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1.
Cancer ; 124(3): 537-545, 2018 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-29044496

RESUMO

BACKGROUND: Despite the success of immune checkpoint and targeted therapy, many patients with melanoma ultimately require further treatment. The combination of carboplatin, paclitaxel, and bevacizumab (CPB) has demonstrated promising activity in a single-arm study. In the current study, the authors performed a randomized phase 2 study to confirm efficacy and to determine whether adding everolimus would increase the activity of the combination. METHODS: Through the North Central Cancer Treatment Group, a total of 149 patients with unresectable AJCC 6th edition stage IV melanoma were randomized from May 2010 to May 2014 to either CPB or CPB with everolimus (CPBE). The primary endpoint was progression-free survival (PFS), with secondary endpoints of overall survival (OS), response rate, and tolerability. RESULTS: The CPB and CPBE treatment arms were balanced with regard to age (median age: 59 years vs 58 years) and high lactate dehydrogenase (48% vs 51%), but were unbalanced with regard to sex (male sex: 72% vs 55%; P = .03). Overall, there was no difference noted with regard to PFS, with a median PFS of 5.6 months for CPB versus 5.1 months for CPBE (hazard ratio [HR], 1.14; 95% confidence interval [95% CI], 0.81-1.62 [P = .44]), or for OS, with a median OS of 14.5 months for CPB versus 10.8 months for CPBE (HR, 1.16; 95% CI, 0.84-1.84). The confirmed response rate was 13% for CPB and 23% for CPBE (P = .13). Toxicity was higher for CPBE compared with CPB (83% for grade 3 + and 14% for grade 4 + vs 63% for grade 3 + and 11% for grade 4+, respectively) (toxicities were graded using the Cancer Therapy Evaluation Program of the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). Common grade 3 + toxicities were neutropenia, leukopenia, and fatigue, which occurred in both treatment arms with comparable frequency. CONCLUSIONS: Both experimental arms demonstrated activity, with a PFS of >5 months. However, the addition of everolimus to CPB failed to improve outcomes, with increased toxicity noted. These findings replicate the moderate antitumor activity of CPB, with future development possibly in combination with targeted or immunotherapy. Cancer 2018;124:537-45. © 2017 American Cancer Society.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Melanoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bevacizumab/administração & dosagem , Carboplatina/administração & dosagem , Intervalo Livre de Doença , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Melanoma/genética , Melanoma/mortalidade , Melanoma/secundário , Pessoa de Meia-Idade , Mutação , Paclitaxel/administração & dosagem , Proteínas Proto-Oncogênicas B-raf/genética
2.
J Clin Oncol ; 27(25): 4082-8, 2009 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-19636020

RESUMO

PURPOSE: Recent changes have occurred in the presurgical planning for breast cancer, including the introduction of preoperative breast magnetic resonance imaging (MRI). We sought to analyze the trends in mastectomy rates and the relationship to preoperative MRI and surgical year at Mayo Clinic, Rochester, MN. PATIENTS AND METHODS: We identified 5,405 patients who underwent surgery between 1997 and 2006. Patients undergoing MRI were identified from a prospective database. Trends in mastectomy rate and the association of MRI with surgery type were analyzed. Multiple logistic regression was used to assess the effect of surgery year and MRI on surgery type, while adjusting for potential confounding variables. RESULTS: Mastectomy rates differed significantly across time (P < .0001), and decreased from 45% in 1997% to 31% in 2003, followed by increasing rates for 2004 to 2006. The use of MRI increased from 10% in 2003% to 23% in 2006 (P < .0001). Patients with MRI were more likely to undergo mastectomy than those without MRI (54% v 36%; P < .0001). However, mastectomy rates increased from 2004 to 2006 predominantly among patients without MRI (29% in 2003% to 41% in 2006; P < .0001). In a multivariable model, both MRI (odds ratio [OR], 1.7; P < .0001) and surgical year (compared to 2003 OR: 1.4 for 2004, 1.8 for 2005, and 1.7 for 2006; P < .0001) were independent predictors of mastectomy. CONCLUSION: After a steady decline, mastectomy rates have increased in recent years with both surgery year and MRI as significant predictors for type of surgery. Further studies are needed to evaluate the role of MRI and other factors influencing surgical planning.


Assuntos
Neoplasias da Mama/cirurgia , Imageamento por Ressonância Magnética/tendências , Mastectomia/tendências , Seleção de Pacientes , Neoplasias da Mama/patologia , Bases de Dados como Assunto , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Minnesota , Estadiamento de Neoplasias , Razão de Chances , Cuidados Pré-Operatórios , Estudos Retrospectivos , Fatores de Tempo
3.
Expert Rev Anticancer Ther ; 8(4): 553-60, 2008 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-18402522

RESUMO

Substantial progress has been made in understanding the pathogenesis of malignant melanoma at the cellular level, leading to the development of several new agents in the treatment of melanoma. The focus of this review is to summarize the emerging therapies and investigational agents in the treatment of melanoma over the last 5 years.


Assuntos
Melanoma/terapia , Neoplasias Cutâneas/terapia , Adjuvantes Imunológicos/uso terapêutico , Transferência Adotiva , Inibidores da Angiogênese/uso terapêutico , Antineoplásicos/uso terapêutico , Vacinas Anticâncer/uso terapêutico , Quimioterapia Adjuvante , Humanos , Imunoterapia , Excisão de Linfonodo , Metástase Linfática , Melanoma/imunologia , Melanoma/secundário , Inibidores de Proteínas Quinases/uso terapêutico , Neoplasias Cutâneas/imunologia , Neoplasias Cutâneas/patologia
4.
Clin Med Oncol ; 2: 223-5, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-21892283

RESUMO

PURPOSE: This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer. METHODS: Six patients with locally advanced, potentially resectable esophageal cancer received pemetrexed 500 mg/m(2) and carboplatin AUC = 6 on days 1 and 22 with 5040 centigray of concomitant radiation in 28 fractions over 5.5 weeks followed by esophagectomy as a prelude to a phase II multi-institutional trial. RESULTS: Only 1 of the 6 patients experienced a grade 4 adverse event (neutropenia). This patient also experienced a grade 3 depression. Of the remaining 5 patients, three experienced at least one grade 3 adverse event (neutropenia, nausea/vomiting, and esophagitis). There were no deaths. Incidentally, one patient manifested a complete pathologic response, three a partial pathologic response, and one stable disease. CONCLUSION: These preliminary observations on safety suggest that this regimen can be further studied in this clinical setting.

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