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Journal of Clinical Oncology, Vol 22, No 17 (September 1), 2004: pp. 3563-3569 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.01.006 Treatment of Children and Adolescents With Stage II Testicular and Stages I and II Ovarian Malignant Germ Cell Tumors: A Pediatric Intergroup StudyPediatric Oncology Group 9048 and Children's Cancer Group 8891From the British Columbia Children's Hospital, Vancouver, British Columbia, Canada; Emory University-Children's Healthcare of Atlanta, Atlanta, GA; Presbyterian-St Luke's Medical Center, University of Colorado, and the Children's Hospital, Denver, CO; Stanford University Medical Center, Stanford, CA; Indiana University Medical Center and James Whitcomb Riley Hospital for Children, Indianapolis, IN; The Children's Oncology Group Statistics Department, The University of Florida, Gainesville, FL; and Wayne State University School of Medicine and Children's Hospital of Michigan, Detroit, MI Address reprint requests to Thomas A. Olson, MD, Division of Pediatric Hematology/Oncology, Ste 100, 2040 Ridgewood Dr, NE, Atlanta, GA 30322; e-mail: tolso01{at}emory.edu; CC: dcorreia{at}childrensoncologygroup.org PURPOSE: To determine whether children with localized gonadal malignant germ cell tumors (MGCT) stage II testicular and stages I and II ovarian treated with four cycles of standard-dose cisplatin combined with etoposide and low-dose bleomycin (PEB) have an event-free survival (EFS) of at least 85% without significant toxicity.
PATIENTS AND METHODS: Between May 1990 and July 1995, eligible pediatric patients with stage II or recurrent from stage I (as a stage II) testicular MGCT and stages I and II ovarian MGCT were enrolled onto this Pediatric Oncology Group and Children's Cancer Group study. PEB chemotherapy consisted of bleomycin 15 U/m2 on day 1, cisplatin 20 mg/m2/d on days 1 to 5, and etoposide 100 mg/m2/d on days 1 to 5. Patients received four cycles of therapy at 21-day intervals. RESULTS: Seventy-four patients with a median age of 10.5 years (range, 8.7 months to 16.7 years) were enrolled. Primary sites included: stage II testicular (n = 17), stage I ovarian (n = 41), and stage II ovarian MGCT (n = 16). Treatment with standard PEB resulted in 6-year EFS of 95% and overall survival (OS) of 95.7%. EFS and OS by primary site were as follows: stage II testicular, 100% and 100%; stage I ovarian, 95.1% and 95.1%; and stage II ovarian, 87.5% and 93.8%, respectively. Two patients died from recurrent disease, and one patient died of secondary acute myelocytic leukemia. Infrequent grade 3 to 4 hematologic toxicity was reported. No grade 3 to 4 renal, pulmonary, or ototoxicity was observed. CONCLUSION: Combination chemotherapy with PEB results in excellent EFS and OS with minimal toxicity in children and adolescents with localized gonadal MGCT. Supported by grant Nos. U10 CA29139 from the Pediatric Oncology Group CA13539 from the Children's Cancer Group. Participating institutions and associated grant numbers are given in the Appendix. Presented in part at the 34th Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, May 16-18, 1998, and 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003. Authors' disclosures of potential conflicts of interest are found at the end of this article.
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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