Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

Oncoplastic breast-conserving surgery (OPBCS) has gained increasing popularity over the last years and tends to be considered the standard of care in surgical practice. OPBCS allows for the resection of larger volumes and tumors with acceptable cosmesis, by incorporating different techniques that have evolved mainly from mastopexy, mammoplasty, and breast reduction or volume replacement techniques, such as perforator flap reconstruction. However, no randomized controlled trial data on indications, methods, decision-making and outcomes are available, and present practice is largely based on evidence from cohort data derived from single- or multi-institutional series. Along with that, the fact that surgical decision-making in OPBCS is highly individualized renders any effort for standardization of these operations highly challenging and controversial. This is a multifactorial phenomenon, owing to anatomic differences such as breast volume, breast shape, lesion volume, localization, ptosis, body mass index (BMI) but also patient preference and availability of surgical techniques. Efforts for standardization of techniques based on tumor location, breast size, and ptosis have been made, but they do not address the principle of tailored treatment and do not cover all clinical scenarios. On the other hand, breast-conserving surgery (BCS) followed by whole breast irradiation (WBI) yields comparable to better outcomes compared with mastectomy without WBI in terms of survival, but much better in terms of quality of life (QoL) and patient-reported outcomes and measures (PROMS), even when compared to the reconstructed breast. At the same time, OPBCS seems to yield superior cosmesis and patient satisfaction compared to traditional wide local excisions (WLE), but it is unclear whether this comes at the cost of increased morbidity or unnecessary revisionary procedures, with an impact on the delivery of systemic treatment, QoL and health economy. In addition, patient preference is a factor that precludes randomization to the method of operation in the traditional meaning, as it would not be ethical to randomize surgery that may be unnecessarily extensive or oncologically dubious. Moreover, surgeon and patient preferences and expectations may involve bias which is hard to define and a non-randomized study on the subject of WLE vs OPBCS could inevitably be unclear in how to address this inherent flaw. PROMS such as QoL and cosmesis are even more important in the case of benign lesions that need to be operated on. This has to do with the fact that no compromises need to be made for the sake of a radical breast cancer operation as well as that benign breast surgery is more common in women of younger age. There, despite the instinctive assessment that a well-placed incision should have better outcomes, there is a complete lack of high-quality data on the matter. At the same time, the decision-making process of the choice of surgical technique is a phenomenon poor Покажи пълното описание...

Inclusion Criteria: 1. Female aged above 18 years. 2. Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview. 3. Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS. 4. ECOG performance status 0-2. Exclusion Criteria 1. Life expectancy of less than 6 months 2. Non candidate for breast conservation 3. Inability to understand given information and give informed consent or undergo study procedures