RESUMEN

PURPOSE: Breast cancer patients receiving hormonal therapies face risks of relapse, increased rates of cardiovascular events, and toxicities of therapy such as aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS). C-reactive protein (CRP), a marker for inflammation, is associated with breast cancer outcomes. We evaluated whether the olive-derived polyphenol hydroxytyrosol combined with omega-3 fatty acids and curcumin would reduce CRP and musculoskeletal symptoms in breast cancer patients receiving adjuvant hormonal therapies. EXPERIMENTAL DESIGN: This prospective, multicenter, open-label, single arm, clinical trial enrolled post-menopausal breast cancer patients (n = 45) with elevated C-reactive protein (CRP) taking predominantly aromatase inhibitors to receive a combination of hydroxytyrosol, omega-3 fatty acids, and curcumin for 1 month. CRP, other inflammation-associated cytokines, and pain scores on the Brief Pain Inventory were measured before therapy, at the end of therapy and 1 month after completion of therapy. RESULTS: CRP levels declined during the therapy [from 8.2 ± 6.4 mg/L at baseline to 5.3 ± 3.2 mg/L (p = 0.014) at 30 days of treatment], and remained decreased during the additional 1 month off therapy. Subjects with the highest baseline CRP levels had the greatest decrease with the therapy. Pain scores also decreased during the therapy. There were no significant adverse events. CONCLUSIONS: The combination of hydroxytyrosol, omega-3 fatty acids, and curcumin reduced inflammation as indicated by a reduction in CRP and reduced pain in patients with aromatase-induced musculoskeletal symptoms. Longer studies comparing this combination to other anti-inflammatories in larger groups of patients with clinical outcome endpoints are warranted.

Asunto(s)

Inhibidores de la Aromatasa/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Curcumina/administración & dosificación , Ácidos Grasos Omega-3/administración & dosificación , Inflamación/tratamiento farmacológico , Dolor Musculoesquelético/tratamiento farmacológico , Alcohol Feniletílico/análogos & derivados , Adulto , Anciano , Anciano de 80 o más Años , Inhibidores de la Aromatasa/uso terapéutico , Neoplasias de la Mama/patología , Proteína C-Reactiva/metabolismo , Quimioterapia Adyuvante/efectos adversos , Curcumina/efectos adversos , Combinación de Medicamentos , Ácidos Grasos Omega-3/efectos adversos , Femenino , Humanos , Inflamación/inducido químicamente , Inflamación/metabolismo , Persona de Mediana Edad , Dolor Musculoesquelético/inducido químicamente , Dolor Musculoesquelético/patología , Alcohol Feniletílico/administración & dosificación , Alcohol Feniletílico/efectos adversos , Proyectos Piloto , Posmenopausia , Estudios Prospectivos

RESUMEN

PURPOSE: Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. METHODS: This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients' medical charts. RESULTS: A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0-64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. CONCLUSION: This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy-mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors.

Asunto(s)

Adenocarcinoma/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Trastuzumab/uso terapéutico , Adenocarcinoma/genética , Adenocarcinoma/patología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/genética , Neoplasias de la Mama/patología , Carboplatino/administración & dosificación , Quimioradioterapia/métodos , Quimioterapia Adyuvante/métodos , Estudios Transversales , Ciclofosfamida/administración & dosificación , Docetaxel , Doxorrubicina/administración & dosificación , Femenino , Humanos , Letrozol , Persona de Mediana Edad , Nitrilos/administración & dosificación , Paclitaxel/administración & dosificación , Receptor ErbB-2/genética , Tamoxifeno/administración & dosificación , Taxoides/administración & dosificación , Triazoles/administración & dosificación

RESUMEN

The aim of the trial was to compare efficacy and safety of the aromatase inhibitor formestane (250 mg i.m. given every 2 weeks) with the progestin megestrol acetate (160 mg administered orally once daily), as second-line therapy in postmenopausal patients with advanced breast cancer previously treated with tamoxifen. A total of 547 patients were enrolled. Analyses revealed no statistically significant or clinically relevant difference between treatments with respect to time endpoints. In the intent-to-treat analysis, the median values for time to failure and overall survival for formestane were 169 and 561 days, respectively. The corresponding values for megestrol acetate were 169 days and 597 days, respectively. Overall response rates were comparable for formestane and megestrol acetate (16.3% vs 20.3%). Formestane was better tolerated than megestrol acetate. In the megestrol acetate group, cardiovascular events, weight increase, and vaginal haemorrhage were significantly more frequent than in the formestane group. Thus, formestane is a suitable alternative to progestins in patients previously treated with tamoxifen.