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- Title
High-dose cisplatin, etoposide, and cyclophosphamide with autologous stem cell reinfusion in patients with responsive metastatic or high-risk primary breast cancer.
- Authors
Somlo, George; Doroshow, James H.; Forman, Stephen J.; Leong, Lucille A.; Margolin, Kim A.; Morgan, Robert J.; Raschko, James W.; Akman, Steven A.; Ahn, Chul; Sniecinski, Irena; Somlo, G; Doroshow, J H; Forman, S J; Leong, L A; Margolin, K A; Morgan, R J Jr; Raschko, J W; Akman, S A; Ahn, C; Sniecinski, I
- Abstract
<bold>Background: </bold>This study was designed to establish the feasibility of combining high-dose cisplatin, etoposide, and cyclophosphamide followed by stem cell rescue in patients with responsive metastatic or high-risk primary breast cancer.<bold>Methods: </bold>Eligibility criteria included the presence of high-risk primary breast cancer (Stage II with 10 or more involved axillary nodes or Stage IIIA or B) or Stage IV disease in complete or partial response; physiologic age 50 years or younger; Karnofsky performance status of 80% or greater; and creatinine clearance of 80 ml/minute or greater. Chemotherapy consisted of escalating doses of cisplatin (50-150 mg/m2 intravenously [IV]) given on days -12 and -5, etoposide (30 mg/kg IV) given on days -12 and -5, and cyclophosphamide (100 mg/kg IV) on day -3. On day 0, autologous bone marrow with or without peripheral stem cells, or granulocyte colony-stimulating factor primed peripheral stem cells alone were reinfused.<bold>Results: </bold>Thirty patients were enrolled in this study. Twenty-eight patients demonstrated no evidence of persistent renal damage after treatment. Two patients suffered symptomatic peripheral neuropathy, and one patient required a hearing aid 3 months after therapy. Hematopoietic toxicities were acceptable. There were two fatalities; Streptococcus viridans bacteremia and adult respiratory distress syndrome developed in one patient; and one patient who received 262 mg/m2 of cisplatin died of renal failure. Twelve of 18 assessable patients with Stage IV disease are without evidence of progression; 3 of these patients are progression-free at 11+, 12+, and 32+ months. With a median follow-up of 16+ months (range, 4-31 months), 7 patients of the group of 11 treated with high-risk primary breast cancer are without evidence of disease.<bold>Conclusions: </bold>The Phase II dose of cisplatin when given on a day -12 and day -5 schedule in combination with etoposide and cyclophosphamide has been established at a total of 250 mg/m2. Dose-limiting toxicity has been defined as renal failure, and response rates were comparable to previously reported high-dose chemotherapeutic regimens.
- Publication
Cancer (0008543X), 1994, Vol 73, Issue 1, p125
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(19940101)73:1<125::AID-CNCR2820730122>3.0.CO;2-W