A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent breast cancer
| Autor: | H Aoyama, M. Narabayashi, Shigemitsu Takashima, Noboru Horikoshi, Tetsuo Taguchi, Iki Adachi, Takashi Watanabe |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Lung Neoplasms Neutropenia Adolescent Paclitaxel Nausea medicine.medical_treatment Bone Neoplasms Breast Neoplasms Docetaxel Adenocarcinoma Gastroenterology Internal medicine Toxicity Tests medicine Humans Infusions Intravenous Aged Aged 80 and over Chemotherapy Leukopenia Performance status business.industry Liver Neoplasms Alopecia Middle Aged medicine.disease Antineoplastic Agents Phytogenic Metastatic breast cancer Carcinoma Papillary Surgery Oncology Carcinoma Medullary Lymphatic Metastasis Vomiting Female Taxoids Neoplasm Recurrence Local medicine.symptom business Research Article medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| DOI: | 10.1038/bjc.1996.37 |
| Popis: | A late phase II clinical trial of RP56976 (docetaxel), derived from Taxus baccata was performed to evaluate anti-tumour activity, time to progression and clinical toxicity in patients with advanced or recurrent breast cancer. The patients, between 15 and 80 years old with performance status (PS) of 0-2, received at least two cycles of docetaxel 60 mg m-2 intravenously at 3-4 week intervals. Of the 81 patients enrolled, the 72 eligible for the study were given a total of 327 cycles, with a median of four cycles each. Five patients obtained a complete response (CR) and 27 a partial response (PR); the response rate (RR) was 44.4% (95% confidence interval 32.7-56.6%). A relatively high RR of 9/28 (32.1%) was observed in patients who had received prior chemotherapy involving anthracyclines. The dose-limiting toxicity was grade 3-4 leucocytopenia or neutropenia, found in 78.9% and 85.9% patients respectively. Other severe (grade > 3) toxicities included alopecia (38%), anorexia (18.3%), nausea/vomiting (11.3%), and fatigue (9.9%). Hypersensitivity reactions, oedema and skin toxicity were not severe and were reversible. One therapy-related death occurred 10 days after the initial dose was given. These findings indicate that docetaxel has potent activity against metastatic breast cancer, and that the dose of 60 mg m-2 is safe. |
| Databáze: | OpenAIRE |
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