Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries. Response-adaptive (RAR) Prospective Randomised, Comperative Clinical Study

Introduction In the last four decades of oncological breast surgery, based on Umberto Veronesi and Bernard Fisher's prospective comparative studies, organ conservation became highly significant in the case of early breast cancer with the application of microscopically negative surgical margin and adjuvant whole breast irradiation (WBI), which is proven to offer the same survival chance as mastectomy.[1,2] However, in practice, the apparent benefits of organ conservation shaded by the need of second surgery, 5-30%, (repeated directed re-excision or mastectomy) due to microscopically positive surgical margins; the 3-5 weeks long, logistically demanding radiotherapy; and the cosmetically impaired or distorted breasts that remains almost 30% of the surgeries. [3-5] The latter can be explained by our published previous prospective study that the patients report significantly intolerable cosmetic results after 10% volume loss from the inner quadrants and approximately 15-20% volume loss from the lateral quadrants, when its associates with adjuvant WBI. [6] Aside from volume reduction, during a traditional breast conserving surgery (BCS) the tumor bed is left behind as a cavity, whose posterior wall is composed of the pectoralis major muscle and the pectoral fascia, while its anterior wall is composed of skin. Already in the early postoperative stage, with the removal of the seroma, the skin retracts and adheres to the breast muscles or to the fascia. This process is accelerated by the irreversible of the complete residual parenchyma and the change of the skin's structure, elasticity and microcirculation during WBI. This could result 10-20% shrinkage of the breast. The breast shows a typical deformity with the directly curved incision line above the tumor as a result of secondary wound healing process mentioned above. Compared to the contralateral side its volume shrunk, the nipple dislocated to the axillary fold due to the adhesion of the upper-outer quadrant in case of this quadrant's volume loss and typical bird beak formation occurs in case of lower quadrants' border excision; while a central excision usually results in a so-called doughnut shaped breast with a central retractation. Additional challenge is the reconstruction of the post-BCS breast because it is more complicated and achieves poorer cosmetic results than the post-mastectomy breast construction. [7] In order to prevent the above listed disadvantages of BCS, a sophisticated organ conservation breast-surgery was developed with the adaptation of plastic surgery techniques in the last decade, which was named Oncoplastic Surgery (OPS) by Werner Audretsch. [8] These surgeries are volume reducing breast lift surgeries or their alterations, which are based on the knowledge of breast anatomy - especially on its blood circulation (e.g. Würinger's Septum), and its structural and aesthetic subunits (e.g. inframammary fold (IMF), nipple and areola complex (NAC)). The surgeries require particular plastic surgery knowledge. The OPS based on volume displacement using and mobilizing the glandular pillars to fill the wound cavity using the advantages of breast ptosis, narrowing the overall base diameter and the "footprint", and repositioning the NAC, which left behind after the radical removal of the tumor. The OPS is suitable to perform real quadrantectomy, even with a better aesthetic result then it is preoperatively. According to each segments of the breast, various oncoplastic techniques can be applied, giving the oncoplastic surgeon an unprecedented freedom to offer a personalized solution. The OPSs can be classified based on their technical complexity or on the level of volume (<20% / 20-50%) needed to be replaced (Level I./II.). [9] Following the OPS, the remaining scars caused by radiation become almost invisible, and due to the lack of wound cavity, adhesion does not occur.

The most popular Level I. oncoplastic techniques are the periareolar or round-block techniques, or retroglandular technique, which was first published in the international literature by the current authors. These techniques are for those malignant tumors (cT< 3cm) which could be possibly located centrally in every quadrant and requires wide surgical excision less than 20% of the entire breast. [10, 11] The literature relied on oncoplastic breast conserving techniques is usually limited to retrospective cohort studies, while its prospective randomized comparison with traditional breast conserving surgery cannot be performed due to ethical reasons.

The purpose of the current clinical study is to scientifically analyze and compare the clinical, oncological and aesthetic results of the standardized oncoplastic breast conserving surgical techniques, round-block versus retroglandular, in one center for unilateral, solitary, malignant breast tumors in a responsive-adaptive (RAR) prospective randomized trial with long term follow-up.

Aim of the study The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) [12] prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries.

According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.