A phase II study of docetaxel (T) and capecitabine (X) combination chemotherapy as first-line chemotherapy for patients (pts) with metastatic breast cancer (MBC)

Abstract

889 Background: The addition of X to T extends survival, time to disease progression (TTP) and response rate (RR) in pts with pretreated MBC. This phase II study evaluated the efficacy and safety of TX as a first-line therapy for pts with stage IV or recurrent breast cancer. Methods: Eligible pts had measurable MBC, ECOG PS of 0–2 and had received no prior chemotherapy for metastasis. Pts received T 75mg/m2 i.v. with routine premedication on day 1 and X 1000mg/m2 p.o. bid on days 1–14, q 3 weeks until disease progression or unacceptable toxicity. Results: Of the 38 pts enrolled, 5 are not evaluable (2 ineligible and 3 lost to follow up after 1 cycle). Of the 33 evaluable pts, 21 had recurrent and 12 stage IV disease with median age of 52 yrs (range 28–68). ER+ was 36%, PR+ 30%, HER2 3+ 18%. Disease free interval for recurrent disease was 24 mo (range 5–96). Metastatic site: lymph nodes (76%), breast (52%), bone (36%), liver (33%), lung (27%), and skin (9%). Previous adjuvant chemotherapy: anthracycline-based (29%); CMF (67%). A total of 178 cycles with median 6 (range 2–10) per pt were given. The mean relative dose intensities for T and X were 85% and 75%, respectively. Adverse event: G3/4 neutropenia (82%, febrile 3%), G3 hand-foot syndrome (12%), and G2 nail changes (79%). There was no treatment-related death. The overall RR was 61% (3 CRs and 17 PRs). RR was significantly higher in pts without prior adjuvant chemotherapy (85% vs. 45%; p=0.02). All 3 CRs and 15/17 PRs were observed in anthracycline-naïve pts. Median TTP was 8.4 mo (95% CI, 7.0–10.9) and median response duration was 7.4 mo (95% CI, 6.6–16.5). After a median follow up of 20.0 mo (range 3.3–27.7), 10 pts died and median survival has not been reached. Conclusion: TX is highly active as first-line therapy for pts with MBC, with a durable TTP and high RR, particularly in pts having received no anthracyclines in adjuvant setting. The rate of G3/4 neutropenia was high, but would likely be reduced through appropriate T dose reductions. (Supported in part by Aventis and Roche Korea) No significant financial relationships to disclose.