Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 25, Issue 24, Pages 3657-3663Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2006.07.4062
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Funding
- NCI NIH HHS [U10-CA76001-09] Funding Source: Medline
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Purpose The American College of Surgeons Oncology Group trial Z0011 was a prospective, randomized, multicenter trial comparing overall survival between patients with positive sentinel lymph nodes ( SLNs) who did and did not undergo axillary lymph node dissection ( ALND). The current study compares complications associated with SLN dissection ( SLND) plus ALND, versus SLND alone. Patients and Methods From May 1999 to December 2004, 891 patients were randomly assigned to SLND + ALND ( n = 445) or SLND alone ( n = 446). Information on wound infection, axillary seroma, paresthesia, brachial plexus injury ( BPI), and lymphedema was available for 821 patients. Results Adverse surgical effects were reported in 70% ( 278 of 399) of patients after SLND + ALND and 25% ( 103 of 411) after SLND alone ( P <= .001). Patients in the SLND + ALND group had more wound infections ( P <= .0016), seromas ( P <= .0001), and paresthesias ( P <= .0001) than those in the SLND-alone group. At 1 year, lymphedema was reported subjectively by 13% ( 37 of 288) of patients after SLND + ALND and 2% ( six of 268) after SLND alone ( P <= .0001). The difference between the two groups' lymphedema, assessed by arm measurements at 30 days ( P = .36), 6 months ( P = .22), and 1 year ( P = .078), although close to the cutoff for significance at 1 year, was not significant. BPIs occurred in less than 1% of patients. Conclusion In trial Z0011, the use of SLND + ALND resulted in more wound infections, axillary seromas, and paresthesias than SLND alone. Lymphedema was more common after SLND + ALND but was significantly different only by subjective report. The use of SLND alone resulted in fewer complications.
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