TY - JOUR
T1 - Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer
T2 - A phase II trial of the NSABP foundation research group
AU - Hamm, John T.
AU - Wilson, John W.
AU - Rastogi, Priya
AU - Lembersky, Barry C.
AU - Tseng, George C.
AU - Song, Young K.
AU - Kim, Wanseop
AU - Robidoux, André
AU - Raymond, Jane M.
AU - Kardinal, Carl G.
AU - Shalaby, Ibrahim A.
AU - Ansari, Rafat
AU - Paik, Soonmyung
AU - Geyer, Charles E.
AU - Wolmark, Norman
PY - 2008/6
Y1 - 2008/6
N2 - Background: This phase II protocol of neoadjuvant chemotherapy with gemcitabine/epirubicin/paclitaxel (GET) was designed to determine the pathologic complete response (pCR) rate in the breast, clinical response rate, disease-free survival, and overall survival at 2 years as well as toxicity in patients with locally advanced breast cancer. This trial also evaluated the feasibility of tissue collection for gene-expression profiling. Patients and Methods: Seventy-six women with stage MB, MIA, and 1MB breast cancer were entered into this trial. Patients received a maximum of 6 cycles of neoadjuvant GET chemotherapy every 21 days (gemcitabine 1000 mg/m2 intravenously [I.V.] on days 1 and 4, epirubicin 90 mg/m2 I.V bolus on day 1, and paclitaxel 175 mg/m2 I.V. on day 1). After chemotherapy, patients underwent surgery and were assessed for pathologic response. Results: The pCR rate among the 74 patients evaluable for efficacy was 23% (95% CI, 14%-34.2%). Adverse events among the 76 patients evaluable for toxicity included anemia requiring transfusion (14.5%), infection with grade 3/4 neutropenia (10.5%), febrile neutropenia (7.9%), and platelet transfusion (6.6%). Infectious complications occurred in 24 patients (31.6%), of whom 18.4% were in the setting of neutropenia. High-quality RNA and successful probe synthesis were obtained from all pretreatment core biopsy specimens that contained tumor cells (n = 66; 88%). Conclusion: Neoadjuvant GET chemotherapy is an active regimen but with substantial toxicity. Tissue collection for gene-expression profiling is feasible in a multi-institutional setting.
AB - Background: This phase II protocol of neoadjuvant chemotherapy with gemcitabine/epirubicin/paclitaxel (GET) was designed to determine the pathologic complete response (pCR) rate in the breast, clinical response rate, disease-free survival, and overall survival at 2 years as well as toxicity in patients with locally advanced breast cancer. This trial also evaluated the feasibility of tissue collection for gene-expression profiling. Patients and Methods: Seventy-six women with stage MB, MIA, and 1MB breast cancer were entered into this trial. Patients received a maximum of 6 cycles of neoadjuvant GET chemotherapy every 21 days (gemcitabine 1000 mg/m2 intravenously [I.V.] on days 1 and 4, epirubicin 90 mg/m2 I.V bolus on day 1, and paclitaxel 175 mg/m2 I.V. on day 1). After chemotherapy, patients underwent surgery and were assessed for pathologic response. Results: The pCR rate among the 74 patients evaluable for efficacy was 23% (95% CI, 14%-34.2%). Adverse events among the 76 patients evaluable for toxicity included anemia requiring transfusion (14.5%), infection with grade 3/4 neutropenia (10.5%), febrile neutropenia (7.9%), and platelet transfusion (6.6%). Infectious complications occurred in 24 patients (31.6%), of whom 18.4% were in the setting of neutropenia. High-quality RNA and successful probe synthesis were obtained from all pretreatment core biopsy specimens that contained tumor cells (n = 66; 88%). Conclusion: Neoadjuvant GET chemotherapy is an active regimen but with substantial toxicity. Tissue collection for gene-expression profiling is feasible in a multi-institutional setting.
KW - Desquamation
KW - Diagonal linear discriminant analysis
KW - Gene-expression profiling
KW - Myalgia
KW - P reoperative chemotherapy
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U2 - 10.3816/CBC.2008.n.029
DO - 10.3816/CBC.2008.n.029
M3 - Article
C2 - 18650156
AN - SCOPUS:46949086552
VL - 8
SP - 257
EP - 263
JO - Clinical Breast Cancer
JF - Clinical Breast Cancer
SN - 1526-8209
IS - 3
ER -