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From the University of South Florida (DR, CC) and Moffitt Cancer Center (DR, CC, CM), Tampa, Florida.
Correspondence: Address correspondence to: Douglas Reintgen, MD, Professor of Surgery, University of South Florida, H. Lee Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL 33612-9416; Fax: 813-979-7211; E-mail: reintgds{at}mofitt.usf.edu
There is a growing need in the United States to establish a formal training program on new technology or surgical techniques for surgeons who have graduated from their residencies. At the present time, this need is fulfilled in a haphazard method with training programs established by proponents or pioneers of the technique, but there is no formal accrediting body for these programs, largely due to the possible perception that a training program will be used to credential surgeons. There is a perceived medical-legal threat to any national body that wanders into this field. National organizations and hospitals must begin to realize that accredited training courses are good for the public, because new technology is disseminated in a structured, orderly fashion. Likewise, clinical guidelines are just what the name implies, guidelines to be used to guide clinical care. They are not to be used to credential surgeons or other physicians. Training programs can introduce a new procedure to the surgical community, but they cannot be used to validate that a surgeon can do the technique accurately.
In this issue of Annals of Surgical Oncology, the article by Zervos et al.,1 which describes a training course for surgeons on the new emerging technology of lymphatic mapping and sentinel lymph node (SLN) biopsy in women with breast cancer, is interesting from a number of viewpoints. The authors have shown 62% of the participants in the training course were actually able to take the technology back to their institutions and establish a viable program in breast lymphatic mapping. Those participants who had a large practice of breast cancer patients, were members of a group practice or were females, were more likely to establish successful programs of radio-guided surgery. The data are supported by the experience from Moffitt Cancer Center. Since 1995, faculty at MCC and the University of South Florida have held monthly 2-day training courses for teams of surgeons, nuclear medicine physicians, and pathologists to instruct them on the new technology of lymphatic mapping. Over 1500 physicians have graduated the program and a retrospective survey showed that 60% of the surgical participants were able to go back to their institutions and establish programs of SLN biopsy. Reasons given for not being able to establish a program were lack of institutional support or lack of support from specialty colleagues.2
The somewhat disturbing data from the Zervos article was that 28% of the surgeons who established programs initiated the procedure without formal Institutional Review Board (IRB) approval and 20% dropped the need for a complete lymph node dissection (CLND) in the SLN-negative patients without consultation with their hospital, medical, and radiotherapy colleagues or their IRBS. This should not be surprising because of the "see one, do one, teach one attitude" of the surgical community. But this philosophy has not served the surgical community or the patients we treat well, particularly with some of the newest procedures that have revolutionized general surgical care in the last 10 years, such as the laparoscopic techniques and radio-guided surgery.
Lymphatic mapping for breast cancer is a coordinated effort that involves a team of physicians, including surgeons, nuclear medicine physicians, and pathologists. Attendance at formal training courses for this team of physicians is encouraged and in some places mandatory in order to perform the procedure. Guidelines have been established by national organizations, such as the American Society of Breast Surgeons, on how best to incorporate this new technology into a surgical practice. Documentation of at least 30 initial cases as a surgeon or first assistant in which the SLN harvest is performed followed by a CLND is considered important as surgeons go through their learning curve with this new technology. Benchmarks that must be met in these first 30 cases are a success rate of more than 85% in identifying an axillary SLN and a skip metastases rate of 0–1 in the first 10 women with metastatic disease to the regional basin. If the success rate of finding an axillary SLN is lower than 85%, then something wrong is being done. A "skip" metastases rate grater than 10% in those patients with metastatic disease would be too high to make the lymphatic mapping a viable staging procedure. After this initial experience, and with the "team" teaching the benchmarks, institutions may make the decision to discontinue the need for a CLND for patients who are SLN negative for those surgeons who have gone through their learning curve. But this decision should be made with the surgeon’s medical and radiotherapy colleagues, because they must also be comfortable with the decision to drop the CLND in the SLN-negative patients.
There are several on-going national trials of breast lymphatic mapping in the United States. The American College of Surgeon’s (ACS) Oncology Group (ACSOG) study will address the role of lymphatic mapping in women with invasive breast cancer and the clinical significance of upstaging with cytokeratin immunohistochemical staining in this population. In this trial, if the SLN is negative by routine histology, a blinded cytokeratin analysis will be performed. Patients will not have further surgery but will be given routine adjuvant therapy. In the other arm of the trial, if the SLN is positive with routine histology, patients will be randomly chosen to receive a CLND and adjuvant therapy vs. no further surgery and adjuvant therapy. The ACS gave implicit approval of the guidelines for training established by the American Society of Breast Surgeons by incorporating the guidelines into the learning phase of surgeons who want to participate in this national trial. The NSABP will enroll 5400 women with invasive breast cancer who are undergoing breast preservation. These patients will be randomized to receive either a SLN biopsy followed by CLND or a SLN and a CLND only if the SLN is positive. Participation in national protocols of breast lymphatic mapping (through the ACSOG or National Surgical Adjuvant Breast and Bowel Project [NSABP]) will provide a level of protection for surgeons and institutions as the technique is introduced and ensures that patients are fully informed that this is a new technique and not yet the standard of care in the country.
Received for publication August 28, 2000. Accepted for publication September 1, 2000.
REFERENCES
This article has been cited by other articles:
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  D. Clarke, R. G. Newcombe, and R. E. Mansel The Learning Curve in Sentinel Node Biopsy: The ALMANAC Experience Ann. Surg. Oncol., March 1, 2004; 11(3_suppl): 211S - 215S. [Abstract] [Full Text] [PDF]
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P.J. Tanis, O.E. Nieweg, A.A. M. Hart, and B.B. R. Kroon The Illusion of the Learning Phase for Lymphatic Mapping Ann. Surg. Oncol., March 1, 2002; 9(2): 142 - 147. [Abstract] [Full Text] [PDF]
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