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months. One nodal recurrence occurred after a positive SLNB,
another after a failed SLNB. The overall rate of nodal disease
was 14% (7 positive SLNB, 1 nodal recurrence). Predictors of
nodal disease were multiple high-risk factors (
P
= .008), PNI
(
P
= .05), and ALI (
P
= .05).
32
The lack of a cutaneous SCC National Tumor Registry im-
pedes large retrospective multi institutional analysis of prog-
nostic factors. Risk factors associated with a higher rate of lo-
cal recurrence andmetastases are currently defined based on
low-moderate evidence and expert consensus.
7,33,34
We evalu-
ated our data using effect size to aid in comparison of the rela-
tive size of effect of each NCCN high-risk feature with regard
to the presence of nodal disease and found that presence of
ALI, presence of PNI, and a large clinical size had a large ef-
fect on the development of nodal disease. The large width of
the CIs around the estimates of the false-negative and false-
omission rates, however, exposes the small sample size and
demonstrates the variability of these estimates. Until higher
level evidence is produced, our results, which are relatively
consistent with the literature, suggest that utilization of the
NCCN guidelines may facilitate appropriate patient selection
for future study design and current consideration for SLNB.
7
Limitations
Limitations of our study include a retrospective design asso-
ciated with missing data of some variables of interest, rela-
tively short follow up including some patients lost to follow
up after the immediate postoperative period, and overall small
numbers despite being the largest single institution report. The
purpose of our study was to review our institutional experi-
ence utilizing SLNB for cutaneous SCC on the head and neck
to provide a basis to optimize future prospective analyses over
a long period of time with long-term follow-up. We included
outcomes data, although not complete, for all patients to add
to the current body of literature on the subject, acknowledg-
ing that, owing to the limited follow up for some of our pa-
tients, the rates of recurrence and false-omission may be un-
derestimates. Despite these limitations, our study provides
unique data, particularly with regard to histologic processing
of the SLNB specimens, and additional evidence to justify fu-
ture investigation incorporating prospectively-collected, ho-
mogeneous, comprehensive data sets based on standardized
treatment algorithms.
Conclusions
Rigorous studywith optimal methodology is necessary to im-
prove surgical and histopathologic protocols for SLNB for cu-
taneous SCC and to advance our understanding of what role
SLNB may play with respect to improved staging for patients
at high risk of nodal metastasis. Further work will be neces-
sary to determine if early identification and intervention leads
to improved outcomes for these patients.
ARTICLE INFORMATION
Accepted for Publication:
June 3, 2016.
Published Online:
July 20, 2016.
doi
: 10.1001/jamaoto.2016.1927 .Author Contributions:
Alison B. Durham had full
access to all of the data in the study and takes
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design:
Durham, Lowe, Malloy,
Bradford, Johnson, McLean.
Acquisition, analysis, or interpretation of data:
All
authors.
Drafting of the manuscript:
Durham, Lowe, Malloy,
Chubb.
Critical revision of the manuscript for important
intellectual content:
Durham, Lowe, Malloy,
McHugh, Bradford, Johnson, McLean.
Statistical analysis:
Chubb.
Administrative, technical, or material support:
Durham, McLean.
Study supervision:
Lowe, Malloy, Bradford,
Johnson, McLean.
Conflict of Interest Disclosures:
All authors have
completed and submitted the ICMJE Form for
Disclosure of Potential Conflicts of Interest and
none were reported.
Previous Presentation:
This study was presented
at the American Head and Neck Society Ninth
International Conference on Head and Neck
Cancer; July 20, 2016; Seattle, Washington.
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