Immediate breast reconstruction

Background

Surgical treatment for patients with breast cancer include breast conserving surgery and mastectomy. In the Netherlands mastectomy is performed in respectively 31% and 35% of the patients with ductal carcinoma in situ (DCIS) and invasive breast cancer. In an attempt to preserve the breast contour after mastectomy, breast reconstruction constitutes an essential part in the treatment for patients with breast cancer. Breast reconstruction can take place simultaneously with the mastectomy (immediate breast reconstruction (IBR)) or delayed. Initial studies evaluating quality of life in patients diagnosed with breast cancer have shown that patients receiving IBR following mastectomy indicate better quality of life on different domains compared to patients without IBR. Despite this knowledge, an average of 28.4% of patients with invasive breast cancer and 45.9% of patients with DCIS underwent IBR after mastectomy in 2020. During the past few years the use of IBR increased; In 2020, an average of 28.4% of patients with invasive breast cancer and 45.9% of patients with DCIS underwent IBR after mastectomy. Still, NBCA data demonstrates a large variation between hospitals in the Netherlands regarding the application of IBR. As shown in figure 1; in some hospitals IBR is currently performed in more than 70% of the patients while in other hospitals the percentage of patients receiving IBR after mastectomy is less than 25%. Several studies have demonstrated multiple factors influencing the use of IBR in the Netherlands. Besides patient and tumor characteristics, hospital organisational factors and expert opinion affect the use of IBR. Since preserving the breast contour after mastectomy contributes to quality of life, understanding current practice in a field with rapidly evolving treatment strategies is important to improve the quality of care for breast cancer patients.

Objective

The aim of the study is to investigate the following questions considering IBR after mastectomy in primary breast cancer patients in the Netherlands.

1. What is the incidence (and type of) IBR after mastectomy nationwide?
2. What is the variation of IBR after mastectomy between hospitals for DCIS?
3. Which factors influence IBR after mastectomy for DCIS?
4. What is the variation of IBR after mastectomy for invasive breast cancer?
5. Which factors influence IBR after mastectomy for invasive breast cancer?
6. What is the outcome regarding short-term complications?
7. What is the outcome after 5 year follow-up regarding breast contour preservation?

Study design

For this study a snapshot design will be used. This design has previously been performed by our research group and the Dutch surgical society as a method to gather prospective data of a large group of patients over a short period of time. All female patients undergoing a mastectomy with or without IRB for either primary DCIS or non-metastatic invasive breast cancer in a period of 12 months are included. All hospitals providing breast cancer care in The Netherlands will be contacted with an informative letter about our research. When the hospital accepts to participate in the collaborative study group a local collaborating researcher will be in charge to provide data from that hospital. Data considering IBR after mastectomy as well as demographic factors together with preoperative, perioperative and postoperative information will be registered. Collaborating researchers will inform all hospitals providing breast cancer care and will be in charge of METC approvals in all participating hospitals. Since the duration of this approval procedure differs between centres, it may appear that hospitals do not start including patients at the same time. However, to avoid bias, the inclusion period will be 12 months for every hospital. Furthermore, we would like to include a solitary follow-up after 1 year where to collect information on all patients regarding final breast contour preservation. During multidisciplinary team meetings (MDTs) the indication for mastectomy, risk factors concerning direct reconstruction, attendance of a plastic surgeon and the final advice of the MDT to perform a direct reconstruction should be noted.

Study population

All female patients undergoing a mastectomy with or without IRB for either primary DCIS or non-metastatic invasive breast cancer in a period of 12 months are included. Women of >18 years who are candidate for mastectomy with or without direct reconstruction are eligible for inclusion. Exclusion criteria are patients of <18 years old, patients undergoing breast conserving surgery and patients with metastatic disease.

Main expected results

The primary outcome of this snapshot study is to create an up-to-date overview of the incidence of IBR following mastectomy, moreover of the decision-making process towards IBR following mastectomy in patients with invasive breast cancer or DCIS in the Netherlands. This study will thereby give an overview of the variation of IBR following mastectomy between hospitals in the Netherlands and provide more knowledge about different factors influencing choice of IBR following mastectomy.

Planning

The first centers are expected to start in the september 2023.