Moving toward Appropriateness of Breast Cancer Care: A Balanced Act to Redefine the Scope of Standard of Care

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“Current issues surrounding the diversity of access to screening and care resulting in poor clinical outcomes are significant barriers in offering optimal breast healthcare among different patient populations.”

Among various suggested changes in breast cancer diagnosis and therapy in recent years, there has been significant emphasis on defining the quality of breast cancer care. Interested stakeholders in this concept have included patients, healthcare providers, payers, professional organizations and advocacy organizations, with different perspectives and ideas. Stemming from expectations directed by the Institute of Medicine (DC, USA), attention to the development of metrics to define quality of patient care has been extended to breast cancer [1]. Currently, descriptive terms define the quality of care. This includes accuracy of diagnosis, delivery of evidence-based therapeutic options, access to care and timelines of care that all lead to desired patient outcomes regardless of age, ethnicity, status of socioeconomics and patient insurance.

Meanwhile, advances in science and technology, and emphasis on early detection and prevention have resulted in life changing interventions in breast cancer diagnosis and therapy. These efforts have made a difference in the betterment of quality of life of many breast cancer patients in resource rich countries. However, low-income countries and medically underserved populations across the globe still suffer from the serious gaps that continue to exist in every step during the course of diagnosis and follow-up management of breast cancer patients [2].

Therefore, the establishment of uniformly accepted metrics in the practice of breast cancer remains a major challenge. Current issues surrounding the diversity of access to screening and care resulting in poor clinical outcomes are significant barriers in offering optimal breast healthcare among different patient populations. In addition, differences in adaptation of evidence-based and time-challenged minimally invasive diagnostic and therapeutic procedures remain to be a major limiting factor to practice a well-balanced, patient-friendly and cost effective breast cancer care.

Aside from traditional certification by medical specialties, there are at least 13 organizations involved in defining and measuring breast cancer quality of care in the USA. The National Comprehensive Cancer Network serves as the basis for detailed and accessible national guidelines for breast care. There are also programs such as the National Accreditation Program for Breast Centers offered by the American College of Surgeons (IL, USA) that is designed to assess the process of adherence to quality measures in breast centers [3]. However, this program is only available to breast centers that participate in this program. In addition, one has to understand that currently, the link between process improvement and true impact on long-term patient outcome is not yet well established. More importantly, the difference between appropriateness of care versus standard of care is not well understood [4].

There are a few scenarios that raise the question regarding our true understanding of the above entities. The best example is the continuous use of open surgical biopsies instead of minimally invasive diagnostic needle biopsies as the initial sampling procedure. Diagnostic sampling procedures including fine-needle aspiration biopsy and core needle biopsy have proven to be superior to open surgical biopsies. These procedures have the ability to provide a nonsurgical approach in the evaluation of palpable and image-detected biopsies. These procedures are cost-effective, and are associated with minimal patient discomfort. Fine-needle aspiration biopsy, in particular, has the advantage of providing an immediate bedside diagnosis, which reduces the anxiety of patients with benign diseases. On the other hand, rendering the diagnosis of malignancy by fine-needle aspiration biopsy offers the opportunity for more rapid treatment planning with equal participation of the patient in the process of decision making. Despite the above-mentioned advantages, there are still significant numbers of open surgical biopsies that are performed on a daily basis worldwide [5,6].

“…total mastectomy followed by axillary dissection, radiotherapy and chemotherapy are considered the standard of care for all breast cancer patients…”

Similarly, as a result of two major clinical trials in Europe and the USA with over 20 years of follow-up, it has been recognized that the long-term survival rate among breast cancer patients who undergo conservation therapy is the same as those that undergo total mastectomy [7,8]. Reports in the literature, however, indicate that a significant number of women with breast cancer are still offered only the option of mastectomy during initial treatment planning. Considering that 75–80% of newly diagnosed breast cancer patients have early-stage breast cancer, it appears that a majority of breast cancer patients are eligible for breast conservation therapy. There is no doubt that breast conservation therapy is associated with a better quality of life by maintaining the sexuality and self-image of many breast cancer patients. The reasons why mastectomy is still offered to many women who are otherwise candidates for conservation therapy are numerous [9]. It appears that low-income women, those who are less educated, older women and those with private insurance are less likely to have breast-conserving surgery. More important is the physician recommendation, which remains the most influential factor in treatment choices. Legitimate reasons for offering mastectomy instead of breast conservation therapy include lack of availability of radiation therapy facilities in close proximity to patients [10–13].

Fear of unknown consequences of the term ‘cancer’ and possible false positives of breast MRI may be other reasons for an increase in the number of mastectomies [14]. On the other hand, there are patients that opt to undergo conservation therapy, and often because of the repeated positive surgical margins, end up having mastectomies. This process emphasizes the need for effective communication between patients and physicians, as many high-grade ductal carcinoma in situ (DCIS) that are multifocal may benefit from mastectomy as the initial surgical intervention. Patients need a great amount of specific information about the nature and extent of their illness and their options for therapy. This remains the responsibility of physicians to appropriately educate their patients [15].

Another major advance in breast surgery has been a change in the pattern of practice of total axillary dissection to sentinel lymph node biopsy. Assessment of the presence or absence of tumor cells in the first axillary lymph node, considered as the sentinel lymph node, has been found to directly relate to the presence or absence of metastatic tumor cells in the entire axillary lymph nodes. Therefore, there is no longer a need to subject all breast cancer patients to total axillary dissection. Offering sentinel lymph node biopsy in clinically node-negative breast cancer patients lowers risks for lymphedema and other discomforts that are often associated with total axillary dissection [16].

There is no doubt that the controversy surrounding the best choice of therapy for each breast cancer patient will continue, unless we recognize the significance of saving a woman's breast and becoming cost conscious. The recent article published by Narod et al. [17] brought similar question in regard to the established current status of cancer therapy for low-grade DCIS. In this observational study of more than 100,000 women with a diagnosis of low-grade DCIS with 20 years follow-up, the author suggested that a majority of patients with a DCIS diagnosis can be spared from the negative impact of surgery and radiation therapy, not to mention the positive influence on health economy. This can be achieved with an associated reduction in the number of unnecessary mastectomies and radiation therapies. The author also reported that the high risk factors for death from breast cancer after the diagnosis of DCIS include young age (35–40 years) and black ethnicity. In addition, the cases of DCIS associated with poor outcome were found to be hormone receptor negative, HER-2/neu oncogene-positive, high-grade DCIS with necrosis, and those that measure more than 5 cm. These high-risk cases of DCIS constitute about 20% of cases that can be identified and undergo cancer therapy. Therefore, it is now possible to identify 80% of low-grade DCIS that may not require extensive surgery and radiation therapy.

The suggested alternatives of observation and close surveillance for low nuclear grade DCIS, and cancer therapy for high-risk DCIS, calls for appropriate diagnosis, given the current controversy about the distinction between low-grade DCIS and atypical ductal hyperplasia [17]. A suggested change in the current terminology of low-grade DCIS versus atypical ductal hyperplasia to ‘borderline breast disease’ is a reasonable approach, and makes it possible to refrain from the use of the term ‘carcinoma’ for lesions that are biologically indolent and nonmalignant. Currently, the term ‘cancer’ is associated with a negative connotation for both patients and physicians, and often leads to overdiagnosis and overtreatment [18].

The recent introduction of molecular classification of breast subtypes and genomic testing such as Oncotype DX® and MammaPrint is another progressive step to better define the type of breast cancer and pattern of tumor behavior. These tests have the possibility of stratifying those breast cancer patients that benefit from chemotherapy versus those that can be spared. These advances are significant in light of minimizing side effects of chemotherapy and financial burden of cancer therapy [19].

Based on the current practice of breast cancer care, total mastectomy followed by axillary dissection, radiotherapy and chemotherapy are considered the standard of care for all breast cancer patients, regardless of the biology, extent of the disease and patient choices [20]. However, with proven alternatives that provide optimal care with less expense and patient discomfort, it is necessary for a change in redefining the standard of care and in providing a personalized and individually tailored option for patients to choose.