Development and evaluation of a computerized clinical outcome assessment tool for head and neck cancer patients.

Paper-based clinical outcome data collection methods have practical limitations when used in clinical settings, as the data are often not summarized in time to facilitate patient-physician communications and therefore cannot be used in clinical decision making. This study aimed to develop a computerized clinical outcome assessment tool (COAT) and evaluate its acceptability, feasibility, and potential clinical applications during clinical encounters for patients with head and neck cancer (HNC).The traditional Chinese (TChi) character version of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) questionnaire was first transcribed and implemented into a touch-screen computerized administration and reporting system (COAT-HNC for short). Each HNC patient was invited to complete the COAT-HNC during their scheduled clinic visits as part of their clinical care. Upon completion, a structured summary report was generated, and subsequently used for treatment evaluation and planning.A cohort of 385 HNC patients were enrolled. Each scale of the computerized TChi FACT-H&N questionnaire demonstrated acceptable internal consistency, with Cronbach coefficient alpha ranging from 0.74 to 0.90. The touch-screen-based and audio-capable COAT-HNC was reported to be easy to use. Patients and physicians were able to utilize the summary report during their clinical encounters to discuss treatment progress and to plan care.It is practically feasible to design, develop, and implement the COAT-HNC system in routine HNC care. The COAT-HNC has the potential to become a valuable tool for data collection and management of clinical outcomes, and appears useful for HNC patients. However, larger studies to demonstrate its clinical usefulness are still needed.

Prognostic nutritional index relevance in chemoradiotherapy for advanced oral cavity, oropharyngeal and hypopharyngeal cancer.

BACKGROUND AND OBJECTIVES: This study was designed to evaluate the impact of the prognostic nutritional index (PNI) on treatment-related toxicities and tolerance in patients with advanced head and neck cancers who were undergoing concurrent chemoradiotherapy (CCRT). METHODS AND STUDY DESIGN: We retrospectively analyzed and compared the clinical characteristic, toxicities and survival of 143 patients with stage III, IVA, and IVB head and neck cancer who were treated with CCRT according to their PNI between 2007 and 2010. RESULTS: Low PNI was correlated with T classification and advanced tumor stage. Patients with low PNI were less likely to tolerate CCRT, required tube feeding support more frequently and had higher percentages of grade 3/4 hematological toxicities, sepsis and toxic death. CONCLUSIONS: Pretreatment PNI predicts treatment-tolerance and toxicity in patients with advanced head and neck cancer undergoing CCRT.

Body image in head and neck cancer patients treated with radiotherapy: the impact of surgical procedures.

BACKGROUND: In this study, we aimed to investigate the impact of surgical procedures on the body image of head and neck cancer patients treated with radiotherapy and with or without radical surgery. METHODS: A cross-sectional survey of 150 patients with head and neck cancer was conducted. Sixty patients had nasopharyngeal cancer treated with definitive radiotherapy without surgery, and 90 patients had oral cavity cancer treated with radical surgery plus adjuvant radiotherapy. All participants completed a 10-item Body Image Scale (BIS) questionnaire to assess body image dissatisfaction. Among all patients, the socio-demographic and clinical variables were age, gender, partnership, education, employment, and radical surgery. In surgically-treated patients, the clinical variables were facial skin sacrificed, mouth angle sacrificed, glossectomy, maxillectomy, and mandibulectomy. ANOVAs, t-tests, and multiple regressions were used to evaluate the relationships between these variables and BIS results. RESULTS: In all patients, radical surgery was the strongest independent predictor of BIS scores. Surgically-treated patients had significantly worse BIS scores than the patients without surgery. In surgically-treated patients, facial skin sacrificed, mouth angle sacrificed, maxillectomy, and mandibulectomy were significantly associated with body image. According to multivariable analyses, inferior maxillectomy and segmental mandibulectomy were independent prognosticators of a poor BIS score in surgically-treated patients. CONCLUSION: Radical surgery for head and neck cancer patients has a significant impact on their body image, especially for those undergoing facial bone destructive surgery.

Impact of the pretreatment Glasgow prognostic score on treatment tolerance, toxicities, and survival in patients with advanced head and neck cancer undergoing concurrent chemoradiotherapy.

BACKGROUND: The purpose of this study was to evaluate the impact of the pretreatment Glasgow prognostic score on treatment-related toxicities, tolerance, and survival in patients with advanced head and neck cancers undergoing concurrent chemoradiotherapy (CRT). METHODS: We retrospectively analyzed and compared the clinical characteristics, toxicities, and survival of 143 patients with stages III, IVA, and IVB head and neck cancer treated with concurrent CRT according to their Glasgow prognostic score between 2007 and 2010. RESULTS: The Glasgow prognostic score was correlated with advanced tumor stage and T/N classification. Patients with a higher Glasgow prognostic score were less likely to tolerate concurrent CRT, experienced more weight loss, required tube feeding support more frequently, and had higher percentage of grade ≥3 hematological toxicities, sepsis, and toxic death. Patients with a Glasgow prognostic score of 0 had better overall and recurrence-free survival than those with a Glasgow prognostic score of 1 or 2. CONCLUSION: Pretreatment Glasgow prognostic score predicts treatment tolerance, toxicity, and survival in patients with advanced head and neck cancer undergoing concurrent CRT.

Glasgow prognostic score after concurrent chemoradiotherapy is a prognostic factor in advanced head and neck cancer.

OBJECTIVE: This study aims to evaluate the impact and potential prognostic roles of the pre- and post-treatment Glasgow prognostic score (GPS) and the change thereof in patients with advanced head and neck cancer undergoing concurrent chemoradiotherapy (CCRT). METHODS: We collected GPS and clinicopathological data of 139 stage III, IVA, and IVB head and neck cancer patients who underwent CCRT between 2008 and 2011. Their GPSs pre- and post-CCRT and the change thereof were analyzed for correlations with recurrence and survival. RESULTS: The GPS changed in 72 (51.8%) patients, with worse scores observed post-CCRT in 65 (90.3%) of the GPS changed patients. Patients in the improved GPS group showed a tendency toward better survival. From the multivariate analysis, the post-CCRT GPS level was an independent prognostic factor in addition to tumor stage. CONCLUSIONS: After CCRT, a high GPS was revealed to be an important predictor of survival for advanced head and neck cancer.

Impact of metformin on patients with advanced head and neck cancer undergoing concurrent chemoradiotherapy.

BACKGROUND: The purpose of this study was to evaluate the impact of metformin on toxicities and survival in patients with head and neck cancer undergoing concurrent chemoradiotherapy (CRT). METHODS: We retrospectively analyzed and compared the clinical characteristics, treatment tolerance, toxicities, and survival of 252 patients with stages III, IVA, and IVB head and neck cancer undergoing concurrent CRT with and without metformin treatment between 2007 and 2010. RESULTS: Among all patients, 39 patients received metformin whereas 219 patients did not. Both groups had similar clinical characteristics and nearly identical disease-free survival and overall survival. However, the metformin group was less likely to tolerate cisplatin, experienced more weight loss, had a tendency to receive lower doses of radiotherapy, required more feeding tube support, and had grade ≥3 nausea/vomiting and hematological toxicities. CONCLUSION: Patients with head and neck cancer undergoing concurrent CRT along with metformin treatment require more careful multidisciplinary assessment and supportive care to ensure successful completion of treatment and avoid treatment-related toxicities.

An elective radiation dose of 46 Gy is feasible in nasopharyngeal carcinoma treated by intensity-modulated radiotherapy: A long-term follow-up result.

The purpose of this study is to compare the treatment outcome of different radiation doses of elective neck irradiation (ENI) in nasopharyngeal carcinoma (NPC) patients treated with intensity-modulated radiotherapy (IMRT).In total, 504 patients with nondisseminated NPC who underwent magnetic resonance imaging before radical IMRT between 2000 and 2008 were retrospectively reviewed. The patients were classified into 2 groups based on the ENI dose: low ENI when the ENI dose was 46 Gy (n = 446) and high ENI when the ENI doses were 50 to 60 Gy (n = 58). All the patients in both the groups received a median dose of 72 Gy to the gross tumor and involved nodes. The fraction size was 2 Gy per fraction. Matching was performed between low ENI and high ENI in a 2:1 ratio, and the matching criteria were N-stage, T-stage, treatment modality, pathology classification, sex, and age.The median follow-up for all patients was 63.5 months. In all patients, the 5-year progression-free survival (PFS), local control (LC), regional control (RC), distant metastasis-free survival (DMFS), overall survival (OS), and cancer-specific survival (CSS) for low ENI and high ENI patients were 69.0% and 63.2% (P = 0.331), 89.0% and 83.9% (P = 0.235), 90.1% and 85.2% (P = 0.246), 86.8% and 76.6% (P = 0.056), 77.5% and 80.8% (P = 0.926), and 84.4% and 82.5% (P = 0.237), respectively. In the matched-pair analysis, the 5-year PFS, LC, RC, DMFS, OS, and CSS for matched low ENI and high ENI patients were 74.1% and 63.2% (P = 0.134), 92.0% and 83.9% (P = 0.152), 90.1% and 85.2% (P = 0.356), 86.2% and 76.6% (P = 0.125), 87.0% and 80.8% (P = 0.102), and 88.6% and 82.5% (P = 0.080), respectively. In the multivariable analysis for all patients, the ENI group was not a significant factor for PFS, LC, RC, DMFS, OS, and CSS.A low ENI dose of 46 Gy in 23 fractions is feasible in NPC patients treated with IMRT, and this concept should be validated in the prospective studies.

Chemoradiotherapy in elderly patients with advanced head and neck cancer under intensive nutritional support.

AIM: To evaluate treatment tolerance, toxicities and survival in elderly patients with advanced head and neck cancer who received inpatient-based intensive nutritional support with concurrent chemoradiotherapy in comparison with younger patients undergoing the same treatment. METHODS: We retrospectively analyzed the records of 126 stage III, IVA and IVB head and neck cancer patients who were treated with concurrent chemoradiotherapy between 2007 and 2009 under an inpatient-based nutritional support program. The clinical characteristics, treatment tolerance, toxicities and survival of patients older than 65 years were compared with those of identically treated patients younger than 65 years. RESULTS: There were 21 patients older than 65 years and 105 patients younger than 65 years. Clinical characteristics and treatment toxicities were similar between the groups, except that the elderly were less likely to tolerate cisplatin, experienced more weight loss, required more feeding tube support and tended to have >grade 3 hematological toxicities and to develop sepsis during the period of chemoradiotherapy. The 1- and 2-year disease-free survival and disease-specific survival rates were nearly identical. CONCLUSION: Age alone should not be considered a contraindication to aggressive chemoradiotherapy for advanced head and neck cancer. Older patients require more careful multidisciplinary assessment of their supportive care needs to ensure successful completion of treatment and avoid further treatment-related toxicity.

Pretreatment performance status and nutrition are associated with early mortality of locally advanced head and neck cancer patients undergoing concurrent chemoradiation.

Unexpected fatal events in patients with head and neck cancers undergoing concurrent chemoradiation therapy are a clinical concern. Malnutrition, which is reported frequently in head and neck cancer patients, are associated with immunity derangement. The purpose of this study was to identify risk factors for early death of patients undergoing chemoradiation. We retrospectively analyzed the records of 194 stage III, IVA, and IVB head and neck cancer patients who were treated with chemoradiation between 2007 and 2009. We defined early death as death while receiving chemoradiation or within 60 days of treatment completion. Risk factors for early death were tested using univariate and multivariate analyses. Fourteen patients (7.2 %) experienced early death, 78.6 % of whom died of infection. Univariate analysis revealed significant correlations between early death and several pretreatment variables, including Eastern Cooperative Oncology Group performance status (PS) >1, hemoglobin <10 g/dL, albumin <3 g/dL, body mass index (BMI) <19 kg/m(2), and peripheral blood total lymphocyte count <700/µL. Multivariate analysis showed that PS >1, BMI <19 kg/m(2), and peripheral blood total lymphocyte count <700/µL were independent variables associated with early death. Poor performance status and malnutrition before chemoradiation independently predict early death in locally advanced head and neck cancer patients undergoing chemoradiation. Cautious management of head and neck cancer patients with these risk factors is required throughout chemoradiation period.

Low body mass index at 3 months following adjuvant chemoradiation affects survival of postoperative locally advanced oral cavity cancer patients.

OBJECTIVES/HYPOTHESIS: To investigate the association between body mass index and outcomes such as recurrence and survival in postoperative locally advanced oral cavity cancer patients who underwent adjuvant chemoradiation. STUDY DESIGN: Retrospective analysis of patient data and outcomes. METHODS: We retrospectively analyzed the records of 61 stage III, IVA, and IVB oral cavity cancer patients who were treated with curative surgery and adjuvant chemoradiation between 2007 and 2009. Each patient's body mass index was recorded throughout the treatment duration and after its completion. The associations between demographic variables, body mass index, and survival outcomes were determined by univariate and multivariate analyses. RESULTS: Overall, body mass index decreased throughout the chemoradiation period and reached the nadir at 3 months after completion of therapy. Univariate analysis showed that patients with body mass index <18.5 kg/m(2) at 3 months after chemoradiation had significantly higher recurrence and decreased survival rates. Multivariate analysis confirmed that body mass index <18.5 kg/m(2) at this time point is an independent predictor for recurrence (P = .039) and overall survival (P = .043). CONCLUSIONS: Early recurrence can be predicted by malnourished status 3 months after treatment completion. Malnourishment has significant negative effects on overall survival in locally advanced postoperative oral cavity cancer patients who are undergoing adjuvant chemoradiation. After therapy is completed, nutritional guidance and care should be continued for patients with this advanced disease.

Treatment results for hypopharyngeal cancer by different treatment strategies and its secondary primary--an experience in Taiwan.

PURPOSE: The aim of this study was to evaluate treatment results in our hypopharyngeal cancer patients. PATIENTS AND METHODS: A total of three hundred and ninety five hypopharyngeal cancer patients received radical treatment at our hospital; 96% were male. The majority were habitual smokers (88%), alcohol drinkers (73%) and/or betel quid chewers (51%). All patients received a CT scan or MRI for tumor staging before treatment. The stage distribution was stage I: 2 (0.5%); stage II: 22 (5.6%); stage III: 57 (14.4%) and stage IV: 314 (79.5%). Radical surgery was used first in 81 patients (20.5%), and the remaining patients (79.5%) received organ preservation-intended treatment (OPIT). In the OPIT group, 46 patients received radiotherapy alone, 156 patients received chemotherapy followed by radiotherapy (CT/RT) and 112 patients received concomitant chemo-radiotherapy (CCRT). RESULTS: The five-year overall survival rates for stages I/II, III and IV were 49.5%, 47.4% and 18.6%, respectively. There was no significant difference in overall and disease-specific survival rates between patients who received radical surgery first and those who received OPIT. In the OPIT group, CCRT tended to preserve the larynx better (p = 0.088), with three-year larynx preservation rates of 44.8% for CCRT and 27.2% for CT/RT. Thirty-seven patients developed a second malignancy, with an annual incidence of 4.6%. CONCLUSIONS: There was no survival difference between OPIT and radical surgery in hypopharyngeal cancer patients at our hospital. CCRT may offer better laryngeal preservation than RT alone or CT/RT. However, prospective studies are still needed to confirm this finding. Additionally, second primary cancers are another important issue for hypopharyngeal cancer management.

Treatment results of postoperative radiotherapy on squamous cell carcinoma of the oral cavity: coexistence of multiple minor risk factors results in higher recurrence rates.

PURPOSE: The aim of this study was to investigate the treatment results of postoperative radiotherapy (PORT) on squamous cell carcinoma of the oral cavity (OSCC). MATERIALS AND METHODS: This study included 302 OSCC patients who were treated by radical surgery and PORT. Indications for PORT include Stage III or IV OSCC according to the 2002 criteria of the American Joint Committee on Cancer, the presence of perineural invasion or lymphatic invasion, the depth of tumor invasion, or a close surgical margin. Patients with major risk factors, such as multiple nodal metastases, a positive surgical margin, or extracapsular spreading, were excluded. The prescribed dose of PORT ranged from 59.4 to 66.6 Gy (median, 63 Gy). RESULTS: The 3-year overall and recurrence-free survival rates were 73% and 70%, respectively. Univariate analysis revealed that differentiation, perineural invasion, lymphatic invasion, bone invasion, location (hard palate and retromolar trigone), invasion depths > or =10mm, and margin distances < or =4mm were significant prognostic factors. The presence of multiple significant factors of univariate analysis correlated with disease recurrence. The 3-year recurrence-free survival rates were 82%, 76%, and 45% for patients with no risk factors, one or two risk factors, and three or more risk factors, respectively. After multivariate analysis, the number of risk factors and lymphatic invasion were significant prognostic factors. CONCLUSION: PORT may be an adequate adjuvant therapy for OSCC patients with one or two risk factors of recurrence. The presence of multiple risk factors and lymphatic invasion correlated with poor prognosis, and more aggressive treatment may need to be considered.

Primary tumor site as a predictor of treatment outcome for definitive radiotherapy of advanced-stage oral cavity cancers.

PURPOSE: To evaluate the outcome of definitive radiotherapy (RT) for oral cavity cancers and to assess prognostic factors. METHODS AND MATERIALS: Definitive RT was performed on 115 patients with oral cavity cancers at Stages III, IVA, and IVB, with a distribution of 6%, 47%, and 47%, respectively. The median dose of RT was 72 Gy (range, 62-76 Gy). Cisplatin-based chemotherapy was administered to 95% of the patients. Eleven patients underwent salvage surgery after RT failure. RESULTS: Eight-eight (76.5%) patients responded partially and 23 (20%) completely; of the patients who responded, 18% and 57%, respectively, experienced a durable effect of treatment. The 3-year overall survival, disease-specific survival, and progression-free survival were 22%, 27%, and 25%, respectively. The 3-year PFS rates based on the primary tumor sites were as follows: Group I (buccal, mouth floor, and gum) 51%, Group II (retromolar and hard palate) 18%, and Group III (tongue and lip) 6% (p < 0.0001). The 3-year progression-free survival was 41% for N0 patients and 19% for patients with N+ disease (p = 0.012). The T stage and RT technique did not affect survival. The patients who underwent salvage surgery demonstrated better 3-year overall survival and disease-specific survival (53% vs. 19%, p = 0.015 and 53% vs. 24%, p = 0.029, respectively). Subsite group, N+, and salvage surgery were the only significant prognostic factors for survival after multivariate analysis. CONCLUSION: The primary tumor site and neck stage are prognostic predictors in advanced-stage oral cancer patients who received radical RT. The primary tumor extension and RT technique did not influence survival.

Hypothyroidism after radiotherapy for nasopharyngeal cancer patients.

PURPOSE: The aim of this study was to determine the long-term incidence and possible predictive factors for posttreatment hypothyroidism in nasopharyngeal carcinoma (NPC) patients after radiotherapy. METHODS AND MATERIALS: Four hundred and eight sequential NPC patients who had received regular annual thyroid hormone surveys prospectively after radiotherapy were included in this study. Median patient age was 47.3 years, and 286 patients were male. Thyroid function was prospectively evaluated by measuring thyroid-stimulating hormone (TSH) and serum free thyroxine (FT4) levels. Low FT4 levels indicated clinical hypothyroidism in this study. RESULTS: With a median follow-up of 4.3 years (range, 0.54-19.7 years), the incidence of low FT4 level was 5.3%, 9.0%, and 19.1% at 3, 5, and 10 years after radiotherapy, respectively. Hypothyroidism was more common with early T stage (p = 0.044), female sex (p = 0.037), and three-dimensional conformal therapy with the altered fractionation technique (p = 0.005) after univariate analysis. N stage, chemotherapy, reirradiation, and neck electron boost did not affect the incidence of hypothyroidism. Younger age and conformal therapy were significant factors that determined clinical hypothyroidism after multivariate analysis. Overall, patients presented with a low FT4 level about 1 year after presenting with an elevated TSH level. CONCLUSION: Among our study group of NPC patients, 19.1% experienced clinical hypothyroidism by 10 years after treatment. Younger age and conformal therapy increased the risk of hypothyroidism. We suggest routine evaluation of thyroid function in NPC patients after radiotherapy. The impact of pituitary injury should be also considered.

Treatment outcome of combined modalities for buccal cancers: unilateral or bilateral neck radiation?

PURPOSE: To evaluate the outcome of treatment for buccal cancers and assess the impact of unilateral vs. bilateral adjuvant neck radiation. METHODS AND MATERIALS: We retrospectively reviewed the course of 145 patients newly diagnosed with buccal squamous cell carcinoma without distant metastases who completed definitive treatment between January 1994 and December 2000. Of 145 patients, 112 (77%) had Stage III or IV disease. All underwent radical surgery with postoperative radiotherapy (median dose, 64 Gy), including unilateral neck treatment in most (n = 120, 82.8%). After 1997, cisplatin-based concomitant chemoradiotherapy was given for high-risk patients with more than two involved lymph nodes, extracapsular spread, and/or positive margins. RESULTS: The 5-year disease-specific survival rate for Stages I-IV was 87%, 83%, 61%, and 60%, respectively (p = 0.01). The most significant prognostic factor was N stage, with the 5-year disease-specific survival rate for N0, N1, and N2 being 79%, 65%, and 54%, respectively (p = 0.001). For patients with more than two lymph nodes or positive extracapsular spread, cisplatin-based concomitant chemoradiotherapy improved locoregional control (p = 0.02). Locoregional control did not differ between patients undergoing unilateral or bilateral neck treatments (p = 0.95). Contralateral neck failure occurred in only 2.1%. CONCLUSIONS: In patients with buccal carcinoma after radical resection, ipsilateral neck radiation is adequate. Bilateral prophylactic neck treatment does not confer an added benefit.

Combined-modality treatment for advanced oral tongue squamous cell carcinoma.

PURPOSE: The aim of this study was to investigate prognostic factors in advanced-stage oral tongue cancer treated with postoperative adjuvant therapy and to identify indications for adjuvant concomitant chemoradiotherapy (CCRT). METHODS AND MATERIALS: We retrospectively reviewed the records of 201 patients with advanced squamous cell carcinoma of the oral tongue managed between January 1995 and November 2002. All had undergone wide excision and neck dissection plus adjuvant radiotherapy or CCRT. Based on postoperative staging, 123 (61.2%) patients had Stage IV and 78 (38.8%) had Stage III disease. All patients were followed for at least 18 months after completion of radiotherapy or until death. The median follow-up was 40.4 months for surviving patients. The median dose of radiotherapy was 64.8 Gy (range, 58.8-72.8 Gy). Cisplatin-based regimens were used for chemotherapy. RESULTS: The 3-year overall survival (OS) and recurrence-free survival (RFS) rates were 48% and 50.8%, respectively. Stage, multiple nodal metastases, differentiation, and extracapsular spread (ECS) significantly affected disease-specific survival on univariate analysis. On multivariate analysis, multiple nodal metastases, differentiation, ECS, and CCRT were independent prognostic factors. If ECS was present, only CCRT significantly improved survival (3-year RFS with ECS and with CCRT = 48.2% vs. without CCRT = 15%, p = 0.038). In the presence of other poor prognostic factors, results of the two treatment strategies did not significantly differ. CONCLUSIONS: Based on this study, ECS appears to be an absolute indication for adjuvant CCRT. CCRT can not be shown to be statistically better than radiotherapy alone in this retrospective series when ECS is not present.