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1.
Therapie ; 72(1): 51-61, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28159197

RESUMO

Estimating net benefit makes possible to clarify the basis for therapeutic decisions on an individual and collective level. This clarification is a must in shared medical decision-making and evidence-based medicine. Numerous methods are available, although none outweigh the others. The complex specifications of net benefit estimation should be tailored to the expectations of the central stakeholder, patient or society, and the unlimited range of potential contexts. The challenges, limitations, constraints and skills to be acquired by all stakeholders were discussed by the participants of the round table. They are described in this article, enabling key messages and guidelines to be presented. The essential priority is to ensure that all stakeholders receive the required training.


Assuntos
Tomada de Decisões , Medição de Risco , Medicina Baseada em Evidências , Humanos
3.
Bull Cancer ; 99 Suppl 1: S16-20, 2012 Jul.
Artigo em Francês | MEDLINE | ID: mdl-22511187

RESUMO

In castrate-refractory prostate cancers, main efficacy endpoints are progression free survival for phase-II trials and overall survival for phase-III trials. However, various progression criteria have been used, and overall survival may become more difficult to impact due to the recent approval of more effective drugs. PSA is useful in clinical practice, provided it is interpreted with caution, but cannot be used as a surrogate endpoint in clinical trials. Finally, circulating tumor cells represent a promising area of development.


Assuntos
Neoplasias da Próstata , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Progressão da Doença , Intervalo Livre de Doença , Humanos , Masculino , Células Neoplásicas Circulantes , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Rech Soins Infirm ; (101): 25-8, 2010 Jun.
Artigo em Francês | MEDLINE | ID: mdl-20608262

RESUMO

The authors mention the existing methods to perform meta-analysis, and show that meta-analysis based on individual patient data (IPD meta-analyses) are the most reliable. Taking the example of 4 successive meta-analysis of clinical trials in advanced colorectal cancer, they illustrate the possibilities of IPD meta-analysis. They conclude that meta-analysis are a powerful tool not only to confirm small differences between treatment modalities, but also to generate hypothesis, to perform exploratory subgroup analysis, and to study potential surrogate endpoints.


Assuntos
Neoplasias Colorretais/enfermagem , Metanálise como Assunto , Humanos , Pesquisa em Enfermagem/métodos , Pesquisa em Enfermagem/normas , Reprodutibilidade dos Testes
6.
Rev Prat ; 59(4): 469-73, 2009 Apr 20.
Artigo em Francês | MEDLINE | ID: mdl-19462864

RESUMO

Biliary tract carcinomas are rare tumours, counting for less than 5% of cancer. Biliary tract carcinomas comprise gallbladder carcinoma and cholangiocarcinoma, which arise from the intrahepatic or extrahepatic bile ducts. These tumours have a poor prognosis, with a median survival of 6 months for advanced disease. Surgical resection is the only potentially curative therapy. Adjuvant treatement by chemotherapy, radiotherapy or radio-chemotherapy might be an option after surgery, however no standard therapy is define. For advanced disease, despite progress of palliative chemotherapy, there is no standard therapy.


Assuntos
Neoplasias do Sistema Biliar/terapia , Neoplasias do Sistema Biliar/tratamento farmacológico , Neoplasias do Sistema Biliar/cirurgia , Humanos
7.
Crit Rev Oncol Hematol ; 68(2): 178-82, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18672379

RESUMO

Pancreatic cancer represents one of the most lethal cancers and treatment of advanced disease remains palliative. Age-related physiologic changes can increase chemotherapy's toxicity but the use of gemcitabine in elderly patients has not been properly evaluated. This observational prospective study evaluated patients aged 70 years and over, receiving gemcitabine for an advanced pancreatic carcinoma. Gemcitabine was delivered according to the usual fixed-dose rate schedule (1000mg/(m(2)week) over 100min, every week, 3 weeks over 4). Thirty-nine patients (median age 74) were treated between November 1999 and August 2004. Twenty-three patients (59%) received 100% of the planned dose-intensity. Grade 3-4 toxicities were neutropenia (38% of patients), thrombocytopenia (28%), anemia (18%) and alopecia (18%). Four partial responses (10%) and 13 stabilizations (33%) were observed. Eight patients (20%) experienced clinical benefit. The median progression free and overall survivals were 7 and 10 months, respectively. Gemcitabine can be administered in selected elderly patients.


Assuntos
Adenocarcinoma/tratamento farmacológico , Antineoplásicos/administração & dosagem , Desoxicitidina/análogos & derivados , Cuidados Paliativos/métodos , Neoplasias Pancreáticas/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Feminino , Humanos , Masculino
8.
Curr Opin Oncol ; 20(4): 466-71, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18525345

RESUMO

PURPOSE OF REVIEW: The purpose of this review is to discuss recently published work on endpoints for early and advanced colorectal cancer, as well as the statistical approaches used to validate surrogate endpoints. RECENT FINDINGS: Most attempts to validate surrogate endpoints have estimated the correlation between the surrogate and the true endpoint, and between the treatment effects on these endpoints. The correlation approach has made it possible to validate disease-free survival and progression-free survival as acceptable surrogates for overall survival in early and advanced disease, respectively. SUMMARY: The search for surrogate endpoints will intensify over the coming years. In parallel, efforts to either standardize or extend the endpoints or both will improve the reliability and relevance of clinical trial results.


Assuntos
Biomarcadores Tumorais/análise , Neoplasias Colorretais/química , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/mortalidade , Determinação de Ponto Final , Humanos , Taxa de Sobrevida
9.
Stat Methods Med Res ; 17(5): 519-27, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18285441

RESUMO

Surrogate endpoints in oncology research and practice have garnered increasing attention over the past two decades. This activity has largely been driven by the promise surrogate endpoints appear to hold: the potential to get new therapies to seriously ill patients more rapidly. However, uncertainties abound. Even agreeing upon a definition of a "valid" surrogate endpoint has not been a straightforward exercise; this article begins by highlighting differences in how this term has been previously captured and applied, as well as laying out the basic criteria essential for its application in advanced colorectal cancer. Ideally, these elements include (but are not limited to) ease of measurement, rapid indication of treatment effect, and, most importantly, reliable and consistent prediction of the true impact of a treatment on the ultimate outcome of interest: overall survival. The strengths and weaknesses of current potential surrogate endpoints in advanced colorectal cancer, including performance status, carcinoembryonic antigen plasma level, overall response rate, time to progression, and disease-free survival, are each considered in turn. Finally, limitations of surrogate endpoints in the clinical setting, including challenges in extrapolation to new therapies, and the incomplete provision of information about potential adverse effects, are discussed. Work remains to be done between physicians and statisticians to bridge the gap between that which is statistically demonstrable and that which will be clinically useful.The term ;surrogate endpoint' was virtually unknown by most oncologists 15 years ago. A search in PubMed [http://www.ncbi.nlm.nih.gov] based on the words ;surrogate and cancer' shows that more than 2000 papers were published in medical journals in the last 20 years, with a dramatic increase of interest in the last five years. Interestingly, the same trend is observed when the words ;surrogate and heart' are entered into PubMed, suggesting that the issue of surrogate endpoints goes beyond the field of oncology, although the frequency of discussion varies (Figure 1; note different y-axis scales for oncology and cardiology).The goal of the present paper is to discuss the main issues surrounding surrogate endpoints from a clinician's point of view, using as an example surrogate endpoints of overall survival (OS) in advanced colorectal cancer (ACC).


Assuntos
Atitude do Pessoal de Saúde , Biomarcadores , Neoplasias Colorretais/fisiopatologia , Análise de Sobrevida , Bibliometria , Humanos , Reprodutibilidade dos Testes
10.
Bull Cancer ; 94(11): 953-6, 2007 Nov.
Artigo em Francês | MEDLINE | ID: mdl-18055312

RESUMO

The purpose of phase II trials is to identify signals in favor of the efficacy of a drug in development. The main pitfall of a phase II study is to conclude by error that a drug has no activity, leading to a stop in the development of a drug which has a real efficacy. In oncology, more and more phase II trials are randomised, even though there are still numerous non randomised studies. Randomisation allows some control on the risk of patient selection bias, inherent to non randomised trials. This bias consists of recruiting by chance a population of patients with high risk or on the contrary low risk of response to the experimental treatment. The present paper describes the various types of randomised phase II trials, their principles, strengths and limits.


Assuntos
Ensaios Clínicos Fase II como Assunto/métodos , Neoplasias/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Fase II como Assunto/normas , Humanos , Distribuição Aleatória , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Viés de Seleção , Resultado do Tratamento
11.
J Clin Oncol ; 25(33): 5218-24, 2007 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-18024867

RESUMO

PURPOSE: The traditional end point for assessing efficacy of first-line chemotherapies for advanced cancer is overall survival (OS), but this end point requires prolonged follow-up and is potentially confounded by the effects of second-line therapies. We investigated whether progression-free survival (PFS) could be considered a valid surrogate for OS in advanced colorectal cancer. PATIENTS AND METHODS: Individual patient data were available from 10 historical trials comparing fluouracil (FU) + leucovorin with either FU alone (1,744 patients) or with raltitrexed (1,345 patients) and from three validation trials comparing FU + leucovorin with or without irinotecan or oxaliplatin (1,263 patients). Correlation coefficients were estimated in historical trials between the end points of PFS and OS, and between the treatment effects on these end points. Treatment effects on OS were predicted in validation trials, and compared with the observed effects. RESULTS: In historical trials, 1,760 patients (57%) had progressed or died at 6 months, and 1,622 (52%) had died at 12 months. The rank correlation coefficient between PFS and OS was equal to 0.82 (95% CI, 0.82 to 0.83). The correlation coefficient between treatment effects on PFS and on OS ranged from 0.99 (95% CI, 0.94 to 1.04) when all trials were considered to 0.74 (95% CI, 0.44 to 1.04) after exclusion of one highly influential trial. In the validation trials, the observed OS hazard ratios were within the 95% prediction intervals. A hazard ratio of 0.77 or lower in terms of PFS would predict a benefit in terms of OS. CONCLUSION: PFS is an acceptable surrogate for OS in advanced colorectal cancer.


Assuntos
Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/tratamento farmacológico , Progressão da Doença , Fluoruracila/administração & dosagem , Humanos , Leucovorina/administração & dosagem
12.
J Clin Oncol ; 25(24): 3732-8, 2007 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-17704423

RESUMO

PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly regimen (fluorouracil [FU] and leucovorin [LV] semi-monthly is LV5FU2) with a monthly regimen of FU and LV (mFU/LV) as well as 24 weeks versus 36 weeks of each regimen as adjuvant treatment of stage II and III colon cancer. PATIENTS AND METHODS: LV5FU2 was administered semimonthly for 2 days as racemate (dl) or levogyre (l-; 200 or 100 mg/m(2)) as a 2-hour infusion, followed by 400 mg/m(2) FU bolus and a 600-mg/m(2) FU 22-hour continuous infusion. FU and LV were administered monthly (mFU/LV) for 5 days as dl- or l-LV 15-minute infusion, followed by a 400 mg/m(2) FU 15-minute infusion. The primary end point was disease-free survival (DFS). RESULTS: Between September 1996 and November 1999, 905 patients with stage II (43%) and III (57%) colon cancer were enrolled. The median follow-up was 6 years. There was no statistically significant difference between mFU/LV and LV5FU2 in terms of DFS (150 v 148 events; hazard ratio [HR],1.01; 95% CI, 0.806 to 1.269; P = .94) and overall survival (OS; 104 v 103 events; HR,1.02; 95% CI, 0.77 to 1.34; P = .91). No statistical difference was observed between 24 or 36 weeks of chemotherapy. Median survival from metastatic relapse was 24 months. The survival of patients with metastatic relapse (n = 243) was significantly longer for patients with a longer time from random assignment to relapse (< 1, 1 to 2, >or= 2 years; log-rank test for trend P, .0497). CONCLUSION: DFS and OS were not statistically different between treatment groups and treatment durations. These data confirm the value of LV5FU2 as control arm in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer and Pan-European Trials in Adjuvant Colon Cancer studies.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Quimioterapia Adjuvante , Neoplasias do Colo/mortalidade , Neoplasias do Colo/patologia , Intervalo Livre de Doença , Esquema de Medicação , Fluoruracila/administração & dosagem , Seguimentos , Humanos , Leucovorina/administração & dosagem , Recidiva Local de Neoplasia , Prognóstico , Taxa de Sobrevida
13.
Arch Surg ; 142(7): 619-23; discussion 623, 2007 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-17638798

RESUMO

HYPOTHESIS: The more rapid and less complicated recovery after palliative stent insertion compared with surgery may theoretically facilitate the early administration of chemotherapy. DESIGN: A retrospective study. SETTING: University tertiary care referral center. PATIENTS: From January 1, 1996, to September 15, 2005, 58 patients with obstructing colon cancer and nonresectable synchronous metastases were treated with self-expanding colonic metallic stent (SEMS) (n = 31) or surgery (n = 27). MAIN OUTCOME MEASURES: Comparison of the use of SEMS and emergency surgery as palliative measures to treat obstructing colon cancer with special reference to time to chemotherapy administration and survival. RESULTS: Mortality and morbidity were comparable between the 2 groups. Median hospital stay was shorter after SEMS insertion than after surgery (median, 8.0 vs 13.5 days, respectively; P < .01). Incidence of stoma creation was lower in patients treated with SEMS than in patients treated with surgery (6% vs 37%, respectively; P = .02). The median time to chemotherapy administration was shorter after SEMS insertion than after surgery (14.0 vs 28.5 days, respectively; P = .002). Three patients with SEMS and 0 patients in the surgical group underwent a curative colonic and hepatic resection after downstaging by chemotherapy (P = .27). Two patients (6%) with SEMS and undergoing chemotherapy had a tumor perforation requiring emergency surgery. There was no difference in survival between the 2 groups (median survival, 13.7 months for SEMS vs 11.4 months for surgery; P = .19). CONCLUSIONS: Insertion of SEMS should be the first step to treat obstructing colon cancer with nonresectable synchronous metastases because it allows chemotherapy to be administered earlier, may increase the resectability rate of metastases, and favorably impacts survival. The risk of tumor perforation while receiving chemotherapy requires attention.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias do Colo/cirurgia , Obstrução Intestinal/cirurgia , Cuidados Paliativos , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Colectomia , Neoplasias do Colo/tratamento farmacológico , Feminino , Hepatectomia , Hospitalização , Humanos , Obstrução Intestinal/tratamento farmacológico , Tempo de Internação , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/cirurgia , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Estadiamento de Neoplasias , Estudos Retrospectivos , Estomas Cirúrgicos , Taxa de Sobrevida , Fatores de Tempo
14.
BMC Cancer ; 6: 285, 2006 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-17156477

RESUMO

BACKGROUND: Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer. METHODS: A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients. RESULTS: Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa. CONCLUSION: There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Desoxicitidina/análogos & derivados , Neoplasias Pancreáticas/tratamento farmacológico , Venenos de Serpentes/uso terapêutico , Adulto , Inibidores da Angiogênese/toxicidade , Antimetabólitos Antineoplásicos/uso terapêutico , Antimetabólitos Antineoplásicos/toxicidade , Divisão Celular/efeitos dos fármacos , Desoxicitidina/uso terapêutico , Desoxicitidina/toxicidade , Humanos , Neoplasias Pancreáticas/irrigação sanguínea , Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/patologia , Qualidade de Vida , Venenos de Serpentes/toxicidade , Inquéritos e Questionários , Taxa de Sobrevida
15.
J Clin Oncol ; 24(31): 4976-82, 2006 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-17075115

RESUMO

PURPOSE: Complete resection of liver metastases of colorectal origin is the only potentially curative treatment. In order to decrease recurrences, the use of adjuvant systemic chemotherapy after liver resection is controversial because no randomized study demonstrated its benefit. PATIENTS AND METHODS: In a multicenter trial, we randomly assigned 173 patients with completely resected (R0) hepatic metastases from colorectal cancer to surgery alone and observation (87 patients) or to surgery followed by 6 months of systemic adjuvant chemotherapy with a fluorouracil and folinic acid monthly regimen (86 patients). The main outcome criterion was disease-free survival. Secondary outcome measures were overall survival and treatment-related toxicity. RESULTS: The intention-to-treat analysis was based on 171 patients, after a median follow-up of 87 months (SE = 5.8). The 5-year disease-free survival rate, after adjustment for major prognostic factors, was 33.5% for patients in the chemotherapy group and 26.7% for patients in the control group (Cox multivariate analysis: odds ratio for recurrence or death = 0.66; 95% CI, 0.46 to 0.96; P = .028). With regard to secondary outcome measures, a trend towards increased overall survival was observed but did not reach statistical significance (5-year overall survival: chemotherapy group, 51.1% v control group, 41.1%; odds ratio for death, 0.73; 95% CI, 0.48 to 1.10; P = .13). CONCLUSION: Despite a suboptimal regimen, which was the standard at the beginning of the study, adjuvant intravenous systemic chemotherapy provided a significant disease-free survival benefit for patients with resected liver metastases from colorectal cancer.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/patologia , Hepatectomia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/cirurgia , Adulto , Idoso , Quimioterapia Adjuvante , Intervalo Livre de Doença , Feminino , Fluoruracila/administração & dosagem , França , Humanos , Infusões Intravenosas , Leucovorina/administração & dosagem , Neoplasias Hepáticas/secundário , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Análise de Sobrevida , Suíça , Resultado do Tratamento
16.
Eur J Radiol ; 59(1): 42-8, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16504446

RESUMO

OBJECTIVE: To describe the computed tomography (CT) features at diagnosis and after treatment of adenocarcinoma of unknown primary (ACUP) mimicking lymphoma of the mediastinum. METHODS: Fifteen patients with pathologically proven ACUP and with primarily mediastinal involvement were initially referred to the Hematologic Department of our institution with a suspected diagnosis of lymphoma, and accounted for our study population. Presenting symptoms and baseline biological values were analyzed. All thoraco-abdominal CT studies were reviewed for the location and size of the mediastinal involvement and associated findings. Follow-up chest CT was performed in 14 patients after radiotherapy, chemotherapy or surgical treatment. RESULTS: The most frequent CT feature was a large anterior and middle mediastinal mass (67%), with no calcification. Associated findings included the presence of lung nodules (40%), compression of large mediastinal vessels (33%) and pleural effusion (27%). Follow-up CT, performed in 14 cases, suggested partial or complete responses in 7 patients (50%) 4 weeks after the treatment onset. CONCLUSIONS: Mediastinal ACUP is a differential diagnosis of large mediastinal masses and is frequently associated with lung nodules and mediastinal vascular compression.


Assuntos
Adenocarcinoma/diagnóstico por imagem , Adenocarcinoma/secundário , Neoplasias do Mediastino/diagnóstico por imagem , Neoplasias do Mediastino/secundário , Neoplasias Primárias Desconhecidas/diagnóstico por imagem , Tomografia Computadorizada Espiral , Adenocarcinoma/terapia , Adulto , Idoso , Diagnóstico Diferencial , Feminino , Seguimentos , Humanos , Linfoma/diagnóstico por imagem , Masculino , Neoplasias do Mediastino/terapia , Pessoa de Meia-Idade , Taxa de Sobrevida , Resultado do Tratamento
17.
Nucl Med Commun ; 26(12): 1059-66, 2005 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-16264351

RESUMO

BACKGROUND: This prospective study was undertaken to address the capacity of positron emission tomography (PET) with 2-[18F]fluoro-2-deoxy-D-glucose (18F-FDG) to determine the primary tumour site of carcinomas with unknown primary site. PATIENTS AND METHODS: Twenty-five patients with metastases from adenocarcinoma or undifferentiated carcinoma of unknown primary site (CUP) were included prospectively. For all patients, extensive imaging was unsuccessful in localizing the primary site. Patients received 370 MBq of 18F-FDG intravenously, and whole-body images were acquired 60 min after injection. All hot spots that could not be attributed to a metastatic site were considered as the primary tumour. The evaluation of FDG PET data was based on clinical and radiological outcome or surgery if indicated. RESULTS: Twenty-four patients were eligible for analysis. All known metastases were visualized. In six patients, FDG PET showed a primary tumour site which was confirmed by follow-up or surgery. In five patients, the primary tumour site was suggested by FDG PET but not confirmed by clinical outcome. No primary tumour was found in the other patients, with a mean follow-up of 15 months. CONCLUSION: In our series, FDG PET allowed the identification of primary tumour site in one quarter of patients with CUP (6/24). We conclude that FDG PET has a place in the initial staging of these patients.


Assuntos
Fluordesoxiglucose F18 , Neoplasias Primárias Desconhecidas/diagnóstico , Neoplasias/diagnóstico por imagem , Neoplasias/diagnóstico , Tomografia por Emissão de Pósitrons/métodos , Adenocarcinoma/patologia , Adulto , Idoso , Reações Falso-Positivas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neoplasias Primárias Desconhecidas/diagnóstico por imagem , Estudos Prospectivos , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Contagem Corporal Total
18.
Int J Technol Assess Health Care ; 21(1): 119-25, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15736523

RESUMO

BACKGROUND: The hazard ratio (HR) is the most appropriate measure for time to event outcomes such as survival. In systematic reviews, HRs can be calculated either from the raw trial data obtained as part of an individual patient data (IPD) meta-analysis or from the appropriate trial-level summary statistics. However, the information required for the latter are seldom reported in sufficient detail to allow reviewers to calculate HRs. In contrast, the median survival and survival rates at specific time points are frequently presented. We aimed to evaluate retrospectively the performance of meta-analyses using median survival times and survival rates by comparing them with meta-analyses using IPD to calculate HRs. METHODS: IPD from thirteen published meta-analyses (MAs) in cancers with high mortality rates were used. Median survival and survival rates were calculated from the IPD rather than taken from publications so that the same trials, patients, and extended follow-up are used in each analysis. RESULTS AND CONCLUSIONS: We show that using median survival times or survival rates at a particular point in time are not reasonable surrogate measures for meta-analyses of survival outcomes and that, wherever possible, HRs should be calculated. Individual trial publications reporting on time to event outcomes, therefore, should provide more detailed statistical information, preferably logHRs and their variances, or their estimators.


Assuntos
Metanálise como Assunto , Neoplasias/mortalidade , Análise de Sobrevida , Interpretação Estatística de Dados , Humanos , Neoplasias/terapia , Estudos Retrospectivos
20.
J Clin Oncol ; 22(3): 484-92, 2004 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-14752071

RESUMO

PURPOSE: Adjuvant therapy of colorectal cancer with oral fluorinated pyrimidines is attractive because of its ease of administration and good tolerability. The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year. PATIENTS AND METHODS: This meta-analysis was performed on individual data from three randomized trials conducted by the Japanese Foundation for Multidisciplinary Treatment for Cancer involving a total of 5,233 patients with stages I to III colorectal cancer. RESULTS: The overall hazard ratio in favor of oral therapy was 0.89 for survival (95% CI, 0.80 to 0.99; P =.04), and 0.85 for disease-free survival (95% CI, 0.77 to 0.93; P <.001). Thus oral therapy reduced the risk of death by 11% and the risk of recurrence or death by 15%. There was no significant heterogeneity between trials, nor did the benefit of oral therapy depend on tumor stage (I, II, or III), tumor site (rectum or colon), patient age, or patient sex. CONCLUSION: Oral fluoropyrimidines improve disease-free survival and survival of patients after resection of early-stage colorectal cancer. These observations support the use of these agents alone after resection of early-stage disease, as well as further testing of oral agents in combination with new drugs that have recently shown antitumor activity in advanced colorectal cancer.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Fluoruracila/análogos & derivados , Neoplasias Retais/tratamento farmacológico , Administração Oral , Idoso , Quimioterapia Adjuvante , Neoplasias do Colo/cirurgia , Feminino , Fluoruracila/administração & dosagem , Humanos , Masculino , Dose Máxima Tolerável , Mitomicina/administração & dosagem , Recidiva Local de Neoplasia/prevenção & controle , Estadiamento de Neoplasias , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Retais/cirurgia , Taxa de Sobrevida , Tegafur/administração & dosagem
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