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1.
N Engl J Med ; 363(23): 2200-10, 2010 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-21121833

RESUMO

BACKGROUND: A regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC) is superior to a regimen of fluorouracil, doxorubicin, and cyclophosphamide (FAC) when used as adjuvant therapy in women with node-positive breast cancer. The value of taxanes in the treatment of node-negative disease has not been determined. METHODS: We randomly assigned 1060 women with axillary-node-negative breast cancer and at least one high-risk factor for recurrence (according to the 1998 St. Gallen criteria) to treatment with TAC or FAC every 3 weeks for six cycles after surgery. The primary end point was disease-free survival after at least 5 years of follow-up. Secondary end points included overall survival and toxicity. RESULTS: At a median follow-up of 77 months, the proportion of patients alive and disease-free was higher among the 539 women in the TAC group (87.8%) than among the 521 women in the FAC group (81.8%), representing a 32% reduction in the risk of recurrence with TAC (hazard ratio, 0.68; 95% confidence interval [CI], 0.49 to 0.93; P=0.01 by the log-rank test). This benefit was consistent, regardless of hormone-receptor status, menopausal status, or number of high-risk factors. The difference in survival rates (TAC, 95.2%; FAC, 93.5%) was not significant (hazard ratio, 0.76; 95% CI, 0.45 to 1.26); however, the number of events was small (TAC, 26; FAC, 34). Rates of grade 3 or 4 adverse events were 28.2% with TAC and 17.0% with FAC (P<0.001). Toxicity associated with TAC was diminished when primary prophylaxis with granulocyte colony-stimulating factor was provided. CONCLUSIONS: As compared with adjuvant FAC, adjuvant TAC improved the rate of disease-free survival among women with high-risk, node-negative breast cancer. (Funded by GEICAM and Sanofi-Aventis; ClinicalTrials.gov number, NCT00121992.).


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Taxoides/administração & dosagem , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/mortalidade , Neoplasias da Mama/cirurgia , Quimioterapia Adjuvante , Ciclofosfamida/administração & dosagem , Docetaxel , Doxorrubicina/administração & dosagem , Feminino , Fluoruracila/administração & dosagem , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Receptor ErbB-2/análise , Receptores de Estrogênio/análise , Fatores de Risco , Taxoides/efeitos adversos , Resultado do Tratamento , Adulto Jovem
2.
N Engl J Med ; 360(14): 1408-17, 2009 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-19339720

RESUMO

BACKGROUND: We investigated the efficacy of cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) as first-line treatment for metastatic colorectal cancer and sought associations between the mutation status of the KRAS gene in tumors and clinical response to cetuximab. METHODS: We randomly assigned patients with epidermal growth factor receptor-positive colorectal cancer with unresectable metastases to receive FOLFIRI either alone or in combination with cetuximab. The primary end point was progression-free survival. RESULTS: A total of 599 patients received cetuximab plus FOLFIRI, and 599 received FOLFIRI alone. The hazard ratio for progression-free survival in the cetuximab-FOLFIRI group as compared with the FOLFIRI group was 0.85 (95% confidence interval [CI], 0.72 to 0.99; P=0.048). There was no significant difference in the overall survival between the two treatment groups (hazard ratio, 0.93; 95% CI, 0.81 to 1.07; P=0.31). There was a significant interaction between treatment group and KRAS mutation status for tumor response (P=0.03) but not for progression-free survival (P=0.07) or overall survival (P=0.44). The hazard ratio for progression-free survival among patients with wild-type-KRAS tumors was 0.68 (95% CI, 0.50 to 0.94), in favor of the cetuximab-FOLFIRI group. The following grade 3 or 4 adverse events were more frequent with cetuximab plus FOLFIRI than with FOLFIRI alone: skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, P<0.001), infusion-related reactions (in 2.5% vs. 0%, P<0.001), and diarrhea (in 15.7% vs. 10.5%, P=0.008). CONCLUSIONS: First-line treatment with cetuximab plus FOLFIRI, as compared with FOLFIRI alone, reduced the risk of progression of metastatic colorectal cancer. The benefit of cetuximab was limited to patients with KRAS wild-type tumors. (ClinicalTrials.gov number, NCT00154102.)


Assuntos
Anticorpos Monoclonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Receptores ErbB/antagonistas & inibidores , Genes ras , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Camptotecina/análogos & derivados , Camptotecina/uso terapêutico , Cetuximab , Neoplasias Colorretais/genética , Progressão da Doença , Feminino , Fluoruracila/uso terapêutico , Humanos , Estimativa de Kaplan-Meier , Leucovorina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Mutação , Metástase Neoplásica/tratamento farmacológico , Adulto Jovem
3.
Qual Life Res ; 18(7): 853-61, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19568958

RESUMO

PURPOSE: The quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented. METHODS: Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling. RESULTS: A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm. CONCLUSION: There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.


Assuntos
Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/psicologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Junção Esofagogástrica/patologia , Cuidados Paliativos/métodos , Neoplasias Gástricas/tratamento farmacológico , Neoplasias Gástricas/psicologia , Adolescente , Adulto , Idoso , Camptotecina/administração & dosagem , Camptotecina/análogos & derivados , Cisplatino/administração & dosagem , Fluoruracila/administração & dosagem , Humanos , Irinotecano , Leucovorina/administração & dosagem , Pessoa de Meia-Idade , Metástase Neoplásica , Qualidade de Vida , Neoplasias Gástricas/patologia , Adulto Jovem
4.
N Engl J Med ; 352(26): 2696-704, 2005 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-15987918

RESUMO

BACKGROUND: Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting. METHODS: We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines. RESULTS: Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). CONCLUSIONS: Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer.


Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antimetabólitos Antineoplásicos/efeitos adversos , Capecitabina , Quimioterapia Adjuvante , Neoplasias do Colo/mortalidade , Neoplasias do Colo/cirurgia , Desoxicitidina/efeitos adversos , Intervalo Livre de Doença , Feminino , Fluoruracila/análogos & derivados , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Análise de Sobrevida
5.
Med Sci Monit ; 14(7): SC7-10, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18591931

RESUMO

BACKGROUND: Docetaxel is a member of the taxoid anticancer agents routinely used in the treatment of high-risk or metastatic breast cancer. A recent study demonstrated that a low response rate to taxane-based neoadjuvant chemotherapy is associated with BRCA1 mutations. Therefore the frequency of BRCA1 mutations in a population of metastatic docetaxel-refractory patients was analyzed. MATERIAL/METHODS: Nineteen treatment-refractory patients were selected from a group of 175 metastatic breast cancer patients treated with docetaxel-based therapy. DNA isolated from blood or from paraffin-embedded tissue samples was screened for three founder mutations common (>80%) in the Polish population. Additionally, the frequency of BRCA1 mutations was compared with the particular phenotype of breast cancer cells. RESULTS: BRCA1 mutations were found in 5 of the 19 of patients (26.3%), all 5 being of the 7 patients with triple-negative breast cancer (71%, p<0.002). CONCLUSIONS: This study indicates that the administration of taxanes, especially docetaxel, to metastatic BRCA1 breast cancer patients requires consideration. Moreover, BRCA1 testing in triple-negative breast cancer patients resistant to docetaxel-based treatment may help to identify families with germinal mutations without a history of hereditary breast cancer.


Assuntos
Proteína BRCA1/genética , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/genética , Resistencia a Medicamentos Antineoplásicos/genética , Mutação/genética , Metástase Neoplásica/genética , Taxoides/uso terapêutico , Adulto , Idoso , Intervalo Livre de Doença , Docetaxel , Feminino , Humanos , Pessoa de Meia-Idade
6.
J Clin Oncol ; 21(6): 968-75, 2003 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-12637459

RESUMO

PURPOSE: This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m(2) plus docetaxel 75 mg/m(2) (n = 214) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (n = 215) on day 1, every 3 weeks for up to eight cycles. RESULTS: Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank P =.014; median TTF, 25.6 v 23.7 weeks; log-rank P =.048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P =.009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v 41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P =.01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%). CONCLUSION: AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Paclitaxel/análogos & derivados , Taxoides , Adulto , Idoso , Antibióticos Antineoplásicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Ciclofosfamida/administração & dosagem , Progressão da Doença , Intervalo Livre de Doença , Docetaxel , Doxorrubicina/administração & dosagem , Feminino , Nível de Saúde , Doenças Hematológicas/induzido quimicamente , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Paclitaxel/administração & dosagem , Qualidade de Vida , Análise de Sobrevida , Resultado do Tratamento , Disfunção Ventricular Esquerda/induzido quimicamente
7.
Eur J Cancer Prev ; 19(4): 308-12, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20473182

RESUMO

Hodgkin's lymphoma is one of the most curable malignancies and most patients achieve a lasting complete remission. In this study, artificial neural network (ANN) analysis was shown to provide significant factors with regard to 5-year recurrence after lymphoma treatment. Data from 114 patients treated for Hodgkin's disease were available for evaluation and comparison. A total of 31 variables were subjected to ANN analysis. The ANN approach as an advanced multivariate data processing method was shown to provide objective prognostic data. Some of these prognostic factors are consistent or even identical to the factors evaluated earlier by other statistical methods.


Assuntos
Doença de Hodgkin/diagnóstico , Redes Neurais de Computação , Adolescente , Adulto , Idoso , Inteligência Artificial , Feminino , Seguimentos , Doença de Hodgkin/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Prevenção Secundária , Adulto Jovem
8.
Rev. argent. cancerol ; 37(1): 41-50, 2009. graf
Artigo em Espanhol | BINACIS | ID: bin-124636

RESUMO

Antecedentes: Se investigó la eficacia de cetuximab más irinotecan, fluorouracilo y leucovorina (FOLFIRI) como tratamiento metastásico y las asociaciones buscadas entre el estado de mutación del gen KRAS en tumores y la respuesta clínica a cetuximab. Métodos: Se asignaro en forma aleatoria pacientes con cáncer colorrectal con expresión positiva del receptor de factor de crecimiento epidérmico, con metástasis irresecables para recibir FOLFIRI, ya sea solo o en combinación con cetuximab. El criterio de valoración primario fue la supervivencia libre de progresión. Conclusión: El tratamiento de primera línea con cetuximab más FOLFIRI, comparado con FOLFIRI solo, redujo el riesgo de progresión del cáncer colorrectal metastásico. El beneficio de cetuximab resultó limitado para pacientes con tumores con KRAS no mutado.(AU)


Assuntos
Neoplasias Colorretais , Tratamento Farmacológico , Interpretação Estatística de Dados
9.
Rev. argent. cancerol ; 37(1): 41-50, 2009. graf
Artigo em Espanhol | LILACS | ID: lil-544732

RESUMO

Antecedentes: Se investigó la eficacia de cetuximab más irinotecan, fluorouracilo y leucovorina (FOLFIRI) como tratamiento metastásico y las asociaciones buscadas entre el estado de mutación del gen KRAS en tumores y la respuesta clínica a cetuximab. Métodos: Se asignaro en forma aleatoria pacientes con cáncer colorrectal con expresión positiva del receptor de factor de crecimiento epidérmico, con metástasis irresecables para recibir FOLFIRI, ya sea solo o en combinación con cetuximab. El criterio de valoración primario fue la supervivencia libre de progresión. Conclusión: El tratamiento de primera línea con cetuximab más FOLFIRI, comparado con FOLFIRI solo, redujo el riesgo de progresión del cáncer colorrectal metastásico. El beneficio de cetuximab resultó limitado para pacientes con tumores con KRAS no mutado.


Assuntos
Neoplasias Colorretais , Tratamento Farmacológico , Interpretação Estatística de Dados
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