Abstract | OBJECTIVE: METHODS: From October 1996, we carried out a phase II trial in 69 heavily pretreated patients with advanced breast cancer with docetaxel 100 mg/m(2) by a 1-hour infusion on day 1, with cycles repeated every 3 weeks. Patients were classified as having primary anthracycline resistance (n = 32), secondary anthracycline resistance (n = 7), anthracycline pretreatment (n = 22) or no anthracycline pretreatment (n = 8). RESULTS: Among 68 evaluable patients, we observed 6 (9%) complete responses and 27 (40%) partial responses, for an overall response rate of 49% (95% confidence interval 37-61%); the disease remained stable in 17 patients (25%). Responses according to the above subgroups were as follows: primary anthracycline resistance 41%, secondary anthracycline resistance 43%, anthracycline pretreatment 64% and no anthracycline pretreatment 43%. The median time to response, median time to progression and median overall survival were 2, 7 and 10 months, respectively. Myelosuppression was the dose-limiting toxicity, with grade 4 neutropenia occurring in 47% of the patients and neutropenic fever in 12%. G-CSF was added in the case of grade 4 febrile neutropenia; a 25% reduction in the dose of docetaxel was required in 4 patients. Other side effects were mild. CONCLUSIONS: The results of the present trial confirm the high activity of docetaxel in heavily pretreated patients with advanced breast cancer, including those with strictly defined anthracycline resistance.
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Authors | P Vici, F Belli, L Di Lauro, A Amodio, F Conti, P Foggi, T Gionfra, M F Morelli, C Botti, A Ferraironi, M Lopez |
Journal | Oncology
(Oncology)
Vol. 60
Issue 1
Pg. 60-5
( 2001)
ISSN: 0030-2414 [Print] Switzerland |
PMID | 11150910
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Antibiotics, Antineoplastic
- Antineoplastic Agents, Phytogenic
- Taxoids
- Granulocyte Colony-Stimulating Factor
- Docetaxel
- Paclitaxel
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Topics |
- Adult
- Aged
- Antibiotics, Antineoplastic
(therapeutic use)
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, pathology)
- Docetaxel
- Drug Administration Schedule
- Drug Resistance, Neoplasm
- Female
- Granulocyte Colony-Stimulating Factor
(therapeutic use)
- Humans
- Infusions, Intravenous
- Middle Aged
- Neutropenia
(chemically induced, drug therapy)
- Paclitaxel
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Survival Analysis
- Taxoids
- Treatment Outcome
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