Abstract
792 Background: There is a need for more effective 2nd line treatment options for MBC. Both docetaxel (D) and gemcitabine (G) have shown efficacy in MBC as single agents. Combination-chemotherapy, even in 2nd line, may have advantages over single agent therapy. Methods: This multicenter phase II study evaluated the efficacy and safety of D and G in patients with anthracycline pretreated MBC. Eligibility criteria included measurable disease, adequate performance status and organ- and hematological functions. Patients received i.v. G 1000 mg/m2 d1 and d8 and on day 8 immediately followed by D 75 mg/m2 every 3 weeks for 6 cycles up to a maximum of 9 cycles. Premedication for D consisted of oral dexamethason 16 mg for 3 days starting the day before D infusion. Response evaluation was performed every 3rd cycle. Results: 34/40 pts have been enrolled, 26 are evaluable for response and toxicity. Anthracycline pretreatment was given for adjuvant purposes (10/26) or for palliative purposes (16/26 patients). This last group received 2nd line palliative chemotherapy. 21/26 Received at least 6 cycles, treatment was discontinued prior to 6 cycles due to progressive disease (PD) in 3/26. Two complete responses and 14 partial responses were observed, leading to an overall response rate of 61% (16/26). Stable disease was observed in 7 patients and 3 patients had PD. The mean response duration was 6.1 months. Mean time to progression was 7.7 months. Hematological toxicity was modest with grade 3–4 (NCI-CTC) leucopenia in 23/184 cycles, febrile leucopenia (grade 3) in 1/184 cycles and grade 3–4 thrombocytopenia in 2/184 cycles. Non-hematological toxicity(grade 3/4): edema 2/184 and diarrhea 1/184 cycles. Conclusions: Combination chemotherapy with gemcitabine 1000 mg/m2 d1 and d8 and docetaxel 75 mg/m2 on d 8 is feasible in anthracycline pretreated MBC and shows promising efficacy. No significant financial relationships to disclose.
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