The combination of Epirubicin and Taxotere (ET), both drugs given at 75 mg/ m2day 1q. 21 days, is widely used in the treatment of advanced breast cancer. We previously reported a phase I study which indicated that Capecitabine 2000 mg/m2/day for 14 consecutive days could be safely combined with full doses of ET. Among 23 patients treated 21 (91%), responded to the treatment. On these premises, we undertook a multicenter phase II trial to confirm the activity of the this regimen (Taxotere 75 mg/m2 IV bolus on day 1. Epirubicin 75 mg/m2 IV bolus on day 1, Capecitabine 2000 mg/m2/day for 14 consecutive days, q. 21 days). From March 2000 to February 2001, six Italian Centers enrolled 67 advanced breast cancer patients (pts), with measurable disease. To date, 65 pts have been evaluated. The median age was 53 years (range 31-68); 33 pts (51%) had locally advanced disease, 32 pts (49%) distant metastasis and 17 (26 %) of them had two or more metastatic sites. Severe non-hematological toxicity was rarely reported. Only one patient experienced a grade 4 non-hematological toxicity (mucositis). Grade 3 non-hematological toxicities were: asthenia 4 pts (6%), mucositis 3 pts (5%), hand-foot syndrome 2 pts (3%). nausea and vomiting 6 pts (9%), diarrhea 1 pts (3%), allergy 1 pt (2%), dyspnea 1 pt (2%). venous thrombosis 1 pt (2%). A mild or moderate increase of ALT and bilirubin was observed in 17 pts (26%), and 7 pts (11%), respectively. Thrombocytopenia was seldom reported: two (3%) pts suffered from it of grade 3. Grade 3/4 anemia was observed in 2 pts (3%). Neutropenia was the predominant toxicity. Forty-six percent of pts had grade 3/4 neutropenia. Ten pts (15%) had febrile neutropenia. Preliminary data on 50 evaluable pts showed an objective response (CR+PR) in 21/26 (81%) locally advanced pts and 17/ 24 (71%) metastatic pts. These data confirmed that Capecitabine can be incorporated with full doses of ET and that this new regimen is highly active in advanced breast cancer. Based on these data, a large multicenter randomized Phase III trial is ongoing.
Capecitabine in association with epirubicin and docetaxel as a first line treatment in advanced breast cancer a multicenter phase II study
Del Mastro L.;Durando A.;Garrone O.;Bellino R.;Baldini A.;
2001-01-01
Abstract
The combination of Epirubicin and Taxotere (ET), both drugs given at 75 mg/ m2day 1q. 21 days, is widely used in the treatment of advanced breast cancer. We previously reported a phase I study which indicated that Capecitabine 2000 mg/m2/day for 14 consecutive days could be safely combined with full doses of ET. Among 23 patients treated 21 (91%), responded to the treatment. On these premises, we undertook a multicenter phase II trial to confirm the activity of the this regimen (Taxotere 75 mg/m2 IV bolus on day 1. Epirubicin 75 mg/m2 IV bolus on day 1, Capecitabine 2000 mg/m2/day for 14 consecutive days, q. 21 days). From March 2000 to February 2001, six Italian Centers enrolled 67 advanced breast cancer patients (pts), with measurable disease. To date, 65 pts have been evaluated. The median age was 53 years (range 31-68); 33 pts (51%) had locally advanced disease, 32 pts (49%) distant metastasis and 17 (26 %) of them had two or more metastatic sites. Severe non-hematological toxicity was rarely reported. Only one patient experienced a grade 4 non-hematological toxicity (mucositis). Grade 3 non-hematological toxicities were: asthenia 4 pts (6%), mucositis 3 pts (5%), hand-foot syndrome 2 pts (3%). nausea and vomiting 6 pts (9%), diarrhea 1 pts (3%), allergy 1 pt (2%), dyspnea 1 pt (2%). venous thrombosis 1 pt (2%). A mild or moderate increase of ALT and bilirubin was observed in 17 pts (26%), and 7 pts (11%), respectively. Thrombocytopenia was seldom reported: two (3%) pts suffered from it of grade 3. Grade 3/4 anemia was observed in 2 pts (3%). Neutropenia was the predominant toxicity. Forty-six percent of pts had grade 3/4 neutropenia. Ten pts (15%) had febrile neutropenia. Preliminary data on 50 evaluable pts showed an objective response (CR+PR) in 21/26 (81%) locally advanced pts and 17/ 24 (71%) metastatic pts. These data confirmed that Capecitabine can be incorporated with full doses of ET and that this new regimen is highly active in advanced breast cancer. Based on these data, a large multicenter randomized Phase III trial is ongoing.
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