberts, K G; Baruchel, A; Soulier, J; Dombret, H; Zhang, J; Larson, R S; Raetz, E A; Carroll, W L; Winick, N J; Aplan, P D; Loh, M L; Mullighan, C G; Hunger, S P; Heerema, N A; Carroll, A J; Dunsmore, K P; Winter, S S
PMCID:5014577
PMID: 26952838
ISSN: 1476-5551
CID: 2237792
Journal of pediatric hematology/oncology. 2016:38(6):409-17.DOI: 10.1097/MPH.0000000000000589

A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia: Children's Oncology Group Study AALL08P1

Rodriguez, Vilmarie; Kairalla, John; Salzer, Wanda L; Raetz, Elizabeth A; Loh, Mignon Lc; Carroll, Andrew J; Heerema, Nyla A; Wood, Brent L; Borowitz, Michael J; Burke, Michael J; Asselin, Barbara L; Devidas, Meenakshi; Winick, Naomi J; Carroll, William L; Hunger, Stephen P; Dreyer, ZoAnn E
AALL08P1 was designed to determine whether biweekly intensified pegaspargase (I-PEG) was feasible and safe in pediatric patients with newly diagnosed high-risk B-precursor lymphoblastic leukemia when given with Children's Oncology Group hemiaugmented BFM therapy. High-risk average (HR-Avg) patients received standard pegaspargase dosing (6 doses), whereas high-risk high (HR-High) patients received I-PEG biweekly from the start of Consolidation until day 1 of Maintenance. Feasibility and safety were defined in advance as >/=65% of patients tolerating at least 8 doses of I-PEG and 90% requiring /=8 total doses of I-PEG and 50% (15/30) took
PMCID:4955695
PMID: 27299599
ISSN: 1536-3678
CID: 2184802
Leukemia & lymphoma. 2016:57(8):1938-41.DOI: 10.3109/10428194.2015.1110747

Decitabine enhances chemosensitivity of early T-cell precursor-acute lymphoblastic leukemia cell lines and patient-derived samples

Lu, Benjamin Y; Thanawala, Shivani U; Zochowski, Kelly C; Burke, Michael J; Carroll, William L; Bhatla, Teena
PMID: 26726842
ISSN: 1029-2403
CID: 1901052
Journal of clinical oncology. 2016:34(20):2380-8.DOI: 10.1200/JCO.2015.62.4544

Dexamethasone and High-Dose Methotrexate Improve Outcome for Children and Young Adults With High-Risk B-Acute Lymphoblastic Leukemia: A Report From Children's Oncology Group Study AALL0232

Larsen, Eric C; Devidas, Meenakshi; Chen, Si; Salzer, Wanda L; Raetz, Elizabeth A; Loh, Mignon L; Mattano, Leonard A Jr; Cole, Catherine; Eicher, Alisa; Haugan, Maureen; Sorenson, Mark; Heerema, Nyla A; Carroll, Andrew A; Gastier-Foster, Julie M; Borowitz, Michael J; Wood, Brent L; Willman, Cheryl L; Winick, Naomi J; Hunger, Stephen P; Carroll, William L
PURPOSE: Survival for children and young adults with high-risk B-acute lymphoblastic leukemia has improved significantly, but 20% to 25% of patients are not cured. Children's Oncology Group study AALL0232 tested two interventions to improve survival. PATIENTS AND METHODS: Between January 2004 and January 2011, AALL0232 enrolled 3,154 participants 1 to 30 years old with newly diagnosed high-risk B-acute lymphoblastic leukemia. By using a 2 x 2 factorial design, 2,914 participants were randomly assigned to receive dexamethasone (14 days) versus prednisone (28 days) during induction and high-dose methotrexate versus Capizzi escalating-dose methotrexate plus pegaspargase during interim maintenance 1. RESULTS: Planned interim monitoring showed the superiority of the high-dose methotrexate regimens, which exceeded the predefined boundary and led to cessation of enrollment in January 2011. At that time, participants randomly assigned to high-dose methotrexate during interim maintenance 1 versus those randomly assigned to Capizzi methotrexate had a 5-year event-free survival (EFS) of 82% versus 75.4% (P = .006). Mature final data showed 5-year EFS rates of 79.6% for high-dose methotrexate and 75.2% for Capizzi methotrexate (P = .008). High-dose methotrexate decreased both marrow and CNS recurrences. Patients 1 to 9 years old who received dexamethasone and high-dose methotrexate had a superior outcome compared with those who received the other three regimens (5-year EFS, 91.2% v 83.2%, 80.8%, and 82.1%; P = .015). Older participants derived no benefit from dexamethasone during induction and experienced excess rates of osteonecrosis. CONCLUSION: High-dose methotrexate is superior to Capizzi methotrexate for the treatment of high-risk B-acute lymphoblastic leukemia, with no increase in acute toxicity. Dexamethasone given during induction benefited younger children but provided no benefit and was associated with a higher risk of osteonecrosis among participants 10 years and older.
PMCID:4981974
PMID: 27114587
ISSN: 1527-7755
CID: 2092442