Factors predicting positive or close surgical margins after Post NACT

  • Research type

    Research Study

  • Full title

    Factors predicting positive or close surgical margins after Post neoadjuvant chemotherapy breast conserving surgery- A retrospective study

  • IRAS ID

    218610

  • Contact name

    B Srinivas Pedamallu

  • Contact email

    srinivas.pedamallu1@nhs.net

  • Sponsor organisation

    Medway NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Neoadjuvant chemotherapy (NACT) is an established primary treatment modality for locally advanced breast carcinoma and also in medium to large tumours (T2 or T3) to facilitate breast conserving surgery. A survival benefit from the neoadjuvant chemotherapy was described as greatest for those who experience pathological complete response. A close (<1mm) or positive surgical margin requires further re-excision surgery or completion mastectomy after breast conserving surgery for adequate oncological control.Our study will aid us to identify factors predicting the need for re-excision after post NACT breast conserving surgery with close(<1mm) or positive surgical margins. This knowledge will help us in surgical planning of these high risk patients to appropriately select breast conserving surgery & mastectomy options for better oncological and cosmetic outcomes.
    Objective: To evaluate factors predicting positive or close (<1mm) surgical margins necessitating re-excision after breast conserving surgery in patients who had neoadjuvant chemotherapy.

    Study Design: Retrospective cohort study

    Participants:
    • All cases of locally advanced or medium to large breast tumours(T2 or T3), which had neoadjuvant chemotherapy in Medway maritime hospital followed by breast conserving surgery or mastectomy and satisfy the inclusion & exclusion criteria, are included in the study.
    Study Interventions and Measures:
    • Review of medical records including radiological imaging, histopathology results and clinical letters.
    • Primary endpoints: Pathological complete response rates, Breast conserving surgery rates
    • Secondary endpoints: Re-excision rates (includes completion mastectomy rates) as a result of close (<1mm) or involved surgical margins after breast conserving surgery.
    • Predictive value of factors studied are young age, presence of tumour calcifications, associated DCIS, vascular invasion, presence of axillary lymph node metastasis, surgical specimen weight, post NACT radiological tumour size.

  • REC name

    West of Scotland REC 1

  • REC reference

    17/WS/0012

  • Date of REC Opinion

    20 Jan 2017

  • REC opinion

    Favourable Opinion