First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study

• Main Authors: Piperno-Neumann Sophie, Tubiana-Mathieu Nicole, Tubiana-Hulin Michele, Gawande Sulochana R, Allouache Djelila, Mefti Fawzia, Bozec Laurence, Genot Jean-Yves
• Format: Article
• Language: English
• Published: BMC 2005-11-01
• Series: BMC Cancer
• Online Access: http://www.biomedcentral.com/1471-2407/5/151

<p>Abstract</p> <p>Background</p> <p>This phase II study evaluated the efficacy and safety of gemcitabine (G) plus paclitaxel (T) as first-line therapy in recurrent or metastatic breast cancer.</p> <p>Methods</p> <p>Patients with locally, recurrent or metastatic breast cancer and no prior chemotherapy for metastatic disease received G 1200 mg/m²on days 1 and 8, and T 175 mg/m²on day 1 (before G) every 21 days for a maximum of 10 cycles.</p> <p>Results</p> <p>Forty patients, 39 metastatic breast cancer and 1 locally-advanced disease, were enrolled. Their median age was 61.5 years, and 85% had a World Health Organization performance status (PS) of 0 or 1. Poor prognostic factors at baseline included visceral involvement (87.5%) and ≥2 metastatic sites (70%). Also, 27 (67.5%) patients had prior adjuvant chemotherapy, 25 of which had prior anthracyclines. A total of 220 cycles (median 6; range, 1–10) were administered. Of the 40 enrolled patients, 2 had complete response and 12 partial response, for an overall response rate of 35.0% for intent-to-treat population. Among 35 patients evaluable for efficacy the response rate was 40%. Additional 14 patients had stable disease, and 7 had progressive disease. The median duration of response was 12 months; median time to progression, 7.2 months; median survival, 25.7 months. Common grade 3/4 toxicities were neutropenia in 17 (42.5%) patients each, grade 3 leukopenia in 19 (47.5%), and grade 3 alopecia in 30 (75.0%) patients; 1 (2.5%) patient had grade 4 thrombocytopenia.</p> <p>Conclusion</p> <p>GT exhibited encouraging activity and tolerable toxicity as first-line therapy in metastatic breast cancer. Phase III trials for further evaluation are ongoing.</p>