The present strategy of treatment for oropharyngeal squamous cell carcinoma of the head and neck is either surgery, radiotherapy or chemoradiotherapy used either alone or as multimodality approach. For stage I and II oropharyngeal carcinoma, available options are Radiotherapy and surgery. Radiotherapy is associated with significant morbidity which gets worse with concomitant radiation or chemotherapy use [1]. Open surgical approaches for OPSCC require either anterior or lateral mandibulotomy and they carry risk of long term morbidity. These include cosmetic issues, malocclusion and trismus and they have negative impact on patient’s quality of life [2,3].

The introduction of robotic technology for transoral surgery has rekindled interest and its use for management of patients of oropharyngeal cancers. O’Malley and Weinstein et al. [4]in there study has shown the benefits of Transoral Robotic Surgery (TORS) for the management of oropharyngeal tumors with the use of Robotic surgical system. They reported that Transoral Robotic surgical system is a safe surgical optrion for use in human patients.

The potential benefits of Transoral Robotic surgery as compared to conventional surgical approaches in the management of head and neck cancers is due to the better visualisation and access to the surgical site. Moreover, due to the use of flexible or angled telescopes whichprovides direct line of surgical site visualization. Moreover, use of specialised retractors in robotic surgery and three dimensional view of surgical site allow the easy access and helps in complete resection of tumor safely without morbidity associated with the procedures like mandibulectomy or pharyngotomy used in conventional surgical procedures [3-5].

Transoral Robotic Surgery (TORS) services commenced in 2016 in the Department of Otolaryngology and Head and Neck Surgery PGIMER, Chandigarh in 2016. The aim of this prospective study was to evaluate the Recurrence at One Year Follow-up of Patients having Early Tumors of Oropharynx undergoing Transoral Robotic Surgery.

Aims and Objectives

To evaluate the Recurrence at One Year Follow-up of Patients having Early Tumors of Oropharynx undergoing Transoral Robotic Surgery.

This prospective study was conducted in patients of T1 and T2 tumours of the oropharynx who were treated by Transoral robotic Surgery between the period August 2016 to October 2018 at the Department of Otolaryngology and Head and Neck surgery, Post Graduate Institute of Medical Education and Research, Chandigarh. An ethical clearance was obtained from the institute Ethical committee. During this period 42 patients were operated by TORS. An informed written consent was obtained in all the cases.

Inclusion Criteria

• Biopsy proven T1, T2 oropharyngeal squamous cell carcinoma 

• Patients with adequate exposure for TORS 

• No need for local reconstruction

• Age group between 18-75 years

• Patients of both gender

Exclusion Criteria

• Patients with Trismus

• Previous surgical treatment for head and Neck cancer

• Tumors of advanced T stage

Patients with positive resection margins on post operative histopathological report, extranodal spread and lymph node involvement were referred to radiotherapy.

All patients were preoperatively worked up with detailed History, clinical examination of the Head and Neck, Computerised tomography scan with contrast from base of skull to 4th thoracic vertebra and MRI with Gadolinium to assess the extent of tumour, Fine needle aspiration cytology, X-ray chest PA view and blood routine tests were also performed. Biopsy of the lesion was done and patients with squamous cell carcinoma of oropharynx were recruited. Pre anaesthetic check up was done for all patients. The excised lesion was sent for histopathological examination with proper marking by sutures. The specimen was also subjected for Human Papilloma Virus (HPV) detection by PCR.

HPV Detection

Tissues was collected from patients who underwent TORS and was stored at 8°C till further processing. DNA was isolated from a small piece of tumor tissue and HPV DNA was detected by using PCR-based method. This method employs PCR primers specific for HPV16 E7 (Jiang and Milner, 2002). Samples positive for HPV16 DNA was further checked for HPV16 RNA expression in tissues. For this total RNA was isolated using Trizol reagent from rest of the sample and cDNA was synthesized using commercially available kits. The cDNA was used for HPV16 E7 PCR using the above mentioned primers to confirm HPV infection.

The outcome of the treatment was studied in two ways:

• Treatment perspective

• Patients perspective

Treatment Perspective

The primary outcome was to see successful excision of the tumor. The secondary outcome measures was to see outcome in relation with status of resection margins, lymph node involvement, HPV positive and HPV negative, subsite of the lesion, Tumor stage and complications if any.

Patients Perspective

One year overall survival and disease free survival, recurrence and mortality.

The patients were followed up in the Department of Otolaryngology Head and Neck Surgery PGIMER Chandigarh. The first follow up was around 2nd week after surgery when the Histopathological report was assessed regarding type of Tumor and the surgical margins, lymph node positivity (in patients who underwent neck dissection). All the patients were asked to follow up once in 2 months up to a period of 1 year.

Patients with positive surgical resection margins and lymph node involvement were advised for adjuvant treatment with radiation therapy.

The data was entered in a predesigned proforma. Descriptive statistics was used to describe different variables. All the statistical tests were two-sided and were performed at a significance level of α  =  0.05 analysis was conducted using IBM SPSS STATISTICS (version 22.0).

During the study period of 26 months from August 2016 to October 2018, total of 42 patients fulfilling the inclusion criteria were enrolled for study. A thorough history, clinical examination, investigations and required intervention were done in all patients.

The mean age of patients enrolled in the study was 53.17±11.491years, range being 28-70 years there were 38 males (90.5%) and 4 females (9.5%) in the study with a male to ratio of 9.5:1 (Table 1).

Disease free survival and recurrence rate was noticed in patients who have been followed up to one year. A total of 5 patients had Recurrence after 1 year of follow up (Table 2).

According to subsite of the tumor in patients who have been followed up to one year, recurrence was in one patient of Soft palate and four patients of carcinoma Tonsil.

Table1: Showing Demographic Variables of Patients

Table 2:  Showing Disease Free Survival at 1 Year Follow Up

Table 3: Showing Recurrence with Relation to Subsite, TNM Stage, Type of Surgery, Surgical Margins, Deep Margins Involvement, Adjuvant Radiotherapy HPV Status @ 1 Year Follow Up

No recurrence was seen in patients with Base of tongue malignancy. At one year follow up recurrence was seen in 2 patients in stage I and 3 patients in stage II. The difference was statistically not significant (p = 0.365). Recurrence was found in three patients in Salvage group and in 2 patients where surgery was done as Upfront (primary modality). There was not statistically significant difference (p = 0.072). At one year follow up two patients had recurrence even with surgical margins being free and three patients had recurrence in which margins were positive on histopathology. Statistically this difference was not significant (p = 0.072) When recurrence/disease free survival was compared with positive deep resection margins 3 patients had recurrence in which post operative resection margins were free and two patients had recurrence in which deep resection margins were involved (p = 1.00) 12 patients out of 16 patients completed one year follow up who received adjuvant radiotherapy and there was no recurrence of tumor in these patients The other 4 patients are yet to finish their follow up. HPV testing could be done in sonly 23 patients out of total 42 patients included in the study due to logistic reasons. No evidence of recurrence was seen in two patients who were HPV positive. In patients who were HPV negative two patients had recurrence after 1 year follow up (Table 3).

Transoral Robotic Surgery (TORS) is a new tool for the management of oropharyngeal tumors. Robotic surgery has facilitated improved visualisation of the tissues of the oropharynx without disfiguring incisions. It also has advantages in causing less speech and swallowing dysfunction.

In our study, a total of 42 patients were followed up for a mean duration of 12 months recruited from August 2016 onwards. The surgical outcome was evaluated on various variables during these follow up visits.

In our study men outnumbered women which is in line with the study by Patel et al. [6]. Males are more than four times as likely as females to develop oropharyngeal squamous cell carcinoma.

In our study, 5 patients (14.70%) experienced disease recurrence in 34 patients during follow up at the end of two year. A study conducted by Choby et al. [7] on 34 patients at university of Pittusburg showed only two patients (6%) with disease recurrence. The patients had significant improvement in there global QOL scale over 1 year after surgery.

In our study locoregional control was 89.65% for 26 patients not receiving any post operative adjuvant radiotherapy. Sixteen patients requiring adjuvant radiotherapy as a result of positive resection margins and lymph node involvement have done well as far as recurrence is concerned in patients at 1 year follow up. A long term follow up of these patients is required to assess the benefits of adjuvant radiotherapy.

TORS may also be used selectively for patients with recurrence after primary radiation therapy with or without chemotherapy. White et al. [8] compared TORS with standard open surgery in TNM stage matched patients undergoing salvage treatment. TORS patients has significantly low rates of tracheostomy and feeding tube use and shorter hospital stay. In our study salvage surgery was done in 9 (21.4%) patients and recurrence was noted in 3 patients (33.3%) as compared with upfront surgery 2 patients (6.06%). Moreover post operative surgical margins were positive in two patients who had recurrence in patients who underwent salvage surgery. Thus, salvage surgery is the best option in patients with recurrence or after chemo-radiation.

Van Loon, et al. [9] conducted the study to show the role of TORS in resection of T1-2N0 oropharyngeal cancers safely and effectively and to determine the functional and oncologic outcomes in these patients. They concluded that patients who were given postoperative radiotherapy had a worse outcome and patients treated with transoral Robotic surgery did well during follow up. They have concluded that TORS seems to be an oncologically safe and effective surgical treatment option for early stage T1-2, N0. In our study oropharyngeal cancer recurred in 5 patients at locoregional site in T1-T2N0 oropharyngeal cancers. Stage III and stage IV patients underwent Transoral Robotic surgery and neck dissection which could explain the better locoregional control in them. In fact, the five patients with recurrence were in stage I and stage II and three patients out of these five patients had positive resection margins on post operative HPE reports. Disease free survival is closely related to complete surgical excision without involved margins. It thus becomes imperative that the Robotic surgery needs to focus on achieving histological negative resection margins.

Additionally we saw some surprising findings on analysis of disease free survival vis a vis the TNM stage. Better control of disease could be due to the combination of neck dissection in these patients resulting in better outcomes.

Li et al. [10] at the Sydney Head and Neck Cancer Institute found that patients with HPV positive were less likely to experience recurrence. In our study HPV p16 E7 was detected in two patients (8.7%) by PCR out of 23. HPV testing could not be done in all the patients due to logistic reasons. Both the patients were comparatively younger with age <45 years and were non smokers. They presented initially in TNM stage IV and there was no recurrence at 1 Year of follow up. Post operative radiotherapy was given to these patients owing to involvement of resection margins and lymph node metastasis.

Surgical robotics is a new technology that holds a significant promise. TORS affords potential advantages and benefits over current treatment modalities. Advantages include better visualisation and better access to tumors via a minimally invasive, less morbid approach, resulting in better overall functional outcome. Based on our study and comparison with the earlier studies available TORS has better outcome in terms of low surgical margins positivity rate, low rate of feeding tube use and its duration, shorter duration of surgery, low tracheostomy rate, shorter hospital stay and high rate of disease free survival. TORS has also shown promise in the salvage setting to provide recurrence free survival. Further studies, including long term studies, are needed.

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6. Patel, M.M. and A.N. Pandya. "Relationship of Oral Cancers with Age, Sex and Site Distribution and Habits." Indian Journal of Pathology and Microbiology, vol. 47, 2004, pp. 195–197.

7. Choby, George W. et al. "Transoral Robotic Surgery Alone for Oropharyngeal Cancer: Quality-of-Life Outcomes." JAMA Otolaryngology–Head & Neck Surgery, vol. 141, no. 6, 1 June 2015, pp. 499–504.

8. White, H. et al. "Salvage Surgery for Recurrent Cancers of the Oropharynx: Comparing TORS with Standard Open Surgical Approaches." JAMA Otolaryngology–Head & Neck Surgery, vol. 139, no. 8, 1 Aug. 2013, pp. 773–777.

9. Van Loon, J.W. et al. "Outcome of Transoral Robotic Surgery for Stage I–II Oropharyngeal Cancer." European Archives of Oto-Rhino-Laryngology, vol. 10, 2014, p. 2939.

10. Li, W. et al. "Human Papillomavirus Positivity Predicts Favourable Outcome for Squamous Carcinoma of the Tonsil." International Journal of Cancer, vol. 106, no. 4, 10 Sept. 2003, pp. 553–558.