Phase II study of pirarubicin in metastatic breast cancer
Autor: | U. Essers, Lutz Edler, H.-E. Wander, Heinz H. Fiebig, B. Greifenberg, E. Salewski, Ulrich R. Kleeberg, Jörg Beyer, L. Reichel |
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Rok vydání: | 1990 |
Předmět: |
Adult
Cancer Research medicine.medical_specialty Nausea Pirarubicin Phases of clinical research Breast Neoplasms Gastroenterology Breast cancer Leukocytopenia Internal medicine Medicine Humans Multicenter Studies as Topic Neoplasm Metastasis Survival rate Aged Performance status business.industry Hematology Middle Aged medicine.disease Metastatic breast cancer Surgery Survival Rate Oncology Doxorubicin Drug Evaluation Female medicine.symptom business medicine.drug Follow-Up Studies |
Zdroj: | Onkologie. 13(3) |
ISSN: | 0378-584X |
Popis: | Pirarubicin is a more lipophilic derivative of doxorubicin, with a higher uptake rate of cells, lower cardiotoxicity and better antitumor efficacy in preclinical models. Thirty-four patients with metastatic breast cancer were treated in a multicenter phase II study with pirarubicin (THP) using a dosage of 75 mg/m2/every 3 weeks. The patients had a median age of 56 years (range 41-73) and a performance status of WHO grade 0-2. Patients pretreated with anthracyclines, or who were older than 75 years and without sufficient bone marrow reserve were excluded. The 32 evaluable patients received a median number of 4 cycles (range 2-8). The myelosuppression was dose-limiting and led to infections (grades 1 and 2) in 5 patients. Twenty-eight patients developed leukocytopenia grade 3 and 4 toxicity and 7 patients experienced thrombocytopenia grade 1 and 2. The drug was subjectively well tolerated and nausea, vomiting and alopecia were mild. One complete remission with a duration of 15.4 months (67 weeks) and 7 partial remissions with a median duration of 9.3 months (40 weeks) were achieved, which resulted in an overall response rate of 25%. Twenty-one patients were stable for 17 weeks (median) under the treatment with pirarubicin. |
Databáze: | OpenAIRE |
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