Trials Flashcards
1
Q
Inclusion criteria for ACOSOG Z0011 breast cancer trial?
Guiliano et al, JAMA 2011
A
Population
- T1/T2 breast cancers (≤5 cm tumours)
- No palpable adenopathy
- 1-2 positive SLNs identified on frozen, touch-prep, H&E stain (permanent)
2
Q
Z0011 trial- two arms of trial
A
All patients underwent lumpectomy and tangential whole breast irradiation
Those with positive SLNs were randomized to either:
ALND vs SLNB alone
ALND (10+ LN harvested)
3
Q
Z0011 trial- endpoints
A
non-inferiority trial
Primary endpoint = overall survival
Secondary endpoint = disease free survival
4
Q
Z0011 trial- results?
A
No difference in 5-year overall survival
- 8% ALND
- 5% SLNB
No difference in 5-year disease free survival
- 2% ALND
- 9% SLNB
