Prof. Alexander Mundinger

SIS President

 

 

Prof. Tadeusz Pienkowski

Past President

 

 

Prof. Eduardo L Cazap

President Elect

 

 

 

 

Call for a unified voice in international breast health

Breast cancer is an international scourge!

Breast cancer is the most frequent cause of morbidity and mortality of women worldwide with more than 1.6 million diagnosed women in 2012 and 2.1 million breast cancer cases forecast worldwide by 2030 (1,2). Nearly half of these cases will impact developed countries and nearly one quarter of global breast cancer cases will impact women in aged 15 to 49 years in developing countries (3,4). Some highly aggressive tumours may not be cured by any therapy, but with the exception of these few killer breast-cancers specific survival depends on many factors including organization of diagnosis and therapy within national health programmes. Fortunately, 80 - 85 % of breast cancer patients will survive in developed countries, however only 50% or less will survive in less developed countries (5). Insufficiently organized breast health care allows curable cancers to kill patients. What a waste of life!

The avenue of success

In the last decades many countries witnessed astonishing improvements in breast cancer care. Screening programmes decreased the threshold to detect small and early cancers. Risk-adopted multimodal therapy now allows patients to survive breast cancer longer at higher stages and at more aggressive tumour biology compared to the past. The major milestones have been (5-10):

In the 1970s the concept of breast conserving therapy with the two components of breast conserving surgery and radiation therapy, supplemented by the implementation of systemic adjuvant treatment that should overcome a later systemic metastasis originating by micrometastases.

In the 1980s the introduction of targeted therapy using anti-oestrogens such as tamoxifen and fulvestrant and, later, aromatase inhibitors as well as oophorectomy to stop the disease progression of metastatic breast cancer. Ultrasound and MRI became important complimentary breast imaging methods and ultrasound-guided biopsy essential for cost efficient tissue sampling.

In the 1990s new concepts of oncoplastic surgery including skin-sparing mastectomy or nipple-sparing mastectomy, and reconstructions with implants or autologous reconstructions by vascularized skin and muscle flaps (latissimus dorsi flap, TRAM flap), or free flaps (DIEP, superior gluteal flap).

The 2000s hallmarks are translation of evidence-based medicine to guideline-driven decisions and the enhancement of quality assurance through more concise and effective procedures, benchmarking and certification of dedicated breast centres. A second revolution of targeted therapies started with trastuzumab in HER2 associated cancers; further, the expansion of the sentinel node concept minimized axillary complications.

The 2010s experienced the era of molecular medicine and broad acceptance of targeted neoadjuvant therapy. For biologically relatively benign tumors intraoperative radiation therapy and minimalized aggressiveness in staging (i.e. not lymph node excision at all in biologically low aggressive tumours) are the new megatrends. The raising awareness of breast cancer within different cultures has become a new challenge for emerging economies that develop a focus on healthcare development.

Barriers that prevent access to good breast health care

Currently, the advantages of modern breast cancer therapy are not equally distributed worldwide. Modern diagnostic tools, radiation facilities and systemic therapy are beyond the scope of most healthcare systems in low-income countries (11-13). Approximately 8% of the world population has access to modern medicine; the other 92% have very limited or no access to it. Those individuals deprived of modern medicine may live in developing countries or may fail to be covered by national cancer control plans in developed economies. The Breast Health Global Initiative identified several main reasons that prevent delivering optimal cancer care to patients such as geographic barriers (lack of proximity of cancer care centres to many areas), financial barriers (costly anti-neoplastic medications and diagnostic procedures) and systemic barriers (lack of infrastructure and well-trained medical personnel) (11-13).

The role of breast centres and call for a global alliance

The era of organ centre certification started with the establishment of specialized breast cancer centres in line with the high incidence of breast cancer, the high mortality rate and the high level of interdisciplinary cooperation in the diagnosis and therapy of breast cancer (13-16). The introduction of quality management and external monitoring aimed to provide for high quality diagnosis and treatment and also included a high annual load of surgical procedures per surgeon. This approach was expected to improve disease-free survival and overall survival, and to reduce mortality rates by about 25-30% (16). The adaptation of this certification process from developed countries to emerging economies is a fundamental tool to improve breast care worldwide. The 1976 founded Senologic International Society (SIS) and its SIS/School of Senology is cooperating in a proactive way with international consortiums and societies to form a global alliance for breast centre accreditation. The SIS/ISS International Breast Centers Accreditation Program, National Accreditation Program for Breast Centers (NAPBC), the National Consortium of Breast Centers (NCBC), EUSOMA and others have presented similar minimum requirements and quality indicators for establishing a breast centre. The major continental and international key players should endeavour to develop a standardized conjoint analysis template for accrediting breast centres, analogous to the construction of the international prototype metre and the copies, which would become national standards.

Guideline adherence and non-adherence

A German cohort study design encompassed women from 1996–97 (N = 389) and from 2003–04 (N = 488). The guideline adherent treatment in German certified breast centres achieved at least a 10% decrease in 5-years breast-cancer specific mortality in breast cancer patients compared to the older treatment groups with guideline non-adherence (14,15). Guideline adherence is of utmost importance. However, a second approach is necessary to reconcile medical perspective and patients needs and expectations in special health problems such as treatment side effects or severe comorbidity. This is the freedom of an interdisciplinary expert group to individualize and fine-tune medical recommendations for severely ill patients. It has been shown that in the setting of certified breast centres this does not decrease the 5-years mortality significantly compared to strict adherence to guidelines (14). This reflects the bright side of guideline non-adherence by experts with state of the art knowledge. A dark side of guideline non-adherence also exists that is based on overwhelming eminence-based beliefs of medical authorities that are not reconciled with new insights of research. Demanding the opposite, i.e. adherence to new guidelines, may support evidence-based medicine on the long term, particularly in countries that have a strong patriarchal tradition of decision-making along traditional paradigms.

One voice to link the continents

Although the major ideas of SIS have been advancing the multi-disciplinary cooperation, specialization and centralization in diagnosis and treatment of breast diseases for over 40 years, this will not be enough for the future. Today, many national societies have adopted and detailed the original SIS concept and they have applied various modifications. SIS has to take the next level now and needs to develop to a platform that establishes links between the national societies and intercontinental federations. In addition to this, regional variations, cultural differences, variability in health systems structure, economical aspects and other factors make necessary to adapt international guidelines, standards and programs to the local characteristics. In this global scenario the vigorous participation of SIS together with this robust network of member national societies is an ideal partnership.

Red flag inadequate breast health care

The common aim is to synchronize the fight against breast cancer and to allow the member societies to speak with one voice and one breast language to the national health providers. There are those who may defend their health care products, even if they are poor and represent societal hazards far below international standards, but SIS members can red flag inadequate breast health care with reference to worldwide agreed upon standards for effective diagnosis and treatments. The increased awareness of patients and survivors will be on their side, with the umbrella International Organizations providing external support.

The next step

The next step is to synchronize the various objectives for quality assessment worldwide that define a centre of excellence. A top down rollout is a successful strategy in transferring high-end technology originally exclusive to luxury cars to lower cost cars for the masses. This approach will also work in breast cancer care. The womens and patients organizations need to enhance and bolster this idea of a global alliance to establish certified breast centres/units. Only international agreed upon standards hold the promise of success. This we have learned and practised for decades in many public sectors such as transportation, construction, energy, education, and medicine. The idea of a certified breast centre may be replicated to achieve multiple breast cancer centres around a reference centre of excellence. This may appear as decentralization, but the centre of excellence maintains the lead role and provides an additional focus on scientific analysis, research and education, adapted to the local conditions.

The future of personalized medicine

Future assessment of individualized risk based on genetic profiling will also change our approaches to diagnose and cure breast cancer in a population-based programme. Large panel molecular genetic testing will become available within decades at much lower costs compared to todays testing. Modern computers and smart phones serve as analogous example of how modern technology proliferates at ever decreasing costs. Also, there will be a better understanding of connected cancer risks that exist based on driver somatic mutations and germ line mutations. Mammographic density is associated with an increased cancer risk. Breast density related single nucleotide polymorphisms are frequently associated with breast cancer associated susceptibility, however not in all cases (17). Why should low risk clients need an average screening interval for mammography? If high risk calls for shorter screening intervals, intervals for low risk clients need to move in the opposite direction. 

Against poverty and war

Poor economic and disastrous social-political situations counteract with these visions and missions. It may be necessary for a country to first focus on other fields of health politics where addressing starvation, perinatal child death, infections or war injuries is the highest priority. But the means to improve care for breast cancer and other health problems converge when coming to practice. Defining aims, following the guidance, controlling the results and repeating the whole circle of quality control will eventually improve the results. Stage of breast cancer at diagnosis and poverty rate explains the geographic variations in breast cancer survival best even in developed economies such as USA and Europe (18,19).

The value of certification

All major studies and meta-analyses emphasize the fundamental role of specialization, centralization and multidisciplinary for improving patient survival when this process has been initiated. Getting on the way to become an accredited centre makes the difference (cited at 10). Surrogate indicators of structural and process quality strongly argue in the same direction (5,6). But also the other side has to be considered. A recent population-based analysis included cancer registry data from 32,789 operated breast cancer patients with no prior cancer diagnosis and with active follow-up in Germany. Astonishingly no survival difference was found between patients with treatment before and after certification of specialized units and also not between certified breast centre patients and non-certified breast cancer patients aged up to 75 years. Thus, it would appear that certification has not influenced survival of breast cancer patients in Germany. Three thoughts might shed light on these unexpected results. First, only those centres receive certification that provide assurance that they have the capability to make the right decisions and provide the necessary means to achieve best breast health care. The process of improvement takes a long time. The certification adds just the final acknowledgement for what a centre achieved. By analogy, also an Olympic medallist will not perform significantly better after being honoured. Secondly, medical progress spreads diffusely in a modern health system with continuing medical education that can generate similar decisions in certified and non-certified breast centres. Thirdly, the interferences by area level characteristics, e.g. the distribution of poverty rate and breast cancer related behaviour and outcomes are complex. A national cancer plan extends the privilege of early breast cancer diagnosis and certified therapy in a specialized centre to an increasing number of clients with socio-economical lower status that are characterized by a decreased life expectancy. More breast cancer patients with primary decreased life expectancy due to lower socio-economic status might impair the survival of the study group compared to a traditional collective with higher socioeconomic status.

Conclusion

Womens awareness worldwide needs to focus on breast cancer (11). Ultrasound may be more suitable for diagnosis of invasive cancers than mammography in developing countries (4), however mammography screening has also been successfully implemented in those countries (20). Making the right decisions justified by sound results of research and updated guidelines is the key to providing the best outcome results of breast cancer care, however this principle is typically subject to financial restraints (10,19). Many well performing centres are currently ready to be certified worldwide, while others that are still evolving would benefit significantly from the certification process. The Senologic International Society (SIS) and the other breast societies and federations offer a way to improve breast health by focussing on international standards, offering educational programs, enhancing interdisciplinary cooperation and increasing public and political awareness. Be aware of these principles and join the call for a global alliance and unified voice in international breast health.

References

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SIS Journal is the Electronic Journal of the Senologic International Society, the World Society of Breast Diseases. ISSN: 1688-8170