| Study (Ref.) |
#Enrolled |
Intervention |
Results |
MDACC ID 03-0023 (McAuliffe JC, 2009)[43];
phase II prospective
randomized |
19 |
Neoadjuvant-600 mg/day,3, 5, or 7 days; adjuvant- 600 mg/day, 2 years |
DFS- 1 year, 94 %; 2 years,87 % |
| RTOG-S01/ ACRIN 6665 32 (Eisenberg BL H. J., 2009)[44]; single arm/ nonrandomized II prospective study |
52 |
Neoadjuvant-600 mg/day,
8-12 weeks; adjuvant-
600 mg/day, 2 years |
PFS at 2 years, 77-83 %; OS at 2 years, 91-93 %
PFS at 5 years localized 57% vs. metastatic 30%
DFS at 5 years localized 77% vs. 68 % metastatic |
|