354 Taxol® (paclitaxel) 225 MG/M2 by 3-hour infusion without G-CSF as a first line therapy in patients with metastatic breast cancer (MBC)

We report the preliminary results on 50 out of 86 pts enrolled to an ongoing trial of Taxol (T) as 2nd line treatment for MBC. T dose is 225 mg/m 2 (3-h infusion) q3w without G-CSF. Eligibility criteria: age 18–75. ECOG PS ≤ 2, measurable disease and adequate organ function. Pts characteristics are: median (med) age 55 (range 36–76); med ECOG PS 1 (0–2); 24 pts received prior adjuvant + metastatic CT (group A) and 26 pts received only 1 prior metastatic CT (group B). Patients received a total of 217 cycles with a med number of T courses/pt of 4 (1–11). Fourty-nine pts are evaluable for toxicity and 46 for efficacy. Grade III/IV neutropenia was observed in 58% cycles. Febrile neutropenia was reported in only 3% cycles and grade III anemia in 5% cycles. No thrombocytopenia grade ≥ 3 was reported. Peripheral neuropathy grade ≥ 2 was noted in 31 pts: 20 (41%) grade II and 11 (22%) grade III. The med cumulative dose of T at appearance of grade III neuropathy was 900 mg/m 2 (450–1350). There were 2 CR, 11 PR, 22 SD and 11 PD, for an objective response rate of 28% (group A: 15%; group B: 38%). Conclusion Taxol 225 mg/m 2 as a 3-h infusion is a safe schedule for 2nd line pts with MBC. These preliminary results suggest an encouraging efficacy in this setting.