Bulletin du cancer
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Twenty years ago, laparoscopic surgery entirely changed the traditional style of surgical operations. However, it was difficult to perform some interventions, particularly in restricted space or if acts of reconstruction are necessary. ⋯ We detail the different technologies and we precise the place of the robotic surgery in oncological surgery. In conclusion, we believe that, in the near future as robotic technology continues to develop, it could replace traditional surgery not only in the treatment of benign diseases but also in malignant illnesses.
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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. ⋯ 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.
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The methodological principles for the planning of interim analyses in a phase III clinical trial are presented in this article. The case for superiority, non-inferiority and futility, and the roles of Data Monitoring Committees are summarized. Several examples are presented to illustrate the methodology and to help investigators by better understanding and planning interim analyses in a phase III clinical trial.
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The main objective of phase I cancer trials is to determine precisely the recommended dose of an anticancer agent as a single agent or in a context of combinations of anticancer agents (including cytotoxic agents, immunotherapy, radiotherapy...), that is administered for the first time in man, to further proceed clinical development with phase II and III trials. The recommended dose must have the greatest efficiency with acceptable toxicity. For the anticancer agents, the ratio risk/benefit is high, since toxicities associated with many cancer therapeutic agents are substantial and because the efficacy is often limited. ⋯ Concerning the targeted anticancer therapies, the therapeutic effect on the target, due to their higher specificity, can be obtained using doses that have few toxicity. Using the toxicity to determine the recommended dose for phase II trials, as it is the case for "classical >> anticancer agents, does not seem to be sufficient. Alternatives to determine the optimal biological dose include measurement of target inhibition, pharmacokinetic analysis and functional imaging.
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Multicenter Study
[Management of anaemia in patient with cancer: results of the F-ACT study (French Anaemia Cancer Treatment)].
Anaemia is one of the most dreaded complications among patients with malignant pathologies. Its causes can be varied and whatever its severity, the impact on the quality of life of the patient remains essential. However, the epidemiologic data concerning anaemia are very few in the literature. ⋯ Approximately 2/3 of the anaemic patients received treatment by erythropoiesis stimulating agent (ESA) and approximately 17% of them did not receive any specific treatment for this anaemia. The median level of Hb at the introduction of the ESA was 10 g/dl. These results, compared with those reported in study ECAS (European Cancer Anaemia Survey) in 2001, seem to show an improvement in the management of anaemia and the use of the ESA, in particular an earlier introduction of this type of treatment since the appearance of anaemia.