A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.

PURPOSE: To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA). METHODS AND MATERIALS: The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed. RESULTS: We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN. CONCLUSIONS: This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis.

Implant time and process efficiency for CT-guided high-dose-rate brachytherapy for cervical cancer.

PURPOSE: This investigation details the time and teamwork required for CT-guided tandem and ring high-dose-rate brachytherapy. METHODS AND MATERIALS: From 2010 to 2012, 217 consecutive implantations were identified on 52 patients. We gathered key workflow times: preoperative, applicator insertion, CT image, treatment planning, treatment, patient recovery, and total time in clinic. Linear fixed-effects models were used, and key workflow times were the outcome variables and factors including age, body mass index, stage, outside referral, number of implant per patient, number of implants per day, and year of implantation were examined as fixed effects. RESULTS: Of the 52 patients, 62% of the patients were Fédération Internationale de Gynécologie et d'Obstétrique Stage 2B, 88% were treated with concurrent chemotherapy, and 23% were treated at an outside facility and referred for the procedure. The mean times (minutes) for each step were as follows: preoperative evaluation, 93; insertion, 23; imaging, 45; treatment planning, 137; treatment, removal, and recovery, 115; total clinic time, 401. For the insertion time, the greater implant number per patient was significantly associated with a decreased total insertion time, with and without adjusting for other covariates, p = 0.002 and p = 0.0005, respectively. Treatment planning time was expedited with increasing number of implant per patient and comparing treatment times in 2012 with those in 2010, p = 0.01 and p < 0.0001, respectively. CONCLUSIONS: Gynecologic brachytherapy requires a skillfully coordinated and efficient team approach. Identifying critical components and the time required for each step in the process is needed to improve the safety and efficiency of brachytherapy. Continuous efforts should be made to enhance the optimal treatment delivery in high-dose-rate gynecologic brachytherapy.

Tobacco use among long-term survivors of head and neck cancer treated with radiation therapy.

PURPOSE: The objective of this study is to determine the prevalence of tobacco consumption (i.e., cigarette use) among survivors of head and neck cancer after treatment with radiation therapy (RT). METHODS AND MATERIALS: A longitudinal study was conducted with 230 patients previously treated with RT for squamous cell carcinoma of the head and neck. All patients were clinically without evidence of disease and had a minimum of 1 year follow-up. Patients were summarily asked about the use of tobacco products at each follow-up visit. To explore for associations between potential predictors of post-RT smoking, the Chi-square test and Spearman's correlation coefficient were employed. RESULTS: The percentage of patients who were actively smoking was 21%, 21%, and 20%, at 1, 2, and 3 years post-RT, respectively. When the analysis was limited to patients with a former smoking history (i.e., excluding all never-smokers), these percentages increased to 32%, 27%, and 25%, respectively. The intensity of smoking at follow-up ranged from one cigarette daily to 2.5 packs daily. Forty-two of 76 (55%) patients who were smoking at diagnosis were found to be smoking at 1-year follow-up compared to 7 of 154 patients who were not (p < 0.001). The only factor that significantly predicted for persistent smoking at follow-up was the presence of a preexisting psychiatric condition (most commonly, a mood disorder) at initial cancer diagnosis. CONCLUSIONS: A significant proportion of former smokers are actively smoking during follow-up despite having completed intensive RT and having their cancers evidently under control. Innovative interventional approaches to target those at highest risk for continued smoking are warranted.

Quality of life among long-term survivors of head and neck cancer treated by intensity-modulated radiotherapy.

IMPORTANCE: Radiation therapy to the head and neck has traditionally been associated with adverse effects that can affect oral health and physical functioning. Although intensity-modulated radiotherapy (IMRT) has been widely adopted as a means of decreasing toxic effects, limited clinical data exist on its potential effect on long-term quality of life. OBJECTIVE: To analyze quality of life among long-term survivors of head and neck cancer treated with IMRT. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional analysis studied 50 consecutive long-term survivors of head and neck cancer from a comprehensive cancer center who had previously undergone IMRT that required bilateral neck irradiation for locally advanced disease. All patients were clinically without evidence of recurrent disease and had at least 5 years of follow-up. MAIN OUTCOMES AND MEASURES: The University of Washington Quality of Life (UW-QOL) scores were reviewed for all study participants. The UW-QOL questionnaire consists of 12 domains that pertain to the degree of quality of life in the categories of pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood, and anxiety. RESULTS: Five years after completion of IMRT, 42 patients (84%) reported that their health-related quality of life was "much better" or "somewhat better" than at the time of cancer diagnosis. With respect to recent health-related quality of life during the preceding 7 days at the time of completing the UW-QOL questionnaire, 40 patients (80%) treated with IMRT reported "outstanding" or "very good" levels of functioning. Five years after completion of treatment, 41 (82%) rated their overall quality of life as "outstanding" or "very good." The lowest domain score on the UW-QOL questionnaire at 5 years pertained to salivary dysfunction. However, 42 patients (84%) reported saliva "of normal consistency" or "less saliva than normal but enough" compared with 8 (16%) reporting "too little saliva." No patient reported having "no saliva." CONCLUSIONS AND RELEVANCE: Our findings add to the body of literature that supports the acceptance of IMRT as standard treatment for head and neck cancer. The fact that most 5-year survivors were satisfied with their quality of lives points to the ability of IMRT to preserve long-term functioning.

Depression among long-term survivors of head and neck cancer treated with radiation therapy.

IMPORTANCE: The diagnosis and subsequent treatment of head and neck cancer can have a potentially devastating impact on psychosocial functioning. Although the long-term physical adverse effects of radiation therapy (RT) for head and neck cancer have been well described, relatively few studies have evaluated psychosocial functioning after treatment. OBJECTIVE: To determine the prevalence of self-reported depression among survivors of head and neck cancer returning for follow-up after being treated with RT. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analysis among 211 comprehensive cancer center patients with squamous cell carcinoma of the head and neck, who had been previously treated with RT and were disease-free with at least 1 year of follow-up. Patients with a history of mood disorder, use of mental health services in the past, or previous or current use of antidepressants or anxiolytics, excluding sleep medications, were specifically excluded. INTERVENTIONS: The University of Washington Quality of Life instrument (UW-QOL), a brief, previously validated, self-administered questionnaire, was used to analyze rates of depression. MAIN OUTCOMES AND MEASURES: The UW-QOL assigned scores of 0, 25, 50, 75, and 100 subjective responses of mood being "extremely depressed," "somewhat depressed," "neither in a good mood or depressed," "generally good," and "excellent," respectively. RESULTS: The mean mood score did not differ at 1, 3, and 5 years after treatment, with scores of 52.0, 55.7, and 62.1, respectively. The proportion of patients who reported their mood as "somewhat depressed" or "extremely depressed" was 17%, 15%, and 13% at 1, 3, and 5 years, respectively. Variables that were significantly associated with post-RT depression included the presence of tracheostomy tube or laryngeal stoma (P = .01), gastrostomy tube dependence (P = .01), and continued smoking at the time of follow-up (P < .001). Among the patients reporting their mood as either "somewhat depressed" or "extremely depressed" at 1, 3, and 5 years, the proportion using antidepressants at the time was 6%, 11%, and 0%, respectively. The corresponding proportion of patients actively undergoing or seeking psychotherapy and/or counseling was 3%, 6%, and 0%, respectively. CONCLUSIONS AND RELEVANCE: Despite a relatively high rate of depression among patients with head and neck cancer in the post-RT setting, mental health services are severely underutilized.

Late esophageal toxicity after radiation therapy for head and neck cancer.

BACKGROUND: The aim of this study was to determine the incidence of esophageal toxicity after radiation therapy for head and neck cancer. METHODS: The records of 211 patients treated by radiation therapy for head and neck cancer were reviewed to identify those with dysphagia lasting more than 90 days after therapy. Late toxicity criteria established by the Radiation Therapy Oncology Group were used to score the symptoms. RESULTS: The incidence of grade 3+ esophageal toxicity at 3 and 6 months was 30% and 19%, respectively. The rate of gastrotomy-tube dependence at 3 and 6 months was 20% and 11%, respectively. Hypopharyngeal and unknown primary site (p = .01, for both), T4 disease (p = .01), and the use of concurrent chemotherapy (p = .001) were associated with grade 3+ esophageal toxicity and stricture formation. CONCLUSION: A significant proportion of patients exhibit symptoms of esophageal toxicity after radiation therapy for head and neck cancer. Therefore, preventive strategies need further investigation.

Clinical-dosimetric analysis of measures of dysphagia including gastrostomy-tube dependence among head and neck cancer patients treated definitively by intensity-modulated radiotherapy with concurrent chemotherapy.

PURPOSE: To investigate the association between dose to various anatomical structures and dysphagia among patients with head and neck cancer treated by definitive intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy. METHODS AND MATERIALS: Thirty-nine patients with squamous cancer of the head and neck were treated by definitive concurrent chemotherapy and IMRT to a median dose of 70 Gy (range, 68 to 72). In each patient, a gastrostomy tube (GT) was prophylacticly placed prior to starting treatment. Prolonged GT dependence was defined as exceeding the median GT duration of 192 days. Dysphagia was scored using standardized quality-of-life instruments. Dose-volume histogram (DVH) data incorporating the superior/middle pharyngeal constrictors (SMPC), inferior pharyngeal constrictor (IPC), cricoid pharyngeal inlet (CPI), and cervical esophagus (CE) were analyzed in relation to prolonged GT dependence, dysphagia, and weight loss. RESULTS: At 3 months and 6 months after treatment, 87% and 44% of patients, respectively, were GT dependent. Spearman's rho analysis identified statistical correlations (p < 0.05) between prolonged GT dependence or high grade dysphagia with IPC V65, IPC V60, IPC Dmean, and CPI Dmax. Logistic regression model showed that IPC V65 > 30%, IPC V60 > 60%, IPC Dmean > 60 Gy, and CPI Dmax > 62 Gy predicted for greater than 50% probability of prolonged GT dependence. CONCLUSION: Our analysis suggests that adhering to the following parameters may decrease the risk of prolonged GT dependence and dysphagia: IPC V65 < 15%, IPC V60 < 40%, IPC Dmean < 55 Gy, and CPI Dmax < 60 Gy.