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The First International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer and Adoption of a Multicenter Trial Protocol

From the Plastic Surgery Unit (GLR, TS, DSS, IGC), Canniesburn Hospital; Oral Pathology Unit (DGM), Glasgow Dental Hospital and School; and the Departments of Clinical Physics (RGB) and Nuclear Medicine (RGB, HWG), Royal Infirmary, Glasgow, United Kingdom.

Correspondence: Address correspondence and reprint requests to: Gary Ross, Head and Neck Research Fellow, Plastic Surgery Unit, Canniesburn Hospital, Switchback Rd., Bearsden, Glasgow, G61 1QL, UK; Fax: 44-141-211-5652; E-mail: gary.ross{at}canniesburn.org

	ABSTRACT

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
Background: Sentinel node biopsy (SNB) is a new technique in staging the clinically N0 neck. On June 25 and 26, 2001, the First International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer took place in Glasgow, United Kingdom.

Methods: Twenty-two centers contributed results on the use of SNB as a staging tool in head and neck squamous cell carcinoma. The pathology of the sentinel node was compared with that of the pathologic neck specimen.

Results: Three hundred sixteen clinically N0 necks were included. Sentinel nodes were identified in 301 necks (95%). Of these 301 necks, 76 necks were staged positive with SNB, and 225 were staged negative. The overall sensitivity of the procedure was 90%. Centers who had performed 10 cases had a lower sensitivity (57%), discovering only 4 of 7 metastatic nodes, in comparison with 72 of 77 metastatic nodes discovered for centers that had performed >10 cases (sensitivity, 94%).

Conclusions: The cumulative results of all those who contributed to the first international conference confirm that there is a role for SNB for staging the clinically N0 neck, and it has a similar sensitivity to that of a staging neck dissection.

Key Words: Head and neck • Neoplasms • Sentinel node biopsy • Elective neck dissection

	INTRODUCTION

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
Sentinel node biopsy (SNB) has been increasingly used for head and neck malignancies since its introduction for melanoma in 1992. More recently, interest has centered on the possibility of its use in squamous cell carcinoma of the head and neck (HNSCC) to stage the clinically N0 neck. This conference brought together international investigators who were experienced in the field, as well as clinicians wishing to start investigating the procedure in their units. It took place over 2 days in Glasgow, during which papers were presented from many centers. There were a number of keynote addresses and free paper sessions. Free papers were presented from 21 different centers throughout the world, other than Canniesburn, and in total >80 delegates participated. This was a most important contribution to the future of SNB in HNSCC. This article highlights the important points from the keynote addresses, documents the cumulative results of all those who took part during the conference, and discusses the major controversies in establishing a uniform multicenter trial protocol.

	STAGING THE CLINICALLY N0 NECK

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
In the early years, radical neck dissection was the only accepted standard of care for the treatment of any neck cancer, but the advent of modified neck dissections and selective organ-function-sparing procedures has since heightened the interest in elective treatment.

Numerous retrospective studies, including that from Canniesburn,¹ indicate that patients whose nodes are treated on an elective basis have better regional control and survival outcome than patients in whom the initial apparently negative neck was not treated until clinically evident disease was present.

Because the prognosis of delayed cervical metastases is poor and the treatment of the clinically negative neck correlates with improved survival, an elective neck dissection must be considered in the treatment of most tongue and floor-of-mouth carcinomas without palpable lymph nodes. Most authors favor elective neck dissection, for which the expected incidence of microscopic or subclinical disease exceeds 20%. In effect, elective dissection is predominantly a staging procedure to pathologically determine the need for adjuvant treatment. Recurrent disease after elective neck dissection does occur, and an elective neck dissection is not a 100% reliable staging tool in the N0 neck with conventional pathologic evaluation. One of the greatest advantages of SNB is that it focuses the pathologic evaluation on one or a few lymph nodes, enabling more exhaustive examination of the tissue for occult metastases.

	SENTINEL NODE BIOPSY

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
The sentinel node concept states that the sentinel lymph node (SLN) is the first node to which a tumor will metastasize via the lymphatics. The technique is based on the premise that lymphatic flow from the primary tumor travels sequentially to the SLN, or first-draining lymph node or nodes, and then on to the remaining regional lymph nodes. Furthermore, the pathologic status of the SLN should accurately reflect the histology of the remaining regional basin. Neck dissection would then be required only where the SLN is positive.

Although SNB has been used in a number of cancers, the concept has been mainly applied to malignant melanoma² and breast cancer.³ In these cancers, SLNs free of tumor imply a regional lymph node basin free of tumor with a high degree of accuracy. In malignant melanoma, it was found that the triple diagnostic technique of lymphoscintigraphy and intraoperative use of blue dye and a gamma probe facilitated SLN identification and improved the accuracy of staging.^4–6

	SNB FOR HNSCC

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
The first reported case of a patient with neck metastases successfully identified by SNB in HNSCC was by Alex and Krag⁷ for a patient with supraglottic cancer. Initially there were difficulties with the technique,^8,9 but subsequently Shoaib et al.¹⁰ reported success using the technique to identify SLNs in cases undergoing neck dissection. This showed that the SLN was successful in identifying subclinical metastases in seven of seven cases with a combination of blue dye and radiocolloid. In the remaining 13 cases, in which SNB was performed with blue dye alone or in the clinically involved neck, the sentinel node was not an accurate reflector of the pathology of the neck. This problem of the clinically node-positive neck has been highlighted by others.¹¹ Work has continued in the clinically N0 patient^12–14 to validate SNB; Shoaib et al.¹⁵ described the technique in 40 clinically N0 patients and showed the sensitivity of the procedure to be 94%. Work in progress was presented from Canniesburn in which sentinel node locations were identified in all true-positive and true-negative cases. A total of 124 sentinel nodes were identified from 52 cases, of which 9 were outside the ipsilateral levels I to III. Of particular interest was that two nodes in level IV contained gross metastasis. This work led the way for the current studies in Canniesburn to stage the clinically N0 neck by using SNB alone.

	SNB ALONE TO STAGE THE CLINICALLY N0 NECK

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
Forty clinically N0 patients in Canniesburn have been staged with SNB alone. Two patient groups have been identified. The first is those patients with early disease (T1/2) who have clinically N0 necks. The second group is those patients with midline tumors or tumors crossing the midline, in which the contralateral clinically N0 neck is staged by SNB and the ipsilateral clinically node-positive neck is staged by an elective neck dissection. Although SNB is cost-effective in patients with early disease (T1/2), the clinical effectiveness of the procedure requires confirmation with long-term follow-up.

	PATHOLOGIC EVALUATION OF SENTINEL NODES

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
Work in SNB for malignant melanoma and breast cancer has recommended that step serial sectioning and immunohistochemistry be used to evaluate SLNs. Gershenwald et al.¹⁶ reported that 80% of recurrences after a negative SNB for melanoma could have been prevented had immunohistochemistry been performed prospectively rather than retrospectively.

The pathologic evaluation of SLNs in the context of a neck dissection has generally been with routine hematoxylin and eosin. The use of additional pathologic evaluation in SNB for HNSCC has been highlighted in our practice by an upstaging of 10% of SLNs with step serial sectioning and an additional 10% with immunohistochemistry.

So far, in T1/2 patients in whom SNB has been used alone to stage the clinically N0 neck, detailed pathologic evaluation of the SLN has accurately reflected the pathology of the neck in 100% of cases. Longer follow-up is required to determine the true sensitivity of the procedure. To provide statistical significance, the results of a multicenter trial are required to answer the question of whether SNB alone is sufficient to stage the clinically N0 neck.

	RESULTS FROM THE CONFERENCE

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
The following results are an analysis of all 22 centers that contributed to the first international conference. Three hundred sixteen clinically N0 necks were included. Sentinel nodes were identified in 301 necks (95%; Fig. 1). Of these 301 necks, 76 necks were staged positive with SNB, and 225 necks were staged negative. Of those staged negative, eight patients had disease elsewhere within the neck specimen. The overall sensitivity of the procedure was 90% (Fig. 2). Centers who had performed 10 cases had a lower sensitivity (57%), discovering only 4 of 7 metastatic nodes, in comparison to 72 of 77 metastatic nodes discovered for centers that had performed >10 cases (sensitivity, 94%; Table 1).

View larger version (32K): [in this window] [in a new window]   FIG. 1. Sentinel node biopsy identification rates in the context of a neck dissection. HNSCC, squamous cell carcinoma of the head and neck.

View larger version (30K): [in this window] [in a new window]   FIG. 2. Sensitivity of sentinel node biopsy in the context of a neck dissection. HNSCC, squamous cell carcinoma of the head and neck.

View this table: [in this window] [in a new window]   TABLE 1. Sensitivities among centers with experience of 10, >10 and 20, and >20 cases of sentinel node biopsy in the context of a neck dissection

	DISCUSSION

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

Variations in Establishing the N0 Neck
Since the advent of sophisticated imaging technology, clinicians have focused on diagnostic refinement in an attempt to define the N0 neck. With the increased knowledge of micrometastatic disease and its postulated effect on prognosis, the definition of the N0 neck has become one that few imaging modalities have the capability to meet. Even compared with routine pathologic evaluation of nodal disease, diagnostic imaging such as computed tomography, magnetic resonance imaging, and ultrasound scanning has shown a specificity^17–20 of 75% to 92%. Ultrasound scanning/fine-needle aspiration cytology^21,22 has been reported to show 100% specificity, although the sensitivity is between 42% and 73%, which is similar to the sensitivities of the other imaging techniques already mentioned. The use of ultrasound scanning/fine-needle aspiration cytology in combination with SNB has shown success and is currently under investigation.²³

Recent reports of the use of positron emission tomography show a higher sensitivity²⁴ of 87% and a specificity²⁵ of 90%. The $1 to $2 million cost of a dedicated positron emission tomography scanner and the small number of false positives prevent this imaging option as a standard of care, and its use as an indicator for surgery is still controversial.²⁵

Current practices of establishing an N0 neck vary, and the inclusion criteria for patients undergoing SNB for the N0 neck will therefore also vary between units. It is recommended, however, that clinical palpation alone be used to establish the N0 neck to create uniform inclusion criteria. Imaging techniques, if performed, could be compared subsequently. This, however, may lead to more positive nodes being identified by SNB than would be seen in a more select population with a rigorous definition of clinical N stage.

Variations in Lymphoscintigraphy
The choice of colloid available to a center is dependent on those that are licensed for use. Within Europe there are two colloids available: Albures^TM and Nanocoll^TM (Nycomed Amersham, Buckinghamshire, UK). Nanocoll is the most frequently used. Both of these colloids are composed of human serum albumin and are not therefore licensed in some countries, such as the United States, where the most common colloid used is sulfur colloid. Antimony sulfur colloid is the most common colloid used in Australasia, and rhenium has been used in Asia.

Different radioactive colloids have varying pharmacokinetic and pharmacodynamic properties. The ideal colloid should selectively identify the sentinel node and should reach the SLN and remain trapped within, therefore reducing nonsentinel node background emissions. This nodal uptake is dependent on the particle size. In general, large particle colloids such as rhenium and Albures are slow moving and remain in the first-echelon node, whereas smaller particle colloids tend to be faster moving, and the colloid tends to pass more quickly to second- and third-echelon and subsequent echelon nodes. Particles with a diameter size of a few nanometers, such as Nanocoll and sulfur colloid, generally pass into the bloodstream more easily than larger particle colloids and are thus less likely to remain at the site of injection. Larger particle colloids, however, are less likely to pass down the lymphatic channel. This may be of particular importance in patients in whom there is disease present within the SLN. It may be that the larger particle colloids are less likely to penetrate into the SLN, either because of disease or blocked lymphatics, and lead to an unidentified sentinel node. The search for an ideal colloid remains elusive, and a uniform colloid available worldwide is as yet unavailable.

Both static and dynamic lymphoscintigraphy has been used at differing times before surgery. It is recommended that there not be more than a 24-hour delay between the lymphoscintigraphy and SLN collection. It is accepted that differing colloids and types of lymphoscintigraphy will be used by different centers, but this should not prevent centers from entering a trial.

Variations in Surgery
Surgery is performed up to 24 hours after injection of radiocolloid. The use of blue dye remains controversial. Blue dye has differing pharmacodynamics and pharmacokinetics from radiocolloid and therefore may provide additional information in the localization of sentinel nodes. It has also been shown that there are a number of cases in which a positive sentinel node has been identified with blue dye only.¹⁵

Centers in favor of blue dye report that it aids in the identification of nodes, although it is accepted that it is most useful in combination with radiocolloid. Because blue dye, radiocolloid, and the use of preoperative lymphoscintigraphy are now an integral part of SNB in both melanoma and breast cancer, it seems reasonable to recommend this triple diagnostic approach for HNSCC. In our practice this has shown a sensitivity¹⁵ of 94%. Generally, surgery has been performed on an untreated field. Previous treatment to the neck or primary tumor site, including adjuvant therapies such as radiotherapy or chemotherapy, may well interrupt or alter the lymphatic drainage system and may therefore alter the drainage of the blue dye/radiocolloid. It is recommended that SNB be performed only on the patient in whom the neck lymphatics are unlikely to have been disrupted.

	CONCLUSION

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 
The cumulative results of all those who presented at the first international conference confirm that there is a role for SNB for staging the clinically N0 neck, and it has a similar sensitivity to that of a staging neck dissection. For SNB to be clinically effective, the number of patients who will develop subsequent disease after a negative SNB should not be more than the number of patients who develop recurrence after supraomohyoid neck dissection. Literature suggests that this should be 10%. It is likely that SNB for T1/2 tumors in the clinically N0 neck is cost-effective, with minimal morbidity. However, the clinical effectiveness needs to be established in the context of a multicenter trial to determine whether it should become a standard of care.

It is accepted that patients with T1/2 tumors accessible to injection are those most likely to benefit from this treatment and that only clinically N0 necks should be recruited onto a multicenter trial. Details of a multicenter trial are available on the Web site http://www.canniesburn.org.

	Acknowledgments

 
The authors thank all those who contributed to the First International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer.

Received for publication September 25, 2001. Accepted for publication January 23, 2002.

	REFERENCES

TOP ABSTRACT INTRODUCTION STAGING THE CLINICALLY N0... SENTINEL NODE BIOPSY SNB FOR HNSCC SNB ALONE TO STAGE... PATHOLOGIC EVALUATION OF... RESULTS FROM THE CONFERENCE DISCUSSION CONCLUSION REFERENCES

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ross, G.L. Articles by Gray, H.W. Search for Related Content PubMed PubMed Citation Articles by Ross, G.L. Articles by Gray, H.W.