Lymph node dissection is not only expensive, it disables thousands of women unnecessarily. For example, a woman named Dana had a mastectomy accompanied by removal of the Iymph glands under her arm 8 years ago. In some women, the fluid that would normally drain through the Iymph channels backs up, causing swelling (Iymphedema). Aside from the limited use of her shoulder and limb, Dana suffers from bouts of cellulitis, infections that sometimes arise from mosquito bites or scratches, requiring her to be on long-term antibiotic management to prevent blood poisoning (septicemia). About 20% of the women who have their nodes removed develop measurable Iymphedema (note 14).
Some oncologists recommend a bone marrow transplant if more than 10 nodes are positive. But the value of adjuvant bone marrow transplantation has not been established.
Lymph nodes were once thought to be the instigators of disease, the source of metastatic dissemination. According to Virchow, malignancy, like the tubercle bacillus, traveled through the Iymph channels and proceeded in an orderly, mechanical fashion from the local site, progressing to the glands under the arms, and from there migrating to distant sites. We now know, contrary to Virchow's theories proposed a dozen decades ago, that the proliferation of malignancy is neither orderly nor mechanical.
Radiation is a known carcinogen that can produce irritable, red, inflamed tissue in the short term; and stiff, thickened, desensitized tissue over time. Radiation following lumpectomy has no proven impact on survival, though it does affect local recurrence. Women who recur have an increased mortality, not because of the local tumor, but because recurrence is the manifestation of biologically more aggressive disease. Recurrence, however, is only symptomatic of increased risk of metastases, not the cause of the disease's spread. Removing the possibility of recurrence no more enhances a woman's health than removing the speedometer of a car alters its speed.
In rural areas like the outlying plains of North Dakota, where women must travel 6 or 8 hours to receive radiation therapy, mastectomy has been recommended over lumpectomy to prevent local recurrence. But women who do not receive radiation following lumpectomy have the same chance of survival as those who do.26, 40,41 The only difference is in the likelihood of local recurrence: 40% of women who do not receive radiation therapy will have a local recurrence within 10 years, whereas 15% who have had radiation following their lumpectomy will have a local recurrence within 10 years. It seems difficult for us to comprehend that how long a woman lives is not dependent on whether the local disease returns. It is not local disease that is life threatening, but the rapidity with which metastatic disease proceeds--something that there is no way to predict as of yet.
Women who recur within 2 years have a 20% chance of living 10 years, whereas women who recur after 5 years have the same chance of survival as those who do not. Recurrence within 2 years may serve as a more valuable marker of disease progression than any other.42 It was shocking when Fisher's study40 demonstrated that local recurrence did not impact survival. Yet doctors seldom make this clear to patients.38(p74) Because the value of radiation is questionable, its role following lumpectomy is currently under scrutiny.
Intensive Follow-Up: Chest X-Rays and Bone Scans
The effort to secure medical certainty is costly, elusive, and usually futile. Because elite medical schools are swollen with prestige, power, and funds, and because their libraries bulge with data, there is a public illusion that medicine is equipped to remedy our complaints. Because people think their doctors are so smart, they find it impossible to believe that they don't know how to help. People want prognostic and diagnostic as well as therapeutic answers.
The belief that an earlier detection of recurrence leads to a higher likelihood of disease control, complete remission, or at least extended survival has led to intensive routine surveillance programs. It now appears that such ardent follow-up screening (chest x-ray and bone scan) for asymptomatic women is a costly measure that has wide acceptance but limited value. Usefulness is a judgment measured by the criteria of quality of life and sur: vival benefit. The early detection of distant metastases has shown no survival advantage. Chest x-rays have not been particularly useful in detecting recurrence, nor has bone-scan surveillance been fruitful in asymptomatic patients.43 After a review of several studies, the following conclusion was reached by Roselli Del Turco et al44: "Periodic intensive follow-up with chest [x-rayJ and bone scan should not be recommended as routine policy."
Chest x-rays were instituted as a public-health protection against tuberculosis: their routine use is considered an expensive and outmoded practice by many. On the other hand, follou-up with a physical exam twice a year and a yearly mammogram are both sensible and cost effective. According to Charles Loprinzi45 of the Mayo Clinic, "retrospective studies ... do not suggest that patients who had routine follow-up testing did any better than those patients who did not.... A history and physical examination are clearly the best methods for obtaining evidence of recurrent breast cancer. Several studies have reported that 75% to 85% of recurrences are detected this way (even when frequent additional tests are performed)."
Every time Lyra, a 52-year-old woman who had a mastectomy 4 years ago, feels an ache in her calves, she worries. She anticipates bone scans every few months with equal parts dread and hopeful expectation. The usefulness of this intensive surveillance ritual is more than questionable. Metastatic bone disease rarely remains asymptomatic for more than 3 months. If Lyra's bone scan is negative, it simply means that the part of the bone scanned did not show evidence of disease. If it is positive, there is little advantage in knowing this before actual symptoms of the disease arise. Most bone metastases will become symptomatic within 90 days. Greater power is attributed to diagnostic instruments than is often warranted--scans are imperfect devices that offer relatively crude measurement. Technology has advanced more rapidly than our understanding of how to derive benefit from it.
A savings of $636 million in the United States for the year 1990 was projected for the minimalist surveillance protocol (history, physical exam, mammogram) over the more intensive series (physical exam, blood cell count and chemistry, antigen level. mammogram, chest x-ray, bone scan) currently in routine use.46 By the year 2000, the cost savings is estimated to be S1 billion. Again, science can only dubiously cater to the best hopes of patients and doctors. Researchers comment: "In conclusion, although the patient and physician may have an intuition that intensive surveillance will detect recurrence earlier and prolong survival compared with minimal surveillance, this feeling is not borne out...."43 In 1990 breast cancer consumed $6.5 billion--more healthcare dollars than any other cancer. After an exhaustive assessment, Herman Kattlove et al37(p142) concluded. "Regrettably, it is easier to estimate the expense of medical care than to project the benefit."
Bone Marrow or Stem-Cell Transplant
In 1995 an independent technology-assessment organization conducted a thorough review of studies, concluding that there is no evidence of any prolonged disease-free or overall survival benefit from the use of either bone-marrow or stem-cell transplants compared with conventional chemotherapy under any circumstances. Reimbursement for these therapies is controversial, and breast cancer patients are seeking insurance coverage ranging between S50,000 and $200,000 for this therapy. Several states have mandated such coverage. This is perhaps another example of both doctors and patients wanting to believe I that if a little is good, more must be better. But 31 studies between 1984 and 1994 showed either no improvement or slightly increased early death rates. Substantial evidence of harm exists for these therapies (note 15).
Making Sense of What We Know: Popular Intuitive Assumptions vs. Counterintuitive Evidence
An advertising concept called "positioning" refers to securing a place for a product in the consumer's mind that, ideally, I will become identified with the function served. Examples of this are the brand Kleenex, which has become synonomous with tissues, and Xerox, which has become a verb for photocopying. Analogously, the paradigm for the mechanical spread of breast cancer has become fixed securely within doctors' minds, and "removal before it spreads" has become the corollary kneejerk response. The delusion lingers that if enough malignant tissue is excised, then the cancer can be evicted and the patient cured.
Prior to and in the absence of prospective, randomized, controlled, double-blind studies, treatment protocols are inevitably the fruit of speculative clinical postulates to be tested over time. This holds true for regimens of chemotherapy, radiation, and surgical procedures. When clinical studies throw those habitual behaviors into question, rather than behaviors adapting, studies are often functionally disregarded. Perhaps this is because habits have encouraged theories to be mistaken for facts. It is within this context that the the Office of Technology Assessment issued a report stating that only 17% to 20% of conventional medical practices are based on scientifically validated evidence, and that 80% to 83% are based solely on anecdotal data (Office of Technology Assessment, US Government Printing Office, Washington, DC; 1988).
For example, it was hypothesized that positive axillary nodes served as a predictor for the spread of the disease. When evidence indicated otherwise, only a few doctors altered their clinical behavior. Similarly, bone scans, chest x-rays, and blood work have been shown to be of little use, yet more than half a billion dollars are spent each year when a physical exam, history, and mammogram are sufficient. Even though radiation following surgery reduces local recurrence, it is clearly established that the reduction of local recurrence does not impact survival. Radiation following surgery is akin to the ancient Greek custom of killing the messenger who has delivered bad news. Still, only a few physicians perform lumpectomies without recommending radiation therapy. Finally, though mastectomy is popularly perceived to be the safest treatment, there is comparable survival benefit between mastectomy, lumpectomy with radiation, and lumpectomy alone--women live the same length of time regardless of which intervention they or their doctor choose. Neither mastectomy nor radiation eradicates the possibility of recurrence--they merely reduce it, and local recurrence itself does not suggest that a woman's chance for a long life is less. Thousands of women and their doctors nevertheless elect mastectomy.
Another major assumption now under question is that people can be separated into two groups: those with metastatic disease and those without. Many leading oncologists now believe that at the time of detection, breast cancer is systemic. In this case, mastectomy plays no role in increasing survival. For the smaller group of women in whom the disease may not be systemic, breast-conserving surgery will remove the local tumor. Finally, when a woman learns that she has breast cancer, and that there is a large probablility the disease is systemic, this does not automatically mean that she will die soon. Roughly 50% to 60% of these women will survive, many for decades. The significant features determining longevity appear to be the biology of the tumor and the resistance of the host.
Times Change... and Remain the Same
Craig Henderson put it simply: "We're all prisoners of our oncogenes." He has taken a leave from clinical medicine to work with molecular biologists in the private sector. Molecular biology is now at the hub of inquiry, prompting a review of customary protocols by some, though the bulk of practice remains the same. At the conclusion of a 1994 symposium of carcinoma of the breast, Marvin Gliedman33(pp351-362), of Albert Einstein College of Medicine queried, "I wonder if breast cancer is a surgical disease any more." Samuel Hellman and Ralph Weichselbaum" of the University of Chicago say that "[b]ecause of the importance of systemic metastases and the current emphasis on treatments for systemic disease, one may question whether as a regional treatment radiation oncology, like surgery, will have an increasingly restricted role in cancer management."