Ten-year follow-up results of a randomised controlled study comparing level-I vs level-III axillary lymph node...

The most appropriate level of axillary dissection for breast cancer remains unclear. The present randomised study compared the treatment results of level-I vs level-III dissection in T1/2/3 and N0/1a/1b (1987 UICC classification) breast cancer without distant metastasis. Between 1995 and 1997, 522 patients were enrolled, and 514 were eligible. They were stratified into breast-conserving surgery or mastectomy, and then further stratified into level-III dissection (group-A, n=258) or level-I dissection (group-B, n=256). All patients were given oral 5-fluorouracil at 200 mg day-1 and tamoxifen at 20 mg day-1, daily for 2 years. Group-A resulted in a significantly longer operation time (77.0 vs 60.5 min, P<0.0001) and significantly larger blood loss (62.1 vs 48.1 ml, P<0.0001) than group-B, but in no significant differences in the frequencies of arm oedema and shoulder disturbance. Group-A resulted in a significantly larger number of dissected nodes than group-B (18.7 vs 14.8, P<0.0001), but in no differences in the number of involved nodes (1.54 vs 1.44). There were no significant differences in the 10-year overall and disease-free survival rates: 89.6 and 76.6% for group-A vs 87.8 and 74.1% for group-B, respectively. In conclusion, level-III dissection resulted in a longer operation time and greater blood loss than level-I, but did not improve the survival rate. Level-III dissection is not a recommended surgery for T1-3/N0-1b breast cancer.