31 Significant response rates for regorafenib treatment were documented in Phase II clinical studies in patients affected by GIST and non-small cell lung cancer.
14 For aggressive B-cell lymphoma, the activity of Y-IT has been documented in the phase I/II study 10 and it was confirmed in a multicenter prospective phase II study involving 102 evaluable patients; 15 in the latter, an overall 44% response rate with 27% complete response CR) rate was observed.
The downstream effects of VEGFR inhibition on DCE-MRI have been documented in >40 phase I trials with a significant reduction in Ktrans and/or IAUGC being reported with multiple agents (Zweifel and Padhani, 2010).
Although it has been suggested by the trends, to date, no statistically significant OS advantage has been documented in a phase III randomised trial using neoadjuvant chemotherapy followed by RT.
Besides PLD, whose activity as a single agent in recurrent/metastatic breast cancer has been documented in several phase II studies (response rate=31 38%) (Ranson et al, 1997; Lyass et al, 2000; O'Brien et al, 2004), gemcitabine (GEM) has also been reported to provide encouraging response rates (range=25 37%) in this clinical setting (Carmichael et al, 1995; Blackstein et al, 2002).
Microcirculatory dysfunction has been documented in the early phase of sepsis and its severity has been related to poor outcome [6,7,15,16].
However, it is noteworthy that no significant progress has been documented in these patients in phase III trials since 1987.
Significant levels of depression have been documented in the early phases of HIV [ 24], suggesting that patients may experience extreme psychological distress, while still being physically asymptomatic.
Its immunosuppressive efficacy has been documented in large-scale prospective phase III studies in renal transplantation [ 1] and multiple sclerosis [ 2, 3].
