TY - JOUR
T1 - “Weekly docetaxel and gemcitabine as first line treatment for metastatic breast cancer: results of a multicenter phase II study”
AU - Cajozzo, Massimo
AU - Palmeri, Sergio
AU - Leonardi, Vincenza
AU - Filippelli, null
AU - Condemi, null
AU - Ferraù, Francesco
AU - Mangiameli, Andrea
AU - Spada, null
AU - Ferraù, null
AU - De Cataldis, null
AU - Leonardi, null
AU - Massidda, Bruno
AU - Farris, null
AU - Comella, Giuseppe
AU - Danova, Marco
AU - Misino, null
AU - Palmeri, Laura
PY - 2005
Y1 - 2005
N2 - Objectives: We conducted a multicenter phase II study to evaluate the clinical effi cacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabineas fi rst-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel35 mg/m 2 and gemcitabine 800 mg/m 2 i.v. on days 1, 8,15 every 28 days. Results: All patients were assessable for toxicity and 56 for effi cacy. Overall response rate was64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrileneutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experiencedgrade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule,in agreement with other published studies, need to befurther confirmed within a phase III study.
AB - Objectives: We conducted a multicenter phase II study to evaluate the clinical effi cacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabineas fi rst-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel35 mg/m 2 and gemcitabine 800 mg/m 2 i.v. on days 1, 8,15 every 28 days. Results: All patients were assessable for toxicity and 56 for effi cacy. Overall response rate was64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrileneutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experiencedgrade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule,in agreement with other published studies, need to befurther confirmed within a phase III study.
UR - http://hdl.handle.net/10447/25924
M3 - Article
VL - 68 (4-6)
SP - 438
EP - 445
JO - Oncology
JF - Oncology
SN - 0030-2414
ER -