To date, many reports have suggested that selective Sentinel Node (SN) biopsy only could be used to manage early breast cancer. However, definitive prove is lacking. AIM: To prove that in early breast cancer patients with a SN biopsy showing micrometastases, refraining from completion axillary lymph-node dissection (ALND) is enough to produce the same prognostic information and disease control as proceeding with completion ALND. METHODS: A randomized prospective clinical trial was devised with two arms. In one arm, patients with SN micrometastases were subject to clinical follow-up (experimental arm). In the other arm, patients were submitted for completion ALND (control arm). All patients were evaluated for recurrence and survival. RESULTS: A total of 247 patients were entered (14 withdrawals): 112 patients in the control arm and 121 in the experimental arm. In the control arm, 15 (13%) completion ALND turned out positive (low burden). Mean time follow-up was 62 months. Four patients recurred: 1/108 (1%) in the control arm and 3/119 (2.5%) in the experimental arm. No differences in disease-free survival were found (p=0.325). No cancer related deaths were seen. Morbidity was more common in the control arm. CONCLUSIONS: Our results strongly suggest that in early breast cancer patients with micrometastasis, selective SN biopsy is enough to provide for loco-regional and distant disease control, without significant deleterious effects on survival.
|Date of Award||3 May 2013|
|Supervisor||Jaume Fernandez-llamazares Rodriguez (Director), Manuel Fraile Lopez Amor (Director) & Juan Francisco Julian Ibañez (Director)|