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.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Land
Stephanie R
SR
National Surgical Adjuvant Breast and Bowel Project Operations and Biostatistics Center, University of Pittsburgh, Pittsburgh, PA 15213, USA. land@pitt.edu
Kopec
Jacek A
JA
Julian
Thomas B
TB
Brown
Ann M
AM
Anderson
Stewart J
SJ
Krag
David N
DN
Christian
Nicholas J
NJ
Costantino
Joseph P
JP
Wolmark
Norman
N
Ganz
Patricia A
PA
D000203:Activities of Daily Living; D001132:Arm; D001365:Axilla / Q000601:surgery; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects*; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000473:pathology; D015412:Mastectomy, Segmental; D008875:Middle Aged; D011788:Quality of Life; D016059:Range of Motion, Articular; D021701:Sentinel Lymph Node Biopsy; D016896:Treatment Outcome