Background： Intraductal administration of cytotoxic agents has been shown to inhibit the development of breast cancer in animal models. The object of this study was to demonstrate the safety of intraductal delivery c...Background： Intraductal administration of cytotoxic agents has been shown to inhibit the development of breast cancer in animal models. The object of this study was to demonstrate the safety of intraductal delivery cytotoxic agents in patients prior to mastectomy. This method is hopeful to be developed as a chemoprevention approach in patients with pre-malignant or non-invasive ductal lesions to prevent breast cancer which will be further developed.Methods： Two drugs, pegylated liposomal doxorubicin（PLD） and carboplatin were administered at three dose levels（PLD： 10, 20, 50 mg and carboplatin 60, 120, 300 mg）. There were five subjects in each group with 15 subjects treated with each drug once. Venous blood samples were obtained for pharmacokinetic analysis. The breast was removed surgically 2-5 days post administration and the treated ducts were marked to enable identification on pathological evaluation. Results： Intraductal administration was generally well-tolerated with mild, transient breast discomfort. In the carboplatin arm, three women at the 300 mg dose experienced mild nausea and vomiting. In the PLD arm most women had mild erythema and swelling of the breast over the 72 hours following the drug administration. Patients receiving the 50 mg dose experienced local erythema until the time of surgery. Pharmacokinetic analysis showed that carboplatin rapidly entered systemic circulation with an early peak time（T max -30 min） with a corresponding plasma ultrafiltrate area under the curve（AUC） consistent with the Calvert Formula using estimated glomerular filtration rate（GFR）. Total plasma doxorubicin had delayed peak concentration times（T max 48 hours） with a linear dose response and peak concentrations substantially lower than expected from equivalent intravenous injection dosing. No doxorubicinol metabolite was detected in the plasma. Conclusions： This study demonstrates that cytotoxic drugs can be safely administered into breast ducts with minimal toxicity.展开更多
OBJECTIVE To evaluate the feasibility of the Breast Imaging Reporting and Data System （BI-RADS） in the categorization of nonpalpable breast lesions （NPBLs） and to determine its value in aiding decision-making for ...OBJECTIVE To evaluate the feasibility of the Breast Imaging Reporting and Data System （BI-RADS） in the categorization of nonpalpable breast lesions （NPBLs） and to determine its value in aiding decision-making for biopsy in a Chinese population. METHODS One hundred and seventy-four nonpalpable breast lesions in 155 female patients examined by mammography were retrospectively categorized according to the BI-RAD System, 4th edition, which was established by the American College of Radiology （ACR）. All the lesions were diagnosed by a histopathological analysis after mammographically guided wire-localization biopsy. RESULTS The 174 Iocalizations yielded 125 （71.8%） benign lesions and 49 （28.2%） cancers, including 14 （28.6%） ductal carcinomas in situ and 35 （71.4%） invasive cancers. The overall positive predictive value （PPV） for cancer was 28.2% （49/174）. After categorization according to the BI- RAD System, there were 12 category 2, 59 category 3, 83 category 4 and 20 category 5 lesions. The PPV for cancer for each category were 0% （0 of 12 lesions） in category 2, 3.4% （2 of 59 lesions） in category 3, 37.3% （31 of 83 lesions） in category 4 and 80.0% （16 of 20 lesions） in category 5. t is concluded that BI-RADS is valuable for the catego- rization of nonpalpable breast lesions in our Chinese population. This system greatly improved the diagnostic specificity of nonpalpable breast lesions and was feasible in aiding decision-making for biopsy. It is suggested that nonpalpable breast lesions in categories BI-RADS 4 and 5 should receive a biopsy because these lesions have a moderate and high positive predictive value for cancer.展开更多
文摘Background： Intraductal administration of cytotoxic agents has been shown to inhibit the development of breast cancer in animal models. The object of this study was to demonstrate the safety of intraductal delivery cytotoxic agents in patients prior to mastectomy. This method is hopeful to be developed as a chemoprevention approach in patients with pre-malignant or non-invasive ductal lesions to prevent breast cancer which will be further developed.Methods： Two drugs, pegylated liposomal doxorubicin（PLD） and carboplatin were administered at three dose levels（PLD： 10, 20, 50 mg and carboplatin 60, 120, 300 mg）. There were five subjects in each group with 15 subjects treated with each drug once. Venous blood samples were obtained for pharmacokinetic analysis. The breast was removed surgically 2-5 days post administration and the treated ducts were marked to enable identification on pathological evaluation. Results： Intraductal administration was generally well-tolerated with mild, transient breast discomfort. In the carboplatin arm, three women at the 300 mg dose experienced mild nausea and vomiting. In the PLD arm most women had mild erythema and swelling of the breast over the 72 hours following the drug administration. Patients receiving the 50 mg dose experienced local erythema until the time of surgery. Pharmacokinetic analysis showed that carboplatin rapidly entered systemic circulation with an early peak time（T max -30 min） with a corresponding plasma ultrafiltrate area under the curve（AUC） consistent with the Calvert Formula using estimated glomerular filtration rate（GFR）. Total plasma doxorubicin had delayed peak concentration times（T max 48 hours） with a linear dose response and peak concentrations substantially lower than expected from equivalent intravenous injection dosing. No doxorubicinol metabolite was detected in the plasma. Conclusions： This study demonstrates that cytotoxic drugs can be safely administered into breast ducts with minimal toxicity.
文摘OBJECTIVE To evaluate the feasibility of the Breast Imaging Reporting and Data System （BI-RADS） in the categorization of nonpalpable breast lesions （NPBLs） and to determine its value in aiding decision-making for biopsy in a Chinese population. METHODS One hundred and seventy-four nonpalpable breast lesions in 155 female patients examined by mammography were retrospectively categorized according to the BI-RAD System, 4th edition, which was established by the American College of Radiology （ACR）. All the lesions were diagnosed by a histopathological analysis after mammographically guided wire-localization biopsy. RESULTS The 174 Iocalizations yielded 125 （71.8%） benign lesions and 49 （28.2%） cancers, including 14 （28.6%） ductal carcinomas in situ and 35 （71.4%） invasive cancers. The overall positive predictive value （PPV） for cancer was 28.2% （49/174）. After categorization according to the BI- RAD System, there were 12 category 2, 59 category 3, 83 category 4 and 20 category 5 lesions. The PPV for cancer for each category were 0% （0 of 12 lesions） in category 2, 3.4% （2 of 59 lesions） in category 3, 37.3% （31 of 83 lesions） in category 4 and 80.0% （16 of 20 lesions） in category 5. t is concluded that BI-RADS is valuable for the catego- rization of nonpalpable breast lesions in our Chinese population. This system greatly improved the diagnostic specificity of nonpalpable breast lesions and was feasible in aiding decision-making for biopsy. It is suggested that nonpalpable breast lesions in categories BI-RADS 4 and 5 should receive a biopsy because these lesions have a moderate and high positive predictive value for cancer.
