Breast cancer is acknowledged as an international priority in health care. It is currently the most common cancer in women worldwide, with demographic trends indicating a continuous increase in incidence. Only in the European Union, it is estimated that by 2020 there will be approximately 372,000 new cases of breast cancer per year and 103,000 deaths [1].

The enormous burden placed by this disease both on the population and on health care systems explains the increasing efforts and resources that have been devoted over the years to the search for a systematic and optimized strategy in breast cancer diagnosis and treatment.

The observation, confirmed in many studies, that being treated by coordinated teams of specialists from various fields of oncology, specifically trained in breast diseases may improve survival rates and patients’ quality of life, has progressively opened the way to a multidisciplinary approach in breast care [2–9]. Today, the Breast Unit model is identified as the gold standard to ensure optimized patient-centered and research-based clinical services for breast cancer patients.

The present chapter reviews the lines of development of this multidisciplinary model of breast cancer care and analyzes the requirements of a highquality breast unit, its potential advantages and the many open issues that still require proper definition and implementation.

The concept of streamlining the evaluation and management of patients with diseases of the breast through a comprehensive program is not new. In the USA, as early as 1931, Dr. Cusham D. Hagensen developed a clinical subspecialty in breast disease, and in Europe, Charles-Marie Gros organized a medical clinic dedicated to breast diseases in Strasbourg in 1960 [10, 11]. But it was not until 1979 that the first free-standing multidisciplinary facility — The Van Nuys Breast Center — was founded in California by Melvin J. Silverstein, opening the way to a “cultural change” in the management of breast diseases and initiating a worldwide debate on the importance of a collaborative approach in breast care [12].

At the First European Breast Cancer Conference in Florence in October 1998, a Statement was issued declaring that “all women across Europe should have access to fully equipped, dedicated Breast Units” [13]. Shortly after, a position paper was published by the European Society of Mastology (EUSOMA) on the standards required for the creation of high-quality breast units across Europe [14, 15].

The European Parliament (EP) issued two resolutions on breast cancer in the European Union (EU) in 2003 and 2006 respectively, calling on the EU member states for the establishment of a network of certified multidisciplinary breast centers essentially meeting the core criteria set by EUSOMA [15, 16]. Similar efforts were initiated also in the United States by the American College of Surgeons who in 2006 developed the National Accreditation Program for Breast Centers (NAPBC) [17], and by the Senologic International Society (SIS) who also approved a voluntary accreditation program for its worldwide affiliated Societies [18].

In 2010, the EP adopted a further “Written Declaration on the Fight Against Breast Cancer in the European Union”, calling for measures to ensure the provision of multidisciplinary specialist breast units and the development of a certification protocol in accordance with the EUSOMA guidelines by 2016 [19].

In Italy, as a response to the call of the EP, a Senate Health Commission in 2010 recommended to activate and certify a proper network of breast units and consequently, in 2012, the Italian Ministry of Health created a Working Group that is currently developing uniform guidelines to assist regional governments in the implementation of this task [20, 21].

The EP has indicated that the creation of breast units in all countries of Europe, including Italy, should refer to the EUSOMA guidelines [22].

Such guidelines indicate that a specialist multidisciplinary breast unit should serve a population of at least 250–300,000 citizens and recruit at least 150 newly diagnosed cases of primary breast cancer (at all ages and stages) each year. This is considered the minimum caseload sufficient to maintain expertise for each team member and to ensure costeffectiveness.

The core team of the breast unit must be guided by a clinical director and include two or more breast surgeons, each personally performing primary surgery on at least 50 newly diagnosed cancers per year and regularly attending a weekly multidisciplinary meeting (MDM). These breast surgeons should be able to undertake basic reconstruction and there should be standard arrangements with one or two nominated plastic surgeons (noncore team members) with special expertise in breast reconstructive techniques.

The core team should also include two or more fully trained radiologists, with continuing experience in all aspects of breast imaging, tissue sampling and image-guided localization procedures. They should read a minimum of 1000 mammograms per year (5000 for those involved in screening programs) and participate in a national or regional quality assurance program.

Other core team members must include a lead pathologist, a medical oncologist, a radiation oncologist, a breast diagnostic radiographer, a data manager and at least two breast care nurses.

The unit must possess suitable and up-to-date imaging equipment and offer access to all services, which even when provided in different locations, must be supervised by the breast unit’s core multidisciplinary team.

All core team members have the obligation to attend a MDM held at least weekly to discuss diagnosis, pathological findings and treatment options for every case treated in the breast unit. The units must have written protocols for diagnosis and for management of cancers at all stages, agreed upon by all core team members. Units must record data on diagnosis, pathology, primary treatment and clinical outcomes. Regular audit meetings should take place, with annual production of performance and audit figures.

Breast units can provide a facilitated access, in one place and at one time, to high-quality diagnosis and treatment. Patients greatly appreciate the opportunity to receive high-quality health and psychosocial care by a broad-based interdisciplinary team of specialists of all areas and of all necessary expertise, in a technically competent manner, with good communication, shared decision- making and cultural sensitivity that can significantly improve the quality and continuum of care [23, 24].

Patients are also starting to acknowledge that being treated in a specialized breast unit can offer improved oncologic outcomes. A significant number of studies support the evidence that multidisciplinarity, specialization and higher caseload can be associated with better survival.

Kesson et al. have documented an 18% lower breast cancer mortality rate and an 11% lower all-cause mortality rate at five years in women receiving multidisciplinary breast cancer care as compared to similar patients treated in neighboring hospitals over the same time period [2].

Sainsbury et al. examined differences in survival in 12,861 women with breast cancer in Yorkshire as a function of consultant caseload and showed that the 5-year breast cancer survival was significantly better for surgical caseloads > 30 cases/year in conjunction with availability of full range treatment options [3]. Similar evidence was provided by Stefoski Mikeljevic and associates who documented a 4% lower survival at 5 years and a 10% increase in the relative risk of death in patients managed by surgeons with workloads of < 30 new cases per year as compared to surgeons with a workload > 50 new cases year [4]. Skinner et al. studied the effect of surgeon and hospital specialization on survival after breast cancer treatment in 29,666 patients from the Los Angeles County Cancer Surveillance Program database. Surgeon specialization appeared as an independent predictor of survival on multivariate analysis, with a 33% reduction in the risk of death at 5 years when treatment was provided by a surgical oncologist accredited by the Society for Surgical Oncology [5].

Chen et al. in a study that examined outcomes in 13,360 breast cancer patients treated with surgery in various hospitals in Taiwan showed that 5-year survival rates by hospital volume in their setting were 77.3% for high-volume (> 585 cases), 74.5% for medium-volume (259–585) and 72.1% for low-volume hospitals (< 258) [9].

Guller and colleagues, in a review of 233,247 patients who received either breast-conserving surgery or mastectomy for localized breast cancer, showed that patients operated on at low-volume hospitals were significantly more likely to die or develop postoperative complications and were less likely to undergo breast-conserving surgery when compared to patients treated in high-volume hospitals [25].

Even though significant efforts have been devoted throughout the world to the creation of multidisciplinary breast units, the process is still challenged by many controversies [26].

In Italy, as in most European countries, there are at least three major barriers that limit the proper development of the Breast Unit model and these are discussed in the Sections 3.5.1–3.5.3.