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Randomized Comparison of Combination Chemotherapy With Etoposide, Bleomycin, and Either High-Dose or Standard-Dose Cisplatin in Children and Adolescents With High-Risk Malignant Germ Cell Tumors: A Pediatric Intergroup Study—Pediatric Oncology Group 9049 and Children's Cancer Group 8882

From the Wayne State University School of Medicine and Children's Hospital of Michigan, Detroit, MI; University of Colorado School of Medicine and The Children's Hospital, and Presbyterian-St Luke's Medical Center, Denver, CO; Stanford University Medical Center, Stanford, CA; Emory University School of Medicine, Atlanta, GA; Indiana University Medical Center and J.W. Riley Hospital for Children, Indianapolis, IN; Johns Hopkins Medical Institutions, Baltimore, MD; St Christopher's Hospital for Children, Philadelphia, PA; Baylor College of Medicine and Texas Children's Hospital, Houston, TX; The Children's Oncology Group Statistics Department, University of Florida, Gainesville, FL; University of Alabama at Birmingham, Birmingham, AL; and British Columbia Children's Hospital, Vancouver, British Columbia, Canada

Address reprint requests to Thomas A. Olson, MD, Division of Pediatric Hematology/Oncology, Emory University School of Medicine, Suite 100, 2040 Ridgewood Dr NE, Atlanta, GA 30322; e-mail: tolso01{at}emory.edu

PURPOSE: To determine in a randomized comparison whether combination chemotherapy with high-dose cisplatin (HDPEB) improves the event-free (EFS) and overall (OS) survival of children and adolescents with high-risk malignant germ cell tumors (MGCT) as compared with standard-dose cisplatin (PEB) and to compare the regimens' toxicity.

RESULTS: One hundred thirty-four eligible patients with advanced testicular (n = 60) or ovarian (n = 74) tumors and 165 with stage I to IV extragonadal tumors were enrolled. HDPEB treatment resulted in significantly improved 6-year EFS rate ± SE (89.6% ± 3.6% v 80.5% ± 4.8% for PEB; P = .0284). There was no significant difference in OS (HDPEB 91.7% ± 3.3% v PEB 86.0% ± 4.1%). Tumor-related deaths were more common after PEB (14 deaths v two deaths). Toxic deaths were more common with HDPEB (six deaths v one death). Other treatment-related toxicities were more common with HDPEB.

CONCLUSION: Combination chemotherapy with HDPEB significantly improves EFS for children with high-risk MGCT. The OS is similar in both regimens, and the significant toxicity associated with HDPEB limits its use.

Supported by Pediatric Oncology Group grants No. U10CA29139 and CA30969 and Children's Cancer Group grant No. CA13539. Additional information on financial support is given in the Appendix.

Presented in part at the 34th Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, May 16–19, 1998.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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