Perioperative Head and Neck Cancer Inventory19 (HNCI) health-related quality-of-life (HRQOL) scores by QOL domain. TORS indicates transoral robotic surgery.
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Dziegielewski PT, Teknos TN, Durmus K, et al. Transoral Robotic Surgery for Oropharyngeal CancerLong-term Quality of Life and Functional Outcomes. JAMA Otolaryngol Head Neck Surg. 2013;139(11):1099–1108. doi:10.1001/jamaoto.2013.2747
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Because treatment for oropharyngeal squamous cell carcinoma (OPSCC), especially in patients of older age, is associated with decreased patient quality of life (QOL) after surgery, demonstration of a less QOL-impairing treatment technique would improve patient satisfaction substantially.
To determine swallowing, speech, and QOL outcomes following transoral robotic surgery (TORS) for OPSCC.
Design, Participants, and Setting
This prospective cohort study of 81 patients with previously untreated OPSCC was conducted at a tertiary care academic comprehensive cancer center.
Primary surgical resection via TORS and neck dissection as indicated.
Main Outcomes and Measures
Patients were asked to complete the Head and Neck Cancer Inventory (HNCI) preoperatively and at 3 weeks as well as 3, 6, and 12 months postoperatively. Swallowing ability was assessed by independence from a gastrostomy tube (G-tube). Clinicopathologic and follow-up data were also collected.
Mean follow-up time was 22.7 months. The HNCI response rates at 3 weeks and 3, 6, and 12 months were 79%, 60%, 63%, and 67% respectively. There were overall declines in speech, eating, aesthetic, social, and overall QOL domains in the early postoperative periods. However, at 1 year post TORS, scores for aesthetic, social, and overall QOL remained high. Radiation therapy was negatively correlated with multiple QOL domains (P < .05 for all comparisons), while age older than 55 years correlated with lower speech and aesthetic scores (P < .05 for both). Human papillomavirus status did not correlate with any QOL domain. G-tube rates at 6 and 12 months were 24% and 9%, respectively. Greater extent of TORS (>1 oropharyngeal site resected) and age older than 55 years predicted the need for a G-tube at any point after TORS (P < .05 for both).
Conclusions and Relevance
Patients with OPSCC treated with TORS maintain a high QOL at 1 year after surgery. Adjuvant treatment and older age tend to decrease QOL. Patients meeting these criteria should be counseled appropriately.
Oropharyngeal squamous cell carcinoma (OPSCC) was historically treated with primary open surgery. Cure rates were low; complication rates were high; and patient health-related quality of life (HRQOL) decreased. In an effort to at least minimize morbidity, a quest for organ preservation protocols was undertaken,1-3 and treatment paradigms shifted toward primary external-beam radiation therapy (XRT) or chemoradiation therapy (CRT). Unfortunately, these protocols failed to provide desired solutions because they were often associated with significant acute and chronic toxic effects.4-6 The result was impaired upper aerodigestive tract function and suboptimal HRQOL.7,8 Therefore, head and neck surgeons are still seeking the ultimate balance between cancer cure, functional outcomes, minimal morbidity, and HRQOL.
In the 1990s transoral laser microsurgery (TLM) was pioneered by Wolfgang Steiner, MD, for laryngeal tumors (as reported by Iro et al9) and eventually was adapted to the oropharynx. Since that time, proponents of primary TLM have demonstrated favorably balanced treatment outcomes in OPSCC.10-14 In 2005, a novel, minimally invasive approach to the oropharynx was born: transoral robotic surgery (TORS).5,15 Soon after, Weinstein et al16 recognized the potential for TORS as an oncologically sound and function-preserving tool for treating OPSCC. The technique improves visualization and adds degrees of freedom to surgical movements. Complication rates are low17 and swallowing function remains high.8,17,18 Initial, limited HRQOL data have shown that speech, eating, social, and overall QOL domains tend to decrease from baseline but remain high at 3 months post TORS.18 However, long-term results with significant patient numbers are lacking.
The aim of this study was to explore the short- and long-term HRQOL as well as functional outcomes in patients with OPSCC undergoing TORS. Second, factors correlated with QOL outcomes and factors predictive of poor swallowing were determined.
Institutional review board research ethics approval was granted by the Ohio State University Office of Responsible Research Practices (OSU-07061). This study was conducted at a tertiary care academic referral center and comprehensive cancer center.
Patients were enrolled from the Head and Neck Cancer Clinic at the Ohio State University Arthur G. James Cancer Hospital at their first new-patient referral visit. Following their consultation with a head and neck surgeon, patients met a study coordinator, who explained the study, obtained written consent, and formally registered patients for the trial. At this time, baseline data were collected. All cases were formally discussed at a weekly head and neck cancer multidisciplinary tumor board prior to finalizing treatment plans. The design was a prospective cohort study with patients enrolled from April 2008 through September 2012. All patients meeting study criteria were offered TORS as a primary treatment technique.
Patient inclusion criteria were (1) biopsy-proven OPSCC; (2) clinical T1 through T3 disease; and (3) scheduled for TORS. Exclusion criteria were (1) inadequate transoral exposure to allow for TORS instrumentation; (2) inability to complete the Head and Neck Cancer Inventory (HNCI)19; (3) preoperative positron-emission computed tomography (PET-CT) image demonstrating distant metastases; and (4) panendoscopy demonstrating an unresectable primary tumor or a synchronous second primary tumor.
The research questions were as follows: (1) What are the short- and long-term QOL outcomes in patients with OPSCC who undergo TORS? (2) What are the short- and long-term G-tube dependence rates in patients with OPSCC who undergo TORS? (3) Are there any perioperative variables predictive of QOL or G-tube dependence in patients with OPSCC who undergo TORS?
Patients with head and neck cancers at the Ohio State University underwent a standard metastatic workup, including a full-body PET-CT scan and panendoscopy.20 Those who chose to undergo TORS were booked for a single-staged procedure including panendoscopy, TORS tumor resection, and concurrent neck dissection. TORS was performed with the da Vinci Surgical System (Intuitive Surgical Inc) after panendoscopy as per previously described protocols.16,18,21 Following tumor resection, frozen section biopsy specimens were taken from all mucosal and deep margins and sent to a head and neck pathologist for immediate analysis. During margin review, the robot was removed from the operative field, and the patient was prepared for concurrent neck dissection. Bilateral neck dissection was performed on patients with lesions encroaching the midline. Following neck dissection, the robot was brought back into the field if margins needed to be revised based on frozen-section analysis.
The extent of TORS resection was determined by the number of oropharyngeal sites (tonsil, base of the tongue [BOT], soft palate) significantly involved in the resection. Significant involvement included at least 1cm of the ipsilateral portion of the subsite. These patients also underwent a local uvular mucosal rotational flap closure of the palate defect. All other patients did not undergo reconstruction but rather were left to heal by secondary intention.
Adjuvant treatment, including XRT or concurrent CRT was delivered within 6 weeks of TORS. Postoperative XRT and/or CRT were offered if high-risk disease features were present, as per National Comprehensive Cancer Network guidelines.22 The mean XRT dose was 65 Gy (60-74 Gy) divided over a 6- to 7-week treatment course. Chemotherapy regimens were either cisplatin (75%) or cetuximab (25%) based with 3 scheduled doses, 3 weeks apart.
Clinicopathologic data was collected prospectively by a research coordinator as it became available. Preoperative data included: age at surgery, sex, race, tissue diagnosis, site of tumor, Charlson Comorbidity Index (CCI), and smoking status/pack year history. Post-operative data included: extent of TORS, type of neck dissection, adjuvant treatment, Human Papilloma Virus (HPV) status, cyclin-dependent kinase inhibitor 2A (p16) status, nodal status, TNM classification, AJCC staging,23 peri-operative complications, length of hospital stay, follow-up time, G-tube dependence, and quality of life scores. The presence of HPV in tumor tissue was determined via chromogenic in situ hybridization for high-risk types of HPV. Immunohistochemical staining was performed on sections of paraffin-embedded tumor tissue for p16. All pathologic protocols were implemented and standardized by a group of Ohio State University head and neck pathologists. Time frames were referenced from the day of surgery (baseline), with assessments occurring at 3 weeks, as well as at 3, 6 and 12 months post TORS.
The HNCI was used to determine head and neck cancer–specific HRQOL.19 This is a validated, quantitative QOL instrument with excellent interrater and intrarater reliability. It uses a 30-item multidimensional survey that measures head and neck cancer–specific outcomes in 4 domains: speech, eating, social disruption, and aesthetics. For each domain, the patient’s functional (ability to perform the task) and attitudinal (satisfaction with the task performance) scores are determined. The final item includes an overall QOL score. Each item is scored on an ordinal scale ranging from 1 to 5, with the scores being converted to a 0 to 100 scale to aid in interpretation.19 Previous studies have stratified mean domain scores into 3 groups: high (70-100), intermediate (31-69), and low (0-30) HRQOL.7,24 Patients were asked to complete the HNCI unaided, in the absence of a health care professional, after their routinely scheduled follow-up visits. The questionnaires were collected by a research coordinator, and the results were input into a database.
G-tube dependence, defined as requiring feeding through a G-tube to maintain daily caloric needs,25 was used as a surrogate for swallowing ability. This is a well accepted standard measure of swallowing function. Patients using G-tube feeding for any caloric needs were coded as G-tube dependent. The rate of G-tube dependence (number of patients using a G-tube/number of patients assessed at time of follow-up) was determined at baseline and at 6- and 12-month post-TORS follow-up.
Statistical analysis was conducted using the SPSS 17.0 software package (SPSS Inc). Continuous variables were compared using the Mann-Whitney U test, and categorical variables were compared using the χ2 test. The Mann-Whitney U test was also used to compare ordinal values across time periods. Perioperative variables potentially predictive of G-tube dependence after TORS were identified in a logistic regression analysis. Perioperative patient and tumor variables correlated with HRQOL domains were identified using correlation analysis based on the Spearman ρ coefficient. All comparisons were 2-tailed, and statistical significance was set as P < .05. Estimated 2- and 4-year survival rates were calculated with Kaplan-Meier analysis.
Ninety-eight patients with OPSCC were evaluated at the Head and Neck Cancer Clinic at the Ohio State University Arthur G. James Cancer Hospital and offered TORS. Eleven patients refused surgical treatment and opted for XRT and/or CRT. Thus, 87 patients with OPSCC were enrolled in the study protocol. Six were excluded: 3 dropped out; 1 cancelled the operation; 1 could not be adequately exposed to allow for TORS; and 1 was found to have distant metastases on preoperative imaging. Thus, 81 patients with OPSCC undergoing TORS were included in the analysis.
The mean age at TORS was 58.3 years (age range, 39.0-80.6 years). Sixteen patients were women (20%) and 65 were men (80%). One patient was African American (1%), while the remainder were white. The mean CCI was 6.6 (CCI range, 2-17). Sixty-two patients (77%) were smokers, with a mean pack-year history of 31.7 years (range, 1-120 years). All patients had SCC, with 65 lesions occurring in a palatine tonsil (80%) and 16 in the BOT (20%). Eight resection margins were positive (10%) as per widely accepted guidelines.26Table 1 lists the tumor and staging data.
Table 2 summarizes treatment details. Two patients withdrew consent for neck dissection at the time of surgery and chose to have neck XRT instead. Two patients had received CRT preoperatively but had persistent disease (3%). Therefore, pathologic staging information could not be obtained for these patients, and they were classified as Nx. The mean number of positive lymph nodes on final pathologic review was 2.2 (range, 0-18); and the mean number of total nodes was 30.7 (range, 5-77). Three patients had neck hematomas requiring operative evacuation within 8 hours of surgery (4%). No sequelae resulted from these cases. Two intraoperative fistulae from the pharynx to the submandibular space were detected. One was repaired with AlloDerm (LifeCell), and the other by transposing the submandibular gland and reinforcing it with a digastric muscle flap. In both cases, no orocutaneous fistulae developed postoperatively. No other perioperative complications requiring operative intervention were encountered. There were no incidences of hypoglossal or lingual nerve injury. The mean length of hospital stay was 3.7 days (range, 1-9 days). The mean follow-up time was 22.7 months (range, 2.5-51.2 months). At last follow-up, 8 patients had died. The 2- and 4-year disease-specific survival rates were 92% and 89%, respectively. There were no cases of 30-day mortality.
All patients were discharged home on a full oral diet, without any patient requiring nasogastric feeding during their hospital stay. No patients were readmitted for dysphagia prior to starting XRT. Seventeen patients required G-tube insertion at some point after TORS (21%) owing to dysphagia and inability to maintain daily caloric needs. In 8 (47%) of these patients, the G-tube was inserted temporarily during XRT and/or CRT and was removed before 1 year post TORS. Four patients (24%) had G-tubes placed for palliative reasons at 12 months or later after TORS. The remaining 5 G-tubes (29%) were placed during XRT and/or CRT; however, these patients could not regain sufficient swallowing function to become G-tube independent. The mean time to G-tube insertion was 5.5 months (range, 1.0-30.8 months) post TORS. One patient had a G-tube inserted preoperatively secondary to previous XRT and did not regain swallowing function after TORS. The specific perioperative G-tube rates are listed in Table 3. Only 1 patient required a tracheostomy tube (1%), which was removed prior to leaving the hospital.
The results of logistic regression analysis of factors predictive of G-tube dependence are reported in Table 4. The analysis was carried out to identify patients at risk of needing a G-tube at some point during treatment and those who would retain the G-tube without maintenance of adequate oral nutrition. Age 55 years or older and greater extent of TORS predicted the need for a G-tube, while advanced pT classification (pT3 or pT4) predicted that the patient would not be able to remove the G-tube once it was inserted. A similar analysis of factors potentially predictive of G-tube dependence at 12 months post TORS was also carried out, and all of the same factors were found not to be statistically significant predictors (P > .05).
Table 5 lists HRQOL outcome values and comparisons. The Figure illustrates the QOL outcomes by time frame and domain. Long-term outcomes are represented at 12 months post TORS with differences and comparisons being calculated from the baseline. Seventy-six patients completed the questionnaire at baseline (94%), 64 (79%) at 3 weeks, 49 (60%) at 3 months, 47 (63%) at 6 months, and 42 (67%) at 12 months post TORS. All patients were able to complete the questionnaire on their own without the assistance of a hospital staff, research team, or family member. There were no statistically significant differences in patient age (P = .61), sex (P = .28), CCI (P = .10), smoking status (P = .36), tumor site (P = .08), T classification (P = .51), N classification (P = .24), overall stage (P = .41), HPV status (P = .62), extent of surgery (P = .58), adjuvant therapy (P = .49), G-tube dependence (P = .16), or complication status (P = .67) between patients who completed and did not complete the questionnaires at 12 months. Table 6 lists clinicopathologic factors and their associations with HRQOL domains on the HNCI.
The goals of head and neck cancer treatment are continually redefined. In recent years, head and neck oncologists have focused on maximizing survival while optimizing QOL during that survival. Many studies have implemented self-assessment QOL tools to determine if these goals are met. Because TORS is a rather novel treatment tool for OPSCC, there is a paucity of HRQOL information. To our knowledge, this is the largest study to evaluate long-term QOL post TORS in a single-center, prospective manner.
The patients studied represent a population similar to those described in previous reports.18,21,27,28 Most patients have early T-classification disease with significant nodal burden. Thus, most patients exhibit stage IV disease. Furthermore, consistent with the current virally induced cancer epidemic,17 more than 70% of patients test HPV+ or p16+, yet more than three-quarters of these patients are still smokers. Patients underwent similar treatment protocols described previously with comparable survival rates.29
Temporal changes for HRQOL scores in this study followed expected trends. All HRQOL scores declined at 3 weeks after TORS. Speech, eating, social, and overall scores continued to drop and bottomed out at 3 months post TORS. This time frame coincides with XRT and/or CRT treatment, during which patients face many challenges with the acute toxic effects of adjuvant treatment.4,30,31 Functional outcomes and HRQOL tend to be lowest at this point; the magnitude of dysfunction often determines how patients recover.18,30 Haughey et al,11 Rich et al,13 and Rigby and Taylor14 have found parallel patterns in TLM for OPSCC. Fortunately, most patients experiencing XRT and/or CRT disturbances tend to recover by 12 months, and their scores return to intermediate to high levels (Figure). Speech attitude, aesthetic, social, and overall scores demonstrated the greatest recovery and were not statistically different from baseline scores (P > .05). Speech function and aesthetic attitude showed partial recovery, but remained significantly below baseline (P < .05). Speech function, eating function, and eating attitude scores dropped the most, with minimal recovery by 12 months (P < .05). While statistical differences helped identify HNCI domains affected most by treatment, these values need to be correlated with clinical meaning. Funk et al24 determined clinically important differences (CIDs) for the HNCI domains to fall into 3 categories: small, medium, and high.24
Speech function showed a statistically significant and small CID from baseline (Figure, A). Previous data indicate that patients with OPSCC treated with primary surgery can maintain significant speech function as long as most of the critical speech structures are maintained.21,32,33 TORS OPSCC resections are largely limited to the tonsillar fossa and/or lateral pharyngeal wall with preservation of most of the soft palate and BOT; thus, it is expected that speech should be preserved. Similar to this study, Leonhardt et al30 also found that speech function is only moderately affected by TORS. However, adjuvant XRT was found to be significantly correlated with lower speech function (P = .01) and speech attitude scores (P = .01) at 12 months post TORS. External-beam radiation therapy is known to cause irreversible long-term fibrosis and impaired mobility of the upper aerodigestive tract,34 which can result in poor long-term functional recovery.30 Age younger than 55 years was also found to correlate with lower speech attitude scores (P = .03). Because younger patients tend to have a higher baseline functional status, it is postulated that their attitude toward lowered HRQOL physical domains declines; thus, producing lower scores.18,35,36
Aesthetic attitude showed a small CID without statistical significance (P > .05) (Table 5). Lower scores were correlated with age younger than 55 years (P = .04), which is often observed in patients with head and neck cancer.37,38 This is likely owing to a dynamic self-perception of facial aesthetics39 and less importance placed on this domain in determining HRQOL with aging.38 Social function and attitude also showed small CIDs over time that were not statistically significant. No perioperative factors correlated with lower scores in these domains. These results compare favorably with previous studies and suggest that social domains are maintained in the long term after TORS and seem to be less affected than in open surgical approaches.40,41
Eating function and attitude were the most affected HRQOL domains at 12 months after TORS (Figure, B). Both domains showed statistically significant and large CIDs from baseline (Table 5). Earlier results from a smaller group of patients showed similar differences but lacked statistical significance.18 Smaller studies, using a different QOL scale, found smaller declines in patient-perceived swallowing function after TORS.28,30 However, poor recovery at 6 and 12 months was also observed in similar patient populations.28,30 Patients who undergo adjuvant XRT or CRT have the lowest eating HRQOL domain scores (P < .05) with differences of nearly 40 (XRT) or 30 (CRT) points compared with their counterparts who avoided XRT or CRT. This finding is not unique; XRT and CRT are known to cause substantial deterioration in perceived swallowing function.7,18,28,30,42 However, when scores for patients who underwent adjuvant CRT vs XRT only were compared, there were no statistically significant correlations (P > .05) or CIDs within eating domains (Table 6). It is postulated that it is adjuvant XRT after TORS, and not the chemotherapy, that influences long-term eating function the most. Previous studies have emphasized the importance of CRT on long-term HRQOL but have not compared XRT directly with CRT in TORS patients.28,30,43 Patients who avoided any adjuvant treatment showed superior HRQOL outcomes, as supported by other data.18,28,30
All patients in the present study were able to tolerate a full oral diet by the time of hospital discharge. The TORS literature quotes return-to-swallowing times of approximately 0 to 14 days.18,44-46 However, it is known that objective swallowing ability will deteriorate with adjuvant treatment.7,8,11,13,28-30,47 A fifth of patients required a G-tube at some point after TORS, with 24% still using their G-tube at 6 months. The most common indication for tube feeding was dysphagia during XRT and/or CRT. Approximately half of these patients were able to regain swallowing ability by 12 months post TORS. It was found that patients with G-tubes had significantly worse HRQOL eating scores, as would be predicted by landmark head and neck cancer QOL literature.7,48
To better counsel patients, it is worth knowing variables predictive of needing a G-tube. In the current analysis, it was found that older patients (≥55 years) were nearly 5 times as likely to need a G-tube after TORS compared with their younger counterparts. This is potentially owing to a lower baseline functional status and less of a capacity for aggressive swallowing therapy in the elderly.
Second, if TORS resection included more than 1 oropharyngeal subsite, patients had a 5.6-fold increased risk of needing a G-tube. This is a novel piece of information in the TORS literature but is supported by previous findings that as more swallowing structures are violated by surgery and/or XRT, swallowing function deteriorates, and recovery is poor.25,49,50 One factor predicted the need for a permanent G-tube after TORS: high pT classification. Patients with pT3 or pT4 tumors were 27 times as likely to not be weaned from G-tube feedings. Previous TORS studies have also shown advanced T classification to be predictive of poor swallowing function and retained G-tubes.8,45
Although most authors were using perioperative tracheostomy tubes with the introduction of TORS, this seems to be a passing trend. Only 1 patient received a perioperative tracheostomy in the present series. The current literature reports tracheostomy rates of 0% to 31%, with most authors demonstrating the safety of the technique without a surgical airway.47
Overall HRQOL scores provide a summary of all patient-perceived outcomes (Figure, D). Overall function showed similar trends to eating domains with initial drop-offs and incomplete recovery. The difference from baseline was a significant medium CID (P < .001). Overall attitude also demonstrated a significant change from baseline, but this represented only a small CID with good 12-month recovery.
Finally, overall 12-month QOL scores demonstrated no significant change from baseline (P > .05). This is despite significant deterioration in eating and speech domains. Previous studies have found similar results with high overall QOL, despite major disruptions in other areas of HRQOL.7,18 Possible explanation for this paradox stems from the definition of QOL: the perceived discrepancy between reality and what a person expected this reality to be.51 It is conceivable that with appropriate preoperative counseling, patients are able to set appropriate expectations, therefore maintaining their pre-TORS overall QOL.
Many studies evaluating HRQOL in OPSCC after surgery or XRT and/or CRT exist with a wide range of outcomes. Recent literature continues to show that XRT and/or CRT have a negative impact on QOL and swallowing function, with xerostomia-related complications being the most prominent obstacles for patients to overcome.52 Minimizing and focusing XRT while avoiding chemotherapy lead to fewer treatment toxic effects and improved outcomes.53-56 Patients with early-stage disease treated with surgery alone demonstrate superior outcomes by avoiding the toxic effects of XRT.27,53,55 Although these data are still preliminary, TORS is showing promise as an optimal treatment strategy in early-stage disease.
Despite the abundance of QOL data available, direct comparisons between treatment techniques remains a challenge. The crux of the matter is a lack of standardized outcome measures.25,56 One study of similar patients who were treated with primary CRT or surgery and XRT (SRT), using the same measures as this study (HNCI) was identified.7 All HRQOL domains in the work published by El-Deiry et al7 demonstrated lower scores than the present TORS cohort. The most striking domain differences were in the mean eating (CRT, 37.8; SRT, 40.8; TORS, 58.2) and speech (CRT, 65.1; SRT, 56.0; TORS, 80.9). Overall QOL also differed (CRT, 55.0; SRT, 64.0; TORS, 76.8). Generally, there appears to be a pattern of increased HRQOL scores favoring TORS. This could very well be to the minimally invasive nature of the technique and lowered XRT dose used in the postoperative setting.
Limitations of this study are acknowledged. Although it is the largest cohort of its kind, 12-month follow-up data were not available for all patients, leaving the data open to selection bias. There was also a lack of a comparison arm, which ideally would be addressed with a randomized trial with primary CRT. Owing to the distance from patients’ homes to our institution, many chose not to undergo adjuvant treatment at The Ohio State University Wexner Medical Center but instead attended other institutions closer to home. Thus, there was a lack of standardization of type and dose of XRT and/or CRT. It would be difficult to convince all patients to travel to a standardized location for adjuvant treatment; thus, eliminating this confounding variable would be unrealistic.
Despite the growing literature on TORS a critical question remains: How can treatment be customized to strike an optimal balance between survival, function, and HRQOL? This study further continues to demonstrate that TORS is an important treatment tool in OPSCC. However, a multi-institutional study with standardized protocol comparing surgery with XRT and/or CRT is necessary to answer this question.
In conclusion, this study is, to our knowledge, the largest prospective, longitudinal single-center study evaluating HRQOL and functional outcomes in patients with OPSCC who undergo TORS. The results show TORS to be safe with excellent overall QOL and functional outcomes. Patients who undergo XRT tend to demonstrate worse HRQOL scores, but by 12 months post TORS, overall QOL returns to baseline values. G-tube rates are low. However, patients with older age, more extensive resections, and advanced pT classification are at increased risk of needing or retaining a G-tube. These results suggest that TORS is a viable alternative to primary CRT in OPSCC treatment.
Corresponding Author: Peter T. Dziegielewski, MD, FRCSC, Room B-225 Starling, Loving Hall Bldg, The Ohio State University, Columbus, OH 43210 (firstname.lastname@example.org).
Submitted for Publication: February 25, 2013; final revision received March 23, 2013; accepted March 25, 2013.
Published Online: April 10, 2013. doi:10.1001/jamaoto.2013.2747.
Author Contributions: Drs Dziegielewski and Ozer had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Dziegielewski, Teknos, Durmus, Old, Kakarala, Ozer.
Acquisition of data: Dziegielewski, Teknos, Durmus, Old, Agrawal, Ozer.
Analysis and interpretation of data: Dziegielewski, Teknos, Old, Marcinow, Ozer.
Drafting of the manuscript: Dziegielewski, Marcinow, and Ozer.
Critical revision of the manuscript for important intellectual content: Dziegielewski, Teknos, Durmus, Old, Agrawal, Kakarala, Ozer.
Statistical analysis: Dziegielewski and Marcinow.
Obtained funding: Teknos.
Administrative, technical, and material support: Teknos, Durmus, Old, Ozer.
Study supervision: Teknos, Old, Kakarala, Ozer.
Conflict of Interest Disclosures: Dr Ozer is a surgical proctor for and has received a research grant from Intuitive Surgical Inc.
Previous Presentation: This study was presented at the American American Head and Neck Society 2013 Annual Meeting; April 10, 2013; Orlando, Florida.