Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston Texas.

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1 ORIGINAL ARTICLE Gastrostomy tube placement in patients with oropharyngeal carcinoma treated with radiotherapy or chemoradiotherapy: Factors affecting placement and dependence Mihir K. Bhayani, MD, Katherine A. Hutcheson, PhD, Denise A. Barringer, MS, Asher Lisec, BS, Clare P. Alvarez, MS, Dianna B. Roberts, PhD, Stephen Y. Lai, MD, PhD*, Jan S. Lewin, PhD* Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston Texas. Accepted 17 September 2012 Published online 16 January 2013 in Wiley Online Library (wileyonlinelibrary.com). DOI /hed ABSTRACT: Background. Although many patients require nutritional support during radiotherapy or chemoradiotherapy for oropharyngeal cancer, little is known regarding the risk factors that predispose to gastrostomy tube (g-tube) placement and prolonged dependence, or the therapeutic interventions that may abrogate these effects. Methods. We performed a retrospective medical chart review of patients who were treated for primary oropharyngeal cancer at a tertiary care center from 2003 to Patients who had a complete response at the primary site at 1-year posttreatment were included. G-tube placement and dependence 6 months were evaluated in relationship to site and stage of primary tumor, baseline characteristics, treatment type, smoking status, and swallowing intervention. Results. We evaluated 474 patients (79%) with oropharyngeal cancer; 215 patients (40%) had concurrent chemotherapy, 73 patients (15%) had induction chemotherapy, and 69 patients (15%) had induction chemotherapy followed by concurrent chemotherapy. Two hundred ninety-three patients (62%) received g-tubes, of which 238 (81%) received the g-tube during radiation. At 1-year follow-up, 41 patients (9%) remained dependent on enteral feedings. Placement of g-tubes and prolonged g-tube dependence were significantly more likely in patients with T3 to 4 tumors (p <.001), baseline self-reported dysphagia (p <.001), odynophagia (p <.001), >10% baseline weight loss (p <.001), and in those treated with concurrent chemoradiotherapy. Patients who reported adherence to exercises had significantly lower rates of g-tube placement (p <.001), and duration of dependence was significantly shorter in those whoreportedadherencetoswallowingexercises(p <.001). Conclusion. Almost 40% of patients with oropharyngeal cancer treated with nonsurgical organ preservation modalities may avoid feeding tube placement. Factors that predispose to g-tube placement and prolonged dependence include T3 to T4 tumors, concurrent chemotherapy, current smoking status, and baseline swallowing dysfunction or weight loss. Adherence to an aggressive swallowing regimen may reduce long-term dependence on enteral nutrition and limit the rate of g-tube placement overall. VC 2013 Wiley Periodicals, Inc. Head Neck 35: , 2013 KEY WORDS: oropharynx, gastrostomy tube, dysphagia, speech pathology, radiation therapy INTRODUCTION Despite the decreased prevalence of smoking in the United States, the incidence of oropharyngeal carcinoma is rising. 1 3 This increase has been attributed to the identification of oncogenic human papillomavirus (HPV) in approximately 70% of all tumors in patients with oropharyngeal carcinoma. 2 Studies have shown that definitive treatment regimens of radiation therapy (RT) alone and in combination with chemotherapy can improve locoregional control, provide functional organ preservation, and maintain survival in patients with locally advanced head and *Corresponding authors: J. Lewin, Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd. Unit 1445, Houston TX jlewin@mdanderson.org; or S. Y. Lai, Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd. Unit 1445, Houston TX sylai@mdanderson.org Ehab Y. Hanna, MD, was recused from consideration of this manuscript. This work was presented at the ASTRO Annual Meeting, Miami, Florida, October Stephen Y. Lai and Jan S. Lewin contributed equally to this work. neck cancer; however, the side effects can be considerable. 4 7 Treatment-related side effects such as mucositis and dysphagia may lead to inadequate oral intake, and consequently severe weight loss and malnutrition in this high-risk population Malnutrition is a recognized complication of head and neck cancer and its treatment. 4 The clinical significance of which is manifested by dehydration-related emergency room visits and hospitalizations, reduced treatment efficacy because of treatment delays, and dose reductions that negatively impact quality of life and overall survival. 5,6 In an effort to avoid malnutrition, patients undergoing RT are commonly referred for placement of a gastrostomy tube (g-tube). The g-tube helps maintain adequate nutrition, prevent weight loss, and eliminate aspiration, particularly in patients with mucositis-induced odynophagia and dysphagia during RT. Despite the benefits of g-tube placement in appropriately selected patients, the timing of g-tube placement remains controversial. Multiple reports encourage prophylactic g-tube placement to prevent weight loss and dehydration; thus, enabling patients to complete treatment without interruption However, other studies have 1634 HEAD & NECK DOI /HED NOVEMBER 2013

2 GASTROSTOMY TUBE PLACEMENT IN OROPHARYNGEAL CANCER shown that patients with prophylactic g-tubes are more likely to have late esophageal toxicity and dysphagia, leading to long-term dependence on enteral feedings. 12 Furthermore, many patients who have feeding tubes maintain long intervals without oral intake that have shown to be predictive of long-term g-tube dependence. 13 In addition, g-tubes have been associated with decreased quality of life scores, and may ultimately lead to frustration and depression that complicates recovery and feeding tube independence. 14 Current studies generally combine head and neck cancer sites (eg, oral and sinonasal cavities, nasopharynx, oropharynx, hypopharynx, and larynx) and report outcomes of nutritional support based on historical groupings of disease site. However, recent literature suggests unique characteristics associated with each subsite in the head and neck that may in fact affect g-tube placement and swallowing-related outcomes. 15 This study represents the first of 2 studies that examines g-tube placement and swallowing-related outcomes in patients with head and neck cancer, specifically patients with tumors of the oropharynx and hypopharynx. Herein, we describe our evaluation of patients with only oropharyngeal carcinoma treated with RT 6 chemotherapy for variables that predicted for g-tube placement and prolonged dependence. PATIENTS AND METHODS We retrospectively reviewed the medical records of 603 consecutive patients who had a primary oropharyngeal cancer of any histology referred for definitive RT (6 chemotherapy) at the University of Texas MD Anderson Cancer Center after approval by the Institutional Review Board. Referrals occurred between January 2002 and December One hundred twenty-nine patients who did not have a complete response at the primary site after RT treatment were excluded from analysis. Medical information regarding patient, disease, and treatment characteristics were collected from the patients records. Self-reported dysphagia and odynophagia at baseline were collected from the patient history. Information was collected regarding weight loss and type of diet at baseline. Details of RT included type of RT, fractionation schedule, total dose, duration of treatment, and number of treatment breaks, if any. Chemotherapy type, number of cycles, and schedule also were noted. Information collected about the g-tube included type, timing of placement (before, during, or after primary RT), duration of placement, and number of nutritional formula (cans) used per day. We defined prolonged feeding tube dependence as any use of the g-tube 6 months past placement. Data regarding amount of oral versus enteral intake and weight were noted at 1, 6 to 12, and 18 to 24 months after completion of primary treatment. We also reviewed the timing of referral to speech pathology (before, during, or after treatment), and results of clinical swallow evaluations or modified barium swallow studies at 1, 6 to 12, and 18 to 24 months after treatment. Speech pathologists prescribed a regular swallowing exercise regimen targeting hyolaryngeal excursion, airway protection, and tongue base retraction. Specific exercises included a modified Shaker, jaw stretch, supraglottic/valsava, falsetto, lingual protrusion/retraction, gargle, yawn, Masako, and effortful swallows. As part of regular follow-up, patients demonstrated an understanding of the specific exercises to the speech pathologist and detailed the number of times per day these exercises were performed. These details were recorded in the patients charts by the speech pathologist. Full adherence was defined by performing exercises >4/day, partial adherence was 4/day, and no adherence. Patients continued exercises until self-directed goals were met. Two primary outcome variables were considered: (1) g-tube placement (yes/no), and (2) prolonged g-tube dependence 6 months. Covariates included T classification, subsite of disease, RT parameters, chemotherapy parameters, smoking history, and swallowing therapy variables. Associations between g-tube outcomes and study variables were compared for statistical significance using SPSS software (SPSS for Windows, SPSS, Chicago, IL). Statistical differences in proportions of patients in the various groups with the outcomes listed above were tested using Pearson chi-square and t test. Multiple logistic regression analyses were conducted to identify independent predictors of g-tube placement and prolonged dependence. A p value of <.05 was considered statistically significant. RESULTS Patient characteristics We evaluated 474 of the 603 patients (79%) with oropharyngeal cancer who had a complete response at the primary site at the end of the treatment period. Median age of the patients was 55.9 years (range, years). Four hundred eleven patients (87%) were men and 63 (13%) were women. One hundred ninety-six patients were never smokers (41%), whereas 178 patients were former smokers (37.5%). Base of tongue was the most common site of primary tumor in 247 patients (52%), followed by tonsil (187 patients; 40%), soft palate (38 patients; 8%), and posterior pharyngeal wall (2 patients; 0.2%). Most patients presented with T2 (172 patients; 37%) and T3 (118 patients; 25%) disease. Additional baseline patient information is summarized in Table 1. Treatment characteristics All patients in the study group received definitive RT therapy. Four hundred forty patients (93%) received intensity-modulated radiation therapy (IMRT), whereas the remaining 34 patients (7%) received 3D conformal treatment. Of the 474 patients, 112 (24%) received accelerated fractionation dosing via concomitant boost technique. Chemotherapy was administered to 359 patients. Seventy-three patients received induction chemotherapy (20%), 218 patients (61%) received concurrent chemotherapy with RT therapy, and 69 patients (19%) received induction followed by concurrent chemoradiotherapy. Chemotherapy agents used and additional treatment characteristics are shown in Table 2. Gastrostomy tube placement and follow-up Table 3 summarizes g-tube placement in our study population. Two hundred ninety-three patients (62%) required placement of a g-tube during the study period; no patient required a treatment break for g-tube placement. Thirtyfour patients (12%) had g-tube placement before HEAD & NECK DOI /HED NOVEMBER

3 BHAYANI ET AL. TABLE 1. Patient characteristics and variables. TABLE 3. Descriptive data of patients receiving gastrostomy tubes. Characteristic No. of patients % Age (median 55.9 y) < Sex Male Female Subsite Base of tongue Tonsil Soft palate Posterior pharyngeal wall T classification Smoking Never Former Current Baseline self-reported dysphagia Yes No Baseline self-reported odynophagia Yes No treatment initiation, whereas 238 patients (81%) had g- tube placement during the treatment period. Twenty-one patients (7%) had g-tube placement after primary treatment was completed. Only 10 patients who had g-tubes did not use more than 3 cans of per day. One hundred fifty-eight patients of the 270 patients (58%) with g-tubes were supplementing their tube feedings with some oral (per os, PO) intake at the end of treatment. TABLE 2. Distribution of treatment regimens delivered. Treatment type No. of patients % Radiation IMRT D conformal Concomitant boost Chemotherapy Induction Concurrent Induction and concurrent None Chemotherapy agent Vandetanib 7 Docetaxel 28 Paclitaxel 139 Cetuximab 66 Cisplatin 221 Carboplatin 138 Ifosfamide 20 5-FU 35 Abbreviations: IMRT, intensity-modulated radiation therapy; 3D, 3-dimensional; 5-FU, 5-fluorouracil. Parameter No. of patients % G-tube placed Yes No Treatment break for placement Yes No Timing of placement Before RT During RT After RT cans per day Yes No G-tube dependence 6 mo 107/ mo 41/ Abbreviations: g-tube, gastrostomy tube; RT, radiation. Median follow-up time after treatment was 51.5 months (range, 3 92 months). At 6 months follow-up, 107 of 470 patients (23%) maintained their feeding tubes. At 12 months after treatment completion, 41 of 464 patients (8.9%) still maintained their feeding tubes. Five of the patients were lost to follow-up and 5 were deceased at 1- year follow-up. At 24 months posttreatment, 17 patients were lost to follow-up and 20 were deceased. However, only 17 patients (3.9%) maintained some nutrition via the g-tube. Factors associated with g-tube placement Multiple study variables were significantly associated with placement of the g-tube based on univariate analysis and are detailed in Table 4. Our results found significantly (p <.01) increased risk of g-tube placement in those patients who had T3/4 disease, 3D conformal RT, concomitant boost doses, and concurrent chemotherapy regimens. We also found patients who presented with baseline swallowing dysfunction were more likely to receive a g- tube (relative risk [RR], 2.0; p ¼.001). Patients who reported an unintentional weight loss that was greater than 10% over the 6-month period preceding treatment were also more likely to receive a feeding tube (RR, 3.9; p ¼.002). Patients who reported adherence to swallowing exercises were less likely to have a g-tube compared with those who did not report adherence (RR, 24.0; p <.001). Smoking history and location of primary site within the oropharynx were not significantly associated with g-tube placement (p ¼.372 and p ¼.435, respectively). Results of a multivariate analysis of the significant associations showed an independent association for patients who received concurrent chemotherapy with RT (RR, 2.3; p ¼.015) and g-tube placement (Figure 1). The multivariate model also found that patients who did not report adherence to swallowing exercises were significantly more likely to have a g-tube placed (RR, 24.7; p <.001; Figure 2) HEAD & NECK DOI /HED NOVEMBER 2013

4 GASTROSTOMY TUBE PLACEMENT IN OROPHARYNGEAL CANCER TABLE 4. Variables affecting placement of G-tubes. Variable G-tube placed (n, %) Relative Risk Univariate Multivariate Smoking Never 116 (59.1) Former 113 (63.5) Current 64 (64.7) NA NS Subsite Tongue Base 158 (64.0) Tonsil 109 (58.6) Soft Palate 25 (65.8) Posterior 1 (50) NA NS Pharyngeal Wall T stage T1/2 137 (52.3) T3/4 156 (74.3) 2.64 <0.001 NS Radiation type IMRT 264 (60.1) 3D Conformal 28 (84.9) NS Concomitant Boost No 205 (56.9) Yes 87 (77.7) 2.63 <0.001 NS Chemotherapy None 49 (43.0) Induction Alone 29 (39.7) Concurrent 214 (75.1) 2.96 < Baseline Dysphagia No 192 (57.3) Yes 101 (73.2) NS Baseline Weight Loss >10% No 252 (59.6) Yes 34 (85.0) NS Non-adherence to Swallowing Exercises No 72 (96) Yes 64 (49.2) 24.0 <0.001 <0.001 Abbreviations: g-tube, gastrostomy tube; NA, not applicable; NS, not significant, IMRT, intensity-modulated radiation therapy; 3D, 3-dimensional. The figures in boldface signify statistically significant values on multivariate analysis. Factors associated with prolonged g-tube dependence FIGURE 1. Gastrostomy tube (g-tube) placement is significantly reduced in patients who do not receive concurrent chemoradiotherapy. We defined prolonged g-tube dependence in our cohort as maintenance of a feeding tube past 6 months of placement. Univariate analyses showed that advanced T classification (T3/4), RT type, concomitant boost technique, and concurrent chemotherapy regimens were significantly associated with prolonged g-tube dependence (Table 5). Several factors associated with swallowing dysfunction and therapy were found to have a significant impact on the length of g-tube dependence. Prolonged g-tube dependence was significantly more likely in patients who had baseline dysphagia before treatment initiation (RR, 2.0; p <.001), those who were completely dependent on tube feedings and had no oral intake (nil per os, NPO) at the end of RT (RR, 2.1; p ¼.003), patients with >10% weight loss during RT (RR, 6.5; p ¼.002), and in patients who did not report adherence to swallowing exercises (RR, 4.74; p <.001). Moreover, patients who reported adherence to swallowing exercises were more likely to maintain PO intake at the end of treatment compared to nonadherent patients (63% vs 37%; p <.001). Smoking status and primary site of tumor were not significantly associated with prolonged g-tube dependence (p ¼.073 and p ¼.917, respectively). Multivariate analysis showed that RT type, weight loss greater than 10% during treatment, and adherence to swallowing exercises were independently associated with prolonged g-tube dependence past 6 months. Patients who reported nonadherence to swallowing exercises were 5 times more likely to maintain their g-tube beyond 6 months (p <.001; Figure 3). DISCUSSION The majority of oropharyngeal cancers are now attributable to oncogenic HPV infection and are seen in a younger patient population. 2 Promising survival rates in these patients with HPV-associated disease have led to a greater emphasis on treatment-related morbidities. 16 A number of investigators have examined nutritional support during RT and chemoradiation in cohorts that aggregate multiple sites of head and neck cancer, thus, limiting the ability to interpret and generalize findings to specific head and neck cancer sites. Alternatively, we have FIGURE 2. Gastrostomy tube (g-tube) placement is significantly reduced in patients who report adherence to swallowing exercises. HEAD & NECK DOI /HED NOVEMBER

5 BHAYANI ET AL. TABLE 5. Variables affecting G-tube dependence (defined as greater than 6 months after placement). Variable G-tube dependence (n, %) Risk Estimate Univariate Multivariate Smoking Never 34 (29.6) Former 48 (43.2) Current 25 (42.4) NA NS T Stage T1/2 34 (25.1) T3/4 73 (48.7) 2.82 <0.001 NS Radiation type IMRT 88 (34.0) 3D Conformal 19 (76.0) < Concomitant Boost No 66 (33.2) Yes 40 (47.1) 1.79 <0.001 NS Chemotherapy None 11 (23.4) Induction Alone 6 (20.6) Concurrent 90 (43.3) NS Baseline Dysphagia No 59 (31.1) Yes 48 (50.5) NS Weight Loss >10% during treatment No 64 (30.3) Yes 33 (57.9) NPO at end of treatment No 52 (30.2) Yes 55 (48.7) NS Non-adherence to swallowing exercises No 39 (55.7) Yes 14 (21.9) 4.95 <0.001 <0.001 Abbreviations: g-tube, gastrostomy tube; NA, not applicable; NS, not significant, IMRT, intensity modulated radiation therapy; 3D, 3-dimensional. The figures in boldface signify statistically significant values on multivariate analysis. restricted our analysis of nutritional support to patients with oropharyngeal cancer treated with definitive RT, with or without chemotherapy, to determine predictors of g-tube outcomes in this clinically distinct subgroup of patients with head and neck cancer. Our multivariable analysis identified concurrent chemotherapy and adherence to swallowing exercise as independent factors that influence rates of g-tube placement in patients with oropharyngeal cancer. In addition, prolonged g-tube dependence (>6 months) was independently associated with 3D-conformal radiotherapy technique, weight loss >10% during treatment, and adherence to swallowing exercises. Other variables that predisposed to g-tube placement and prolonged dependence in our study included advanced T classification, concomitant boost fractionation, and baseline functional status. Multiple reports have shown that prophylactic feeding tubes prevent significant treatment-related weight loss and allow patients to complete treatment without interruption These reports also advocate that placement of prophylactic feeding tubes decreases time for functional recovery and consequently, g-tube dependence. However, 38% of patients with oropharyngeal tumors in our study did not require feeding tubes at any point during or after treatment and the majority of patients who did require a feeding tube had one placed during RT. Additionally, no patient required a treatment break for tube placement. At our institution, in addition to thorough medical scrutiny, patients also undergo close surveillance of nutritional status and swallowing function before, during, and after RT. We, therefore, believe careful observation and monitoring of both medical and functional status, likely allows a high proportion of patients to maintain oral nutrition, thereby avoiding unnecessary placement of feeding tubes during treatment. Our findings are consistent with other investigations that show 20% to 60% of patients may avoid feeding tube placement during RT, and that prophylactically placed feeding tubes often go unused We agree with other practitioners who reserve feeding tube placement for highrisk patients and those who cannot safely maintain oral intake throughout RT given the ability of many patients to maintain oral nutrition during RT therapy along with the adverse effect g-tubes may have on long-term swallowing function. In any case, we also believe that a more thorough understanding of the clinical factors associated with g-tube placement is needed to identify high-risk patients to guide these clinical decisions, as there is currently no evidencedbased consensus on the issue. 15 Treatment intensification with concurrent chemotherapy and accelerated fractionation schedules were associated with significantly higher rates of g-tube placement and prolonged g-tube dependence. Although the addition of concurrent chemotherapy was independently associated with g-tube outcomes, induction chemotherapy alone did not affect g-tube placement rates in our cohort, consistent with previous data that show swallowing function is not affected by chemotherapy alone. 26 Despite the small percentage of patients (7.2%) in our study who received 3D conformal treatment, we also found the use of 3D conformal RT techniques to be significantly associated with increased rates of g-tube placement and prolonged tube dependence compared with the use of IMRT. Although radiotherapy intensification has been shown to improve locoregional control in patients with oropharyngeal FIGURE 3. Length of gastrostomy tube (g-tube) dependence is significantly decreased in patients who report adherence to swallowing exercise regimen HEAD & NECK DOI /HED NOVEMBER 2013

6 GASTROSTOMY TUBE PLACEMENT IN OROPHARYNGEAL CANCER cancer, the cost has been increased severity and duration of treatment-related toxicity leading to increased g-tube dependence More conformal planning with IMRT that restricts the dose to pharyngeal musculature uninvolved with the tumor has been shown to reduce significant dysphagia and prolonged g-tube dependence These results were confirmed in our analysis that showed significantly lower rates of g-tube placement and prolonged dependence in our patient subset who received IMRT. Baseline clinical variables that predict for increased mucosal toxicity during treatment were also identified in our study. Patients with advanced stage tumors of the oropharynx are more apt to report dysphagia and baseline weight loss. Our results found these patients were more likely to have a g-tube placed. This finding is consistent with previous reports that patients with advanced tumor stage and pretreatment dysphagia are more likely to have weight loss during treatment. 20,35 Interestingly, smoking status at baseline did not significantly predict g-tube placement or prolonged tube dependence in our study. In our accompanying article that analyzes g-tube rates and dependence in patients with tumors of the hypopharynx (Bhayani et al 36 ), we found that smoking can contribute to mucosal toxicity, increase g-tube placement, and dependence similar to the findings in other reports. Our results may be different because only 21% of our patients reported that they were currently smoking. Although current smokers did have a higher proportion of g-tube placement and prolonged dependence, the results were not statistically significant. The goal of functional organ preservation in patients with head and neck cancer is to maintain the patient s baseline speech and swallow function without compromising survival. Patients with cancer of the oropharynx experience significant impact to swallowing function because of the critical role the base of tongue and the pharyngeal constrictors play in the normal propulsion of food through the pharynx. 37,38 Prophylactic G-tube placement in patients with head and neck cancer has been found to increase late esophageal toxicity, stricture, and atrophy of pharyngeal musculature. 13,30,39,40 In addition, Gillespie et al 13 found significant correlation with dysphagia scores in patients who were NPO 2 weeks or more during chemoradiotherapy. These findings correlate with our results that patients who were NPO at the end of treatment were 2 times more likely to have prolonged g-tube dependence. Therefore, practitioners should encourage patients to maintain PO intake as much as possible during treatment. Dietary modifications and swallowing strategies can be prescribed by the speech pathologist to minimize aspiration risk and maintain maximal PO intake. The benefit of prophylactic swallowing therapy is increasingly supported by clinical studies. To our knowledge, this is the first study that objectively documents an independent association between adherence to swallowing exercises during RT and reduced rates of g-tube placement and length of g-tube dependence in patients with oropharyngeal tumors. Prophylactic swallowing therapy encourages ongoing use of the swallowing musculature during treatment by avoiding NPO periods and providing targeted preventive swallowing exercises. Favorable outcomes reported in patients who receive preventive swallowing exercises include superior swallowing-related quality of life scores, 41,42 better base of tongue retraction and epiglottic inversion, 43 and larger postradiotherapy muscle mass and T2 signal intensity of the genioglossus, mylohyoid, and hyoglossus. 44 Thus, it is the practice at our institution to prescribe preventive swallowing exercise to all patients before definitive radiotherapy or chemoradiotherapy for head and neck cancer. Patient referral to speech pathology is essential for the functional rehabilitation of patients with oropharyngeal carcinoma who are undergoing RT. The speech pathologist provides therapeutic swallowing exercises that the patient can perform at home. Only 49% of patients who reported adherence to swallowing exercises received a g- tube compared to 96% of patients who did not adhere to the exercise regimen. These results were significant on univariate and multivariate analyses. More important, only 20% of patients who reported adherence to swallowing exercises maintained a g-tube past 6 months compared with 56% of patients who were nonadherent to swallowing exercises. Adherence to swallowing exercises also contributed to increased likelihood of maintaining PO intake at the end of RT, and patients who reported nonadherence to swallowing exercises were 5 times more likely to maintain their g-tube beyond 6 months. These results emphasize the critical role of the speech pathologist on the multidisciplinary team. Interestingly, a recent report found patients are more likely to remain adherent to therapeutic exercise regimens when the speech pathologist is an active member of the multidisciplinary team. 45 The major strengths of this study are the large sample size and the analysis of a single subsite treated with a nonsurgical therapy, which eliminates the confounding variables associated with other subsites of disease and local effects of surgery. Although we were unable to assess the effect of HPV-positive oropharyngeal carcinoma in g-tube practices and swallowing outcomes, this investigation will be vital to future studies as the incidence of HPV-associated disease continues to rise. Furthermore, our ability to definitively determine predictors of g-tube outcomes was limited by the use of a retrospective, observational study design. Therefore, future studies that are prospectively designed will be needed to further evaluate and predict g-tube placement and dependence. CONCLUSION G-tube placement and dependence is affected by multiple variables in patients with oropharyngeal cancer undergoing nonsurgical therapy. From our experience and data, all patients with oropharyngeal carcinoma undergoing RT would benefit from early referral to a speech pathologist to begin a proactive swallowing exercise regimen. Patient adherence to exercise regimens is critical to reduce longterm use and dependence on feeding tubes. REFERENCES 1. 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