Phase II trial of preoperative chemotherapy for breast cancer: Japan Breast Cancer Research Network (JBCRN)-02 trial

Neoadjuvant chemotherapy (NAC) is one of the main strategies for patients with locally advanced breast cancer. In our previous study, biological markers such as estrogen receptor (ER), progesterone receptor (PgR), and HER2 were essential predictors of the effectiveness of NAC to help individualize t...

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Bibliographic Details
Published in:Anticancer research 2011-04, Vol.31 (4), p.1483-1487
Main Authors: Iwase, S, Yamamoto, D, Kuroda, Y, Kawaguchi, T, Kitamura, K, Odagiri, H, Teramoto, S, Akazawa, K, Nagumo, Y
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biomarkers, Tumor - metabolism
Breast Neoplasms - drug therapy
Breast Neoplasms - mortality
Breast Neoplasms - surgery
Cyclophosphamide - administration & dosage
Doxorubicin - administration & dosage
Female
Humans
Ki-67 Antigen - metabolism
Middle Aged
Neoadjuvant Therapy
Paclitaxel - administration & dosage
Prognosis
Prospective Studies
Receptor, ErbB-2 - metabolism
Receptors, Estrogen - metabolism
Receptors, Progesterone - metabolism
Survival Rate
Young Adult
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Summary:Neoadjuvant chemotherapy (NAC) is one of the main strategies for patients with locally advanced breast cancer. In our previous study, biological markers such as estrogen receptor (ER), progesterone receptor (PgR), and HER2 were essential predictors of the effectiveness of NAC to help individualize treatment. This study examined the effect of NAC on the disease-free survival (DFS) of breast cancer patients. Furthermore, the study was expanded by adding Ki-67 as a biological marker, and examined the correlation between Ki-67 and the prognosis. Between September 2005 and September 2007, 43 patients with breast cancer received NAC and surgery. Four cycles of DC (doxorubicin: 60 mg/m(2) and cyclophosphamide: 500 mg/m(2)) were administered intravenously (i.v.) on day 1 every 21 days, followed by 12 cycles of paclitaxel i.v. (80 mg/m(2)) every 7 days, prior to surgery. The primary endpoint was the pathological complete response (pCR) rate and the secondary endpoint was DFS; the pCR rate was estimated for each groups stratified by the presence or absence of different factors (PcR, ER/PgR, and Ki-67). The clinical response (cCR+cPR) rate was 81.0%, and the pCR rate was 25.6%. The pCR rate was 75, 50, 9 and 0% in HER2(+)/ER(-), HER2(+)/ER(+), HER2(-)/ER(-), and HER2(-)/ER(+) patients, respectively. The 4-year DFS rate was estimated at 78% for all patients. The HER2 status was an independent predictor of pathological complete response (pCR). The DFS rate of patients with lower Ki-67 values (
ISSN:1791-7530