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\begin{document}

\title{A single centre's experience of 23 cases of total rhinectomy for the
treatment of nasal vestibule squamous cell carcinoma.}



\author[1]{Emilien Chabrillac}%
\author[2]{Ashish Talawdekar}%
\author[3]{Satya Garikipati}%
\author[2]{Iain Varley}%
\author[2]{Sara Sionis}%
\author[2]{Nigel Beasley}%
\author[2]{Richard Jackson}%
\affil[1]{Cancer University Institute Toulouse Oncopole Department of Surgery}%
\affil[2]{Sheffield Teaching Hospitals NHS Foundation Trust}%
\affil[3]{Weston Park Hospital}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Objectives: This study aims to analyse the management outcomes of total
rhinectomy (TR) for nasal squamous cell carcinomas (SCCs) involving the
vestibule, and to identify prognostic factors for disease recurrence.
Design: A retrospective single centre study was conducted between
September 2003 and February 2021 including all patients who underwent a
TR for a SCC involving the nasal vestibule. Results: 23 patients were
included in the study. Tumours originated from the septum (n=12),
vestibule (n=8) or skin (n=3). Six TR (26.1\%) were salvage procedures,
after primary radiotherapy or nose-preserving rhinectomy. Seven patients
had a concurrent neck dissection and 17 patients (73.9\%) received
adjuvant treatment (14 patients had radiotherapy and 3 had
chemoradiotherapy). After a median follow-up of 32 months, six patients
(26.1\%) presented with tumour recurrence. Three patients (13\%) had
nodal-only recurrence. The estimated 5-year overall survival,
disease-free survival and disease-specific survival was 67.5\%, 66.3\%
and 80.7\% respectively. Positive excision margins were a predictive
factor for tumour recurrence after TR (p=0.0401). Conclusions: For nasal
vestibule SCCs not amenable to limited surgical resection, TR along with
adjuvant radiotherapy provide good oncological outcomes and should be
considered the main treatment option.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Squamous cell carcinoma (SCC) of the nasal vestibule is a rare
malignancy (1,2). Risk factors for nasal carcinomas include male gender,
smoking and exposure to organic solvents (3). Human Papilloma Virus
infection has been identified in a significant proportion of tumours,
although its prognostic impact remains unclear (4,5). Nasal vestibule
malignancies can present with non-specific symptoms, sometimes
masquerading as a dermatosis (6) and leading to a delay in diagnosis.

Due to the heterogeneity of published series, the level of evidence
regarding the management of nasal SCC remains low. There is a lack of
consensus for the treatment of both the primary tumour and the
clinically N0 neck. While most authors recommend upfront surgery
(rhinectomy) even for early stage tumours (2,7--9), interstitial
brachytherapy and radiotherapy seem to be acceptable non-surgical
alternatives (2,10,11). However, for locally advanced tumours, surgery
in the form of Total Rhinectomy (TR) remains the mainstay of treatment
(12,13). For the nodal management of cN0 vestibule SCCs, authors have
recommended several strategies including surveillance, elective neck
dissection and prophylactic radiotherapy (7,13).

The staging of nasal tumours is also controversial with three main
tumour classifications being used i.e. Wang's classification,
8\textsuperscript{th} edition of AJCC staging system for tumours of the
nasal cavity and ethmoid sinus, and the AJCC staging system for
nonmelanoma skin cancer of head and neck region (see table 1) (14,15).
Wang's classification is specifically designed for vestibule tumours,
and therefore may better represent the natural evolution of tumours at
this anatomical subsite (15,16). Indeed, the local extension pathways
and the specific lymphatic drainage of nasal cavity malignancies justify
using a specific classification system to infer disease management
(17,18).

The need for clear excisional margins alongside the anatomical and
cosmetic constraints make indications for partial rhinectomies rare.
Furthermore, they require a challenging surgical reconstruction (16)
whereas prosthetic reconstruction after TR brings satisfactory cosmetic
outcomes (19). However, the psychological impact of TR can be
significant and therefore must not be underestimated (19).

The aim of this retrospective single centre study was to analyse the
outcomes of TR for the treatment of nasal vestibule SCCs and to identify
risk factors for disease recurrence.

\textbf{Material and methods}

A retrospective case series was conducted in a regional tertiary centre
for management of head and neck malignancies. All patients undergoing TR
for a SCC of the nasal vestibule between September 2003 and February
2021 were included. Patients with a follow-up shorter than three months
were excluded. Patients undergoing TR for nasal malignancies other than
SCC were also excluded (as outlined in figure 1). This study was
registered with the local research and development department as a
quality improvement project (reference number 10343). The methodology
was in accordance with the Process 2020 Guideline
(\emph{http://www.processguideline.com/}).

Due to the absence of clear-cut recommendations or guidelines, the
regional multidisciplinary team proposed upfront surgery (partial or
total rhinectomy) whenever feasible. For clinically N0 (cN0) necks, the
multidisciplinary team generally recommended an elective neck dissection
for very advanced tumours only. Adjuvant radiotherapy was indicated for
positive or close margins or advanced T stage. Prophylactic irradiation
of the neck for N0 disease was not considered. Concurrent chemotherapy
was considered if tumour was locally advanced (T4) or in the presence of
nodal metastasis with extracapsular extension.

Patient charts were reviewed retrospectively to identify the following
information; gender, age, comorbidities, risk factors, tumour staging,
histological findings, type of surgery and reconstruction,
complications, adjuvant therapy and follow-up. The main endpoints were
Overall Survival (OS), Disease-Free Survival (DFS), Disease-Specific
Survival (DSS), and the prognostic factors for recurrence.

\emph{Statistical analysis}

Estimations of survival were calculated using the Kaplan-Meier method.
Patients that developed disease recurrence (recurrence group) and those
that did not (remission group) were compared using the Fisher's exact
test for qualitative variables and the Mann-Whitney test for
quantitative variables. A p-value \textless{} 0.05 was considered
statistically significant. Statistical analysis was performed using
GraphPad Prism version 8.4.2.

\textbf{Results}

Overall, 23 patients underwent TR for SCC of the nasal vestibule, of
which 69.6\% were males and 30.4\% were females (gender ratio 2.29:1).
The median age was 63 years (range 38 -- 87). Twenty patients (87\%) had
a history of smoking, and alcohol abuse was noted in two patients
(8.7\%). Four patients (17.4\%) were immunocompromised including two
cases of haematological malignancy (multiple myeloma, chronic
lymphocytic leukaemia) and two patients taking immune suppressant
medication. The median time between the initial presentation of symptoms
and surgery was 7 months (range 3 -- 18). Pre-operative imaging for
staging included MRI (100\%), CT (86.4\%) and/or PET-CT (4.5\%).
Clinical T staging using the Wang's classification and the AJCC
classification for nasal cavity cancers (thus excluding the three
primaries of cutaneous origin) are shown in Table 2. Six patients
(26.1\%) presented with symptoms of recurrent disease, either following
radiotherapy (n=3) or nose-preserving surgery (n=3). The outlines of
patients' presentation and treatment are shown in Figure 1.

Surgery was performed by ENT surgeons (73.9\%) or maxillofacial surgeons
(26.1\%) and consisted of a TR, which was extended in six cases (26.1\%)
to the maxilla, the orbit or the ethmoid sinus. Seven patients (30.4\%)
underwent a concurrent neck dissection, due to a clinical suspicion of
nodal involvement (cN+) or an extensive tumour requiring free flap
reconstruction in two cases (8.7\%). All patients were offered
prosthetic rehabilitation. Late complications included nasolacrimal duct
obstruction (20\%) and mucocele (5\%). The psychological issues and
abutment complications related to the prosthesis were not studied.

On histological analysis, all tumours involved the nasal vestibule and
originated from either the septum (n=12), vestibule (n=8) or skin (n=3).
The main pathological characteristics are presented in Table 2,
alongside statistical comparisons between patients that developed
disease recurrence (recurrence group) and those that did not (remission
group). Notably, three SCCs from the remission group presented with
adenosquamous features. Five patients (21.7\%) required re-operation for
further surgical excision in the month following the TR. Among the seven
patients who underwent neck dissection, only one had a pathological
nodal involvement, demonstrating extracapsular extension. Seventeen
patients (73.9\%) received adjuvant treatment, with 14 patients having
radiotherapy and 3 having chemoradiotherapy.

After a median follow-up of 32 months (range 3 -- 195), six patients
(26.1\%) presented with tumour recurrence. The median time to recurrence
was 12 months (range 5 -- 25). One recurrence at the primary site was
treated via a salvage cranio-facial resection, the patient was alive and
disease free 15 years after treatment. Three patients developed regional
recurrence (13\%) and were treated by salvage neck dissection, of which
two were also given further radiotherapy treatment. One of these
patients subsequently developed metastatic disease to the lung and died.
Finally, there was one case of both local and regional recurrence
(involving the retropharyngeal lymph nodes) and one case of local
recurrence alongside metastatic disease involving the lung, pleura and
bone. Both patients received palliative care and died during follow-up.
Overall, seven patients (30.4\%) died during the study period, because
of the disease evolution in three cases (13\%) or due to another
malignancy in four cases (17.4\%). The estimated 5-year OS, DFS and DSS
was 67.5\% {[}IC95: 41--84.1{]}, 66.3\% {[}IC95: 49.1--83.4{]} and
80.7\% {[}IC95: 50.3--93.5{]} respectively (see figure 2).

\textbf{Discussion}

This study reports the oncological outcomes of TR in a series of
locally-advanced nasal vestibule SCC. Unlike most series of TR within
the literature (6,19--21), our cohort has the advantage of having a
homogeneous tumour histology. The largest published series of total or
subtotal rhinectomies dates back to 1988 and included 51 patients, with
only 25 SCCs and mainly lesions originating from the skin (6). Yet the
origin of the tumour is an additional confounding factor since it may
influence the natural evolution and prognosis. Bouaoud \emph{et
al.}published the most conclusive study on this topic, with a series of
TR for 35 locally advanced SCCs (13).

\emph{Prognostic factors}

Our series identified positive excision margins as predictive factor for
tumour recurrence after TR (p=0.0401). This reiterates the importance of
complete tumour excision with sufficiently clear margins. In cases of
involved margins, considerations should be made for further surgical
resection and the use of adjuvant treatment. To our knowledge, only one
similar study found statistically significant factors predictive for
recurrence i.e., better local control and DSS in case of clear margins,
and better regional control in cases of bilateral neck prophylactic
treatment (13). On multivariate analysis, they also observed that R1 or
R2 margins were associated with a poorer DFS, despite this not reaching
statistical significance (13).

In our series, there was no correlation between the risk of tumour
recurrence and the Wang classification (p\textgreater{}0.9999), clinical
T stage (p\textgreater{}0.9999) and pathological T stage of 8th edition
of AJCC for tumours of the nasal cavity (p=0.2898). Several other series
of vestibule SCCs emphasised the absence of association between rates of
recurrence and the Wang or AJCC classification (8,9). However, the
population-based study by Agger \emph{et al.} including 174 vestibule
SCCs found a significant association between DSS and the Wang
classification (2). Controversy remains regarding the accuracy of the
current staging classifications available for vestibule SCCs (8), whilst
further series may help to develop more appropriate and specific staging
systems.

\section*{Primary tumour treatment}

{\label{primary-tumour-treatment}}

In the largest series of nasal vestibule SCCs published to this date,
the 5-year DSS and OS was only 74\% and 50\%, reaffirming the need for
an aggressive treatment strategy even for early-stage tumours (2). The
authors of this series reported significantly higher 5-year locoregional
control for Wang T1 tumours in case of surgery alone (94\%) or surgery
with adjuvant radiotherapy (87\%) compared to radiotherapy alone (61\%)
(2). Indeed, many authors recommend upfront surgery regardless of the
stage of the tumour (2,7--9), albeit the level of evidence remains
limited.

Interstitial brachytherapy or even radiotherapy seem to be acceptable
non-surgical alternatives for early-stage SCCs. In a systematic review
by Tagliaferri \emph{et al.} , the 5-year local control rate following
brachytherapy ranged from 69 to 97\%, with 79\% of patients having good
cosmetic outcomes despite the risk of soft tissue necrosis (10). The two
largest series were published by the same team and concerned only Wang
T1 and T2 tumours (22,23). Tumour size \textless{}1.5cm resulted in a
significantly better local and regional control, whilst tumour volume
[?]2.3cm\textsuperscript{3} was associated to a worse regional control
(22,23). Radiotherapy alone or with a boost of brachytherapy seems to
provide poorer local control rates, which remain acceptable for
early-stage SCCs (2,11,24).

There is a clearer consensus regarding the management of
locally-advanced nasal vestibule SCCs in the form of surgery alongside
adjuvant radiotherapy (2,12,13). Several authors reported worse outcomes
when treating Wang T2 and T3 tumours using radiotherapy alone compared
to surgery with or without adjuvant radiotherapy (2,12).

Bouaoud \emph{et al.} observed a significantly better DFS and OS in
patients treated by adjuvant radiotherapy after TR for locally-advanced
SCCs. They also proposed neo-adjuvant chemotherapy for fast-growing
lesions, although there is no statistical evidence to support this claim
(13).

Zaoui \emph{et al.} recommended adjuvant radiotherapy only for advanced
staged tumours. In their series of 26 vestibule SCCs treated by primary
surgery, which included only 50\% of patients having TR, only two
patients received postoperative radiotherapy. Despite low rates of
adjuvant radiotherapy the 5-year DFS was 86.7\% (8). In a similar series
of 30 vestibule SCCs, also including 50\% of patients having TR,
Koopman\emph{et al.} achieved a 5-year DFS of 91.7\%. Only seven
patients in this series received adjuvant radiotherapy in instances of
cartilage invasion, invasion of the upper lip or resection margins of
1mm or less from the tumour. They observed that poor tumour
differentiation was significantly associated with poorer OS, but had no
significant impact on DFS (9).

\section*{Neck management}

{\label{neck-management}}

In a systematic review of vestibule SCCs, the overall incidence of nodal
disease varied from 4 to 40\% between series (18). This heterogeneity
explains the discrepancies noted between authors and their
recommendations of surveillance, elective nodal dissection or
prophylactic radiotherapy for the management of cN0 vestibule SCC
(7,13). Scurry \emph{et al.} published a meta-analysis of nasal cavity
SCCs with and without prophylactic neck treatment, irrespective of the
type of treatment of the primary tumour. They observed a 18.1\% rate of
regional recurrence, approaching the 20\% cut-off, often cited as
suggestive of consideration for elective nodal treatment (17). Other
authors observed a significant association between tumour size or volume
and regional control (22,23). In our series, the rate of regional
recurrence was 13\% despite the absence of prophylactic irradiation of
the neck for N0 disease.

Some authors advocate neck dissection only for cases of suspected
metastasis in early-stage lesions (7,9). Sentinel lymph node biopsy
could be developed in this indication, to select patients requiring a
neck dissection (25). Bouaouad \emph{et al.} recommended treating lymph
nodes systematically and bilaterally for locally-advanced tumours,
either by neck dissection if cN+ or by RT if cN0, since they found
better regional control when bilateral neck prophylactic treatment was
performed (13). Treatment of the neck should at least include levels I,
II and III, however, metastasis to the pre-auricular, facial and
retropharyngeal lymph nodes are possible and should be considered
(13,18).

\section*{Limitations}

{\label{limitations}}

Limitations of this study include its retrospective nature, however,
utilising all available resources minimised the risk of missing data.
Furthermore, due to the limited sample size of this study it was not
possible to identify other prognostic factors affecting disease
recurrence aside from positive excision margins.

\textbf{Conclusion}

For nasal vestibule SCCs not amenable to limited surgical resection, TR
along with radiotherapy provide good oncological outcomes and should be
considered the main treatment option. Larger studies, particularly in
the form of prospective multi-centre studies, are warranted to
consolidate the existing findings within the literature and to determine
the best management for cN0 necks.



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