Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer. The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.
pathologic complete response
The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate.
Time frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
survival (Relapse-free survival, overall survival)
Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods
Time frame: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy
early metabolic response
Early metabolic response were evaluated by serial FDG PET/CT before and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle). Declining of SUV were calculated
Time frame: before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)
predictive factors
Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis
Time frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
hematologic toxicity
Hematologic toxicities are evaluated every q 3weeks during chemotherapy. Neutropenia,thrombocytopenia, and anemia are evaluated during chemotherapy (per cycles) by NCI CTCAE v3.0 criteria.
Time frame: every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)
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