文档介绍：Background
Sentinel node (SN) biopsy has replaced the axillary lymph node dissection (ALND) if cN0
If axillary SN+ (AxSN+) and indication for axillary treatment, ALND is standard of care
ALND is associated with high rates of side effects
Axillary radiotherapy (AxRT) provides good regional control with limited side effects in cN0
Deutsch et al, IJROBP 2008
Hoebers et al, Cancer 2000
Fisher et al, NEJM 2002
Louis-Sylvestre et al, JCO 2004
Hypothesis
Axillary radiotherapy provides local control and survival comparable to ALND with fewer side effects in women with a positive axillary SN
Eligibility Criteria
Inclusion
Invasive breast cancer -5 cm
Clinically N0
BCT or mastectomy
Any age
Informed consent
Exclusion
Multicentric disease
Neoadjuvant systemic treatment
Previous axillary treatment
Prior malignancy
Trial design
cT1-2
N0
R
SNB
Stratification: institution Adjuvant systemic therapy by choice
ALND
AxRT
AxSN+
AxSN-
Objectives
Primary: To demonstrate non-inferiority in axillary recurrence rate
Secondary:
1. To compare overall survival (OS) and disease-free survival (DFS)
2. To compare lymphedema, shoulder function and Quality of Life (QoL)
Endpoints and statistical design
Primary: 5-years axillary recurrence free rate
Non inferiority hypothesis (design):
assumption: ALND 98%; AxRT >96%
one-sided log-rank; alpha = ; power = 80%
52 events needed
Secondary:
Efficacy: OS and DFS
Safety: shoulder function, lymphedema, QoL
AxRT
Timing: Start < 12 weeks after SNB
Extent: level I + II + III + medial SC
Dose & schedule: 25 x 2 Gy or equivalent
Quality control: dummy run
Hurkmans et al, Radiother Oncol 2003
Timing:
< 12 weeks after SNB
Extent:
Level I + II mandatory Level III optional
Additional AxRT:
≥ 4 positive nodes
ALND
RESULTS
2001- 2010: 4806 patients enrolled (4766 required)
All included patients n = 4806