A randomized study comparing the nutritional effects of radiotherapy with cetuximab versus cisplatin in patients with advanced head and neck cancer.

BACKGROUND: Head and neck cancer (HNC) patients have a high risk of developing malnutrition. This randomized study aimed to compare the effect of weekly cisplatin or cetuximab combined with radiotherapy on weight loss at 3 months after treatment was started. Secondary outcomes were the prevalence of malnutrition using the Global Leadership Initiative on Malnutrition (GLIM) criteria, feeding tube dependence and health related quality of life from a nutritional perspective. METHODS: Patients from the ARTSCAN III study with advanced HNC were assessed for weight, body composition, enteral tube dependence and selected quality-of-life scores (EORTC QLQ-C30 and QLQ-H&N35) at diagnosis and 6 weeks 3, 6 and 12 months after treatment initiation. RESULTS: Of the 80 patients, 38 and 42 were randomized to receive cetuximab and cisplatin treatment, respectively. There was no significant difference in weight loss at 3 months between the two study groups. However, the cetuximab group had significantly less weight loss, fewer enteral feeding tubes and better physical functioning at the end of treatment but more pain-related problems 3 months after treatment initiation. No differences between the groups were found at 6 and 12 months. The prevalence of malnutrition was not significantly different at any time point. CONCLUSION: The hypothesized benefit of concomitant treatment with cetuximab over cisplatin regarding the prevalence of malnutrition was not supported by this study.

Fatigue in Long-Term Head and Neck Cancer Survivors From Diagnosis Until Five Years After Treatment.

OBJECTIVES: Fatigue due to cancer is a challenging symptom that might be long-lasting after cancer treatment. The aim of this study was to follow the development of fatigue among head and neck cancer (HNC) patients prospectively and longitudinally and to analyze predictors for acute and chronic fatigue. METHODS: HNC patients treated with curative intent were included at diagnosis and completed the following questionnaires multiple times, up to 5 years after treatment: the EORTC QLQ-FA12 for fatigue, EORTC QLQ-C30, and HNC-specific EORTC QLQ-H&N35 together with an anxiety and depression questionnaire. Predictors of fatigue were evaluated at 3 months and 5 years after treatment. RESULTS: Of the 311 study participants, 74% responded at the 5-year follow-up. Physical fatigue was significantly worse 3 months after treatment, while emotional and cognitive fatigue were the worst at diagnosis and at 3 months. All fatigue domains were significantly better after 1 year, and the fatigue scores remained stable from 1 until 5 years after treatment. Three months after chemoradiotherapy, physical fatigue was more significant, but no long-term differences due to treatment modalities were found. Depression and anxiety were predictors for chronic emotional fatigue, and local HN pain and swallowing problems were predictors for chronic physical fatigue. Better global quality of life at diagnosis was associated with less physical and emotional fatigue. CONCLUSION: Fatigue was worst in the short term for HNC patients and improved after 1 year, and long-term fatigue remained stable up to 5 years after treatment. A few predictors for chronic fatigue were found. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:2211-2221, 2023.

Fatigue in Patients With Head and Neck Cancer Treated With Radiation Therapy: A Prospective Study of Patient-Reported Outcomes and Their Association With Radiation Dose to the Cerebellum.

Purpose: Although fatigue is a known side effect in patients with head and neck cancer (HNC) receiving radiation therapy, knowledge regarding long-term fatigue and dose-response relationships to organs at risk is scarce. The aim of this prospective study was to analyze patient-reported fatigue in patients with HNC receiving radiation therapy and to explore any possible association with organ-at-risk doses. Methods and Materials: Patients with HNC referred for curative radiation therapy were eligible for inclusion in the study. To assess patient-reported fatigue, quality of life questionnaires (European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-FA12) were distributed before treatment and 1, 3, 6, 12, 24, and 60 months after the start of treatment. Mean dose (Dmean) and near maximum dose (D2%) of the cerebellum and brain stem were evaluated in relation to baseline-adjusted fatigue scores at 3 months. Results: One hundred twenty-six patients treated with intensity modulated radiation therapy between 2008 and 2010 were available for final analysis. Female sex and age <60 years were associated with higher fatigue at baseline, whereas patients also treated with chemotherapy had reduced physical and emotional fatigue at 6 months. Physical fatigue (QLQ-FA12 scale) increased from baseline up to 3 months (29 vs 59; P < .0001) but showed no difference compared with baseline from 1 to 5 years. Emotional fatigue was significantly lower at 5 years compared with baseline (14 vs 28; P < .0001). Patients with cerebellum Dmean > 3.5 Gy had higher mean physical fatigue scores at 3 months (38 vs 27; P = .036). Conclusions: Although there is a significant increase in fatigue scores for patients with HNC up to 1 year after radiation therapy, this study showed a return to baseline levels at 5 years. A possible association was found between physical fatigue and a higher mean dose to the cerebellum.

The effect of age on health-related quality of life for head and neck cancer patients up to 1 year after curative treatment.

OBJECTIVES: The aim was to evaluate the effect of age on health-related quality of life (HRQOL) for patients with head and neck cancer (HNC), treated with curative intent, in the Western healthcare region of Sweden. MATERIALS AND METHODS: In this prospective observational study, 311 HNC patients completed quality of life questionnaires for cancer (EORTC QLQ-C30 and EORTC QLQ-H&N35) and for older patients with cancer (EORT QLQ-ELD14) at diagnosis and 3, 6, and 12 months after start of treatment. Mean scores for patients ≥70 years old were compared to younger patients (50 to 69 years old) to assess differences in HRQOL. RESULTS: Of the 311 study participants, 105 patients were ≥70 years old (median age 76.7), of which 32 were ≥80 years of age. Most HRQOL scores were equal or better for older adult patients at 3 months after treatment, but physical function was better for younger adult patients up to 12 months after treatment. At 6 months the HRQOL was similar (older patients had less appetite loss and financial difficulties), while the oldest patients (≥80 years) had worse fatigue, role function, and feeling ill at 12 months. For the EORTC-ELD-14 questionnaire, older patients scored better for worries at diagnosis and reported more difficulties in maintaining purpose at 12 months after treatment. CONCLUSION: When curative treatment is administered, older adult patients with HNC have similar or even better HRQOL compared to younger adult patients, except for physical function, during the first year.

Long-Term Aspects of Quality of Life in Head and Neck Cancer Patients Treated With Intensity Modulated Radiation Therapy: A 5-Year Longitudinal Follow-up and Comparison with a Normal Population Cohort.

PURPOSE: Knowledge of long-term health-related quality of life (HRQOL) in patients with advanced head and neck cancer treated with intensity modulated radiation therapy is scarce. METHODS AND MATERIALS: HRQOL in 126 patients with advanced head and neck cancer treated with intensity modulated radiation therapy was followed longitudinally from diagnosis to 5 years after treatment with the European Organization for Research and Treatment of Cancer's QLQ-C30, the European Organization for Research and Treatment of Cancer's Head and Neck Cancer Module, and the M.D. Anderson Dysphagia Inventory. The survivors' HRQOL was compared with an age- and sex-matched normal population cohort. RESULTS: At 5 years, 73 of the 95 surviving patients had completed the study. Significant reductions in general pain (29 vs 12), head and neck (HN) pain (22 vs 14), and feeling ill (20 vs 10) were found, and emotional functioning (70 vs 83) and global quality of life (67 vs 74) improved, compared with baseline values. Conversely, dry mouth (19 vs 56), senses (8 vs 27), teeth problems (10 vs 22), opening mouth (19 vs 56), and sticky saliva (15 vs 40) were markedly worse, although significant improvements had occurred over time after treatment. Anderson Dysphagia Inventory scores >80 at 5 years indicated good swallowing function. In a subgroup analysis, dry mouth and senses were significantly better in patients treated with chemoradiotherapy. Comparison to a normal population cohort's HRQOL shows that the study group experienced a wide array of symptoms affecting their quality of life. CONCLUSIONS: The results of this large, long-term follow-up study show that a majority of patients report a reasonable quality of life 5 years after treatment and that there seems to be continuous improvement over time. Comparison with a normal population cohort, however, underlines the fact that classical side effects remain, even with improved radiation techniques. Additional emphasis on normal-tissue-sparing radiation therapy is warranted, with close attention devoted to HRQOL outcomes.

Bioelectrical phase angle at diagnosis as a prognostic factor for survival in advanced head and neck cancer.

OBJECTIVE: Bioelectrical impedance analysis (BIA) is used to measure the patient's body composition, fat-free mass, phase angle (PA), and standardized phase angle (SPA), which are affected by malnutrition. Low values of PA and SPA have been found to be negative prognostic factors for survival in different types of cancer and other severe diseases. The aim of the current study was to investigate whether PA and SPA can be used to predict survival in head and neck (HN) cancer. METHODS: One hundred twenty-eight patients with advanced HN cancer treated in Western Sweden 2002-2006 were examined with BIA at diagnosis, and PA and SPA were calculated. Patients' age, gender, tumor site, TNM stage, and performance status were obtained, and weight, height, and BIA were measured. Survival up to 12 years was ascertained. RESULTS: The mean PA was 5.85° and the median was 5.91°. Lower PA and SPA values were significantly associated with shorter overall survival in univariate analyses, together with higher age, oral cancer, higher T class, worse performance status, more weight loss before diagnosis, lower: weight, height, BMI, and reactance. Age, performance status, T class, and PA were significant factors for the overall survival in the multivariable analysis. A PA cutoff value at 5.95° provided the best prediction of 5-year survival. CONCLUSIONS: PA and SPA at diagnosis are significant factors for survival in patients with advanced HN cancer. They are promising prognostic tools to use in treatment planning; further studies are needed.

Impact on quality of life of IMRT versus 3-D conformal radiation therapy in head and neck cancer patients: A case control study.

OBJECTIVE: The purpose of this study was to prospectively and longitudinally compare the health-related quality of life (HRQOL) outcomes between head and neck (HN) cancer patients treated with parotid-sparing intensity modulated radiation therapy (IMRT) and patients treated with 3-dimensional conventional radiation therapy (3D-CRT). METHODS AND MATERIALS: Before and up to 12 months after treatment, HRQOL was recorded in patients with HN cancer who were referred to the Department of Oncology at Sahlgrenska University Hospital for curative IMRT. The study group's HRQOL was compared with a matched group of patients from previous descriptive HRQOL studies treated with 3D-CRT. Both groups' HRQOL was measured by the European Organization for Research and Treatment for Cancer QLQ-C30 and European Organization for Research and Treatment for Cancer QLQ-HN35 at 6 time points in the first year after diagnosis. RESULTS: Two hundred and seven patients were included, 111 treated with IMRT and 96 matched controls treated with 3D-CRT. Both groups' HRQOL deteriorated during and after treatment. Just after treatment, worse HRQOL scores were observed in the IMRT group regarding insomnia (38 vs 27; P = .032), appetite loss (64 vs 50; P = .019), senses (54 vs 41; P = .017), and coughing (39 vs 26, P = .009). At 12 months, however, significantly better HRQOL scores were observed in the IMRT group regarding problems with dry mouth (72 vs 62; P = .018), pain (28 vs 20; P = .018), sexuality (37 vs 23; P = .016), social contacts (10 vs 6; P = .026), cognitive functioning (79 vs 87; P = .0057), and financial difficulties (12 vs 20; P = .0019). CONCLUSIONS: This study further supports the hypothesis that the introduction of IMRT has improved the long-term quality of life of HN cancer patients who have been treated with radiation therapy, but might cause more acute side effects. Longer follow-up is needed to study late complications.

Population-based reference values for the European Organization for Research and Treatment of Cancer Head and Neck module.

BACKGROUND: The purpose of this study was to establish population-based norms for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-HN35) to be used as references to facilitate the interpretation of results from health-related quality of life (HRQOL) studies of patients with head and neck cancer. METHODS: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and QLQ-HN35 were sent to a random sample representing the Swedish general population. RESULTS: The response rate was 69% (1504 participants of 2200 invited). The scores for the QLQ-C30 were comparable to previously published reference values. The reference values for the QLQ-HN35 were low, indicating few head and neck-specific problems in the population. For illustrative purposes, we also compared these reference values to our previously published HRQOL results obtained from patients with head and neck cancer at diagnosis and from 3-year survivors. CONCLUSION: These new reference values for EORTC QLQ-HN35 may be useful in future HRQOL studies.

Effect of prophylactic percutaneous endoscopic gastrostomy tube on swallowing in advanced head and neck cancer: A randomized controlled study.

BACKGROUND: Dysphagia is common in head and neck cancer. A percutaneous endoscopic gastrostomy (PEG) tube is used to facilitate nutrition; however, some retrospective studies have indicated that the PEG tube causes dysphagia. METHODS: A randomized study of patients with head and neck cancer was conducted with up to 10 years of follow-up. Patients were randomized to either the prophylactic PEG tube group (study group) or the common clinical nutritional support group (control group). At each follow-up, a dietician assessed the oral intake, noted the patients' weight, and if the patients used a PEG tube. Dysphagia was also assessed by the quality of life questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC-QLQ-H&N35). RESULTS: One hundred thirty-four patients were included in this study. There was no significant difference in swallowing function between the groups after 12 months, 24 months, and 8 years based on the EORTC-QLQ-H&N35, the oral intake scale, tube dependence, esophageal intervention, weight, body mass index (BMI), and overall survival. CONCLUSION: A prophylactic PEG tube can be used without an increased risk of long-term dysphagia in patients with head and neck cancer. © 2017 Wiley Periodicals, Inc. Head Neck 39: 908-915, 2017.

An exploration of factors predicting malnutrition in patients with advanced head and neck cancer.

OBJECTIVES/HYPOTHESIS: Malnutrition is common among head and neck cancer patients and negatively impacts on survival and quality of life. This study aimed to identify predictors of malnutrition at time of diagnosis in order to identify patients at risk and enable early nutritional support and prevent malnutrition. MATERIALS AND METHOD: A total of 134 patients with advanced oral and pharyngeal cancer were included in the study. Weight, body mass index (BMI), fat free mass (FFM), dysphagia, and quality of life were measured at diagnosis and after 6 months. Two definitions for malnutrition were applied: >10% weight loss and BMI <20 after 6 months. RESULTS: Six months after diagnosis, 66% of the patients were malnourished as per the >10% weight loss definition, and 26% of the patients were malnourished as per the BMI < 20 weight loss definition. In multivariate analysis, low BMI followed by low FFM and dysphagia were the strongest predictors for malnutrition using BMI <20. Chemotherapy and high BMI at diagnosis were the strongest predictors of malnutrition using the 10% weight loss definition. For patients treated with chemotherapy, the risk for malnutrition was very high both for patients with normal BMI (67%) and for patients with BMI 30 (89%). CONCLUSION: Unintended weight loss more than 10% seems to be the most reasonable definition of malnutrition for identifying predictors of this in head and neck cancer patients. The weight loss correlated significantly to a loss of FFM. Treatment with chemotherapy was a strong predictor, as was a high BMI at time of diagnosis. This is an important finding since overweight patients might not be considered at high risk for developing malnutrition, and consequently nutritional support for them might be delayed.

Impact of prophylactic percutaneous endoscopic gastrostomy on malnutrition and quality of life in patients with head and neck cancer: a randomized study.

BACKGROUND: The purpose of this randomized study was to examine if a prophylactic percutaneous endoscopic gastrostomy (PEG) for enteral nutrition could prevent malnutrition, reduce hospital stay, and improve health-related quality of life (HRQOL). METHODS: One hundred thirty-four patients with advanced head and neck cancer were randomized to either prophylactic PEG (study group) or clinical praxis (control group). Patients' weight, body mass index (BMI), need for hospitalization, and HRQOL were noted at 7 occasions during 2 years. RESULTS: No difference in hospital stay was found. After 6 months, HRQOL was significantly better and the weight loss was significantly less in the study group. The number of malnourished patients were consistently about 10% lower in the study group during the first study year. The study group started to use enteral feeding significantly earlier and for a significantly longer time period (p < .0001). CONCLUSION: Prophylactic PEG was associated with significantly earlier start and longer use of enteral nutrition, fewer malnourished patients over time, and improved HRQOL at 6 months posttreatment start.

Health-related quality of life in patients with pharyngeal carcinoma: a five-year follow-up.

PURPOSE: The purpose was to evaluate the health-related quality of life (HRQL) of patients with pharyngeal carcinoma at diagnosis and after 1 and 5 years in relation to tumor location and treatment modality in a prospective multicenter study. METHODS: Eighty-nine patients with pharyngeal carcinoma (mean age, 60.0 years; 76% men) were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35). RESULTS: Problems with dry mouth and teeth became worse between diagnosis and the 5-year follow-up. Problems with thick secretions and teeth increased between 1 and 5 years. The HRQL at diagnosis was associated with survival. Patients with oropharyngeal carcinoma reported better HRQL than patients with hypopharyngeal carcinoma. CONCLUSIONS: For patients with pharyngeal carcinoma, the HRQL at diagnosis seems to be an important factor for the prognosis of both HRQL over time and survival. Treatment of pharyngeal carcinoma often results in long-term side effects such as dry mouth, problems with teeth, and thick secretions.

Quality of life and head and neck cancer: a 5 year prospective study.

OBJECTIVES: Assessment of health-related quality of life (HRQL) in head and neck cancer patients from diagnosis to 5 years after start of treatment. STUDY DESIGN: A prospective, descriptive study METHODS: three hundred fifty-seven patients from Norway and Sweden filled in HRQL questionnaires, the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H and N35, six times during the first year and then after 5 years. At 5 years, 167 (87%) of the 192 living patients filled in questionnaires. RESULTS: Group data: clinical significant improvements in HRQL were not found between 1 and 5 years. Problems with teeth, opening of the mouth, dryness in the mouth, and sticky saliva were persistent or worsening. Similar findings were found regardless of sex, age, stage, or site when clinical significant changes are considered. Patients who died between 1 and 5 years reported reduced HRQL on 15 of 28 scales at 1 year compared with the survivors. Individual data: 40% of patients reported improved global HRQL from diagnosis to 5 years after start of treatment. In addition, 11% had "top scores" at both assessment points. The pattern in global HRQL scores also applies for most of the other function and symptom scales. CONCLUSION: After the first year after treatment, recovery of the persisting side effects of treatment cannot be expected for the group as a whole. Patients must be prepared for this. Some individual patients experience improvement in global HRQL. HRQL assessments in daily clinical practice can identify patients who are in need of additional support and symptom relief.

Longitudinal evaluation of patients with cancer in the oral tongue, tonsils, or base of tongue--does interstitial radiation dose affect quality of life?

PURPOSE: To evaluate health-related quality of life (HRQL) in patients with oral tongue, tonsil, or base of tongue cancer in a prospective longitudinal study and explore correlations between HRQL scores and interstitial radiation dose, dose rate, and volume of implant. METHODS AND MATERIALS: Ninety patients with oral tongue cancer (n=30) and tonsil or base of tongue cancer (n=60) were assessed with the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and the European Organization of Research and Treatment of Cancer Head and Neck module at diagnosis, and after 3, 12, and 36 months of starting treatment. RESULTS: The HRQL of all patients decreased during treatment. Most HRQL scores returned to baseline values after 3 years; however, 60% of patients with oral tongue cancer and 80% with tonsil and base of tongue cancer reported problems with dry mouth and half of the patients with tonsil and base of tongue cancer reported problems with swallowing solid food at the 3-year followup. No correlations between brachytherapy quality indices and HRQL scores were found. CONCLUSIONS: Patients with oral tongue, tonsil, or base of tongue cancer reported significant problems with dry mouth and swallowing solid food throughout this 3-year followup study.

Quality of life as predictor of weight loss in patients with head and neck cancer.

BACKGROUND: The purpose of this prospective study was to evaluate whether a relationship exists between malnutrition (> or =10% weight loss) and health-related quality of life (HRQL) in patients with head and neck cancer and whether weight loss can be predicted with HRQL questionnaires. METHODS: Weight and HRQL were monitored in 49 patients. HRQL was assessed longitudinally, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), the EORTC Head and Neck Cancer module (QLQ-H&N35), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: At diagnosis, those patients who had a weight loss greater than 10% (n = 20) after treatment scored significantly worse on 15 of 28 HRQL variables than did patients who lost less (n = 29). The largest difference (Delta > or =20) was found for role functioning, fatigue, loss of appetite, global quality of life, sticky saliva, and swallowing. Differences in HRQL persisted even after 3 years. The fatigue scale was the only significant predictor of weight loss (p = .005) at diagnosis. CONCLUSIONS: Patients with head and neck cancer who are at risk of severe weight loss developing during treatment may be detected with the aid of HRQL questionnaires at diagnosis.

Health-related quality of life five years after diagnosis of laryngeal carcinoma.

PURPOSE: To evaluate the health-related quality of life (HRQL) of patients with laryngeal carcinoma in a prospective longitudinal multicenter study at diagnosis, after 1 and 5 years in relation to tumor location and treatment modality. SUBJECTS AND METHODS: Eighty-six patients (mean age 66 years; 84% males) with laryngeal carcinoma were evaluated with standardized HRQL questionnaires: the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), the EORTC QLQ-Head and Neck Cancer Module (EORTC QLQ-H&N35), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: Some significant changes in HRQL were found between diagnosis and 5 years after diagnosis, depending on the treatment given. The patients' ability to speak improved whereas some general functions deteriorated and treatment-related side effects increased. When comparing HRQL at 1 and 5 years after diagnosis, it appears that most values at the 1-year follow-up assessment persist until 5 years, but a few deteriorate. The HRQL at diagnosis seems to be associated with survival rate after 5 years, and the global quality of life scale at diagnosis tends to predict HRQL after 5 years. CONCLUSIONS: The use of HRQL questionnaires is valuable when comparing different treatments and as an aid in predicting treatment side effects. Evaluation of HRQL at diagnosis for patients with laryngeal carcinoma seems to be of value for the prognosis of HRQL over time and for the prognosis of survival.

Effects of psychosocial intervention on quality of life in patients with head and neck cancer.

BACKGROUND: A longitudinal, prospective, case-control study evaluated if a psychosocial support program improved health-related quality of life (HRQL) in head and neck (H&N) cancer patients. METHODS: One hundred forty-four H&N cancer patients were included: 52 study patients and 92 controls. The study group met the support team repeatedly throughout the first year after diagnosis. HRQL was assessed three times during the first year and after 3 years using the EORTC QLQ-C30, EORTC QLQ-H&N35, and HADS. RESULTS: A few statistically significant differences were found, all favoring the controls. Controls reported better global quality of life after 1 year and felt less ill after 3 years. Depression and treatment-related side effects were prevalent in both groups. CONCLUSIONS: Our psychosocial support program did not improve HRQL in H&N cancer patients. Its effectiveness may be improved by evaluating and actively integrating HRQL assessments during the program, thereby enabling rapid and adequate symptomatic treatment and/or psychologic intervention.