ABSTRACT
PURPOSE: Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures. METHODS: Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year. RESULTS: In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs. CONCLUSION: Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.
Subject(s)
Biosimilar Pharmaceuticals , Breast Neoplasms/drug therapy , Heart Failure , Trastuzumab , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/pharmacokinetics , Biosimilar Pharmaceuticals/administration & dosage , Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/pharmacokinetics , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Drug Monitoring/methods , Female , Heart Failure/chemically induced , Heart Failure/diagnosis , Humans , Middle Aged , Neoplasm Staging , Receptor, ErbB-2/antagonists & inhibitors , Trastuzumab/administration & dosage , Trastuzumab/adverse effects , Trastuzumab/pharmacokinetics , Treatment OutcomeABSTRACT
Fulvestrant (Faslodex) reduces markers of hormone sensitivity and proliferation in postmenopausal women. This Phase II double-blind, randomised, multicentre study compared the effects of a single 250mg intramuscular dose of fulvestrant and placebo 14-21 days prior to surgery of curative intent on the oestrogen receptor (ER), progesterone receptor and Ki67 levels in 66 premenopausal women with ER-positive primary breast cancer. There were no statistically significant differences between fulvestrant and placebo with respect to any of the three markers analysed. The most common adverse events in both groups were nausea, headache and pyrexia. Fulvestrant 250mg had no effects on markers of hormone-sensitivity and proliferation in premenopausal women with primary breast cancer when measured at 14-21 days after injection. These findings suggest that a higher fulvestrant dose may be required in this patient population. Further clinical trials are necessary to evaluate the efficacy of fulvestrant in premenopausal women.
Subject(s)
Antineoplastic Agents, Hormonal/administration & dosage , Breast Neoplasms/drug therapy , Estradiol/analogs & derivatives , Receptors, Estrogen/metabolism , Adult , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/blood , Biomarkers, Tumor/metabolism , Breast Neoplasms/metabolism , Estradiol/administration & dosage , Estradiol/adverse effects , Estradiol/blood , Female , Follicular Phase , Fulvestrant , Humans , Ki-67 Antigen/metabolism , Luteal Phase , Middle Aged , Receptors, Progesterone/metabolismABSTRACT
Halitosis--unpleasant smell from a mouth is widely spread pathology. Approximately one-fourth of world's population is suffering from this disease. Appearance of Halitosis is related not only with dental problems, but also with somatic disease. Unpleasant smell from a mouth is associated with activity of gram negative anaerobic microflora in places unavailable to oxygen. Generally, Halitosis is related with presence of pathologic paradontical areas and carious cavities. Treatment of unpleasant smell from a mouth is accomplished with eradication of infected areas via antimicrobial treatment. For prophylaxis major factors are hygiene and rinsing of oral cavity.
Subject(s)
Halitosis , Halitosis/diagnosis , Halitosis/etiology , Halitosis/therapy , HumansABSTRACT
The lymphatic mapping and sentinel lymphadenectomy procedure is a highly accurate method of axillary staging in breast cancer. Because no other method accurately predicts axillary node status without complete axillary dissection, this technique has a potential to become the standard method of axillary staging for breast cancer in near future. The aim of the study was to evaluate efficiency of lymphatic mapping by intradermal injection of vital blue dye for sentinel node identification in T(1-2) N(0-1) M(0) stage breast cancer patients. The sentinel lymph node biopsy with total axillary dissection was performed in 36 patients. The efficiency of lymphatic mapping by intradermal injection of vital blue dye (identification rate) was 97,2%, specificity--100% and the false-negative rate was 2,8%.
Subject(s)
Breast Neoplasms/pathology , Lymph Nodes/pathology , Methylene Blue/administration & dosage , Adult , Aged , Axilla , Female , Humans , Injections, Intradermal , Lymphatic Metastasis/pathology , Middle Aged , Neoplasm Staging , Sensitivity and Specificity , Sentinel Lymph Node Biopsy/methodsABSTRACT
The sentinel node concept assumes that a malignancy that metastasizes by the lymphatic route will initially travel to one or a few lymph node(s). Although a tumor may disseminate to other nodes, it will remain in the sentinel node, and therefore the status of the entire basin is predicted by the sentinel node. The sentinel lymph node biopsy with total axillary dissection was performed on 99 patients. The identification rate was 69,7%, specificity 62,6%, and the false-negative rate was 7,1%. The impact of some prognostic factors on efficacy of visualization was also investigated. It was shown that the age of patients, stage of disease, localization of primary tumor, and method of injection of methylene blue were important prognostic factors for effective identification of sentinel lymph nodes in breast cancer patients.
