European guidelines on breast cancer screening and diagnosis

Should clip-marking vs. no clip-marking after needle core biopsy/vacuum assisted needle core biopsy be used for surgical therapy planning in patients with breast cancer lesions?

The GDG agreed by consensus to support a conditional recommendation for the intervention. 

Palpable lesions possibly candidate for neoadjuvant therapy and non-palpable lesions: the GDG considered both types of lesion and agreed that the evidence did not support distinguishing these subgroups in this recommendation or in any of the Evidence to Decision considerations. The GDG noted that lesions that are initially palpable may later become non-palpable following neoadjuvant chemotherapy.

• The GDG noted that effective communication at the time of clip insertion is essential to ensure that women understand the implications of clip insertion on future management.
• The GDG noted that the timing of clip insertion is critical and whether it is feasible to insert clips during initial biopsies instead of a follow-up procedure may change the harm/benefit ratio because of the additional stress, complications and costs associated with placing the clip in a second time.

The GDG noted that monitoring for whether clips are inserted in the correct position in relation to a lesion is important. The GDG suggests further consideration of assessment mechanisms for the appropriateness of clip position either by radiology follow-up imaging or pathology. The GDG refers this to the ECIBC's Quality Assurance Scheme Development Group for consideration.

• The GDG suggested improved research with higher quality of evidence from observational studies or where clip-marking is not routinely used considering the use of randomised studies for high quality evidence.
• The GDG noted that improved evidence on the effectiveness is very important. Some members suggested that in the context of clinical equipoise randomised trials would provide higher quality evidence.
• The GDG suggested further research on the local effects of clips and impacts on the psychological well being for women and whether there is an impact of clips on breast cancer progression or recurrence.
• The GDG suggested improved cost-effectiveness evidence on the use of clip-marking and comparing the economic impact of clip-marking on the need for additional procedures such as biopsies and surgeries.
• The GDG suggested research on the use of clip-marking for palpable vs. non-palpable lesions.