What to do about axillary lymph nodes has become one of the hot topics in the management of early breast cancer. Is it safe to rely on a biopsy of just one "sentinel" node to decide whether or not the cancer has spread to other underarm nodes? Is it necessary to know the status of the nodes at all? Would leaving them alone, even when they are positive, make any difference in overall survival?
Into this mix of unresolved issues, a few surgeons are now swirling a new question: Could endoscopy be a better way to remove the nodes than conventional surgery?
The benefits, say proponents of the less invasive procedure, could be fewer complications and a faster recovery time. Endoscopy involves very small incisions, through which the nodes are removed with the help of camera-guided instruments.
A major disadvantage of endoscopy is its longer operating time. It also can be more expensive than conventional surgery, although this may differ from one country to another and has to be balanced against other factors, say proponents.
But an even greater challenge to endoscopy, at least in the United States, may be the growing use of sentinel node biopsy. Both are used in generally the same group of patients with early stage breast cancer. Whether endoscopy offers any advantage over this other relatively noninvasive technique remains a murky, and unaddressed, issue.
So far only a handful of surgeons, almost all of them in Europe, have used endoscopy to remove the axillary nodes. The technique was pioneered in the early 1990s by François Suzanne, M.D., whose department at Hotel Dieu C.H.U. de Clermont-Ferrand, Clermont, France, has performed several hundred of these procedures since 1992.
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The total surgery lumpectomy plus endoscopy takes well over an hour, sometimes up to 3 hours, according to Suzanne, compared to about 60 minutes for lumpectomy plus conventional axillary node removal. But he is enthusiastic about the results. In the 150 cases reported at San Antonio all of those performed in his department between January 1994 and December 1997 only 11 women (7.33%) had pain after the procedure and only 12 (8%) had trouble moving their arms. Short-term numbness and swelling were also rare. Long-term or delayed complications were even fewer and there were no cases of lymphedema.
Few Published Accounts
In conventional lymph node dissection, over 80% of patients have at least one postoperative complication, according to a recent editorial by David Krag, M.D., University of Vermont, Burlington, in The New England Journal of Medicine. The most severe side effect, long-term lymphedema, may affect about 5% to 15% of breast cancer survivors for years after surgery. Short-term pain and loss of arm function are more common.
Besides Suzanne, only a few other investigators have published on endoscopy for axillary node dissection. The literature includes a report of one randomized trial, by J. Salvat, M.D., and colleagues at Centre Hospitalier Thonon, France, with 40 patients. These investigators concluded that endoscopy collected comparable numbers of lymph nodes as open surgery, but that there was also a potential risk: the nodes collected by endoscopy were more likely to be fractured, leading perhaps to release of malignant cells into the axilla.
Suzanne's report at San Antonio also referred to crushed nodes in about 13.1% of nodes compared to 7.8% in standard surgery. But this is a problem that recedes as surgeons gain experience, he said.
Suzanne has spent a good deal of time teaching axillary endoscopy to other surgeons. He estimates it is necessary to practice between 15 and 30 cases to learn the technique (surgeons in training follow endoscopy with a conventional dissection). He said he knows of about 500 endoscopic axillary dissections performed to date in Europe, including about 300 in France, 100 in Switzerland, and another 100 divided between Germany, Belgium, Italy, Spain, and Sweden.
In the United States, the number is far lower. In fact, the first report of endoscopic axillary dissections in the United States appeared just this year, in the January issue of Surgical Endoscopy, where Jonathan Sackier, M.D., and colleagues described a pilot study with 23 patients. Unlike the Europeans, these investigators at George Washington University, Washington, D.C., used endoscopy for sentinel node dissection rather than a more extensive axillary removal.
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The latter point is important, Sackier said, because there are those who believe that endoscopy makes it harder to see nerves and other anatomic features and may therefore increase the risk of injury. In Sackier's opinion, endoscopy reduces the risk. "You have a hugely magnified view on the screen," he said. "Anyone who has ever seen the view through a scope knows that it is magnificent."
Sackier said he is continuing to use endoscopy for sentinel node removal in phase I studies.
Two other U.S. sites may soon be studying endoscopy in breast cancer patients. One is Stanford University in Palo Alto, Calif., where France's Suzanne has been invited to spend some time as a visiting professor. Stanford's Stefanie Jeffrey, M.D., who learned the technique from Suzanne in France, said that he would probably be arriving in late summer or autumn.
The other place is Washington University in St. Louis, where L. Michael Brunt, M.D., and colleagues have reported piloting the procedure in cadavers and animals. They plan now to go forward with a trial in patients, Brunt said. "There is definite interest among the breast surgeons here."
And what about those problems of time and expense? "There's no question that it is more expensive," said Brunt. There are the equipment costs, he points out, and that includes some disposable items. In France, however, Suzanne says endoscopy is not more expensive than conventional surgery and the hospital stay is much shorter following endoscopy 1 to 2 days for endoscopy versus 4 to 7 days for conventional surgery.
As for the longer operating time, endoscopy proponents argue that experience makes a difference. "We're sensitive to the time issue," said Sackier. "But once doctors and operating room staff become used to the technique, it will take less time."
An Improvement?
The other big question in the United States whether endoscopy can improve much on open sentinel node dissection has yet to be addressed. Sentinel node dissection also uses a small incision and has low complication rates, points out Armando Giuliano, M.D., John Wayne Cancer Center, Santa Monica, Calif. "It seems possible that endoscopy can only complicate matters."
Mindful of this, the Stanford investigators are fashioning a protocol that will probably call for patients with tumors over 1 cm who are more likely to require axillary dissection beyond the sentinel node, Jeffrey said. And in St. Louis, the protocol would be for patients who need a complete axillary dissection, according to Brunt.
Two large randomized studies of open sentinel node biopsy are due to start accruing patients this spring in the United States. Giuliano, principal investigator of one and the University of Vermont's Krag, who is leading the other, expect the studies to answer some major questions about the procedure, including its impact on survival and local recurrence rates.
By contrast, the study of axillary endoscopy is just beginning and no one can say whether it will ever reach the stage of a large randomized trial. Sackier said he is optimistic but emphasized that it will take much more time and study to determine the fate of the procedure. "It's extraordinarily dangerous to try to be a prophet," he said.
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