Vinorelbine and capecitabine combination as first-line treatment in patients with metastatic breast cancer: Final results of a multicentric trial in Egypt (original) (raw)

Journal of Clinical Oncology

Abstract

ABSTRACT Background: The efficacy of vinorelbine with capecitabine was shown to be more than just additive in vitro. Moreover, vinorelbine-capecitabine combination demonstrated promising antitumor activity in the clinical setting. Based on this data we conducted a multicentric phase II study to evaluate the efficacy and safety of this combination. Methods: We report results for the 45 metastatic breast cancer patients enrolled (Nov 2005 to Nov 2006), first line treatment, at least one measurable lesion. Treatment schedule: vinorelbine 25 mg/m2 I.V. day 1 and 8, capecitabine 1,000 mg/m2 twice daily, day 1–14 q 21 days. Primary endpoint: objective response rate. Patients: Average age 49 years; range (28 -68). Median WHO PS 1; range (0–2). 96% of patients had received prior neo/adjuvant anthracycline based chemotherapy (CT) without taxanes. No adjuvant CT within the last 3 months. The most frequent metastatic sites were lung (76%), liver (49%), and bone (29%). 24% of pts had one metastatic site, 56% had 2, 18% had 3 and 2% had more than 3 sites. 6 pts (13%) had one or more metastatic sites associated to a local recurrence. Results: The median number of chemotherapy cycles was 6; range (3–6), total number of cycles: 244. All pts were evaluable for response. An objective tumor response was achieved in 29 pts 64%, (OR = CR + PR), complete response CR in 2 (4%) pts. 8 (18%) pts had stable disease. The median time to progression is 9 months. The median survival is not yet reached (median duration of follow-up of 13.5 months). The majority of adverse events were mild to moderate. No WHO grade 4 toxicities were noted. 6 (13%) pts developed Gr 3 neutropenia, Gr 3 nausea/vomiting and oral stomatitis were reported in 7 (16%) and 5 (11%) pts respectively. 3 patients developed Gr 3 hand foot syndrome. Conclusions: Vinorelbine-capecitabine combination shows high activity and good tolerance as first-line treatment for MBC.

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