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1.
Acta Clin Belg ; 71(6): 383-388, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27285571

RESUMO

Metastatic salivary gland carcinoma is a rare malignancy. A subset of these tumors overexpresses the human epidermal growth factor receptor 2 (HER-2), which is considered a poor prognostic marker. Targeted therapy with the monoclonal antibody trastuzumab can be a treatment option in these patients. We describe six cases of metastatic salivary gland carcinoma treated with trastuzumab in combination with a taxane. Three of these patients had salivary duct cancer, two had mucoepidermoid carcinoma and one patient was treated for acinic cell carcinoma. The therapy was well tolerated. We observed five partial responses and a median progression free survival of 10.8 months, which compares favorably with the reported outcome of combination chemotherapy. One patient achieved a complete and durable remission. When HER-2 and androgen receptor were co-expressed, trastuzumab-based treatment appeared to be more active than androgen deprivation in our experience.


Assuntos
Hidrocarbonetos Aromáticos com Pontes/uso terapêutico , Receptor ErbB-2/biossíntese , Neoplasias das Glândulas Salivares/secundário , Glândulas Salivares/diagnóstico por imagem , Taxoides/uso terapêutico , Trastuzumab/uso terapêutico , Idoso , Antineoplásicos/uso terapêutico , Quimioterapia Combinada , Humanos , Imuno-Histoquímica , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neoplasias das Glândulas Salivares/tratamento farmacológico , Neoplasias das Glândulas Salivares/metabolismo , Glândulas Salivares/metabolismo
2.
Cancer Chemother Pharmacol ; 77(1): 99-108, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26650227

RESUMO

PURPOSE: This study determined the safety, maximum tolerated dose (MTD), pharmacokinetics, and preliminary efficacy of BI 847325, an oral dual MEK and Aurora kinase inhibitor, in patients with refractory solid tumors. METHODS: This trial recruited patients with an advanced non-resectable and/or metastatic solid tumor following failure of conventional treatment (NCT01324830; 1287.1). BI 847325 was administered orally, once daily (starting at 6 mg in the first cohort) using two dosing schedules: Schedule A (2 weeks on, 1 week off) and Schedule B (three periods of 5 days on, 2 days off). The primary objective was to identify the MTD of BI 847325 for both dosing schedules. RESULTS: Sixty-nine patients (Schedule A, n = 47; Schedule B, n = 22) were treated. The MTD was 120 mg per day for Schedule A (cumulative dose of 1680 mg per 3-week cycle) and 150 mg per day for Schedule B (cumulative dose of 2250 mg per 3-week cycle). Reversible hematologic and gastrointestinal toxicities were the most common dose-limiting toxicities. One patient with esophageal cancer (receiving 160 mg BI 847325, Schedule A) experienced a partial response for 67 days, and 21 patients (n = 11 [23.4%], Schedule A; n = 10 [45.5%], Schedule B) had stable disease. Pharmacokinetic analyses showed at least bi-exponential disposition, with high inter-subject variability. There was no obvious relationship between markers of MEK or Aurora kinase inhibition and exposure to BI 847325 (exploratory analysis). CONCLUSIONS: This first-in-human trial suggests that BI 847325 has an acceptable safety profile. However, due to insufficient drug exposure at the MTD to achieve relevant MEK inhibition, a decision was taken to halt the development of BI 847325.


Assuntos
Compostos de Anilina/administração & dosagem , Antineoplásicos/administração & dosagem , Indóis/administração & dosagem , Neoplasias/tratamento farmacológico , Inibidores de Proteínas Quinases/administração & dosagem , Administração Oral , Adulto , Idoso , Compostos de Anilina/efeitos adversos , Compostos de Anilina/uso terapêutico , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Aurora Quinases/antagonistas & inibidores , Esquema de Medicação , Feminino , Humanos , Indóis/efeitos adversos , Indóis/uso terapêutico , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Quinases de Proteína Quinase Ativadas por Mitógeno/antagonistas & inibidores , Neoplasias/patologia , Inibidores de Proteínas Quinases/efeitos adversos , Inibidores de Proteínas Quinases/uso terapêutico
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