Patient-reported outcomes in sentinel node-negative adjuvant breast cancer patients receiving sentinel-node biopsy or axillary dissection: National Surgical Adjuvant Breast and Bowel Project phase III protocol B-32

Abstract

Purpose: Sentinel lymph node resection (SNR) may reduce morbidity while providing the same clinical utility as conventional axillary dissection (AD). National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 is a randomized phase III trial comparing SNR immediately followed by AD (SNAD) to SNR and subsequent AD if SN is positive. We report the definitive patient-reported outcomes (PRO) comparisons.

Patients and methods: Eligible patients had clinically node-negative, operable invasive breast cancer. The PRO substudy included all SN-negative participants enrolled May 2001 to February 2004 at community institutions in the United States (n = 749; 78% age > or = 50; 87% clinical tumor size < or = 2.0 cm; 84% lumpectomy; 87% white). They completed questionnaires presurgery, 1 and 2 to 3 weeks postoperatively, and every 6 months through year 3. Arm symptoms, arm use avoidance, activity limitations, and quality of life (QOL) were compared with intent-to-treat two-sample t-tests and repeated measures analyses.

Results: Arm symptoms were significantly more bothersome for SNAD compared with SNR patients at 6 months (mean, 4.8 v 3.0; P < .001) and at 12 months (3.6 v 2.5; P = .006). Longitudinally, SNAD patients were more likely to experience ipsilateral arm and breast symptoms, restricted work and social activity, and impaired QOL (P < or = .002 all items). From 12 to 36 months, fewer than 15% of either SNAD or SNR patients reported moderate or greater severity of any given symptom or activity limitation.

Conclusion: Arm morbidity was greater with SNAD than with SNR. Despite considerable fears about complications from AD for breast cancer, this study demonstrates that initial problems with either surgery resolve over time.

Fig 1.

CONSORT diagram. SN, sentinel node; SNAD, SN resection followed by axillary dissection; SNR, sentinel node resection.

Fig 2.

National Surgical Adjuvant Breast and Bowel Project B-32 schema. (*) Patients in whom a sentinel lymph node is not identified will go on for axillary dissection.

Fig 3.

(A) Longitudinal graph of the proportion of patients with any restriction in recreational or social activity, among those with no restriction at baseline. P values from repeated measures logistic regression are shown. (B) Longitudinal graph of the percentage of patients with any restriction in occupational activity, among those with no restriction at baseline. P values from repeated measures logistic regression are shown. (C) Longitudinal graph of the mean quality of life score. P values from repeated measures linear regression are shown. SNAD, sentinel node resection followed by axillary dissection; SNR, sentinel node resection; QOL, quality of life.

Fig A1.

Box plots illustrate the distribution of major end point scales. Boxes are drawn from the 25th to the 75th percentile. Heavy horizontal lines within boxes are drawn at the median. Circles are potential outliers; larger circles reflect multiple equal observations. SNAD, sentinel node resection followed by axillary dissection; SNR, sentinel node resection.