1. Oncological Outcome & Patient Satisfaction with Skin-Sparing Mastectomy & Immediate Breast Reconstruction at The LBI: A Prospective Observational Study Prof. Kefah Mokbel MS, FRCS The London Breast Institute

2. Introduction Most women with early breast cancer (BC) are managed with breast-conserving therapy (BCT) Approximately one-third undergo mastectomy –patient preference –BCT not oncologically adequate or aesthetically acceptable Lack of level-1 evidence regarding –optimal type of mastectomy –subsequent technique and timing of reconstruction –skin-sparing mastectomy (SSM) and immediate breast reconstruction (IBR)

3. Current trends in IBR rates IBR in the USA (1999-2003) Immediate breast reconstruction rate = 23.6% (range of 22.2% to 25.3%). IBR rate in the UK = 21% Independent predictors of immediate breast reconstruction after mastectomy include: private insurance hospital in an urban location teaching hospital white race hospital region in the south age between the 3rd and 6th decades low number of comorbidities

4. Skin-Sparing Mastectomy En-bloc removal of all glandular tissue, nipple–areola complex (NAC) and in some cases adjacent biopsy scars and skin overlying superficial tumours with maximal preservation of breast skin envelope and infra-mammary fold [1] Facilitates immediate breast reconstruction (IBR) with autologous tissue and/or prosthetic implants by utilising the native skin envelope to optimise contour, texture, colour and scarring of the reconstructed breast [1] Single-stage procedure –hospital admissions, return to employment and elimination of post-mastectomy pre-reconstruction period 1. Cunnick GH, Mokbel K. Skin-sparing mastectomy. Am J Surg. 2004;188(1):78–84

5. Skin-Sparing Mastectomy Aesthetic advantages tempered by concerns about oncological safety Complete excision of glandular tissue can be more demanding Perceived increase in risk of local recurrence (LR) attributed to preservation of skin envelope. Post-mastectomy radiotherapy (PMR) is recommended for those at high-risk. One-third of breast surgeons avoid SSM and IBR – concerns over oncological safety or uncertainty of the benefits or indications [2] 2. Singletary SE, Robb GL. Oncologic safety of skin-sparing mastectomy. Ann Surg Oncol. 2003;10:95–97

6. Breast Reconstruction Following Mastectomy Implant only Conventional flap +/- implant LD flap Free flaps: DIEP GAP

7. Breast Reconstruction: Recent Advances Biological Implants Strattice: acellular dermal matrix Autologous Adipose-derived Stem Cells: formation of new subcutaneous tissue Coleman fat transfer Cytorie technology Stem cell reconstruction

8. Aims of Study Recently, several studies have supported the oncological adequacy of SSM in selected early-stage BC, excluding inflammatory BC and tumours with extensive skin involvement of the skin [1] In this study, the oncological outcome, post-operative morbidity and patients’ satisfaction with SSM and IBR using the latissimus dorsi (LD) myocutaneous flap and/or breast prosthesis is evaluated 1. Cunnick GH, Mokbel K. Skin-sparing mastectomy. Am J Surg. 2004;188(1):78–84

9. Patients & Methods Prospective cohort of 127 consecutive women with early-stage BC Selection criteria –pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement. –1 patient had T3 BC The principal indication for surgery was BC –7 procedures were undertaken as risk-reducing prophylactic mastectomies –1 BRCA-1 gene carrier, 5 contra-lateral BC

10. Patients & Methods Pre-operatively counselling regarding ablative and reconstructive options available Surgical recommendations made case-by-case following discussion of tumour and patient factors within multidisciplinary team Surgical procedures were performed by the same surgeon, 2001 - 2008 All 127 women underwent SSM and IBR –117 unilateral and 10 bilateral procedures, total of 137 cases Nipple-preserving SSM (NP-SSM) & IBR undertaken in 10 cases (6 patients)

11. Patients & Methods IBR employed –LD pedicle-flap and implant (n = 86, including 1 bilateral case) –implant only (n = 51, including 9 bilateral cases) Initial implant was tissue expander, subsequently replaced with an anatomically profiled bio-dimensional cohesive silicon implant at the same time as nipple reconstruction or contra-lateral adjustment Nipple reconstruction was performed in 69 (54%) patients –trefoil local flap technique (n = 61), nipple sharing (n = 6), skin graft (n = 1) and Monocryl mesh (n = 1)

12. Patients & Methods 30 (23.6%) patients underwent contra-lateral surgery for symmetry/cosmesis –19 augmentations & 11 mastopexy/reduction mammoplasties Patients at high risk of requiring PMR –encouraged to opt for SSM and IBR using tissue expander alone –‘immediate-delayed’ strategy in 11 cases. All patients underwent clinical examination on a 6 monthly basis and annual surveillance mammography. Satisfaction assessed using a linear visual analogue scale, 0 - 10 –postal questionnaire or interview

13. Surgical Considerations SSM performed through peri-areolar incision –occasionally short horizontal incisions at the 3 and 9 o’clock positions added –infra-mammary fold was preserved in all cases Intra-operative frozen section analysis of sub-areola tissue for NP-SSM Patients with clinically negative axillae underwent sentinel lymph node biopsy (SLNB) –axillary node clearance if intra-operative frozen section showed malignancy Subsequent replacement of tissue expander with definitive implant prosthesis performed through short infra-mammary incisions –prosthesis placed in sub-muscular pocket

14. Results Median patients' age = 47 years (range = 27-72) Histopathological analysis of resection specimens –invasive carcinoma (+/- DCIS) in 105 cases –pure DCIS in 25 cases –BRCA-1 mutation - bilateral prophylactic mastectomies - normal histology Median tumour size = 28mm (range 1mm - 100mm) –all superficial surgical margins were clear –2 patients with extensive multi-centric disease, tumour focally extended to the medial surgical margin, one received PMR

15. Results Lymph nodes involved in 45 patients –41 macro-metastasis, 4 micro-metastatic spread Adjuvant chemotherapy required by 38 patients Prior RT had been received by 6 patients and 21 women underwent PMR –LD flap and implant reconstruction = 10, implant only reconstruction = 11

16. Results No LR after median follow-up of 36 months (range = 6-101 months) Overall survival = 99.2% –8 patients developed distant disease –1 patient died of metastatic breast cancer, another died of lung cancer No cases of partial or total LD flap loss Morbidities –Infection - requiring implant removal in 2 (1.5%) cases –1 patient (smoker) developed marginal ischemia of the skin envelope –Chemotherapy delayed by 2 weeks in 1 patient due to infection –Blood transfusion was required by 2 patients

17. Results All patients undergoing LD reconstruction developed donor site seromas –requiring percutaneous drainage as outpatient, median inpatient stay = 5 days Significant capsule formation in 87% of patients who had either prior RT or PMR vs. 13% without RT. –Capsulotomy performed when exchanging tissue expander for definitive prosthesis –1 patient required further capsulotomy several months after definitive prosthesis 82/127 (64.6%) completed satisfaction survey –median score of 9 (range = 5-10) –IBR using LD + implant (mean = 9.3, median = 10) –implant only (mean = 9, median = 10)

18. SSM

19. SSM plus IBR

20. The LD Flap

21. SSM and LD Flap Recon.

22. SSM plus IBR

24. Nipple Reconstruction

26. NS-SSM plus IBR

27. Conclusions SSM and IBR is oncologically adequate in selected patients with Tis, T1 and T2 tumours in the absence of extensive skin involvement NAC preservation is possible, provided the tumour is not close to the nipple and a frozen section protocol is followed Radiotherapy is not a contra-indication for SSM & IBR SSM and IBR is associated with high levels of satisfaction and low morbidity

28. Thank You