The Cost of Treatment

Standard-of-care and especially state-of-the-art treatments for high-risk primary and metastatic breast cancer commonly involve different criteria than for early stage primary breast cancer, which is more broadly systematized and easier to characterize.

Because most clinical trials in drug development are done with metastatic patients, treatment for these patients undergoes a process of constant evolution, rather than changing periodically as the product of consensus documents or meetings of experts in the field, as is generally true with adjuvant treatment for earlystage breast cancer.

The sheer complexity of describing how standardized treatment should be offered to address such a widely variable disease is in itself challenging, and often leads to confusion for patients because of differing treatment recommendations when a second opinion or consultation is sought. By contrast, early-stage primary breast cancer seems relatively straightforward, though of course it possesses its own complexities.

In addition, it is in the nature of evolving research that treatment regimens and practices offered in sophisticated research centers may take significant time to filter down into community clinics. Disparities may exist in treatments for high-risk and metastatic disease between the teaching hospitals and major cancer centers which have strong research programs, and the community cancer clinics and hospitals where most patients are still being treated.

Among the many treatment guidelines developed for breast cancer, aspects of high-risk and metastatic disease are sometimes included, but more often are not a focus. Every two years, for example, international cancer researchers and physicians meet in Switzerland for the St. Gallen Consensus Conference on Therapy of Primary Breast Cancer.

The National Comprehensive Cancer Network (NCCN), a cooperative network of 19 leading cancer centers, issues clinical practice guidelines in breast cancer, and in many other cancers. These guidelines rely on evidence from the latest trials, as well as expert consensus opinions. NCCN algorithms or “decision trees” for treatment of various stages of breast cancer are publicly available on their website. Their recommended workups and treatment guidelines for high-risk and metastatic breast cancer are reviewed on an ongoing basis.

The NIH Consensus Guideline document for adjuvant treatment, last issued in the year 2000, also includes some recommendations for high-risk, locally advanced disease.59

Certainly, one of the most frequently consulted guidelines sites is PDQ, the National Cancer Institute's (NCI's) comprehensive cancer information database, which includes a treatment guideline for health professionals.60 In this peer-reviewed statement, which is updated monthly, the section marked Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer provides a concise narrative review of standard treatment options. Offering an idea of the variability and difficulty of discussing treatment options in the metastatic setting, it concludes with the following summary, which offers a sense of how much has yet to be understood about optimal treatment in advanced breast cancer:

The rate of disease progression, the presence or absence of co-morbid medical conditions, and physician/patient preference will influence the choice of therapy in individual patients. At this time, there are no data supporting the superiority of any particular regimen. Sequential use of single agents or combinations can be used for patients who relapse. Combinations of chemotherapy and hormone therapy have not shown an overall survival advantage over the sequential use of these agents.