Abstract |
ICRF-159, at a dose of 300 mg/m2, was given orally every 8 hours for nine doses every 21 days to 40 patients with metastatic breast cancer refractory to hormonal therapy and cyclophosphamide, methotrexate, 5-fluorouracil, and adriamycin chemotherapy. Two patients with soft tissue disease had short-lived partial responses. The hematologic toxicity was severe. Three patients required rbc transfusions. Four patients became septic at the nadir of leukopenia; two of these patients died while leukopenic. Two patients had platelet counts less than 25,000/mm3. All patients who were nonevaluable or who had life-threatening or lethal toxicity were nonambulatory. Since the 19 nonambulatory patients had a median survival of only 1.25 months as compared to 7 months in ambulatory patients, it is recommended that future phase II trials in chemotherapy-refractory breast cancer be limited to ambulatory patients. Although ICRF-159 has minimal antineoplastic effects, it is not recommended for further investigations in metastatic breast cancer, even at more hematologically tolerable doses of 250 mg/m2 every 8 hours for nine doses.
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Authors | R H Creech, P F Engstrom, D T Harris, R B Catalano, R E Bellet |
Journal | Cancer treatment reports
(Cancer Treat Rep)
Vol. 63
Issue 1
Pg. 111-4
(Jan 1979)
ISSN: 0361-5960 [Print] United States |
PMID | 369681
(Publication Type: Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
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Topics |
- Blood Cell Count
- Breast Neoplasms
(drug therapy)
- Clinical Trials as Topic
- Drug Evaluation
- Female
- Humans
- Neoplasm Metastasis
- Piperazines
(therapeutic use)
- Razoxane
(adverse effects, therapeutic use)
- Time Factors
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