Bulletin du cancer
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We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.
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The recent development of antiangiogenic agents has revolutionized the management of renal cell carcinoma. In less than two-years, the French health authorities have approved the use of four drugs (sorafenib, sunitinib bevacizumab, temsirolimus) for the treatment of locally advanced or metastatic renal cell carcinoma. ⋯ The management of toxic effects is essential to ensure treatment compliance and patient quality of life. The present report describes in detail the adverse events associated with each therapeutic class and the management of side effects.