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Phase II study of sequential administration of vinorelbine -capecitabine combination followed by weekly docetaxel as first line chemotherapy for advanced breast cancer.

817 Background: The combination of vinorelbine (N) and capecitabine (C) has demonstrated to be active and safe regimen for advanced breast cancer (ABC) (Ghosn; ASCO 03); capecitabine and docetaxel (D) combination in anthracycline failure has demonstrated an interesting outcomes, but with high toxicity profile. In order to improve patient clinical benefit by minimizing toxicity, we conducted a phase II trial with these 3 agents in sequential schedule.


METHODS
Eligible patients (pts) had ABC (locally advanced or metastatic), measurable disease, no prior chemotherapy for ABC, WHO PS<2, adequate bone morrow, renal and hepatic functions and written informed consent. Pts received 4 cycles of N: 25 mg/m2 on day 1 & day 8 in combination with C: 825 mg/m2 twice a day from day 1 to day 14 every 3 weeks. Pts with objective response or stable disease received twelve consecutive weeks of D: 25 mg/m2.


RESULTS
Between July 02 and Sept 03, forty-two consecutive pts were enrolled into the study; median age: 58 years (36-79), median WHO PS: 1 (0-2), 7 pts were stage IV at diagnosis. Sites involved; visceral: 78.5%, bone: 33%, adjuvant chemotherapy: 67% (anthracycline: 57%, anthra + taxane: 9.5%), prior hormonal therapy: 62%. Up to day, so far thirty pts were evaluable for efficacy and 36 pts for toxicity. Twenty-four pts achieved an objective response (ORR: 80%) including one complete response, 3 pts had a stable disease and disease progression occurred in 3 pts. The treatment was well tolerated, WHO grade 3-4 neutropenia (14% pts) and febrile neutropenia (8% pts), grade 3-4 thrombocytopenia and anemia were seen in one pt respectively. No severe clinical toxicity was reported, Grade 1-2 hand-foot syndrome (7% pts), nausea/vomiting (8%), asthenia, diarrhea, edema and nail disorders were occurred in 3% of pts respectively.


CONCLUSIONS
The sequential treatment of N+C followed by weekly D as first line chemotherapy is highly active and well tolerated regimen, response rates were not affected by prior adjuvant chemotherapy or visceral involvement. Final results will be presented at the meeting. No significant financial relationships to disclose.