High dose daily XXXX and hypofractionated intensively accelerated radiotherapy for locally advanced @entity0 . A phase I/II study and report on early and late sequellae.

@entity1 @entity137 @entity82 @entity0 @entity5 @entity8503 @entity391 @entity5300 @entity519
Intrinsic radioresistance, @entity5 @entity519 and ability of @entity5 cells to undergo rapid repopulation during radiotherapy are associated with failure of radiotherapy. Tumors with low alpha/beta-ratio values or @entity5 unable to undergo re-oxygenation, are unlikely to be eradicated with standard radiotherapy. Although the therapeutic efficacy of accelerated regimens based on low-dose per fraction may be high since they minimize the adverse role of rapid @entity5 repopulation, the cellular compartment with low alpha/beta-ratio values (i.e. @entity519 cells) remains a limiting factor. Accelerated hypofractionation, which may be more effective in such @entity5 , cannot be safely applied unless normal tissues are protected. In the present study we assessed the feasibility of hypofractionated and accelerated radiotherapy supported by cytoprotection (HypoARC) with high dose daily @entity8503 . Fifteen @entity0 @entity1 with locally advanced disease entered radiation-dose escalation protocoL Twelve consecutive fractions of 3.5-4Gy (5 fractions/week) were given to the breast/chest wall, supraclavicular and axillary area, within 17 days. A high dose of @entity8503 , at 1,000 mg flat dose, was given 20 minutes before each radiotherapy fraction. @entity8503 administration was well- tolerated with minor side-effects ( @entity391 in 6 out of 15 and hypotention in 2 out of 15 @entity1 ). Radiation induced @entity137 was negligible (grade 3 in 1 out of 15 @entity1 ). Ten out of 15 @entity1 survived more than 12 months and 7 out of 15 more than 18 months following HypoARC. None of these @entity1 showed any signs of late sequellae, such as @entity82 , or @entity5300 . Complete and partial responses were obtained in 11 out of 15 (73%) and in 4 out of 15 (27%) @entity1 , respectively. High dose daily @entity8503 during hypofractionated radiotherapy is feasible. HypoARC regimen is well-tolerated, effective and has minimal acute and late @entity137 to normal breast, chest and axillary tissues.
