SLN Clinical Trial Phase

By | July 3, 2019

From 1999 to 2002, a third phase of multicenter clinical trials, focusing on axillary lymph node dissection (ALND), was conducted: randomized comparisons between “ALND vs. omission of ALND” and “ALND vs. radiotherapy” were performed, analyzing their respective disease-free survival rate, overall survival rate and lymph node recurrence rate, including sentinel node-negative and sentinel node-positive cases.
The results obtained from “ALND vs. omission of ALND” showed no significant disparity in node recurrence rate and overall survival rate if

  • the metastasis of the sentinel node was negative or a micro-metastasis (<2mm diameter)
  • up to 2 sentinel lymph node metastases, regardless of their diameter and if radiotherapy for the entire breast was indicated after partial mastectomy.

In addition to that, regardless of sentinel node size and number, there were no substantial differences in local recurrence rate or overall survival rate after ALND compared to radiotherapy (axillary to supraclavicular area).
The meta-analysis results of further clinical trials for the two groups “ALND vs. omission of ALND” and “ALND vs. radiotherapy” also provided no significant differences in survival rates.
According to the Japan Breast Cancer Society Guidelines 2018 edition, omission of ALND is

  • strongly recommended in cases of sentinel node-negative or micro-metastasis and
  • weakly recommended in cases of sentinel node-positive and breast-conserving therapy.

As for total mastectomy, ALND is strongly recommended, unless radiotherapy is given. In that case, omission of ALND is weakly recommended.
As a result of various clinical trials validating its efficiency, sentinel lymph node biopsy is now an essential procedure in early breast cancer therapy as well as providing optimal axillary treatment. Even in facilities where nuclear medicine cannot be handled, the use of a magnetic probe like TAKUMI makes it possible to perform safe and accurate sentinel lymph node biopsies.