The TeaM ( T h e r a peutic M ammaplasty) study: Protocol for a prospective multi-centre cohort study to evaluate the practice and outcomes of therapeutic mammaplasty

Abstract

HighlightsMulticentre prospective study involving breast and plastic surgical units across the UK.Will produce valuable data regarding the practice and outcomes of therapeutic mammaplasty.Will inform decision-making and lead to future definitive study.Will strengthen the collaborative network to facilitate the delivery of future projects.Will increase awareness of the techniques among trainees such that participation is educational.

Therapeutic mammaplasty is a safe and effective alternative to mastectomy with or without immediate breast reconstruction

“…The methods for the iBRA‐2 and TeaM prospective cohort studies have been reported previously. The two studies collected identical data items during an overlapping time interval and 37 centres participated in both studies, supporting the validity of a pooled analysis.…”

“…Consecutive patients undergoing mastectomy with or without IBR for invasive or preinvasive breast cancer at participating centres between July and December 2016 were recruited prospectively to the iBRA‐2 study. Patients undergoing TM, defined as ‘the oncoplastic application of breast reduction or mastopexy techniques including removal of skin to reduce the skin envelope to treat invasive or pre‐invasive (ductal carcinoma in situ ; DCIS) breast cancer using breast conserving surgery’, at participating centres between 1 September 2016 and 30 June 2017 were recruited to the TeaM study. The surgeon‐reported indication for offering TM was recorded prospectively, and only the subgroup of patients offered TM to avoid mastectomy were included in the present study.…”

“…Time to adjuvant treatment was defined as the interval from the last cancer surgery to the first dose of chemotherapy or first fraction of radiotherapy. Adequate margins were defined in the TeaM study according to local policy.…”

“…The protocol papers and primary analyses for both studies have been published. The combined analysis was not preplanned at the point of primary study design.…”

Do we need higher‐level evidence of improved quality of life outcomes before promoting uptake of oncoplastic breast conservation surgery techniques?

“…In conclusion, to date, there is consistent but low‐level evidence of better QoL outcomes and non‐inferior oncological outcomes with OBCS techniques. The planned UK prospective multicentre Therapeutic Mammoplasty (TeaM) study will provide high‐quality evidence regarding both aspects for that group of procedures . In the meantime, we feel that the broader application of OBCS techniques can continue to safely evolve as long as the principles of good surgical cancer management are followed.…”