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| |  High-Dose Chemotherapy Regimen Effective for Germ-Cell Cancer DUARTE, Calif.-- Oct. 29, 1996 -- A three-drug chemotherapy regimen combined with autologous, or self-derived, stem-cell support is effective in treating patients with advanced testicular cancer, according to a study conducted at the City of Hope National Medical Center in Duarte. The results of the study are published in the October 1996 issue of the Journal of Clinical Oncology. Based on the City of Hope results and data from other institutions, the investigators believe it is likely that 33 percent to 50 percent of carefully selected patients can be cured by the use of this high-dose chemotherapy regimen. Previously, in less-carefully-selected patients, only 15 percent to 25 percent achieved durable complete remissions. Germ-cell cancers are characterized by a proliferation of cells that are immature forms of either sperm in the male testis or ova in the female ovary. Last year, 5,500 people in the United States were diagnosed with germ-cell cancers. "To increase the proportion of patients with advanced germ-cell cancer who benefit from chemotherapy regimens and reduced toxicity, the City of Hope team investigated the effectiveness of two cycles of three chemotherapeutic agents, ifosfamide, carboplatin and etoposide, given at high doses and supported with autologous stem cells,'" explained Kim Margolin, M.D., principal investigator and staff physician in the City of Hope departments of Medical Oncology and Hematology/Bone Marrow Transplantation. The study group consisted of 20 advanced germ-cell cancer patients who had been diagnosed as having poor-prognosis, chemotherapeutically sensitive germ-cell cancer, said James H. Doroshow, M.D., director, Department of Medical Oncology and Therapeutics Research, and study co-investigator. Stem cells were harvested from the bone marrow and/or circulating blood prior to the high-dose chemotherapy regimen and infused after each of two treatment cycles to shorten the time to recover from high-dose chemotherapy. After a median follow-up period of 45 months, nine patients were alive and disease-free. One patient with embryonal cancer developed growing lung metastases three months after high-dose chemotherapy and underwent complete surgical removal of lung metastases, and remains disease-free at more than 63 months. Eight patients are continuously cancer-free at 23 to more than 70 months. Eleven patients died of their germ-cell tumors between four and 23 months following treatment. "The fact that no patients died as a result of this therapy or developed debilitating damage to their nervous system, hearing loss or severe kidney damage is also encouraging," said Margolin. "The excellent safety and tolerability profile of this regimen and its encouraging activity in poor-prognosis patients make it worthy of further study as part of initial therapy in randomized protocols for high-risk disease and early in the treatment of relapsed germ-cell cancer," added Doroshow. Other City of Hope investigators included: Chul Ahn, Ph.D., assistant research scientist, Department of Biostatistics; and Victor Hamasaki, M.D., Lucille Leong, M.D., Robert J. Morgan Jr., M.D., James Raschko, M.D., Stephen Shibata, M.D., George Somlo, M.D., and Merry Tetef, M.D., staff physicians, Department of Medical Oncology and Therapeutics Research. Founded in 1913, City of Hope is one of the world's leading research and treatment centers for cancer and other life-threatening diseases, including diabetes. The largest provider of bone-marrow transplantation services in California, City of Hope is a National Cancer Institute-designated Clinical Cancer Research Center.
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