From applicator-based (Paris system) implantations to rhinoseptoplasty: the concept of anatomic implantation for interventional radiotherapy in squamous cell carcinoma of the nasal vestibule. Short term results in a monoinstitutional series
0 Abstract
Aim: Interventional radiotherapy (IRT) is being increasingly advocated as the standard treatment for the primary lesion in nasal vestibule squamous cell carcinoma (NV-SCC). The respect of the anatomical planes of the nose tip during implantation has been hypothesized to reduce the classical IRT toxicities on the cartilages, such as septal and even alar perforations. The present work describes a monoinstitutional series of NV-SCC treated with an IRT technique that follows the above principle (anatomical implantation), with a focus on IRT toxicities.
Methods: All consecutive patients with nasal vestibule (NV) carcinoma treated between March 2022 and October 2023 with IRT on the primary lesion at Azienda Ospedaliera Universitaria di Sassari and Mater Olbia Hospital were included.
Results: A total of 15 patients were treated with IRT following the principles of anatomical implantation. The only treatment-related toxicity observed has been the mechanical damage to the skin from the buttons used to stabilize the plastic tubes.
Conclusion: IRT with anatomical implantation allows a high nose preservation rate and very good cosmetic results, which appear to be decisive advantages in comparison with traditional surgery, while confirming comparable effectiveness from an oncological point of view. However, in the present series, we describe typical skin toxicity that may have a negative impact on cosmetic results. We propose a new strategy involving the use of a soft medium such as a sponge to protect the skin from damage.
Keywords
INTRODUCTION
Nasal vestibule squamous cell carcinoma (NV-SCC) is classically considered a rare type of cancer. It has been reported to account for less than 1% of all head and neck malignancies, with an incidence of 0.3-0.4/100,000 person per year[1]. However, data on the incidence is unreliable because the nasal vestibule (NV) is not a clearly defined anatomic area and a specific WHO International Classification of Diseases (ICD) code has not been assigned. The current Union for International Cancer Control (UICC)/American Joint Committee on Cancer (AJCC) staging system classifies primary lesions of the NV with the same criteria as ethmoid and nasal cavity proper.
The recent interest on these issues and the systematic description of the peculiar clinical features of NV-SCC[2-4] has brought to propose new standards for classification and staging of these malignancies[3-6]. These include the definition of clear anatomical boundaries for the NV itself, a specific WHO code for the site and the adoption of a specific separate T classification, making NV the third subsite within nasal cavity and paranasal sinuses[7].
Surgery (mostly consisting of partial or total rhinectomy) has been the traditional, predominant treatment for NV-SCC[8-16]. Interventional radiotherapy (IRT) has demonstrated non-inferiority to upfront surgery in terms of local-recurrence free survival (LRFS) and disease-specific survival (DSS)[6,8,9,17-27], while providing superior local control compared to external beam radiation therapy (EBRT)[6,20,28-32]. However, when surgery is selected, in view of the specific spread pattern of NV-SCC among cartilages, with early skin invasion, a through resection of the ala/nasal wall is most often indicated, requiring complex and unpredictable multiple reconstructive surgeries or the creation and fitting of a bone-anchored prosthesis (epithesis) for cosmetic restoration[33-39]. On the contrary, IRT allows the preservation of the cartilaginous framework, leading to much more favorable functional[3,40] and cosmetic outcomes[6,21]. Based on these findings, the Italian Society of Otolaryngology defined IRT as the therapeutic standard for the primary lesions in NV-SCC[41] without bone involvement.
To achieve optimal cosmetic and functional results through IRT, the necessity to preserve the perichondral layer feeding the cartilage has been outlined, and novel criteria for the implantation of the applicators have been described, thus defining the concept of “anatomic implantation”[17].
In the present work, we evaluate a monoinstitutional series of NV-SCC treated with IRT through anatomic implantation (“anatomic IRT”) and focus on specific toxicities and strategies to avoid them.
METHODS
Patients
Patients with NV-SCC, treated between March 2022 and October 2023 with IRT within the North Sardinia Tumor Board, involving the Otolaryngology Division of the University Hospital of Sassari and the Radiation Oncology Division of Mater Olbia Hospital, have been included. This study adhered to the ethical principles outlined in the Declaration of Helsinki. Ethical approval was not mandated by Italian law (GU No. 76, 31 March 2008) due to its observational retrospective design. Informed consent for the procedure and photographic documentation were obtained.
The minimal required work-up included physical examination, rhinoscopy, rigid nasal endoscopy, neck ultrasound performed by the head and neck surgeon (FB) and contrast-enhanced computed tomography (CT) of the face, neck and chest. Whenever the actual spread in soft tissues of the nose/cheek/superior lip was not clearly defined, magnetic resonance imaging (MRI) completed the diagnostic work-up of the primary tumor. In case of doubts concerning lymph nodes at imaging, an ultrasound-guided fine needle aspiration biopsy (FNAB) of the suspicious node(s) was performed.
For staging purposes, we used both the Rome Classification and the UICC/AJCC system for T, and the UICC/AJCC system for N classification[42].
Treatment modalities
A variable number of 6-Fr flexible implant tubes were inserted using metal guide channels [Figure 1] and fixed by buttons that can be anchored to the skin by stitches and are anyway going to be adherent to increase the reliability of the treatment plan [Figure 2]. The implants are best applied under general anesthesia; orotracheal intubation is preferred and a laryngeal mask should be avoided to minimize the hindrance by the anesthesiology tube which should be stabilized as far away as possible from the operating field. The implantation was performed by a head and neck surgeon in the presence of experienced IRT radiation oncologists.
Figure 1. Metal guides are placed altogether before the introduction of implants (plastic tube). Introducing a metal guide with a plastic tube already in place would put the latter at risk of being severed and therefore being unusable for the following IRT. IRT: Interventional radiotherapy.
Figure 2. Stabilization of implants is achieved by anchoring them with buttons in an interstitial implant.
Infiltration of the subperichondral planes with local anesthetics, with or without adrenaline, as in functional nose surgery, is fundamental to obtain analgesia in case of local anesthesia and is helpful in facilitating the optimal catheter path along the planes avoiding piercing of the mucoperichondrium. The exact configuration and number of catheters is tailored to the extent, depth, and shape of the lesion according to pre-implant MRI or CT scan, clinical experience, work-up data, and intraoperative findings. The dose is prescribed after implant encompassing the full clinical target volume (CTV) and sparing as much as possible the surrounding healthy structures. For this reason, interaction between the surgeon and the IRT radiation oncologist is always recommended at the implantation phase in the surgical theater.
Anatomic implantation
With this technique, a “fully interstitial” implant is preferable. However, when this approach is insufficient for adequate CTV coverage by overreaching all the limits of the lesion, alternative methods can be used to obtain complete coverage and stabilize the tubes. A scenario may be the presence of a bulky skin spread, which can be approached with a “contact” strategy, by placing the tubes on the skin in the area of such exophytic spread [Figure 3]. A different, very common situation is the extension of the lesion posterior to the limit of the NV, which is the plane tangential to the piriform opening[4,42]. If this extension is limited and close to the nasal spine, the problem can be overcome with plastic tube placement in the superior lip under the spine, which is useful as well to cover possible spread to the superior lip itself [Figures 4 and 5]. More often, a fully interstitial implant placement may not adequately cover the CTV in case of spread beyond the piriform aperture, because of the bony structures; thus, endocavitary implantation may be needed. The latter has been performed in the present series by fixation to sponge packing of blind end tubes [Figure 6]; this is a simple and non-traumatic procedure, and the presence of the packing in the nasal cavity has the additional advantage of improving dose delivery by eliminating the interface with air, and capturing 200% isodoses directly around the catheters, thereby preventing mucosal toxicity.
Figure 3. An example of a patient with squamous cell carcinoma of the inferior wall of NV featuring an exophytic growth towards the superior lip and the inferior nasal spine, which can be approached with a “contact” strategy, by placing the tubes on the skin in the area of such superficial spread and stabilizing them through an interstitial path away from the CTV. NV: Nasal vestibule; CTV: clinical target volume.
Figure 4. (A) A bulky lesion of the inferior wall of the vestibule extensively invaded the superior lip; (B and C) Catheters were placed both along the “classical” subperichondral paths and perpendicular to them along the coronal main axis of the superior lip; (D and E) This allowed the target volume to be completely covered with a fully interstitial implant. Modified from Malignancies of the Nasal Vestibule. Editor Francesco Bussu. Springer.
Figure 5. The images illustrate an example of a patient diagnosed with T4a stage SCC of the NV (Rome classification): the tumor invades the inferior nasal spine and the hard palate. SCC: Squamous cell carcinoma; NV: nasal vestibule.
Figure 6. Endocavitary implants for NV-SCC, characterized by plastic tubes fixed preliminarily on Merocel® nasal packing. In the past, we sutured the plastic tubes onto the nasal packing (A) (modified from Malignancies of the Nasal Vestibule. Editor Francesco Bussu. Springer) but tightening them too much could have blocked and made them unusable, so that, on the contrary, we experienced issues concerning stability and therefore reliability of the treatment plan. In the present series, we have always preliminarily placed the plastic tubes inside the nasal packing. When using this trick, made possible by passing the metal guides inside the Merocel® (B), blind tubes are stabilized on the packing by their larger ends on the distal extremity and by buttons on the proximal one (C). NV-SCC: Nasal vestibule squamous cell carcinoma.
The recording of a 20% grade 2 persistent skin toxicity (see results) in the first ten patients prompted us to add a trick to our implantation to reduce such specific toxicity. We started to interpose a soft medium between the buttons and the skin, a simple trick to perform, made with easily available materials, which is safe and does not significantly lengthen the surgical procedure.
Such medium can also be obtained from a Freiburg flap surface mold (if available), by detaching single silicon spheres (Figure 7, case from Policlinico Agostino Gemelli Hospital, Rome). In the present series, the bearings have been manufactured prior to the implant, using small squares of Merocel® and perforating them with the help of a needle guide for plastic tubes to make insertion and sliding easier [Figure 8]. The pads are positioned during the implantation between the anchoring button and the skin (both at the entry and exit points) [Figure 9].
Figure 7. Freiburg flap silicon spheres can be used to protect the skin from mechanical damage (courtesy of Luca Tagliaferri, Policlinico Agostino Gemelli Hospital, Rome).
Figure 8. Merocel® fragments are perforated using a metal guide needle for plastic tubes.
Figure 9. Two perforated sponge fragments are inserted into the plastic tubes beneath the anchoring button, and both fragments remain in contact with the skin protecting from mechanical damage.
Pre-plan evaluation of MRI and/or CT imaging is performed to define the extent of target volume. After the surgical procedure, a planning CT is acquired to perform implant reconstruction and target delineation. A new CT scan is acquired to check implant stability and to proceed to replanning if necessary.
Delivery
High dose rate (HDR) IRT was applied using an I-192 source, delivered by a Bravos (Varian Medical Systems) afterloader with a standardized fractionation: 44-Gy total dose, 3 Gy per fraction, except for first and last fractions of 4 Gy, two fractions per day, 6-hour interval between the fractions, and maximum overall treatment time of ten days.
Removal of the implant was done immediately after the treatment was finished. The removal was done in the outpatient ENT office of Mater Olbia Hospital.
Toxicities have been systematically recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
RESULTS
A total of 15 patients were included in the study. Out of these, seven patients were able to achieve coverage with a fully interstitial delivery, while the remaining eight cases required concomitant intracavitary implants (mixed delivery) [Figure 10, Table 1].
Figure 10. A series of tumors, before and after implantation and the final results. Patient 1: NV-SCC arising in the medial wall (columella) and treated with fully interstitial implant (A) with complete response, mild acute mucosal and skin toxicity (B) and excellent midterm (3 months) cosmetic results (C); Patient 2: Recurrent NV-SCC with an extensive skin invasion after multiple surgeries (D), treated with a mixed implant (1 endocavitary catheter) (E). IRT confirms an impressive ability to preserve the nasal framework while obtaining complete response (F); Patient 3: NV-SCC arising in the lateral wall (G) is treated with mixed implant (H) with complete response and satisfying cosmetic results at two months (I and J). NV-SCC: Nasal vestibule squamous cell carcinoma; IRT: interventional radiotherapy.
Patients and tumors characteristics
| esFeatures | ||
| Age, years | Median | 59.13 |
| Range | 27-79 | |
| Sex, No. (%) | Male | 10 (66.6) |
| Female | 5 (33.4) | |
| Primary vs. recurrent (%) | Primary | 12 (80) |
| Recurrent | 3 (20) | |
| Subsite of primary, No. (%) | Ala/limen nasi | 8 (53.4) |
| Inferior border/superior lip | 4 (26.6) | |
| Septum/columella | 3 (20) | |
| UICC/AJCC cT classification, No. (%) | T1 | 2 (13.4) |
| T4a | 13 (86.6) | |
| Rome cT classification, No. (%) | 1 | 1 (6.7) |
| 2a | 8 (53.2) | |
| 2b | 3 (20) | |
| 3 | 2 (13.4) | |
| 4a | 1 (6.7) | |
| cN stage, No. (%) | 0 | 12 (80) |
| 1 | 2 (13.3) | |
| 3b | 1 (6.7) | |
| Delivery (%) | Pure interstitial | 6 (40) |
| Mixed (interstitial + endocavitary) | 9 (60) | |
| Interstitial plastic tubes, No. | Median | 9.13 |
| Range | 5-15 | |
| Endocavitary plastic tubes (in the nine mixed implantations), No. | Median | 2.88 |
| Range | 1-9 | |
| Oncological outcomes (%) | Alive and in FU | 14 (93.3) |
| Died for other causes | 1 (6.7) | |
| Follow-up time, months | Median | 7.22 |
| Range | 1-21 | |
| Post-IRT local recurrence (%) | Recurrence | 1 (6.7) |
| No evidence of recurrence | 14 (93.3) | |
| Regional recurrence (%) | Recurrence | 2 (13.4) |
| No evidence of recurrence | 13 (86.6) | |
| Cosmetic defect, No. (%) | None | 13 (86.6) |
| Perinasal skin scars | 2 (13.4) | |
The median volume of the CTV in the selected series was 21.50 cc (range 8.30-83.89).
The CTV coverage was optimized by capturing 200% isodoses directly around the catheters and 300% inside the catheters. A dosimetric accuracy analysis was performed before each treatment and the Dose non-uniformity ratio (DNR) was calculated, resulting in a median value of 0.54 (range 0.7-0.44).
Out of the three patients with cervical lymph node involvement (cN+), one had evident positive neck nodes in preoperative imaging, while the other two were diagnosed with neck metastasis through FNAB in the context of a lump clinic, as previously described[43,44]. The three cN+ patients additionally underwent functional neck dissection (ND), while elective ND was not performed in the remaining cN0 cases. At follow-up, two patients were found to have residual/recurrent disease. One patient had a locoregional relapse of the disease, while the other had an isolated regional recurrence. Both cases occurred within the first four months after treatment and underwent salvage surgery. None of the patients died as a result of the disease. The average follow-up was seven months.
No instances of septal or alar perforations were recorded after treatment. Treatment-related toxicity was observed in two patients who experienced skin scarring in the area corresponding to the buttons (two of the first ten patients, 30%). It was discovered that these scars were associated with the close adherence of the implant to the skin, which was done to maximize stability of the implant and reliability of the treatment plan. The scarring appeared to be primarily due to mechanical damage rather than irradiation, as the scars were located away from the areas irradiated with high doses [Figure 11].
Figure 11. A bulky lesion of the lateral wall of the NV (A and B) treated by IRT (C and D) with complete response and skin scars at the level of the buttons (E and F); (G and H) As evident from the treatment plan, this toxicity was not associated with hotspots but with mechanical damage. NV: Nasal vestibule; IRT: interventional radiotherapy.
For the last five patients, a skin sparing technique, as described in the methods section, was employed during the implantation process. No significant skin scarring was observed in these patients [Figure 12].
Figure 12. One of the five patients with NV-SCC (A) underwent IRT with mixed implantation (B); (C) There is no evident cutaneous toxicity three months after irradiation. NV-SCC: Nasal vestibule squamous cell carcinoma; IRT: interventional radiotherapy.
DISCUSSION
The present results confirm that the NV’s anatomy makes it well-suited for IRT, given the absence of adjacent vital structures [organs at risks (OARs)] and the resistance of the cartilaginous rigid framework to radiation-induced toxicity[3,5,18]. This explains why, with equal oncological outcomes, IRT ensures the preservation of the nasal pyramid and therefore cosmetic results much superior compared to surgery[16-21], which, also in recent series, almost always requires rhinectomy[45].
However, also with brachytherapy and IRT, toxicities such as septal and alar perforations have been reported[3,41], particularly when interstitial dose delivery is used[23]. Such complications are likely due to mechanical damage and disruption of the perichondrium, which supplies blood to the cartilage, rather than irradiation to the cartilage itself[3,17,18].
To address this issue, new principles of anatomic implantation have been developed that avoid piercing of the perichondrium, therefore indicating the subperichondral planes of (rhino)-septoplasty as the optimal path for plastic tubes[3,17,18] (“anatomic IRT”).
This study is the first objective assessment of the results of anatomic IRT. As expected, no septal or alar perforations have been observed. However, skin scarring as a specific toxicity resulting from excessive adherence of the buttons to the skin for stabilization has been reported. To address this issue, we describe a strategy to minimize this minor yet concerning toxicity, with promising initial results.
One potential future strategy to improve fixation and minimize complications, while keeping the principles of anatomic implantation, may be the use of individual 3D printed molds[46,47].
In terms of oncological effectiveness, our results suggest a high rate of local control with IRT. However, it is important to note that IRT is only a local treatment and nodal involvement at diagnosis is a crucial factor for survival in NV-SCC[47-55], as well as in most head and neck mucosal malignancies. In our study, 20% of cases had positive nodes at diagnosis and were managed with surgery (bilateral comprehensive neck dissection), and a 20% nodal relapse rate was observed. In this regard, the role of sentinel lymph node biopsy surely warrants further investigation. All neck metastases at diagnosis and recurrences in previously observed cN0 were at level I; the recurrence in the already operated cN+ case occurred at level IX. Notably, the ultrasound-guided FNAB, obtained by a head and neck surgeon, allowed the detection of two-thirds of cN+ cases, which had been classified as cN0 at morphological imaging. This highlights the importance of comprehensive neck evaluation in the management of NV-SCC. In fact, small nodes in level I are most often present and are usually interpreted as reactive/aspecific; the ultrasound screening of a well-trained head and neck surgeon and the FNAB performed in the lump clinic with rapid on-site evaluation[43,44] seem to be powerful tools for the early detection and treatment of neck metastasis in this disease, with a probable impact on prognosis. On the other hand, the inclusion of neck evaluation in a lump clinic in the work-up of NV-SCC clearly increases the reliability of the cN0 staging and therefore the safety of neck observation.
Our experience[16,20], supported also by the findings of this study, suggests that local recurrence typically occurs within the first months after IRT. Therefore, a series with an average follow-up period of seven months provides useful information regarding local control.
Furthermore, even if evidence on the subject is still lacking, the salvageability of local recurrences is, in theory, very good, as it would involve anyway a rhinectomy and diagnosis of recurrence can be relatively easy and early.
Regarding dosimetric parameters, it is important to note that IRT is characterized by a highly favorable dose distribution. It delivers high doses to the target area with a very rapid fall-off in surrounding tissues[56]. Specifically, assessing doses to critical OARs, such as the eyes and lens, is crucial but largely depends on the distance of the CTV from the ocular region[57]. For this reason, we consistently monitor the dose to the eyes and lens, which typically remains below established constraints; however, in certain situations, additional measures may be implemented to further reduce the dose[58].
However, the following limitations should be kept in mind when reading these results.
Limitations of the study
• Most of the data about the comparison of different treatment modalities are not direct, but extrapolated from different series. However, if the current results are confirmed, it could not be ethically acceptable to keep proposing total rhinectomy when a nose preservation option with the same oncological results is available[41].
• This is a relatively small series with a short follow-up, making it difficult to detect small differences or to generalize the findings broadly; yet, the described disease is considered rare, and our focus is mainly on acute and subacute toxicity, therefore providing valuable information.
• While immediate and short-term benefits are clear, a deeper exploration of long-term outcomes, particularly concerning regional recurrence rates and long-term cosmetic results (which, for example, may be impacted by the development of radiation-induced telangiectasia), is needed.
In conclusion, our findings, even if to be considered preliminary because of the small numbers and the short follow-up, confirm the excellent local control achieved with IRT and the low occurrence of classical toxicities (septal and alar perforations) with the anatomic implantation thus supporting the adoption of anatomic IRT as treatment of choice for a primary lesion in NV-SCC without bone invasion[41], as recently suggested by the Italian Society of Otolaryngology. The present result also points to the possibility of reducing skin toxicity, therefore further improving cosmetic outcomes in these patients.
DECLARATIONS
Authors’ contributions
Study conception and design: Tropiano P, Bussu F, Riu FG, Rijken JA
Data acquisition: Tondo A, Varrucciu S, Tropiano P
Quality control of data and algorithms: Tagliaferri L, Varrucciu S, Gallus R, Mattiucci GC, De Ridder M, Rijken JA, Scheurleer WFJ, D’Aviero A, Fionda B, Riu FG, Bussu F
Data analysis and interpretation: Tropiano P, Bussu F, Tondo A, Varrucciu S
Manuscript preparation: Tropiano P, Bussu F, Tondo A
Manuscript editing: Tropiano P, Bussu F, Tondo A, Riu FG
Manuscript review: Tagliaferri L, Varrucciu S, Gallus R, Mattiucci GC, De Ridder M, Rijken JA, Scheurleer WFJ, D’Aviero A, Fionda B, Riu FG, Bussu F
Availability of data and materials
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Financial support and sponsorship
None.
Conflicts of interest
All authors declared that there are no conflicts of interest.
Ethical approval and consent to participate
The current study was done in accordance with the ethical standards of each institutional committee on human experimentation, the Declaration of Helsinki. Data were analyzed with an observational retrospective design, and in this case, mandatory ethical approval is not required under Italian law (GU No. 76 31 March 2008). Informed consent was obtained from the patients for the procedure.
Consent for publication
Patients’ written informed consent for publication was obtained.
Copyright
© The Author(s) 2024.
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Cite This Article
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Tropiano, P.; Tagliaferri L.; Tondo A.; Varrucciu S.; Gallus R.; Mattiucci G. C.; De Ridder M.; Rijken J. A.; Scheurleer W. F. J.; D’Aviero A.; Fionda B.; Riu F. G.; Bussu F. From applicator-based (Paris system) implantations to rhinoseptoplasty: the concept of anatomic implantation for interventional radiotherapy in squamous cell carcinoma of the nasal vestibule. Short term results in a monoinstitutional series. Mini-invasive. Surg. 2024, 8, 17. http://dx.doi.org/10.20517/2574-1225.2024.41
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