TY - JOUR
T1 - Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer
T2 - A phase II study
AU - Conte, P. F.
AU - Donati, S.
AU - Gennari, A.
AU - Guarneri, V.
AU - Orlandini, C.
AU - Rondini, M.
AU - Roncella, M.
AU - Marini, L.
AU - Collecchi, P.
AU - Viacava, P.
AU - Naccarato, A. G.
AU - Degli Esposti, R.
AU - Bonardi, S.
AU - Bottini, A.
AU - Saracchini, S.
AU - Tumolo, S.
AU - Gullo, G.
AU - Santoro, A.
AU - Crino, L.
PY - 2005/8/22
Y1 - 2005/8/22
N2 - This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II-IIIA breast cancer were treated with gemcitabine 1000 mg m-2 over 30 min on days 1 and 4, epirubicin 90 mg m-2 as an intravenous bolus on day 1, and taxol 175 mg m-2 as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8-97.8), with 26.8% complete responses (95% CI 13.3-40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8-25.4); 15 patients (36.6%; 95% CI 21.9-51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles (granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (≥20% in 71.4% of the patients) and at definitive surgery (28.6%, P
AB - This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II-IIIA breast cancer were treated with gemcitabine 1000 mg m-2 over 30 min on days 1 and 4, epirubicin 90 mg m-2 as an intravenous bolus on day 1, and taxol 175 mg m-2 as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8-97.8), with 26.8% complete responses (95% CI 13.3-40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8-25.4); 15 patients (36.6%; 95% CI 21.9-51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles (granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (≥20% in 71.4% of the patients) and at definitive surgery (28.6%, P
KW - Breast cancer
KW - Epirubicin
KW - Gemcitabine
KW - Pathological complete response
KW - Primary chemotherapy
KW - Taxol
UR - http://www.scopus.com/inward/record.url?scp=24944535396&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=24944535396&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6602723
DO - 10.1038/sj.bjc.6602723
M3 - Article
C2 - 16052214
AN - SCOPUS:24944535396
VL - 93
SP - 406
EP - 411
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 4
ER -