Unfortunately this does not happen very often for second-line treatment of cancer, and even less so for successive treatments. This is clearly a wholly unacceptable situation in a medical science that pretends to methodological rigor research integrity, and it is long overdue that standards authorities, as I and others have been calling for years, finally issue comprehensive guidelines for the consistent use of survival endpoints, and that journals aid this initiative in demanding clear and standard definitions for any and all survival endpoints and analyses used in any study submitted for publication. Dr de Bono has received consulting fees and nonfinancial support from Astellas Pharma, AstraZeneca, Genentech, Roche, and Sanofi. Thirty-six studies compared different chemotherapy regimens and included no hormone agents or targeted therapies; six studies had a targeted agent in at least one of the arms, regardless of the use of other drugs; 16 studies evaluated hormone therapies with or without chemotherapy. On the other hand, some cancer therapies can be curative or at least give a meaningful respite from the disease.
When you enter three or more characters, a list of up to 10 suggestions will popup under the textbox. Statistics can provide helpful information but they are not the only factor used for treatment planning. About half of the patients in each arm had visceral metastases. Full details from this study will be presented at an upcoming scientific meeting and in a peer-reviewed publication. Reck M, Shepherd F, Pérol M, et al. Short assessment intervals and ongoing physician and patient education regarding the goal of treatment have been found to help minimize patient withdrawal and loss to followup. Any clinical trial report in the technical literature will describe what those criteria were.
Patients with those characteristics might well live longer than others even if the new treatment is actually no better than the old. While most well-designed comparative studies address this issue, they should still be monitored for asymmetry. Relevant discussion may be found on the. When I do need more treatment, I'll do CapTem again. Although we have no reason to believe that such selection criteria have introduced bias in our analysis, it is conceivable that the assessment of articles published in other journals would lead to different conclusions, especially with regard to the frequency of use of primary end points and other quantitative issues relating to time-dependent end points. Döhner H, Stilgenbauer S, Benner A, et al.
Although the number of radiographic progression events decreased in both treatment arms, the number of deaths remained the same in the enzalutamide arm and increased in the placebo arm. Given the key role played by the choice of end points for clinical trials and for drug approval, we assessed the recent literature on advanced breast cancer regarding the use of efficacy end points in randomized trials, with the specific aim of quantifying the frequency of their use. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. These drugs are not expected to provide the same objective response rates of earlier drugs, and instead act to prevent progression rather than cause tumors to regress and thereby impact mortality. All other causes of death censored.
Such studies have been published in only eight of the target journals since no articles from the Journal of the National Cancer Institute or The Lancet fulfilled the selection criteria. Patient characteristics were well balanced between the study arms. Not infrequently a big deal is made out of treatments which improve median survival by only a few weeks or months. We also carried out exploratory analyses by comparing studies that were grouped according to specific characteristics. Also if tumors shrink and this effect lasts for a significant amount of time it is likely the patient has gotten a benefit.
A second consideration regarding the limitations of our study is the fact that its design does not allow the assessment of publication bias. I don't get the specific values for tumor shrinkage % like many of you but I do my own 2 dimensional calculation when they do give me the same numbers, and it shows about 50-75 reduction with no progression. Consequently, Kendall τ generally results in a value closer to 0 no correlation than Spearman ρ does. The primary endpoint was progression-free survival. He has received consulting fees from AstraZeneca. Monitor and evaluate patients for fever and infections and treat appropriately.
Mr Phung is an employee of Astellas Pharma. If the treatment really works, it will have long lasting benefits. Median survival is the measure of how long individuals will live with a certain disease or treatment. Ideally, identification of a surrogate endpoint in a drug study provides a reliable signal that the clinical endpoint of the study has been met. Use the arrow keys to move through the suggestions. Methods: We searched PubMed for randomized trials published between 2000 and 2007 in 10 leading medical journals.