Literature DB >> 22010014

Pilot induction regimen incorporating pharmacokinetically guided topotecan for treatment of newly diagnosed high-risk neuroblastoma: a Children's Oncology Group study.

Julie R Park1, Jeffrey R Scott, Clinton F Stewart, Wendy B London, Arlene Naranjo, Victor M Santana, Peter J Shaw, Susan L Cohn, Katherine K Matthay.   

Abstract

PURPOSE: To assess the feasibility of adding dose-intensive topotecan and cyclophosphamide to induction therapy for newly diagnosed high-risk neuroblastoma (HRNB). PATIENTS AND METHODS: Enrolled patients received two cycles of topotecan (approximately 1.2 mg/m(2)/d) and cyclophosphamide (400 mg/m(2)/d) for 5 days followed by four cycles of multiagent chemotherapy (Memorial Sloan-Kettering Cancer Center [MSKCC] regimen). Pharmacokinetically guided topotecan dosing (target systemic exposure with area under the curve of 50 to 70 ng/mL/hr) was performed. Peripheral-blood stem cell (PBSC) harvest and surgical resection of residual primary tumor occurred after cycles 2 and 5, respectively. Patients achieving at least a partial response received myeloablative chemotherapy with PBSC rescue and radiation to the presurgical primary tumor volume. Oral 13-cis-retinoic acid maintenance therapy was administered twice daily for 14 days in six 28-day cycles.
RESULTS: Thirty-one patients were enrolled onto the study. No deaths related to toxicity or dose-limiting toxicities occurred during induction. Mucositis rarely occurred after topotecan cycles (9.7%) in contrast to 30% after MSKCC cycles. Thirty patients underwent PBSC collection with median 31.1 × 10(6) CD34+ cells/kg (range, 1.8 to 541.8 × 10(6) CD34+ cells/kg), all negative for tumor contamination by immunocytochemical analysis. Targeted topotecan systemic exposure was achieved in 26 (84%) of 31 patients. At the end of induction, 26 patients (84%) had tumor response and one patient had progressive disease. In the overall cohort, 3-year event-free and overall survival were 37.8% ± 9.4% and 57.1% ± 9.4%, respectively.
CONCLUSION: This pilot induction regimen was well tolerated with expected and reversible toxicities. These data support investigation of efficacy in a phase III clinical trial for newly diagnosed HRNB.

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Year:  2011        PMID: 22010014      PMCID: PMC3221519          DOI: 10.1200/JCO.2010.34.3293

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN: 0732-183X            Impact factor:   44.544


  48 in total

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Authors:  D G Tubergen; C F Stewart; C B Pratt; W C Zamboni; N Winick; V M Santana; Z A Dryer; J Kurtzberg; B Bell; H Grier; T J Vietti
Journal:  J Pediatr Hematol Oncol       Date:  1996-11       Impact factor: 1.289

2.  Interpatient variability in bioavailability of the intravenous formulation of topotecan given orally to children with recurrent solid tumors.

Authors:  W C Zamboni; L C Bowman; M Tan; V M Santana; P J Houghton; W H Meyer; C B Pratt; R L Heideman; A J Gajjar; A S Pappo; C F Stewart
Journal:  Cancer Chemother Pharmacol       Date:  1999       Impact factor: 3.333

3.  Multivariate analysis of risk factors in stage 4 neuroblastoma patients over the age of one year treated with megatherapy and stem-cell transplantation: a report from the European Bone Marrow Transplantation Solid Tumor Registry.

Authors:  R Ladenstein; T Philip; C Lasset; O Hartmann; A Garaventa; R Pinkerton; J Michon; J Pritchard; T Klingebiel; B Kremens; A Pearson; C Coze; P Paolucci; D Frappaz; H Gadner; F Chauvin
Journal:  J Clin Oncol       Date:  1998-03       Impact factor: 44.544

4.  Phase I study of topotecan in combination with cyclophosphamide in pediatric patients with malignant solid tumors: a Pediatric Oncology Group Study.

Authors:  R L Saylors; C F Stewart; W C Zamboni; D A Wall; B Bell; K C Stine; T J Vietti
Journal:  J Clin Oncol       Date:  1998-03       Impact factor: 44.544

5.  Relationship between topotecan systemic exposure and tumor response in human neuroblastoma xenografts.

Authors:  W C Zamboni; C F Stewart; J Thompson; V M Santana; P J Cheshire; L B Richmond; X Luo; C Poquette; J A Houghton; P J Houghton
Journal:  J Natl Cancer Inst       Date:  1998-04-01       Impact factor: 13.506

6.  Phase II randomized comparison of topotecan plus cyclophosphamide versus topotecan alone in children with recurrent or refractory neuroblastoma: a Children's Oncology Group study.

Authors:  Wendy B London; Christopher N Frantz; Laura A Campbell; Robert C Seeger; Babette A Brumback; Susan L Cohn; Katherine K Matthay; Robert P Castleberry; Lisa Diller
Journal:  J Clin Oncol       Date:  2010-07-26       Impact factor: 44.544

7.  Phase I and pharmacologic study of topotecan in patients with impaired renal function.

Authors:  S O'Reilly; E K Rowinsky; W Slichenmyer; R C Donehower; A A Forastiere; D S Ettinger; T L Chen; S Sartorius; L B Grochow
Journal:  J Clin Oncol       Date:  1996-12       Impact factor: 44.544

8.  Topotecan in pediatric patients with recurrent and progressive solid tumors: a Pediatric Oncology Group phase II study.

Authors:  R Nitschke; J Parkhurst; J Sullivan; M B Harris; M Bernstein; C Pratt
Journal:  J Pediatr Hematol Oncol       Date:  1998 Jul-Aug       Impact factor: 1.289

9.  Cytotoxic effects of topotecan combined with various anticancer agents in human cancer cell lines.

Authors:  S H Kaufmann; D Peereboom; C A Buckwalter; P A Svingen; L B Grochow; R C Donehower; E K Rowinsky
Journal:  J Natl Cancer Inst       Date:  1996-06-05       Impact factor: 13.506

10.  Highly effective induction therapy for stage 4 neuroblastoma in children over 1 year of age.

Authors:  B H Kushner; M P LaQuaglia; M A Bonilla; K Lindsley; N Rosenfield; S Yeh; J Eddy; W L Gerald; G Heller; N K Cheung
Journal:  J Clin Oncol       Date:  1994-12       Impact factor: 44.544

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  43 in total

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Authors:  Steve E Braunstein; Wendy B London; Susan G Kreissman; Judith G Villablanca; Andrew M Davidoff; Kenneth DeSantes; Robert P Castleberry; Kevin Murray; Lisa Diller; Katherine Matthay; Susan L Cohn; Barry Shulkin; Daniel von Allmen; Marguerite T Parisi; Collin Van Ryn; Julie R Park; Michael P La Quaglia; Daphne A Haas-Kogan
Journal:  Pediatr Blood Cancer       Date:  2019-04-09       Impact factor: 3.167

2.  Association between end-induction response according to the revised International Neuroblastoma Response Criteria (INRC) and outcome in high-risk neuroblastoma patients.

Authors:  Erin K Barr; Kathryn Laurie; Kristen Wroblewski; Mark A Applebaum; Susan L Cohn
Journal:  Pediatr Blood Cancer       Date:  2020-07-25       Impact factor: 3.167

3.  Consolidation Therapy for Newly Diagnosed Pediatric Patients with High-Risk Neuroblastoma Using Busulfan/Melphalan, Autologous Hematopoietic Cell Transplantation, Anti-GD2 Antibody, Granulocyte-Macrophage Colony-Stimulating Factor, Interleukin-2, and Haploidentical Natural Killer Cells.

Authors:  Aimee C Talleur; Brandon M Triplett; Sara Federico; Ewelina Mamcarz; William Janssen; Jianrong Wu; David Shook; Wing Leung; Wayne L Furman
Journal:  Biol Blood Marrow Transplant       Date:  2017-07-18       Impact factor: 5.742

4.  Predictors of differential response to induction therapy in high-risk neuroblastoma: A report from the Children's Oncology Group (COG).

Authors:  Navin Pinto; Arlene Naranjo; Emily Hibbitts; Susan G Kreissman; M Meaghan Granger; Meredith S Irwin; Rochelle Bagatell; Wendy B London; Emily G Greengard; Julie R Park; Steven G DuBois
Journal:  Eur J Cancer       Date:  2019-04-01       Impact factor: 9.162

Review 5.  Determining the optimal dose in the development of anticancer agents.

Authors:  Ron H J Mathijssen; Alex Sparreboom; Jaap Verweij
Journal:  Nat Rev Clin Oncol       Date:  2014-03-25       Impact factor: 66.675

Review 6.  Retinoic acid postconsolidation therapy for high-risk neuroblastoma patients treated with autologous haematopoietic stem cell transplantation.

Authors:  Frank Peinemann; Elvira C van Dalen; Heike Enk; Frank Berthold
Journal:  Cochrane Database Syst Rev       Date:  2017-08-25

7.  Establishing a high-risk neuroblastoma cohort using the Pediatric Health Information System Database.

Authors:  Richard Aplenc; Rochelle Bagatell; Ami V Desai; Marko Kavcic; Yuan-Shung Huang; Nicole Herbst; Brian T Fisher; Alix E Seif; Yimei Li; Sean Hennessy
Journal:  Pediatr Blood Cancer       Date:  2014-01-13       Impact factor: 3.167

Review 8.  Neuroblastoma: clinical and biological approach to risk stratification and treatment.

Authors:  Vanessa P Tolbert; Katherine K Matthay
Journal:  Cell Tissue Res       Date:  2018-03-23       Impact factor: 5.249

9.  Prolonged progression-free survival after consolidating second or later remissions of neuroblastoma with Anti-GD2 immunotherapy and isotretinoin: a prospective Phase II study.

Authors:  Brian H Kushner; Irina Ostrovnaya; Irene Y Cheung; Deborah Kuk; Kim Kramer; Shakeel Modak; Karima Yataghene; N K Cheung
Journal:  Oncoimmunology       Date:  2015-05-22       Impact factor: 8.110

10.  FTY720 inhibits tumor growth and enhances the tumor-suppressive effect of topotecan in neuroblastoma by interfering with the sphingolipid signaling pathway.

Authors:  Mei-Hong Li; Timothy Hla; Fernando Ferrer
Journal:  Pediatr Blood Cancer       Date:  2013-05-23       Impact factor: 3.167

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