ARE NEEDLE BIOPSIES SAFE?
A June 2004 report from the John Wayne Cancer Institute in California has rekindled a long-standing debate over whether or not needle biopsies are safe. The paper set out to examine whether this technique, widely used to obtain specimens in cases of suspected cancer, might itself allow malignant cells to spread from an isolated tumor to nearby lymph nodes. The authors reluctantly conclude that a needle biopsy may indeed increase the spread of the disease by 50 percent compared to patients who receive the more traditional excisional biopsies (or "lumpectomies").
This is a rigorous study, and it comes with an excellent pedigree. The lead author, Nora M. Hansen, MD, was chief surgical resident at the University of Chicago (1994-1995) before coming to the John Wayne Cancer Institute in Santa Monica, Calif., in 1997. She is currently Assistant Director of the Joyce Eisenberg Keefer Breast Center, Saint John's Hospital and Health Center, Santa Monica.
John Wayne Cancer Institute, a division of Saint John's Hospital, is the institution that pioneered the procedure known as sentinel node biopsy. This is a technique for identifying the first lymph node to which a tumor is likely to spread. By removing that node and examining it at the time of surgery, it is possible to predict with great accuracy whether the cancer has indeed spread. This enables the surgeon to remove only those lymph nodes that have become involved with cancer, instead of resorting to wholesale lymph node dissection, a procedure which can leave a patient with long-term pain, edema, disfigurement and impairment of limb mobility.
The report was published in a prestigious journal, the American Medical Association's Archives of Surgery, which has been published continuously since 1885. The study was conducted by a team of John Wayne scientists which, in addition to Dr. Hansen, included Armando G. Giuliano, MD, chairman of the American College of Surgeons Breast Oncology Committee and the author of over 200 scientific articles on breast cancer. I emphasize the credentials of the study's authors in order to make the point that this is a group of well-respected clinicians and assuredly not a group of mavericks.
Hansen and her colleagues wanted to discover whether the common method used to obtain specimens from a breast tumor influenced the subsequent spread of disease to the sentinel node (SN). She and her colleagues therefore studied 663 women who were known to have breast cancer. Of these, about half had been biopsied with a needle — either a fine needle aspiration (FNA) or a large-gauge needle core biopsy. The other half had undergone the physical removal of their tumor (i.e., an excisional biopsy or lumpectomy). The study found that women who had had either kind of needle biopsy were fifty percent more likely to have cancer in their sentinel nodes than women who underwent the surgical removal of the whole tumor with excisional biopsy.
The report's authors state: "Manipulation of an intact tumor by FNA or large-gauge needle core biopsy is associated with an increase in the incidence of SN metastases, perhaps due in part to the mechanical disruption of the tumor by the needle." This is a discreet way of saying that needle biopsy, an increasingly common procedure, was itself responsible for spreading the cancer, although the authors take pains to qualify this disturbing conclusion by suggesting that not every cluster of cancer cells found in the regional lymph nodes will inevitably end up developing into clinically apparent cancer.
The implications of this study are vast, since patients who are found to have cancer in their lymph nodes are automatically classified at a higher stage and therefore face much more extensive treatment than those who have small tumors that are limited to the breast.
Instead of being told that they have stage I cancer and that surgery "got it all," they are now delivered the frightening news that the cancer has spread outside its capsule and gotten into the lymphatic system. They then face the possible dissection of the affected chain of lymph nodes and aggressive chemotherapy, radiation and/or hormonal therapy to wipe out the stray cancer cells (Chu 1999).
The report also potentially throws a monkey wrench into the smooth running early detection 'machine' that every year identifies and treats hundreds of thousands of Americans with cancer. Indeed, over the last few decades the needle biopsy has become an essential element in the detection not only of breast cancer, but also of many other kinds of cancer. The advantages of the technique are many: needle biopsies are nearly painless and bloodless in-office procedures, and much less expensive and time-consuming than surgical biopsies. The procedure consists of a hollow needle being inserted into a suspected tumor in order to retrieve samples for microscopic examination. In certain cases the tumor may have to be punctured four to six separate times in the process of obtaining adequate tissue for diagnostic purposes.
Get a Band-Aid and Go Home
Is it really safe to puncture a tumor in this way, especially when the tumor is anatomically walled off or encapsulated from the rest of the body? Isn't this running the risk of spreading the disease, either into the track formed by the needle, or, worse, by spilling cells directly into the lymphatic system or bloodstream? Has this procedure really been carefully thought out and researched before being implemented on such a massive scale?
To read the mainstream media, you would think that the medical profession is uniformly in favor of this procedure. For example:
- • A 1999 report in the Journal of American Medical Association enthusiastically endorsed the use of needle biopsies.
- • "A painful surgical biopsy of breast tissue may no longer be necessary," a CNN website enthused, in interpreting the study. Needle biopsies are "just as reliable, less expensive, and more comfortable" than the surgical alternative for diagnosing breast cancer" (Salvatore 1999).
- • Jack E. Meyer and colleagues at Boston's Brigham and Women's Hospital reviewed 1,836 cases of breast cancer diagnosed with the aid of a needle. They found large-core needle biopsies "accurate, safe and well accepted by patients and referring physicians." Instead of an operation, with local or general anesthesia, and possible deformation of the breast, patients experienced a one-hour in-office procedure.
"When the procedure's over you get a Band-Aid and you go home," said Meyer (Salvatore 1999).
To summarize: in principle the needle biopsy seems like a win-win situation. It is a simple office procedure, convenient, bloodless and virtually pain-free for patients. One would certainly not dispense with a test like this for trivial reasons. Currently, 1.2 million US women a year undergo breast biopsies. Between 20 and 25 percent of these tests show cancer, according to Dr. Neil Gorrin, assistant chief of surgery at Kaiser Permanente Medical Center in South San Francisco (Viddya 2001). That means that virtually all the women in the US who were diagnosed with breast cancer (215,990 this year) went through this procedure.
Yet concerns have been raised about the safety of invasive biopsies since they were first introduced more than a century ago.
The surgical biopsy first came to prominence in the 1870s, through the work of Carl Ruge and Johan Veit of the University of Berlin, who showed that only 10 out of 23 women who had undergone surgery for cervical cancer actually turned out to have the disease. At that time, surgeons in their arrogance simply assumed that they could recognize cancer when they saw it: they viewed the suggestion that tumors should be biopsied before excision as a direct challenge to their diagnostic and clinical acumen. But the work of Ruge and Veit effectively changed the prevailing tide of opinion.
Remarkably, fine needle biopsies - described as "a new instrument for the diagnosis of tumors" - were first reported for head-and-neck cancer by M. Kun in 1847. They were soon forgotten, but were subsequently revived by Hayes E. Martin, MD, and Edward B. Ellis, MD, of Memorial Sloan-Kettering, in the 1920s (Martin 1930). Needle biopsies were performed on a large scale at Memorial in the 1930s; however, the technique did not gain many adherents in the US during that time. Needle biopsies later underwent a resurgence in Scandinavia during the 1950s and 1960s, and it was from there that the trend spread to the rest of the world, including back to the United States (Das 2003).
By the time of World War I biopsy became routine practice in the US, endorsed by both the American Cancer Society and the American Medical Association.
However, by no means everyone in the medical establishment was convinced that biopsy was an unqualified good. James Ewing, the dean of American cancer pathologists, explicitly condemned puncturing unbroken skin for the purpose of sampling deeper lesions. He wrote: "It is especially to be avoided with...tumors of the breast, and all growths in which incisions of the skin involve also incisions through the tumor capsule" (Pack 1940: 43).
That would of course preclude most of the situations in which needle biopsies are currently done.
Ewing was not alone. The editor of the influential New York Medical Record had this to say on the subject:
"[O]ne who harpoons or excises a piece of tissue from a tumor with unbroken cutaneous or mucous surface, especially an encapsulated tumor, and then waits a day or two while the specimen is being examined, will almost inevitably destroy his patient's chance of recovery by operation....To resort to indiscriminate digging into all tumors on the chance of thereby reaching a diagnosis, which can usually be made by safer measures, and which moreover is not absolutely necessary, is positively wicked...." (Pack 1940).
Strong words! The author ends on a peculiarly modern note: "[A] physician acting on this advice would have no defense whatever if the heirs of his patient should bring a malpractice suit" (cited in Pack 1940:44).
Tens of thousands of needle biopsies are performed each year in the US alone, and the procedure is universally assumed to be safe and reliable. Yet there is evidence to suggest that needle biopsy may not be as harmless or uncomplicated a procedure as once thought. In fact, it may in some cases inadvertently cause cancer cells to break away from a tumor, thus enabling spread beyond the immediate tumor area.
In 1940, the first American textbook on cancer treatment contained warnings on the dangers of biopsies. "The medical literature is full of pleas for and against biopsy of all types of tumors," wrote Cushman D. Haagensen, MD, of Columbia University, NY, in 1940. Some doctors are "inquisitive but afraid of doing harm with biopsy" (Haagensen 1940). Bradley Coley, MD, a bone surgeon at Memorial Sloan-Kettering Cancer Center (and son of the famous immunotherapy pioneer, William B. Coley, MD), wrote that "there is some doubt as to the harmlessness of needling such tumors. It may not be a wholly innocuous procedure" (Pack 1940). A survey taken at the time showed that most surgeons agreed that the excision of suspect tissue was to be condemned and avoided.
Yet so widely and unquestioningly accepted has needle biopsy now become that anyone who raises a criticism of the technique runs the risk of incurring the wrath of his or her professional colleagues. For example, in July 2004 The British Medical Journal ran an article by a group of Australian surgeons, cautioning against the use of needle biopsies of the liver explicitly on grounds of the serious risk of needle track seeding of the tumor (Metcalfe 2004). The researchers stated that there were "certainly... medicolegal implications for people who perform fine needle aspiration of any malignant lesion." A radiologist, replied indignantly to the editor of the august British Medical Journal, accusing him of practicing "tabloid journalism" by running this article (Joseph 2004).
Have needle biopsies become standard practice because they have been proved safe through a rigorous series of studies, culminating in the yardstick of scientific measurement, randomized controlled trials (RCTs)? Or have the safety issues raised long ago by such luminaries as James Ewing, Cushman D. Haagensen and Bradley Coley simply been swept under the rug?
It may surprise readers, especially those who have undergone this procedure, to know that controversy over the safety of needle biopsies has quietly persisted into the modern period. Despite the unshakable assurance with which a standard textbook states that "the available evidence indicates that no increased risk of dissemination can be demonstrated in patients treated by needle biopsy" (Pilch p. 501), doubts remain. Apart from anything else, this statement rests on two papers, one dating from the 1950s and the other from 1962, both written by the same Sloan-Kettering doctor, Guy F. Robbins, MD, neither of which was based on a proper clinical trial (Kaae 1952; Robbins 1954).
Dr. David Kinne, a Memorial Sloan-Kettering breast surgeon, supported needle biopsy and cited as proof of the technique's safety the claim that there was no difference in survival between patients who received needle biopsies and those who received excisional biopsies. He then authoritatively averred, "This establishes that no dispersal of tumor cells is caused by aspiration biopsy." But that seems like an awfully big conceptual leap based on limited data, especially since the data he quoted in support of his assertion was already three decades old by the time that he cited it.
But even Dr. Kinne had to admit that "the extent to which needle aspiration biopsy may contribute - to a greater or lesser extent than surgical biopsy - to the hematogenous [blood-borne, ed.] dispersal of tumor cells has not specifically been determined" (Harris 1991:107).
One can follow the fate of needle biopsies through various editions the American Cancer Society's textbook on cancer. In the 4th edition (1974), the editor, Philip Rubin, MD, of the University of Rochester, wrote with refreshing bluntness that surgical biopsies "may contribute to the spread of cancer in some cases."
He elaborated: "Needle biopsy is occasionally used, [but]...a needle track may harbor nests of cells which may form the basis for a later recurrent spread....Incisional biopsy of certain highly malignant tumors through an open operative field may be contraindicated because of risk of spread of the tumor throughout the operative field" (ibid.)
Yet by the 7th Edition (1991), this concern was less apparent. The only caveat in this edition is a whittled down version of the earlier statement, conceding that one of the disadvantages of the larger core needle biopsy is "seeding of the needle track with tumor cells." But now Dr. Rubin and his colleagues were quick to reassure the reader that "with the advent of FNA [fine needle aspiration, ed.], this [core needle biopsy] technique is now used infrequently for palpable lesions..." (p. 43). As if FNA had been conclusively proven free of the risk of needle track seeding.
Finally, the most recent ACS version of the textbook, Clinical Oncology (2001), no longer offers any cautionary words whatsoever on the danger of biopsies. In fact, it states flat out, "biopsy of the breast under local anesthesia has virtually no disadvantages," an amazing statement in a field that is filled with complicated trade-offs of benefit and risk. There is not one word about the possibility of spreading cancer through biopsy.
Many sources that at the very least should discuss the possible downside of needle biopsy act as if there were no controversy whatsoever. Yet, if you examine the medical literature you do find studies similar to that of the John Wayne Institute authors, throwing doubt on the propriety of puncturing tumors in order to recover tissue for sampling.
Earlier in 2004, for example, the four Australian surgeons mentioned above (Metcalfe 2004), published a study in the British Medical Journal on the risks of fine needle biopsy of metastatic tumors in the liver. The title of the article succinctly summarizes their view: "Useless and dangerous—fine needle aspiration of hepatic colorectal metastases" (Metcalfe 2004).
Why dangerous? Aside from the acknowledged small risk of hemorrhage, there is the question of seeding the tumor in the track of the needle. Opinion is divided on how frequently this occurs. Some authors believe the incidence is small, i.e., between 0.003% to 0.07%. But more recently, the authors report, much higher rates (0.4% to 5.1%) of needle track metastases have been reported when FNAC [fine needle aspiration cytology, ed.] is used in liver lesions, usually for primary liver tumors (Takamori 2000; Chapoutot 1999; Kim 2000; Durand 2001; Herszenyi 1995). Thus, it is possible that one in twenty needle biopsies of the liver results in a new tumor.
The latest reports on needle biopsies certainly reopen a concern that has troubled many observers for a long time. I myself raised these concerns in my first book, The Cancer Industry (1980), quoting the 1974 ACS textbook cited above. I certainly respect Dr. Hansen's cautious and scientific approach. It is true that the full clinical significance of these lymph node metastases is not known (that is, how many of them would go on to develop into full-blown metastatic cancers, and how many would remain dormant in the local lymph nodes).
What is more certain, however, is the devastating effect that the development of such metastases has on the patients involved. First, instead of being told that they have a tumor that is almost certain to be cured by localized treatment (surgery with or without adjuvant radiation), they learn instead that the cancer has now escaped out of a confined area and has been seeded into another part of their body. Second, they will almost certainly now be strongly urged to take highly toxic combinations of chemotherapy with all its unpleasant and dangerous side effects, a treatment that would not have been necessary had the tumor remained confined to its site of origin.
Imagine the outrage these patients will feel when they learn that many of these sentinel node metastases were caused not by the natural progression of their disease but directly by the actions of well-intentioned (but ill informed) doctors. Imagine, further, what will happen when patients find out that questions have been raised about the safety and advisability of needle biopsies for a number of years by some of the finest minds in oncology. Imagine the disruption of the smooth functioning of the "cancer industry" when patients start demanding less invasive ways of diagnosing tumors. And imagine the class action lawsuits.
I think it is because of nightmare scenarios like this that no one in the medical community has yet come forward to draw the obvious conclusions from this provocative study for the general public. Doctors are silent. Politicians are unaware. And journalists, whom we look to as a "fourth estate" in issues of public policy, are silent on this, as on most of the really outrageous developments in the cancer field.
How else do we explain the fact that despite the impeccable credentials of the John Wayne Cancer Institute team, and prominence of the journal in question, this report has generally been ignored, as has the equally disturbing report on liver metastases in the British Medical Journal. Although Reuters did cover the John Wayne study at the time it was published (June, 2004), a scant three months later I could find only a handful of websites that still mentioned it, out of 82,000 that mention needle biopsies in general.
Needle aspiration biopsy continues to be viewed as the gold standard of diagnostic aids (Crabtree 2004). The whole notion that biopsies may themselves spread cancer may be too hot to handle for most of the media and the medical profession. It is one of those medical secrets that, it seems, is best left unexplored.
NOTE: Readers will inevitably want to know what options are open to patients who want to avoid needle biopsies. First of all, one should fully explore imaging techniques such as CT, MRI, PET scans and ultrasound. PET scans are particularly sensitive, and can often detect minute metastases, even before they become clinically apparent. It should be borne in mind, though, that such scans do subject the patient to transient doses of radiation. Mammograms have become increasingly accurate over the years, although there, too, questions have been raised about the exposure to ionizing radiation involved, and there are also legitimate concerns about the compression of the breast that accompanies most such tests, which itself may on occasion be responsible for dislodging clusters of cancer cells, thereby facilitating spread.
An innovative and non-toxic kind of diagnostic test is thermography, which detects abnormal patterns of heat emanating from areas of high metabolic activity. Although thermography has had its ups and downs, the result of a four year, multi-center clinical trial, led by the University of Southern California, was unambiguous: "Infrared imaging offers a safe, noninvasive procedure that would be valuable as an adjunct to mammography in determining whether a lesion is benign or malignant." The sensitivity of the test in this study was an astonishing 99 percent (Perisky 2003).
Source: http://cancerdecisions.com/020605.html ~ Dr. Ralph Moss