Aspiration risk and postoperative radiation for head and neck cancer.

The aim of the study was to assess the aspiration risk following postoperative radiation for head and neck cancer. Thirty-seven patients had Modified Barium Swallow before and following treatment. Dysphagia severity was graded from 1 to 7. Before treatment there were sixteen grade 1, seventeen grade 2, three grade 3 and one grade 5. Following postoperative radiation, two patients had grade 1, eleven patients had grade 2, thirteen patients had grade 3, four patients had grade 4, four patients had grade 5, one patients had grade 6, and two patients had grade 7. Nineteen percent (7/37) of the patients developed aspiration (grade 5-7). Aspiration is life-threatening and may develop for all tumor sites and stages.

Long-term aspiration following treatment for head and neck cancer.

BACKGROUND: Dysphagia and aspiration are long-term complications with life-threatening consequences following treatment of head and neck cancer. We would like to assess the prevalence of aspiration in patients with long-term persistence of dysphagia (1 year or more) following treatment for head and neck cancer and to identify potential risk factors of aspiration. METHODS: Modified barium swallow (MBS) examinations were performed in cancer-free patients who complained of dysphagia following treatment for head and neck cancer. The severity of the dysphagia was graded on a scale of 1-7. RESULTS: Between 1992 and 2004, 74 patients with dysphagia underwent MBS 12-152 months following treatment (median 29 months). There were 2 grade 1, 22 grade 3, 21 grade 4, 11 grade 5, 7 grade 6, and 11 grade 7 cases. Twenty-nine patients (39%) had long-term aspiration at a median follow-up of 25 months (range 12-82). Eighteen patients (24%) required permanent gastrostomy because of severe aspiration. Type of treatment and disease stage did not seem to influence long-term aspiration risk. CONCLUSION: Patients with long-term dysphagia after treatment for head and neck cancer are at risk of aspiration. MBS should be performed to identify these patients.

Dysphagia severity and aspiration following postoperative radiation for locally advanced oropharyngeal cancer.

UNLABELLED: The aim of the present study was to assess dysphagia severity following postoperative radiation for locally advanced oropharyngeal cancer. PATIENTS AND METHODS: Eighteen patients with oropharyngeal carcinoma had undergone postoperative radiation. There were eight base of tongue, eight tonsils, and two soft palate carcinomas. All the patients had undergone modified barium swallow (MBS) to assess the persistence of dysphagia (more than one month) post-treatment. All the patients were cancer-free at the time of the swallowing study. Dysphagia severity was graded as 1-7. RESULTS: At a median follow-up of 12 months, there were three grade 2, four grade 3, two grade 4, five grade 5, two grade 6, and two grade 7. Only three patients (17%) had normal swallow post-treatment. Six patients (33%) had mild to moderate dysphagia (grade 3-4). Nine patients (50%) developed aspiration (grade 5-7). Among the patients who developed aspiration, four (22%) required tube feeding for severe aspiration. CONCLUSION: Long-term (more than one year) dysphagia following postoperative radiation for oropharyngeal cancer may be symptomatic of permanent damage to the swallowing mechanism. Evaluation of patients who complain of persistence of dysphagia a year or more following treatment should include MBS, because of the increased risk of aspiration.

Impact of swallowing therapy on aspiration rate following treatment for locally advanced head and neck cancer.

This study examines the efficacy of swallowing therapy in cancer-free patients who developed aspiration following treatment for locally advanced head and neck cancer. The records of 41 patients who underwent swallowing therapy for aspiration were reviewed. All patients were cancer free at a median follow-up of 25 months (6-150 months). Their treatment were respectively chemoradiation (24), and postoperative radiation (17). All patients had two or more modified barium swallow (MBS). Dysphagia severity was graded from 1 to 7. Dysphagia grade was compared before and following swallowing therapy. Before swallowing therapy, there were 16 grade 5 (trace aspiration), and 25 grade 6-7 (severe aspiration). In the chemoradiation group, there were nine grade 5, five grade 6, and 10 grade 7. Corresponding numbers for the postoperative group were: seven grade 5, seven grade 6, and three grade 7. Following swallowing therapy, there were six grade 3, seven grade 4, 10 grade 5, six grade 6, and 12 grade 7. In the chemoradiation group, there were four grade 3, three grade 4, four grade 5, five grade 6, and eight grade 7. In the postoperative group, there were two grade 3, four grade 4, six grade 5, one grade 6, and four grade 7. Overall, 13 patients (32%) had improvement of their dysphagia severity. Seven of them were in the chemoradiation group (29%), and six (35%) were in the postoperative group. Among 25 patients who presented with grade 6-7 aspiration, only nine (36%) improved to grade 5 or less. Four of them (27%) were in the chemoradiation group, and five (29%) were in the postoperative group. Swallowing therapy is effective to improve dysphagia severity and reduce the need for tube feedings. However, a significant number of patients still suffered from chronic severe aspiration. New strategies must be devised to improve their outcome.

Aspiration occurence during chemoradiation for head and neck cancer.

AIM: To assess the risk of developing aspiration during chemoradiation for head and neck cancer. PATIENTS AND METHODS: A retrospective review of 114 patients who underwent concurrent chemoradiation for locally advanced head and neck cancer was undertaken. Patients were determined as having aspiration if they had pneumonia on chest-X-ray (CXR) and/or had documented aspiration on the modified barium swallow (MBS) during their treatment. RESULTS: Fifteen patients (13%) developed aspiration during chemoradiation. Twelve patients (10%) had aspiration demonstrated on CXR alone (9 patients) or combined with MBS (3 patients). Three patients (3%) had aspiration on MBS alone. Three of the six patients with aspiration observed on MBS had normal swallowing on their pretreatment MBS. All 15 patients had severe mucositis and neutropenia at the time of the aspiration. Despite broad-spectrum antibiotics and supportive care, six patients (5%) died. CONCLUSION: Aspiration may develop during chemoradiation for head and neck cancer because of radiation-induced altered swallow.

Evaluation and management of swallowing dysfunction following chemoradiation for head and neck cancer.

PURPOSE OF REVIEW: Concurrent chemoradiation offers excellent local control and survival for patients with locally advanced head and neck cancer while allowing anatomic organ preservation. Treatment toxicity is significant, however, often resulting in long-term dysphagia and aspiration. We review the prevalence of post-treatment swallowing dysfunction, describe current thinking about its pathogenesis and management, and signal possible directions for future research. RECENT FINDINGS: Apoptosis from chemoradiation induces abnormal motility of the upper aerodigestive tract, resulting in stasis of the bolus in all phases of the swallow, and resulting in aspiration when the larynx is not protected during swallow. Long-term scarring may result in stenosis of the upper digestive tract. Recent findings suggest the role of transforming growth factor beta 1 in the pathogenesis of normal tissue damage and late scarring induced by radiation. Aspiration is often silent, and therefore a modified barium swallow or videofluoroscopy are required for its diagnosis. Swallowing therapy may improve swallowing efficiency and reduce the aspiration rate, and should be started immediately. SUMMARY: Successful management of swallowing dysfunction following chemoradiation is a complex undertaking requiring a team approach. Collaboration among different specialists (physicians, speech pathologist, dietitian, and psychologists) remains the key to a desirable outcome.

Aspiration rate following chemoradiation for head and neck cancer: an underreported occurrence.

BACKGROUND AND PURPOSE: We would like to assess the prevalence of aspiration before and following chemoradiation for head and neck cancer. PATIENTS AND METHODS: We reviewed retrospectively the Modified Barium Swallow (MBS) in 63 patients who underwent concurrent chemotherapy and radiation for head and neck cancer. MBS was performed prior to treatment to determine the need for immediate gastrostomy tube placement. MBS was repeated following treatment to assess the safety of oral feeding prior to removal of tube feeding. All patients were cancer free at the time of the swallowing study. No patient had surgery. Dysphagia severity was graded on a scale of 1-7. Tube feedings were continued if patients were diagnosed to have severe aspiration (grade 6-7) or continued weight loss. Patients with abnormal swallow (grade 3-7) received swallowing therapy following MBS. RESULTS: Before treatment, there were 18 grade 1, 18 grade 2, 9 grade 3, 8 grade 4, 3 grade 5, 3 grade 6, and 4 grade 7. Following chemoradiation, at a median follow-up of 2 months (1-10 months), one patient had grade 1, eight patients had grade 2, nine patients had grade 3, eight patients had grade 4, 13 patients had grade 5, seven patients had grade 6, and 11 patients had grade 7. Six patients died from aspiration pneumonia (one before, three during, and two post-treatment), and did not have the second MBS. Overall, 37/63 (59%) patients developed aspiration, six of them (9%) fatal. If we excluded the 10 patients who had severe aspiration at diagnosis and the six patients who died from pneumonia, the prevalence of severe aspiration was 33% (21/63). CONCLUSIONS: Aspiration remained a significant morbidity following chemoradiation for head and neck cancer. Its prevalence is underreported in the literature because of its often silent nature. Diagnostic studies such as MBS should be part of future head and neck cancer prospective studies to assess the prevalence of aspiration, and for rehabilitation.

Safety and effectiveness of prophylactic gastrostomy tubes for head and neck cancer patients undergoing chemoradiation.

BACKGROUND: We would like to assess the safety and effectiveness of prophylactic percutaneous endoscopic gastrostomy (PEG) tube feedings during concurrent chemoradiation for head and neck cancer. METHODS: Patients who underwent chemotherapy and radiation for head and neck malignancies were evaluated for their ability to resume oral feeding following treatment. All patients underwent PEG tube placement prior to the treatment because of the expected mucositis. Gastrostomy tubes were removed following treatment when the patients were able to resume oral feedings without aspiration. RESULTS: Between March 1999 and 2006, 104 patients with locally advanced head and neck cancer underwent concurrent chemotherapy and radiation. One patient declined placement of gastrostomy tube. Ninety patients (86%) developed grade 3-4 mucositis during chemoradiation. Five patients died during treatment from aspiration pneumonia and sepsis. One hundred two patients lost weight during treatment. The mean and median weight loss during concurrent therapy was, respectively, 8.5 and 8 kg (1-23.5 kg). Following treatment, tube feedings were continued 1-41 months (mean: 8 months; median: 5 months) because of continued weight loss, chronic dysphagia, or aspiration. At a median follow-up of 19 months (1-62 months), no patient developed serious complications from tube feedings. CONCLUSION: Dysphagia resulting from the severe mucositis produced severe weight loss, despite tube feedings. Gastrostomy tube feedings are safe. Gastrostomy tubes should be placed prophylactically for patients undergoing chemoradiation for head and neck cancer.

Evolution of chronic dysphagia following treatment for head and neck cancer.

We would like to assess the evolution of chronic dysphagia (1 year or more) following treatment for head and neck cancer. Modified barium swallow (MBS) examinations were performed in cancer-free patients who complained of dysphagia following treatment for head and neck cancer. The severity of the dysphagia was graded on a scale of 1-7. Each patient had at least 2 MBS. Severity of dysphagia was compared between the first and last MBS study to determine whether the swallowing dysfunction had returned to normal. Patients with complaint of dysphagia and normal MBS also underwent a regular barium swallow to assess the structural integrity of the pharynx and esophagus. Between 1996 and 2001, 25 patients with dysphagia underwent repeat MBS following treatment. Swallowing dysfunction did not return to normal in the majority of the patients. At a median time of 26 months following treatment (range 15-82 months), only two patient (8%) had normalization of the swallowing. The severity of dysphagia decreased in eight patients (32%), remained unchanged in 12 patients (48%), and worsened in five patients (20%). Eight patients (32%) still had aspiration problems at 12-83 months following treatment. Six patients (24%) required dilation because of pharyngeal stenosis. Three patients who required dilation had improvement of the dysphagia severity. Chronic dysphagia is a relentless process possibly due to excessive scarring. Patients with chronic dysphagia are at risk of malnutrition, and aspiration. Management of chronic dysphagia requires a team approach with nutritional support, psychological counseling, dilation, and tube feedings when indicated.

Dysphagia severity following chemoradiation and postoperative radiation for head and neck cancer.

OBJECTIVE: The purpose of the study is to evaluate dysphagia severity following chemoradiation and postoperative radiation for head and neck cancer, and particularly the aspiration risk because of its potential life-threatening consequence. MATERIALS AND METHODS: We reviewed retrospectively the modified barium swallow (MBS) results in 110 patients who complained of dysphagia following chemoradiation (57) and postoperative radiation (53) of their head and neck cancer. Patients were selected if they were cancer free at the time of the swallowing study. Dysphagia severity was graded on a scale of 1-7. Patients were grouped according to the dysphagia severity: mild (grades 2-3), moderate (grades 4-5), and severe (grades 6-7). RESULTS: Mean and median dysphagia grades were 4.84/5 and 4.12/4 for chemoradiation and postoperative radiation respectively. The mean difference between the two groups is statistically significant (p=0.02). Mild dysphagia occurred in 13 patients (22%) of the chemoradiation group and 17 (32%) of the postoperative group. Corresponding number for the moderate group was 25 (43%) and 25 (48%), respectively. Severe dysphagia was significant in the chemoradiation group (34%) compared to the postoperative group (19%). However, the difference was not statistically significant (p=0.29). There was a higher proportion of patients with large tumor (T3-T4) in the chemoradiation group who developed severe dysphagia. CONCLUSION: Dysphagia remained a significant morbidity of chemoradiation and postoperative radiation for head and neck cancer. Dysphagia may be more severe in the chemoradiation group because of the higher proportion of patients with large tumor, the high radiation dose, and a high number of oropharyngeal tumors. Aspiration occurred in both groups. Diagnostic studies such as MBS should be part of future head and neck cancer prospective studies to assess the prevalence of aspiration, as it may be silent.

Impact of dysphagia on quality of life after treatment of head-and-neck cancer.

PURPOSE: To evaluate the quality of life (QOL) associated with dysphagia after head-and-neck cancer treatment. METHODS AND MATERIALS: Of a total population of 104, a retrospective analysis of 73 patients who complained of dysphagia after primary radiotherapy (RT), chemoradiotherapy, and postoperative RT for head-and-neck malignancies were evaluated. All patients underwent a modified barium swallow examination to assess the severity of dysphagia, graded on a scale of 1-7. QOL was evaluated by the University of Washington (UW) and Hospital Anxiety and Depression questionnaires. The QOL scores obtained were compared with those from the 31 patients who were free of dysphagia after treatment. The QOL scores were also graded according to the dysphagia severity. RESULTS: The UW and Hospital Anxiety and Depression scores were reduced and elevated, respectively, in the dysphagia group compared with the no dysphagia group (p = 0.0005). The UW scores were also substantially lower among patients with moderate-to-severe (Grade 4-7) compared with no or mild (Grade 2-3) dysphagia (p = 0.0005). The corresponding Hospital Anxiety (p = 0.005) and Depression (p = 0.0001) scores were also greater for the moderate-to-severe group. The UW QOL subscale scores showed a statistically significant decrease for swallowing (p = 0.00005), speech (p = 0.0005), recreation/entertainment (p = 0.0005), disfigurement (p = 0.0006), activity (p = 0.005), eating (p = 0.002), shoulder disability (p = 0.006), and pain (p = 0.004). CONCLUSION: Dysphagia is a significant morbidity of head-and-neck cancer treatment, and the severity of dysphagia correlated with a compromised QOL, anxiety, and depression. Patients with moderate-to-severe dysphagia require a team approach involving nutritional support, physical therapy, speech rehabilitation, pain management, and psychological counseling.

Severity and duration of chronic dysphagia following treatment for head and neck cancer.

UNLABELLED: The purpose of this investigation was to evaluate chronic dysphagia (lasting 3 or more months) following treatment for head and neck cancer. Since dysphagia is a common sequela post therapy in cancer survivors, it may be helpful for the clinician to be aware of the persistence of dysphagia as well as its usual severity. Modified Barium Swallow (MBS) examinations were performed in cancer-free patients who complained of dysphagia following treatment for head and neck cancer. The severity of the dysphagia was graded on a scale of 1 to 7. Each patient had sequential MBS and underwent swallowing therapy in between. The severity of dysphagia was compared between the first and last MBS study to determine whether the swallowing function had returned to normal. RESULTS: Between 1996 and 2004, 12 patients with dysphagia underwent repeated MBS following treatment. Swallowing function did not return to normal in all patients. At a median time of 29 months following treatment (range 8 to 94 months), the severity of dysphagia decreased in 8 patients (67%), remained unchanged in 3 patients (25%) and worsened in 1 patient (8%). Chronic dysphagia following treatment is unlikely to resolve with time despite rehabilitation therapy. Excessive scarring following treatment may be responsible for the persistence and severity of dysphagia. Physicians should be aware of the long-term effects of dysphagia on patient nutrition and psychological well-being.

Analysis of factors influencing Dysphagia severity following treatment of head and neck cancer.

The aim was to assess the influence of treatment, tumor stages and sites on the severity of dysphagia following treatment. Sequential modified barium swallow (MBS) examinations were performed in patients who complained of chronic dysphagia following treatment of their head and neck cancer. Patients were selected if they were cancer free at their last MBS and had 2 or more MBS studies. Dysphagia severity was graded on a scale of 1 to 7. Dysphagia grade was compared between the first and last MBS to assess its evolution. Between 1996 and 2005, 63 patients with chronic dysphagia underwent MBS to assess dysphagia severity for nutritional support. Twenty-one patients (33%) had improvement of their dysphagia. Two of these patients (3%) achieved normalization of the swallowing. Twenty-five patients (40%) had no change of the dysphagia severity. Dysphagia grade increased in 17 patients (27%). Analysis of patient characteristics did not show any significant difference between these three groups of patients. MBS is a useful tool to monitor dysphagia severity and to identify aspiration risk. Stages of disease and treatment modality do not seem to impact on the course of dysphagia.

Prevalence of pharyngeal and esophageal stenosis following radiation for head and neck cancer.

OBJECTIVE: To evaluate the risk and outcome of pharyngoesophageal stenosis in patients who complained of dysphagia following radiation for head and neck cancer. DESIGN: Retrospective study. SETTING: Veterans Administration hospital. PATIENTS: Patients who complained of persistent dysphagia following radiation alone or combined with surgery or chemotherapy for head and neck cancer. Patients were selected if they were cancer free at the time of the swallowing study. All patients had modified barium swallow (MBS) and an endoscopic examination for initial evaluation of their dysphagia. Traditional barium swallow was requested when there was a suspicion of pharyngoesophageal stenosis on MBS. RESULTS: Two hundred twenty-two patients underwent MBS for evaluation of dysphagia posttreatment. Traditional barium swallow confirmed the diagnosis of pharyngeal (n = 2) or esophageal (n = 14) stenosis in 16 patients. Eight patients had esophageal stenosis on endoscopic examination. All patients underwent dilatation for relief of their dysphagia. The number of dilatations performed was, respectively, one in 12 patients, two in 4 patients, three in 3 patients, four in 3 patients, five in one patient, and six in one patient. CONCLUSION: Pharyngeal and/or cervical esophageal stenosis may be the cause of dysphagia following radiation for head and neck cancer. Esophageal dilatations often offer temporary relief of the dysphagia.

Risk of aspiration following radiation for non-nasopharyngeal head and neck cancer.

OBJECTIVE: We assessed the rate of aspiration following radiation for non-nasopharyngeal head and neck cancer. DESIGN: Retrospective study. SETTING: Veterans Administration Hospital. PATIENTS: Thirty-three patients who underwent radiation for head and neck cancer. Modified barium swallow was performed prior to and following treatment to assess the persistence of dysphagia and aspiration risk. All patients were cancer free at the time of the swallowing study. Dysphagia severity was graded from 1 to 7. RESULTS: Preradiation baseline dysphagia was observed as follows: 10 grade 1, 14 grade 2, 9 grade 3, and 1 grade 4. Following radiation, at a median follow-up of 3 months, nine patients had grade 1, eight patients had grade 2, six patients had grade 3, two patients had grade 4, three patients had grade 5, two patients had grade 6, and three patients had grade 7. Overall, 24% (8 of 33) of the patients developed aspiration (grades 5-7). Fifteen percent (5 of 33) of the patients had severe aspiration (grades 6-7) requiring tube feedings. All patients who developed severe aspiration continued to require tube feedings more than 1 year following treatment completion. CONCLUSION: Aspiration is a significant source of morbidity following radiation for non-nasopharyngeal head and neck cancer. Aspiration may develop for all tumour stages or sites. Diagnostic studies such as modified barium swallow should be included in future prospective head and neck cancer studies to assess the prevalence of aspiration because of its often silent nature.

Effectiveness of the cough reflex in patients with aspiration following radiation for head and neck cancer.

The effectiveness of the cough reflex in patients who aspirated following radiation for head and neck cancer was evaluated in 89 patients (49 chemoradiation, 33 postoperative radiation, and 7 radiation alone). All patients had modified barium swallow because of dysphagia. The cough reflex was graded as present and effective, ineffective, intermittently effective, or absent. All patients were cancer-free at the time of the swallowing study. The cough reflex was present and effective in 46 patients (52%), ineffective in 17 patients (19%), and absent in 26 patients (29%) on initial investigation. Among the 43 patients who had ineffective or absent cough reflex, their treatment was chemoradiation (26), postoperative radiation (13), and radiation alone (4). In 30 patients who had sequential modified barium swallow, the cough reflex was constantly effective, ineffective, or intermittently effective in 12 (40%), 13 (43%), and 5 (17%) patients, respectively. The cough reflex was frequently ineffective or absent in patients who aspirated following radiation for head and neck cancer. Cough may also be intermittently ineffective to protect the airways following radiation.

Aspiration rate following nonsurgical therapy for laryngeal cancer.

The aim of this study was to evaluate the aspiration rate following nonsurgical therapy, i.e. chemoradiation or radiation alone for laryngeal cancer. Modified barium swallow was performed in 43 patients who complained of dysphagia following chemoradiation (n = 22) or radiation alone (n = 21) for laryngeal cancer. Patients were selected if they were cancer free at the time of the swallowing study. Dysphagia severity was graded on a scale of 1-7. Patients were grouped according to the dysphagia severity: no aspiration (grade 1-4), and severe (grade 5-7). Mean and median dysphagia grades were 4.4/5 and 3.5/3 for chemoradiation and radiation, respectively. Aspiration occurred in 12 patients (54%) of the chemoradiation group and 7 (33%) of the radiation alone group (p = 0.13). There was a higher proportion of patients with large tumor (T3-T4) in the chemoradiation group (64%) compared to the radiation group (5%) (p = 0.0001). Aspiration is a significant source of morbidity in patients treated for laryngeal cancer with chemoradiation or radiation alone. Aspiration occurred in both groups. Although the observed difference in aspiration rates did not achieve statistical significance, the higher aspiration rate in the chemoradiation group may be due to a higher proportion of large tumors, to the additional toxic effect of chemotherapy, or to the small number of patients in both groups. Diagnostic studies such as modified barium swallow should be part of future laryngeal cancer prospective studies to assess the prevalence of aspiration as it may be silent.

Concurrent chemoradiation for locally advanced oropharyngeal cancer.

PURPOSE: The aim of this study was to assess the survival, pattern of failure, morbidity, and prognostic factors of concurrent chemoradiation for locally advanced oropharyngeal cancer. MATERIALS AND METHODS: A retrospective survey of patients who underwent chemotherapy and radiation for locally advanced oropharyngeal carcinoma at the Veteran Affairs North Texas Health Care System, Dallas, Tex. RESULTS: Between December 1999 and September 2004, 48 patients with locally advanced oropharyngeal cancer underwent concurrent chemotherapy and radiation. At a median follow-up of 23 months, the 3- and 5-year survival for the whole group were, respectively, 52% and 41%. Seventeen patients (35%) developed recurrences. There were 12 (25%) locoregional failures (6 local failures alone and 6 local and regional failures). Distant metastases developed in 8 patients (5 alone, 3 associated with locoregional failures). Four patients (8%) developed second primaries. No difference was observed in survival between base of tongue and tonsillar carcinoma (P = .32). The 5-year survival for T1-T2 and T3-T4 tumors was, respectively, 84% and 27% (P = .01). No patient with T1-T2 tumors developed distant metastases (P = .04). Forty-five patients (94%) developed toxicity grade 3 to 4 (40 mucositis and 26 hematological). The median weight loss was 18 lb (range, 0-47 lb). Eight patients (16%) developed aspiration pneumonia during and after treatment. Five patients (10%) died of aspiration (2 during and 3 post treatment). Four patients (8%) developed esophageal strictures requiring repeated dilatations post treatment. Two patients had radionecrosis (1 soft tissue and 1 bone) requiring hyperbaric oxygen. Eighteen patients (37%) had prolonged tube feedings (>3 months) after treatments because of severe dysphagia or aspiration. CONCLUSION: Concurrent chemoradiation provided good locoregional control for locally advanced oropharyngeal carcinoma. Patients with small tumors (T1-T2) had excellent survival. The poor prognosis associated with large tumors may be due to the risk of developing distant metastases. Acute and late toxicities remained significant. Aspiration pneumonia and severe dysphagia were the most prevalent complications of the combined modality approach.

Risks of clinically significant upper gastrointestinal events with etodolac and naproxen: a historical cohort analysis.

BACKGROUND AND AIMS: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. METHODS: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. RESULTS: The incidence of CSUGI events was .78% and .24% for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was .99% and .24% for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of .39 (95% confidence interval, .20-.76; P = .006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. CONCLUSIONS: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.