Accepted Manuscript Quality of life and functional evaluation in patients with tongue base tumors treated exclusively with transoral robotic surgery: a 1-year follow-up study Giuseppe Mercante, MD, head of Dept., Alessandra Masiello, ST, Isabella Sperduti, MS, Giovanni Cristalli, MD, Raul Pellini, MD, Giuseppe Spriano, MD PII:
S1010-5182(15)00201-2
DOI:
10.1016/j.jcms.2015.06.024
Reference:
YJCMS 2098
To appear in:
Journal of Cranio-Maxillo-Facial Surgery
Received Date: 27 January 2015 Revised Date:
15 June 2015
Accepted Date: 19 June 2015
Please cite this article as: Mercante G, Masiello A, Sperduti I, Cristalli G, Pellini R, Spriano G, Quality of life and functional evaluation in patients with tongue base tumors treated exclusively with transoral robotic surgery: a 1-year follow-up study, Journal of Cranio-Maxillofacial Surgery (2015), doi: 10.1016/ j.jcms.2015.06.024. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 Quality of life and functional evaluation in patients with tongue base tumors treated
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exclusively with transoral robotic surgery: a 1-year follow-up study
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Giuseppe Mercante, MD a
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Alessandra Masiello, ST a
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Isabella Sperduti, MS b
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Giovanni Cristalli, MD a
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Raul Pellini, MD a
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Giuseppe Spriano, MD a
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a
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Cancer Institute Rome, Italy (head of Dept.: Giuseppe Spriano, MD) .
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b
Department of Otolaryngology - Head and Neck Surgery. Regina Elena National
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Biostastics-Scientific Direction. Regina Elena National Cancer Institute Rome, Italy.
Corresponding author:
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Giuseppe Mercante.
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Department of Otolaryngology - Head and Neck Surgery.Regina Elena National Cancer Institute.
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Via Elio Chianesi 53; 00144 Rome, Italy.Phone +390652666770; fax +390652662015.
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e-mail:
[email protected]
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All authors have no conflict of interest to declare.
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There are no financial disclosures to be made.
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ACCEPTED MANUSCRIPT Background To evaluate quality-of-life (QoL), swallowing and voice in patients with base of tongue (BOT) tumors treated with transoral robotic surgery (TORS) alone without any adjuvant
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treatment. Methods
The study was a prospective, single-center cohort trial. Swallowing, QoL and voice were
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evaluated in 13 patients with T1 or T2 oropharyngeal carcinomas of the BOT. Patients underwent evaluation using the following: a dysphagia score (DS); fiberoptic endoscopic
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evaluation-of-swallowing with the penetration aspiration scale (PAS); the MD-Anderson Dysphagia Inventory (MDADI); and the Voice Handicap Index-10 (VHI-10). Results
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Subjective (DS) and objective (PAS) evaluation of swallowing produced mean scores of 1.08, 2.23 and 1.46 before surgery and at 6 and 12 months after surgery, respectively, for both tests. A significant difference was found when comparing DS and PAS data at
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baseline and 6 months after surgery; while no difference was observed between the baseline and 12 months after surgery. The mean values of the MDADI and VHI scores
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recorded before surgery, and at 6 and 12 months after surgery did not show any statistical difference.
Conclusions
Objective swallowing deterioration in the first 6 months after TORS alone for BOT tumors was possible, but complete recovery of deglutition was observed within 12 months. No changes were reported in the patients’ self-perceived status of swallowing and voice dysfunction, and related QoL after 1 year.
ACCEPTED MANUSCRIPT Keywords: Base of tongue; Oropharyngeal cancer; Quality of life; Trans-oral robotic surgery;
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TORS; Swallowing
ACCEPTED MANUSCRIPT INTRODUCTION In the last few decades, the rate of oropharyngeal cancer (OPC) has significantly risen due to an epidemic of the human papillomavirus (HPV) (Nasman et al., 2009). The number of
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cases in the US per year is expected to double by the year 2030 (Chaturvedi et al., 2011). It is of crucial importance for the future to consider OPC prevention and treatment of patients at an early stage. In the 1990s the published literature reported better diseasespecific survival for early-stage patients (stages I and II) treated with surgery alone than for
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other treatments such as radiotherapy (RT) alone, or surgery followed by RT, and RT with
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concurrent chemotherapy (CRT) (Zhen et al., 2004). The good results achieved by surgery were not paralleled by a good quality of life (QoL) due to the high morbidity rate related to the open surgical technique (Cantu et al., 2006). The advent of intensity-modulated radiation therapy (IMRT) shifted the therapeutic protocols towards an organ preservation approach (Parsons et al., 2002; Bourhis et al., 2012). The NCCN guidelines (2012) offered
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the choice between RT or CRT or surgery alone for treating patients with early stage OPC. However, evidence of RT or concurrent CRT having a clear advantage over the use of
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combined treatment (primary surgery followed by RT or CRT) (Koch, 2000) or surgery alone is still lacking (Panesar et al., 2006), whilst toxicity of intensive CRT, causing severe
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dysphagia with dependence on a gastrostomy tube, were documented (Forastiere and Trotti, 1999; Caudell et al., 2009). Some authors proposed transoral laser surgery (TLS) for OPCs in order to reduce the morbidity of the treatment (Haughey and Sinha, 2012; Canis et al., 2013a and b). This goal has been achieved by transoral robotic surgery (TORS), that has been used for the removal of pharyngeal and laryngeal cancers aiming to improve functional and aesthetic outcomes without worsening the survival (Genden et al., 2009; Dowthwaite et al., 2012). In 2006, O’Malley et al. published the first three cases of base of the tongue (BOT) tumors excised by TORS. In the following years, many
ACCEPTED MANUSCRIPT authors confirmed the feasibility and benefits of the procedure since the FDA’s approval in 2009 (Sinclair et al., 2011; Moore and Price, 2011). Oncologic results of TORS followed by (C)RT and CRT alone seem to be comparable for
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the treatment of locally advanced oropharyngeal tumors (Dowthwaite et al., 2012; Hutcheson et al., 2014). Some authors reported better functional outcomes, especially in terms of swallowing, comparing TORS followed by (C)RT with CRT alone advocating the de-intensification of the adjuvant treatment after TORS (Moore et al., 2009; White et al.,
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2010; Hutcheson et al., 2014)-.
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T1–2, N0–1 oropharyngeal tumors can be treated by both surgery alone and (C)RT with similar oncologic outcomes (NCCN, 2012). Some papers compared the functional results of both procedures for OPC treatment, but little data is available on the real impact of the two treatments on a single subsite (Zhen et al., 2004; de Almeida et al., 2014). Moreover,
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the addition of adjuvant therapy conceals the real functional outcome of TORS. The aim of this prospective observational study was to record the one-year follow-up QoL and to evaluate swallowing and voice in patients with BOT tumors treated with TORS
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alone without any adjuvant treatment.
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MATERIAL AND METHODS Patient characteristics
Data were collected from a group of consecutive patients who underwent TORS for tumors of the BOT from November 2010 to October 2013 at the Department of Otolaryngology, Head Neck Surgery of the Regina Elena National Cancer Institute in Rome, Italy. The study was a prospective, single-center cohort trial. Approval of the local ethics committee was obtained to perform a clinical trial using the da Vinci Robot (Intuitive Surgical Inc., Sunnyvale, CA, USA) for the resection of head and neck tumors. An informed consent form was obtained by all patients after attending a counseling session on the alternatives to surgery.
ACCEPTED MANUSCRIPT The study’s inclusion criteria included the following: T1–2 oropharyngeal carcinoma of the BOT amenable to transoral radical ‘en bloc’ resection. The indication of TORS was based on clinical evaluation and magnetic resonance imaging (MRI) or computed tomography scan. Patients with tumor of the BOT with superficial extension or infiltration into the intrinsic muscles ≤3 cm were
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included in the study, while infiltration of the extrinsic muscle by tumor (cT4a) represented a contraindication to surgery. Patients with a mouth opening of less than 2.5 cm and/or distant metastasis were excluded from the study. Previous treatment for head neck malignancy and the presence of adverse features identified in the final pathology report such as positive or close (0.05) (Table 2).
Objective endoscopic evaluation of swallowing by FEES reported a PA score of 1.08, 2.23 and 1.46; before surgery (PAS0), at 6 (PAS6) and 12 months (PAS12) after surgery, respectively (Table 1). Statistical analysis revealed a significant difference between PAS0 vs PAS6 (p = 0.03), while no differences were present when comparing PAS6 vs PAS12 and PAS0 vs PAS12 (p >0.05) (Table 2).
ACCEPTED MANUSCRIPT The mean values of the subgroups of MDADI before surgery, and at 6 and 12 months after surgery were: global = 76.92, 78.46 and 86.15; emotional = 73.85, 75.85 and 81.54; functional = 73.85, 76.92 and 83.38; physical = 73.85, 71.69 and 76.77 (Table 1). The mean values of the subgroups of VHI before surgery, and at 6 and 12 months after
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surgery were: emotional = 3.33, 7.75 and 6.08; functional = 3.33, 7.75 and 6.08; physical = 3.33, 7.25 and 5.42 (Table 1).There was no statistical difference comparing MDADI and VHI data before and after surgery (at 6 and 12 months of follow up), therefore no further
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test was performed (Table 2).
Fig.1 and 2 show the distribution of cases according to the DS0, DS6 and DS12 and to the
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PAS0, PAS6 and PAS12. All patients were alive, without evidence of disease at the last follow-up. DISCUSSION
Open surgical approaches to the oropharynx for the treatment of OPC are associated with
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morbidities such as cosmetic deformity, malocclusion, and dysphagia. Therefore, in the last few decades, a trend toward using RT or concurrent CRT as a primary modality in cases of OPC has been observed (Forastiere and Trotti, 1999; Parsons and Halkitis, 2002)
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obtaining similar oncologic results. However, initial enthusiasm in favor of applying nonsurgical approaches decreased due to the functional results; and 29–60% of patients
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experienced dysphagia at 1 year after (C)RT, causing dependence on a gastrostomy tube and a decrease in QoL (Forastiere and Trotti, 1999; Caudell et al., 2009; Bhayani et al., 2013; Al-Mamgani et al., 2013). The introduction of transoral laser surgery (TLS) (Steiner et al., 2003) and, especially, TORS (O'Malley et al., 2006; Weinstein et al., 2010) into the surgical armamentarium to overcome these issues posed some open-ended questions regarding the advantage of moving back to upfront surgery in patients with OPC. Published data demonstrated that only one third of patients with early-stage OPC undergoing surgery would avoid adjuvant treatment (Moore et al., 2009; White et al., 2010;
ACCEPTED MANUSCRIPT Dowthwaite et al., 2012; Hutcheson et al., 2014) because of the absence of clear margins or nodal metastasis (N2 or N3, nodal disease in levels IV or V) or adverse features such as extracapsular nodal spread, pT3 or pT4 primary, perineural invasion or vascular embolism, observed in the final pathology report. Therefore, over 65% of patients undergo
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adjuvant treatment after TORS, increasing the time and cost of the cure and adding bias to the data analysis. Some authors support TORS in the presence of OPC because of the advantage in terms of correct staging, the possibility of avoiding adjuvant treatments,
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better QoL due to the de-intensification of RT (Moore et al., 2009; White et al., 2010; Hurtuk et al., 2011; Dowthwaite et al., 2012; Leonhardt et al., 2012; Chung et al., 2014;
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Hutcheson et al., 2014).
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The first published data on early stage OPCs and TORS confirmed the good oncologic and functional outcomes of this approach, nevertheless, the low number of cases, the presence of different subsites and the use of postoperative adjuvant treatment represented
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biases in the analysis of functional outcomes. In order to address this issue, this prospective observational study recorded the one-year follow-up QoL score and evaluated swallowing and voice in patients with tumors of the BOT treated with TORS alone and not
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followed by any adjuvant treatment.
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In the present study, all cases underwent temporary tracheostomy at the beginning of surgery. The decision was made by the surgeon in order to begin the procedure in the safest way guaranteeing respiration at the end of the operation and to better manage eventual complications such as hemorrhage. The use of tracheostomy in the literature is less frequent than that observed in our study, even though the published papers focused on tonsil tumors and the authors preferred to extubate patients 24–48 hours after surgery. (Holsinger et al., 2005; Weinstein et al., 2007; Genden et al., 2009; Moore et al., 2009; Sinclair et al., 2011; More et al., 2013).
ACCEPTED MANUSCRIPT A NGFT was placed in eight patients (61.5%) for a median time of 5 days. The purpose of NGFT positioning was to avoid aspiration in the first postoperative period. It was removed when the patient was able to tolerate an oral diet without risk of aspiration confirmed by clinical examination. All patients were discharged without NGFT. The patient who required
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the NGFT for the longest time (21 days) was the one who underwent BOT resection which extended into the supraglottis. The rapid recovery of swallowing was confirmed by a literature review which reported early oral intake by the first two postoperative days in over
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90% of cases and replacement of the NGFT with percutaneous endoscopic gastrostomy (PEG) in less than 3% of cases after surgery and before the adjuvant treatment. This data
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significantly differs with the PEG dependency rates reported after primary (C)RT (9–39%) (de Arruda et al., 2006; Lawson et al., 2008; Leonhardt et al., 2012; Hutcheson et al., 2014; de Almeida et al., 2014). Some authors supported the role of TORS in the deintensification of the adjuvant treatment because of the low rates of PEG dependency (0–
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9%) resulting in an improved QoL for the patient (Moore et al., 2009; Dowthwaite et al., 2012; Leonhardt et al., 2012).
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Subjective evaluation of swallowing by the patient (DS) and objective endoscopic evaluation of swallowing by FEES (PAS) showed the same scores before surgery and 6
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and 12 months after surgery, confirming a correspondence between the two methods. Statistical analysis showed a difference between the scores registered at baseline and 6 months after surgery, while no difference was present when comparing swallowing before and 12 months after surgery. This data suggests that a worsening of swallowing can be expected after TORS for BOT tumors even when there is an early recovery and an oral diet can be taken. The swallowing seems to return to baseline at 12 months. Patients have to be advised of the low risk of coughing during liquid food deglutition, because of the material entering into the airways, in any case, the risk of pneumonia is very low. Other papers described significant drops in dietary scores 6 months after TORS for OPCs but
ACCEPTED MANUSCRIPT this was in part associated with the acute toxicities of adjuvant treatment; furthermore, a possible bias related to different subsites has to be considered (Moore et al., 2009; Hurtuk et al., 2011 Genden et al., 2011; Leonhardt et al., 2012). The present study showed that TORS alone for the treatment of BOT tumors plays a role in the deterioration of swallowing
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in the first 6 months after surgery, but the one-year follow-up evaluation confirmed that a complete recovery of deglutition was to be expected within 12 months.
Subjective evaluation of QoL and dysphagia have been investigated with the MDADI. This
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QoL questionnaire assessed the emotional, physical, and functional consequences of deglutition impairment (Chen et al., 2001).The MDADI scores at baseline, 6 and 12
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months after surgery ranged from 73.85 to 86.15. These data did not differ from those of other published series of OPC patients treated with TORS (Iseli et al., 2009; Sinclair et al., 2011; More et al., 2013). The MDADI confirmed that, even in the presence of significant differences in swallowing between baseline and 6 months after TORS alone for BOT
their QoL.
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tumors documented by DS and PAS, the patients did not complain about any changes in
Few data are available in literature regarding the evaluation of patients’ self-perceived
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status in relation to voice dysfunction (Weinstein et al., 2007; Moore et al., 2009; Genden et al., 2011; Leonhardt et al., 2012; Weinstein et al., 2012). In the present study, this
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parameter was measured with the VHI (Rosen et al., 2004). Statistical analysis of our data did not find any differences in the VHI scores before and after surgery confirming that, for patients treated with TORS, there is little impact of resection on speech compared with baseline. This result was, probably, expected by the majority of authors who did not consider further investigation of this parameter. Additionally, a critical analysis of our data showed a negative trend of VHI scores 6 months after surgery followed by an improvement 12 months after TORS. The longitudinal design and the inclusion of both objective and self-report evaluations are notable strengths of the study, but a concern is
ACCEPTED MANUSCRIPT represented by the sample size. Even if it is quite a homogeneous sample of patients with BOT tumors (10 T1 and 3 T2
