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Bending the Curve Trial by Trial
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NSABP B-32

Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer

Phase 3N = 5,611NCT00003830

Population
Women with invasive breast cancer and clinically negative axillary nodes; outcome analysis in 3986 SLN-negative patients with follow-up information.
Design
Randomised phase 3 trial at 80 centres in Canada and the USA, May 1999 to February 2004: SLN resection plus ALND (group 1) versus SLN resection alone with ALND only if SLNs were positive (group 2); allocation 1:1 by biased-coin minimisation; outcome analyses in patients with pathologically negative sentinel nodes and follow-up data.
Primary endpoint
OS
Arms
  • SLN resection + ALND (group 1) (control, n = 1,975): Sentinel-lymph-node resection plus axillary lymph node dissection
  • SLN resection alone (group 2) (experimental, n = 2,011): Sentinel-lymph-node resection alone, with ALND only if SLNs positive
People
Krag DN, NSABP
OSHR 1.20 (95% CI 0.96–1.50)Δ 96-month OS−1.5 pointsDFSHR 1.05 (95% CI 0.90–1.22)Δ 96-month DFS−0.9 points
Show the numbers
Results reported for NSABP B-32
EndpointAnalysisSLN resection alone (group 2)SLN resection + ALND (group 1)Effect
OSSLN-negative patients with follow-up information (n=3986)primaryKrag 201090.3% at 8 y (88.8–91.8%)91.8% at 8 y (90.4–93.3%)HR 1.20 (95% CI 0.96–1.50)P=0.12Abstract states the log-rank comparison of groups 1 and 2; the direction of the HR is not stated (group 2 had more deaths: 169 of 2011 vs 140 of 1975). Mean time on study 95.6 months.
DFSSLN-negative patients with follow-up information (n=3986)primaryKrag 201081.5% at 8 y (79.6–83.4%)82.4% at 8 y (80.5–84.4%)HR 1.05 (95% CI 0.90–1.22)P=0.54Direction of the HR not stated in the abstract.
Results reported for NSABP B-32
EndpointAnalysisSLN resection alone (group 2)SLN resection + ALND (group 1)Effect
OSSLN-negative patients with follow-up information (n=3986)primaryKrag 201090.3% at 8 y (88.8–91.8%)91.8% at 8 y (90.4–93.3%)HR 1.20 (95% CI 0.96–1.50)P=0.12Abstract states the log-rank comparison of groups 1 and 2; the direction of the HR is not stated (group 2 had more deaths: 169 of 2011 vs 140 of 1975). Mean time on study 95.6 months.
DFSSLN-negative patients with follow-up information (n=3986)primaryKrag 201081.5% at 8 y (79.6–83.4%)82.4% at 8 y (80.5–84.4%)HR 1.05 (95% CI 0.90–1.22)P=0.54Direction of the HR not stated in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.20.96–1.5
DFS1.050.9–1.22
Primary publication: Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11(10):927-33. PubMedDOI

Appears in

Sources

  1. Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11(10):927-33.

    PubMedDOI