Publications by authors named "Beverly Bell"

11 Publications

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In reply.

J Pediatr Hematol Oncol 2014 Aug;36(6):501-2

*Department of Neurology, University at Buffalo School of Medicine §Department of Pediatrics, Roswell Park Cancer Institute, Buffalo, NY †Department of Pediatrics, University of Miami Miller School of Medicine and Holtz Children's Hospital, Miami, FL ‡Department of Radiological Sciences St Jude Children's Research Hospital Memphis, TN ∥Department of Pediatrics, Georgia Health Science Center, Augusta, GA ¶Department of Pediatrics, West Virginia University Health Science Center Charleston, WV.

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http://dx.doi.org/10.1097/MPH.0000000000000145DOI Listing
August 2014

Dose intensification of methotrexate and cytarabine during intensified continuation chemotherapy for high-risk B-precursor acute lymphoblastic leukemia: POG 9406: a report from the Children's Oncology Group.

J Pediatr Hematol Oncol 2014 Jul;36(5):353-61

*MACC Fund Center for Cancer and Blood Disorders, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI †Department of Biostatistics, Colleges of Medicine and Public Health and Health Professions ††Department of Health Outcomes and Policy and Clinical and Translational Science Institute, College of Medicine, University of Florida ¶Children's Oncology Group, Department of Biostatistics, Gainesville, FL ‡Department of Pediatrics, Golisano Children's Hospital at University of Rochester Medical Center, Rochester #New York Medical College, Valhalla, NY §Department of Pediatrics, Georgia Health Sciences University, Augusta, GA ∥Department of Pediatrics, Charleston Division, West Virginia University, Charleston, WV **Department of Pediatric Hematology/Oncology, University of Mississippi Medical Center, Jackson, MS ‡‡Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX §§Pediatric Blood and Marrow Transplant Program, Duke University Medical Center, Durham, NC.

Purpose: To determine the efficacy and toxicity of higher dose versus standard dose intravenous methotrexate (MTX) and pulses of high-dose cytosine arabinoside with asparaginase versus standard dose cytosine arabinoside and teniposide during intensified continuation therapy for higher risk pediatric B-precursor acute lymphoblastic leukemia (ALL).

Patients And Methods: From 1994 to 1999, the Pediatric Oncology Group conducted a randomized phase III clinical trial in higher risk pediatric B-precursor ALL. A total of 784 patients were randomized in a 2×2 factorial design to receive MTX 1 g/m versus 2.5 g/m and to cytosine arabinoside/teniposide versus high-dose cytosine arabinoside/asparaginase during intensified continuation therapy.

Results: Patients receiving standard dose MTX had a 5-year disease-free survival (DFS) of 71.8±2.4%; patients receiving higher dose MTX had a 5-year DFS of 71.7±2.4% (P=0.55). Outcomes on cytosine arabinoside/teniposide (DFS of 70.4±2.4) were similar to higher dose cytosine arabinoside/asparaginase (DFS of 73.1±2.3%) (P=0.41). Overall survival rates were not different between MTX doses or cytosine arabinoside/teniposide versus cytosine arabinoside/asparaginase.

Conclusions: Increasing MTX dosing to 2.5 g/m did not improve outcomes in higher risk pediatric B-precursor ALL. Giving high-dose cytarabine and asparaginase pulses instead of standard dose cytarabine and teniposide produced nonsignificant differences in outcomes, allowing for teniposide to be removed from ALL therapy.
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http://dx.doi.org/10.1097/MPH.0000000000000131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4120865PMC
July 2014

Neurocognitive and neuroradiologic central nervous system late effects in children treated on Pediatric Oncology Group (POG) P9605 (standard risk) and P9201 (lesser risk) acute lymphoblastic leukemia protocols (ACCL0131): a methotrexate consequence? A report from the Children's Oncology Group.

J Pediatr Hematol Oncol 2014 Jan;36(1):8-15

*Department of Neurology, University at Buffalo School of Medicine ∥Department of Pediatrics, Roswell Park Cancer Institute, Buffalo, NY †Department of Pediatrics, University of Miami Miller School of Medicine and Holtz Children's Hospital, Miami, FL ‡Statistics and Data Center, Children's Oncology Group, Monrovia, CA §Department of Radiological Sciences, St Jude Children's Research Hospital, Memphis, TN ¶Department of Pediatrics, Georgia Health Science Center, Augusta, GA #Department of Pediatrics, West Virginia University Health Science Center, Charleston, WV.

Concerns about long-term methotrexate (MTX) neurotoxicity in the 1990s led to modifications in intrathecal (IT) therapy, leucovorin rescue, and frequency of systemic MTX administration in children with acute lymphoblastic leukemia. In this study, neurocognitive outcomes and neuroradiologic evidence of leukoencephalopathy were compared in children treated with intense central nervous system (CNS)-directed therapy (P9605) versus those receiving fewer CNS-directed treatment days during intensive consolidation (P9201). A total of 66 children from 16 Pediatric Oncology Group institutions with "standard-risk" acute lymphoblastic leukemia, 1.00 to 9.99 years at diagnosis, without evidence of CNS leukemia at diagnosis were enrolled on ACCL0131: 28 from P9201 and 38 from P9605. Magnetic resonance imaging scans and standard neuropsychological tests were performed ≥2.6 years after the end of treatment. Significantly more P9605 patients developed leukoencephalopathy compared with P9201 patients (68%, 95% confidence interval 49%-83% vs. 22%, 95% confidence interval 5%-44%; P=0.001) identified as late as 7.7 years after the end of treatment. Overall, 40% of patients scored <85 on either Verbal or Performance IQ. Children on both studies had significant attention problems, but P9605 children scored below average on more neurocognitive measures than those treated on P9201 (82%, 14/17 measures vs. 24%, 4/17 measures). This supports ongoing concerns about intensive MTX exposure as a major contributor to CNS late effects.
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http://dx.doi.org/10.1097/MPH.0000000000000000DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4465396PMC
January 2014

From promise to reality: achieving the value of an EHR.

Healthc Financ Manage 2011 Feb;65(2):50-6

EHR Implementation Practice, CSC, Columbus, Ohio, USA.

Implementing an electronic health record (EHR) can transform the clinical process and patient care among other positive outcomes. Hospitals can help physicians adopt the new technology by showing how it can enhance patient care and improve outcomes. An EHR implementation project should be a multidisciplinary coordinated effort.
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February 2011

Pediatric primary intramedullary spinal cord glioblastoma.

Rare Tumors 2010 Sep 30;2(3):e48. Epub 2010 Sep 30.

Departments of Pathology.

Spinal cord tumors in pediatric patients are rare, representing less than 1% of all central nervous system tumors. Two cases of pediatric primary intramedullary spinal cord glioblastoma at ages 14 and 8 years are reported. Both patients presented with rapid onset paraparesis and quadraparesis. Magnetic resonance imaging in both showed heterogeneously enhancing solitary mass lesions localized to lower cervical and upper thoracic spinal cord parenchyma. Histopathologic diagnosis was glioblastoma. Case #1 had a small cell component (primitive neuroectodermal tumor-like areas), higher Ki67, and p53 labeling indices, and a relatively stable karyotype with only minimal single copy losses involving regions: Chr8;pter-30480019, Chr16;pter-29754532, Chr16;56160245-88668979, and Chr19;32848902-qter on retrospective comparative genomic hybridization using formalin-fixed, paraffin-embedded samples. Case #2 had relatively bland histomorphology and negligible p53 immunoreactivity. Both underwent multimodal therapy including gross total resection, postoperative radiation and chemotherapy. However, there was no significant improvement in neurological deficits, and overall survival in both cases was 14 months.This report highlights the broad histological spectrum and poor overall survival despite multi modality therapy. The finding of relatively unique genotypic abnormalities resembling pediatric embryonal tumors in one case may highlight the value of genome-wide profiling in development of effective therapy. The differences in management with intracranial and low-grade spinal cord gliomas and current management issues are discussed.
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http://dx.doi.org/10.4081/rt.2010.e48DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2994522PMC
September 2010

Prospective analysis of TEL gene rearrangements in childhood acute lymphoblastic leukemia: a Children's Oncology Group study.

J Clin Oncol 2008 May;26(13):2186-91

Department of Oncology, Mail Stop 260, St Jude Children's Research Hospital, 332 N Lauderdale St, Memphis, TN 38105-2794, USA.

Purpose: To prospectively determine the prognostic significance of the TEL-AML1 fusion in children with acute lymphoblastic leukemia (ALL).

Patients And Methods: TEL gene status was determined for 926 patients with B-precursor ALL enrolled on the Pediatric Oncology Group ALinC 16 trials and patients were observed for a median time of 8 years.

Results: Rearrangements of the TEL gene were detected in 244 patients (26%). The estimated 5-year event-free survival rate (+/- SE) for patients with TEL rearrangements was 86% +/- 2%, compared with 72% +/- 2% for those with germline TEL (P < .0001). TEL rearrangements were associated with a superior outcome among patients with standard-risk ALL, high-risk ALL, and rapid early responses to therapy. In a multivariate analysis that included risk group, sex, and day 15 marrow status, TEL status was an independent predictor of outcome (P = .0002).

Conclusion: We conclude that TEL gene status should be incorporated into risk classification schemes and suggest that patients who have standard-risk features, the TEL-AML1 fusion, and rapid early responses to therapy, should be treated with antimetabolite-based therapy designed to maintain their high cure rates and avoid late effects.
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http://dx.doi.org/10.1200/JCO.2007.14.3552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485397PMC
May 2008

F-18-FDG-PET/CT leads to diagnosis of cryptococcal pneumonia where recurrent metastatic rhabdomyosarcoma was suspected.

Clin Nucl Med 2007 May;32(5):401-3

School of Medicine, Medical College of Georgia, 1120 15th Street, Augusta, GA 30912, USA.

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http://dx.doi.org/10.1097/01.rlu.0000259630.99988.d3DOI Listing
May 2007

Antimetabolite therapy for lesser-risk B-lineage acute lymphoblastic leukemia of childhood: a report from Children's Oncology Group Study P9201.

Blood 2007 Aug 18;110(4):1105-11. Epub 2007 Apr 18.

Department of Pediatrics, Wake Forest University Medical Center, Winston-Salem, NC, USA.

Pediatric Oncology Group (POG) protocol 9201 enrolled children with lesser-risk B-lineage acute lymphoblastic leukemia (ALL) defined by age (1-9), white blood cell count (WBC) less than 50 x 10(9)/L (50,000/microL), DNA findings of trisomies 4 and 10 (or DNA index > 1.16), and lack of overt central nervous system (CNS) leukemia. After vincristine, prednisone, and asparaginase induction, 650 of 653 eligible patients attained remission (3 induction deaths) and received 6 courses of intravenous methotrexate (1 g/m(2)) with daily mercaptopurine. Weekly intramuscular methotrexate was added during maintenance; pulses of vincristine and prednisone were administered with periodic intrathecal chemotherapy. Treatment duration was 2.5 years. No alkylators, epipodophylotoxins, anthracyclines, or radiation were given. The 6-year event-free survival (EFS) was 86.6% with overall survival (OS) of 97.2%. Patients with less than 5% marrow blasts on induction day 15 had superior EFS. A difference not reaching conventional statistical significance (P = .068) was noted for superior outcomes in patients with trisomies of chromosomes 4 and 10 versus those lacking double trisomies. Sex, ethnicity, CNS status, and WBC were not predictive. This indicates the great majority of children with lesser-risk B-lineage ALL are curable without agents with substantial late effects.
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http://dx.doi.org/10.1182/blood-2006-12-061689DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1939894PMC
August 2007

Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India.

AIDS Res Ther 2006 Feb 20;3. Epub 2006 Feb 20.

National AIDS Research Institute, India.

Background: The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India.

Methods: Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.5% PRO 2000 Gel for intra-vaginal application twice daily for 14 consecutive days.

Results: Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use. There were 17 (40%, 95% CI 26%-57%) mild AEs and 7 (17%, 95% CI 7%-31%) moderate AEs. There were no serious adverse events and no AEs judged probably or definitely related to product use. Genitourinary discomfort was reported by 2/30 (6.67%) participants in the low-risk cohort as compared to 4/12 (33.3%) women in the high-risk cohort (p = 0.03). Intermenstrual bleeding was reported in 2/30 (6.7%, 95% CI 1.0-22.1) women from the low risk cohort and 3/12 (25%, 95% CI 5.5-57.2) women from the high-risk cohort. One participant showed mild elevation of blood gamma glutamyl transferase and two showed mild elevations in total bilirubin. None of the participants showed detectable PRO 2000 in their blood after 14 days of product use.

Conclusion: 0.5% PRO 2000 Gel appeared to be safe when used twice-daily by sexually active HIV-uninfected women from Pune, India. Although genitourinary discomfort and metrorrhagia were more common in the high-risk cohort, ongoing Phase II/IIb trial would provide data for generalization of this finding.
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http://dx.doi.org/10.1186/1742-6405-3-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1435917PMC
February 2006

Vincristine-induced neuropathy as the initial presentation of charcot-marie-tooth disease in acute lymphoblastic leukemia: a Pediatric Oncology Group study.

J Pediatr Hematol Oncol 2003 Apr;25(4):316-20

Department of Pediatrics, Wake Forest University, Winston-Salem, North Carolina 27157-1081, USA.

Purpose: After profound peripheral neurotoxicity during induction chemotherapy for acute lymphoblastic leukemia (ALL) in the index patient with Charcot-Marie-Tooth hereditary neuropathy (CMT), study coordinators of the Pediatric Oncology Group (POG) front-line ALL protocols reviewed patient registrations to identify any other patients with possible CMT. The goal was to provide preliminary information about patients with undiagnosed CMT who develop ALL.

Patients And Methods: Five children with ALL who were enrolled in POG B-precursor or T-cell ALL protocols from 1994 to 1999 subsequently were determined to have CMT hereditary neuropathy. Their clinical presentations and treatment records were reviewed in detail. Records of all patients entered on POG 9201 (lesser-risk ALL) were reviewed to identify all cases of significant vincristine toxicity noted in the first 6 months of treatment.

Results: The five identified patients all had substantial peripheral neurotoxicity that required alteration in treatment and/or orthopedic/physical therapy evaluation and follow-up. The POG 9201 review identified 25 of 686 patients (3.6%) with significant peripheral neuropathy. Three of 25 were diagnosed with CMT; the others have had no testing reported.

Conclusions: A family history of CMT or other peripheral neuropathy should be sought at the time of diagnosis of ALL. Testing for CMT should be considered in any child with substantial vincristine-induced peripheral neurotoxicity. Treatment of such patients must be individualized. Testing of all patients with significant peripheral neuropathy would be necessary to determine the percentage of such neuropathy explained by underlying CMT.
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http://dx.doi.org/10.1097/00043426-200304000-00010DOI Listing
April 2003