Research

Are Biopsies Safe?
No, They cause the cancer to spread and do a lot of permanent damage to the prostate.


MOSS Reports February 6, 2006

This week I conclude the discussion I began last week, concerning the potential complications of 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.

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ARE NEEDLE BIOPSIES SAFE? - PART II

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).

ACS Textbook

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.

Conclusions

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).


--Ralph W. Moss, Ph.D.

References:

American Cancer Society (ACS). Classics in oncology:'Biopsy by needle puncture and aspiration,' by Hayes E. Martin and Edward B. Ellis, 1930. CA Cancer J Clin. 1986;36:71-82.

Berg JW, Robbins GF. A late look at the safety of aspiration biopsy. Cancer 1962:15:826.

Chapoutot C, Perney P, Fabre D, et al. [Needle-track seeding after ultrasound-guided puncture of hepatocellular carcinoma. A study of 150 patients.] Gastroenterol Clin Biol 1999;23: 552-6.

Chen, AM, Haffty, BG, Lee CH. Local recurrence of breast cancer after breast conservation therapy in patients examined by means of stereotactic core-needle biopsy. Radiology 2002;225:707-712.

Christopherson WM. Cytoloogic detection and diagnosis of cancer. Its contributions and limitations. Cancer 1983;53:1201).

Chu KU, Turner RR, Hansen NM et al. Do all patients with sentinel node metastasis from breast carcinoma need complete axillary node dissection? Ann Surg 1999;229:536-541

Crabtree, Sissy. Chief Justice William Rehnquist's thyroid cancer diagnosis draws attention to importance of thyroid awareness, according to AACE. US Newswire,

October 25, 2004. Retrieved October 26, 2004 from:
http://releases.usnewswire.com/GetRelease.asp?id=38817

Das DK. Fine-needle aspiration cytology: Its origin, development, and present status with special reference to a developing country, India. Diagnostic Cytopathology 2003;28:345-351.

Durand F, Regimbeau JM, Belghiti J, et al. Assessment of the benefits and risks of percutaneous biopsy before surgical resection of hepatocellular carcinoma. J Hepatol 2001;35: 254-8

Engzell U, Esposti PL, Rubio C, Sigurdson A, Zajicek J. Investigation on tumour spread in connection with aspiration biopsy. Acta Radiol Ther Phys Biol. 1971 Aug;10(4):385-98.

Frable MA, Frable WJ. Fine-needle aspiration biopsy revisited. Laryngoscope. 1982 Dec;92(12):1414-8.

Frable WJ, Frable MA. Thin-needle aspiration biopsy: the diagnosis of head and neck tumors revisited. Cancer. 1979 Apr;43(4):1541-8.

Harter LP, Curtis JS, Ponto G, Craig PH. Malignant seeding of the needle track during stereotaxic core needle breast biopsy. Radiology. 1992;185:713-4.

Herszenyi L, Farinati F, Cecchetto A, Marafin C, de Maria N, Cardin R, et al. Fine-needle biopsy in focal liver lesions: the usefulness of a screening programme and the role of cytology and microhistology. Ital J Gastroenterol 1995;27: 473-8.

Hutchison, GB and Shapiro S. Lead time gained by diagnostic screening for breast cancer. JNCI 1968;41:666-673.

Joseph, Anton E. Fine needle aspiration of hepatic colorectal metastases [letter]. BMJ 2004;329:290.

Kaae S. The risk involved by biopsy in breast cancer. Acta Radiol 1952;37:469.
Kim SH, Lim HK, Lee WJ, et al. Needle-track implantation hepatocellular carcinoma: frequency and CT findings after biopsy with a 19.5-gauge automated biopsy gun.
Abdom Imaging 2000;25: 246-50.

Knight R, Horiuchi K, Parker SH, Ratzer ER, Fenoglio ME. Risk of needle-track seeding after diagnostic image-guided core needle biopsy in breast cancer. JSLS. 2002 Jul-Sep;6(3):207-9.

Kun M: A new instrument for the diagnosis of tumors. Month J Med Sci 1847; 7: 853-4.

Martin HE, Ellis EB. Biopsy by needle puncture and aspiration. Ann Surg 1930; 92:169-81

Matsuguma H, Nakahara R, Kitamura T, et al. Pleural recurrence after needle biopsy of the lung: An analysis in patients with completely resected stage I non-small cell lung cancer. Abstract No. 7177. Journal of Clinical Oncology, 2004 ASCO
Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 7177.

Metcalfe MS, Bridgewater FHG, Mullin EJ, et al. Useless and dangerous-fine needle aspiration of hepatic colorectal metastases. BMJ 2004;328:507-508.

Meyer JE, Smith DN, Lester SC, et al. Large-core needle biopsy of nonpalpable breast lesions. JAMA 1999 May 5;281(17):1638-41.

National Cancer Institute. Number of cancer survivors growing According to new report. June 24, 2004. Retrieved October 31, 2004 from:
http://www.cancer.gov/newscenter/pressreleases/MMWRCancerSurvivorship

Parisky YR, Sardi A, Hamm R, Hughes K, Esserman L, Rust S, Callahan K. Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions. AJR Am J Roentgenol 2003 Jan;180(1):263-9.

Pilch, Yosef H. Surgical Oncology. New York: McGraw Hill, 1984.

Robbins, GF, et al. Is aspiration biopsy of breast cancer dangerous to the patient? Cancer 1954:7:774.

Salvatore, Steve. Study endorses quick, easy breast biopsy. CNN website, May 4, 1999. Retrieved October 25, 2004 from:
http://www.cnn.com/HEALTH/9905/04/breast.biopsy/

Takamori R, Wong LL, Dang C, et al. Needle-track implantation from hepatocellular cancer: is needle biopsy of the liver always necessary? Liver Transpl 2000;6: 67-72.

Some sources that did cover the John Wayne story:
http://www.drpressman.com/News/news06-04.htm
http://www.cancerpage.com/news/article.asp?id=7228
http://www.doctorbob.com/2004k_06_22news16.html
http://www.healthnewsexpress.com/Articles2004/NeedleBiopsy.aspx