"The study found that women who had had either kind of needle
biopsy were fifty percent more likely to have cancer in their
sentinel (lymph) nodes than women who underwent the surgical
removal of the whole tumor with excisional biopsy."

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com
Newsletter #169 01/30/05
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THE MOSS REPORTS

This week I begin a two-part discussion of an increasingly common
medical procedure - diagnostic needle biopsy.

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.

Monitoring the world of cancer diagnosis and treatment has been my
life's work.  The fruit of my thirty-year involvement in this
field is The Moss Reports, a comprehensive library of reports
detailing the conventional and alternative treatment of more than
two hundred different cancer diagnoses.

For a cancer patient, a Moss Report represents an invaluable guide
and handbook for the journey ahead.

If you would like to order a Moss Report for yourself or someone
you love, you can do so from our website, www.cancerdecisions.com,
or by calling Diane at 1-800-980-1234 (814-238-3367 from outside
the US).

We look forward to helping you.

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).

Win-Win

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).

To be concluded, with references, next week.