Randomized phase-III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen Journal Article


Authors: Finlay, J. L.; Boyett, J. M.; Yates, A. J.; Wisoff, J. H.; Milstein, J. M.; Geyer, J. R.; Bertolone, S. J.; McGuire, P.; Cherlow, J. M.; Tefft, M.; Turski, P. A.; Wara, W. M.; Edwards, M.; Sutton, L. N.; Berger, M. S.; Epstein, F.; Ayers, G.; Allen, J. C.; Packer, R. J.; for the Children's Cancer Group
Article Title: Randomized phase-III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen
Abstract: Purpose: In a previous randomized trial, the addition of adjuvant chemotherapy to postoperative radiotherapy proved beneficial in the treatment of childhood high-grade astrocytomas. The present study tests the hypothesis sis that an eight-drug adjuvant chemotherapy regimen would improve survival in such children compared with the three-drug regimen of the prior study. Patients and Methods: Between April 1985 and May 1990, patients between the ages of 18 months and 21 years with newly diagnosed high-grade astrocytomas were eligible for this study, as determined by the treating institution's histopathologic diagnosis. Treatment consisted of postoperative local-field radiotherapy and adjuvant chemotherapy, either lomustine (CCNU), vincristine, and prednisone (control regimen) or eight-drugs-in-1-day chemotherapy (experimental regimen). Two cycles of postoperative preirradiation chemotherapy were administered in the experimental regimen. Patients were evaluated radiographically every 3 months after irradiation. Results: Eighty-five eligible patients were randomized to the control regimen and 87 to the experimental regimen. The progression-free survival (PFS) and overall survival (OS) at 5 years were 33% (SE = 5%) and 36% (SE = 6%), respectively. There was no statistical difference in outcome between the two chemotherapy regimens. In patients with confirmed diagnoses of anaplastic astrocytoma (AA) or glioblastoma multiforme (GEM), anaplastic astrocytoma, greeter than 90% resection, and nonmidline tumor location were characteristics predictive of an improved PFS. There was a difference in toxicity between the two chemotherapeutic regimens, with greeter myelosuppression and hearing loss in the experimental regimen. Tumor recurrence occurred primarily within the primary tumor site. Conclusions: There is no benefit to the treatment of high rode astrocytomas in children with eight-drugs-in-1-day chemotherapy compared with CCNU, vincristine, and prednisone. Extent of tumor resection and histopathologic diagnosis are significant prognostic variables. The overall outcome for children with high-grade astrocytomas remains poor.
Keywords: survival; chemotherapy; tumors; surgical resection; children; clinical-trials; radiation-therapy; glioblastoma-multiforme; gliomas; prognosis
Journal Title: Journal of Clinical Oncology
Volume: 13
Issue: 1
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1995-01-01
Start Page: 112
End Page: 123
Language: English
ACCESSION: WOS:A1995QA32500017
DOI: 10.1200/jco.1995.13.1.112
PROVIDER: wos
PUBMED: 7799011
Notes: Article -- Source: Wos
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  1. Jonathan Finlay
    67 Finlay