| Autor: |
Brugnatelli, Silvia, Danova, Marco, De Bella, Manuela Tamburo, Vaglica, Marina, Manuguerra, Giovanna, Riccardi, Alberto, Palmeri, Sergio |
| Předmět: |
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| Zdroj: |
Oncology; 2002, Vol. 62 Issue 1, p33-38, 6p, 3 Charts |
| Abstrakt: |
Objective: This study was designed to determine the maximum tolerable dose (MTD) of gemcitabine plus docetaxel, both given on a weekly schedule, in patients with pretreated metastatic breast cancer (MBC). Methods: Heavily pretreated patients with MBC, aged 18–75 years with World Health Organization performance status of 0–2 were enrolled. Three escalating weekly doses of docetaxel (30, 35 and 40 mg/m[sup 2] ) followed by a weekly fixed dose of gemcitabine, 800 mg/m[sup 2] , were administered on days 1, 8 and 15 of a 28-day cycle. Dose-limiting toxicity (DLT) included grade >3 hematologic toxicity and grade >2 stomatitis, asthenia, diarrhea or organ-specific toxicity (except alopecia). Dose escalation was stopped if ≥3 of 5 patients at any dose level experienced DLT. Results: Eighteen patients (median age 56 years) received a mean of 4.1 (range 1–6) cycles. Asthenia, stomatitis and leukopenia were the main DLTs. One of 5 patients had DLT at dose level 1 and 2 of 5 patients at dose level 2. At dose level 3, 3 of 5 patients had DLTs. Three additional patients treated at dose level 3 confirmed that the MTD had been reached. Therefore, the recommended docetaxel dose in combination with gemcitabine 800 mg/m[sup 2] for phase II studies was established at the next lower dose, 35 mg/m[sup 2] . Of 12 evaluable patients, 7 (58%) achieved an objective response. Conclusions: Gemcitabine 800 mg/m[sup 2] plus docetaxel 35 mg/m[sup 2] on days 1, 8 and 15 of a 28-day cycle is a safe regimen which shows activity in heavily pretreated patients with MBC. Further phase II investigations with this combination are now warranted.Copyright © 2002 S. Karger AG, Basel [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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