Evaluation on the Sex-Specific Association Between Cigarette Smoke Exposure and Inflammation Markers-C-Reactive Protein and White Blood Cell Count.

INTRODUCTION: Cigarette smoke increases peripheral white blood cell (WBC) count. However, the dose-dependent association between smoking and C-reactive protein (CRP), an important inflammatory marker, has been reported as inconsistent. AIMS AND METHODS: Here, we evaluated the associations between smoking and CRP using both smoking questionnaires and urine cotinine as exposure markers. The Korea National Health and Nutrition Examination Survey data were used for analyzing the associations. Multiple regression analyses were performed to examine the associations between cigarette smoke exposure, as assessed by questionnaires and urine cotinine, and health effects, as measured by CRP and WBC count, controlling for potential confounders. The confounders, including age, sex, body mass index, blood pressure, cholesterol, glucose, alanine aminotransferase, and uric acid, were selected a priori based on the literature. RESULTS: A total of 11 435 participants were included for analysis. For the exposure-response relationship, the results indicated a significant increase in CRP levels in male smokers compared to male nonsmokers (p = .002), whereas no significant increase was found in female smokers compared to female nonsmokers (p = .680). For the dose-response relationship, a significant positive association was observed between urine cotinine and CRP in male smokers (p = .018), whereas no significant association was found in female smokers (p = .508). WBC count consistently showed significant exposure-response and dose-response relationships in both sexes. CONCLUSIONS: WBC count was found to be a consistent effect marker of cigarette smoke exposure, while the association between CRP level and smoking was inconsistent and varied by sex. The sex-specific response to cigarette smoke exposure warrants further exploration in future studies. IMPLICATIONS: Cigarette smoke exposure is known to increase inflammation and has been thought to increase CRP, a significant inflammation marker. However, recent studies have reported conflicting results regarding the dose-dependent association between cigarette smoke exposure and CRP. This study found that the association between smoking and CRP is inconsistent and varies by sex, showing significant exposure response in men but not in women. Furthermore, the study suggests that WBC count is a more consistent marker for cigarette smoke exposure.

Effectiveness of personalized treatment stage-adjusted digital therapeutics in colorectal cancer: a randomized controlled trial.

BACKGROUND: Colorectal cancer survivors often experience decline in physical performance and poor quality of life after surgery and during adjuvant therapies. In these patients, preserving skeletal muscle mass and high-quality nourishment are essential to reduce postoperative complications and improve quality of life and cancer-specific survival. Digital therapeutics have emerged as an encouraging tool for cancer survivors. However, to the best of our knowledge, randomized clinical trials applying personalized mobile application and smart bands as a supportive tool to several colorectal patients remain to be conducted, intervening immediately after the surgical treatment. METHODS: This study is a prospective, multi-center, single-blinded, two-armed, randomized controlled trial. The study aims to recruit 324 patients from three hospitals. Patients will be randomly allocated to two groups for one year of rehabilitation, starting immediately after the operation: a digital healthcare system rehabilitation (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective of this protocol is to clarify the effect of digital healthcare system rehabilitation on skeletal muscle mass increment in patients with colorectal cancer. The secondary outcomes would be the improvement in quality of life measured by EORTC QLQ C30 and CR29, enhanced physical fitness level measured by grip strength test, 30-sec chair stand test and 2-min walk test, increased physical activity measured by IPAQ-SF, alleviated pain intensity, decreased severity of the LARS, weight, and fat mass. These measurements will be held on enrollment and at 1, 3, 6 and 12 months thereafter. DISCUSSION: This study will compare the effect of personalized treatment stage-adjusted digital health interventions on immediate postoperative rehabilitation with that of conventional education-based rehabilitation in patients with colorectal cancer. This will be the first randomized clinical trial performing immediate postoperative rehabilitation in a large number of patients with colorectal cancer with a tailored digital health intervention, modified according to the treatment phase and patient condition. The study will add foundations for the application of comprehensive digital healthcare programs focusing on individuality in postoperative rehabilitation of patients with cancer. TRIAL REGISTRATION: NCT05046756. Registered on 11 May 2021.

Association of clinical manifestations of secondary lymphedema and lymph node dissection sites in the lower extremities of patients with melanoma.

BACKGROUND: Lymphedema is a chronic, debilitating disease that often requires life-long management. Predicting clinical manifestations and prognosis is crucial in clinical practice because the treatment of lymphedema should be individualized for best clinical outcome. The aim of this study is to explore the location and severity of lymphedema secondary to inguinal and/or iliac lymph node dissection (LND) in patients with melanoma. METHODS: Patients with melanoma who received LND at a single tertiary medical center between 1 January 2010 and 31 September 2022 were retrospectively reviewed. Patient who received inguinal LND only were designate as the inguinal group while those who received both ilioinguinal LND were included in the ilioinguinal group. Volumetric measurement was used to objectify the severity and location of lymphedema. Clinical data was acquired for 12-15 months of follow-up. RESULTS: Among 81 patients, 43 (53%) had developed lymphedema in the lower extremities at an average of 33 days after the surgery. Initially, patients manifested with medial thigh lymphedema in the inguinal group while patients were presented with whole leg lymphedema in the ilioinguinal group. Lower leg volume of the ilioinguinal group was significantly higher than the inguinal group. After more than 12 months of lymphedema treatment, upper leg volume was higher in the ilioinguinal group than the inguinal group (12.7% vs 5.4%, p < 0.05). CONCLUSION: Lymphedema developed in early post-op period. The ilioinguinal group presented with a larger volume of lymphedema in the distal area of the legs. Even after sufficient treatment, predominant lymphedema remained in the proximal leg for the ilioinguinal group. Patients with both inguinal and iliac LND were associated with more severe lymphedema. Based on the dissection sites, the clinical manifestations and prognosis of leg lymphedema can vary widely. Thus, clinicians should consider the dissection site when approaching melanoma patients with lymphedema.

Comparison of Proportional Mortality Between Korean Atomic Bomb Survivors and the General Population During 1992-2019.

BACKGROUND: Atomic bombs dropped on Hiroshima and Nagasaki in Japan in August 1945 were estimated to have killed approximately 70,000 Koreans. In Japan, studies on the health status and mortality of atomic bomb survivors compared with the non-exposed population have been conducted. However, there have been no studies related to the mortality of Korean atomic bomb survivors. Therefore, we aimed to study the cause of death of atomic bomb survivors compared to that of the general population. METHODS: Of 2,299 atomic bomb survivors registered with the Korean Red Cross, 2,176 were included in the study. In the general population, the number of deaths by age group was calculated from 1992 to 2019, and 6,377,781 individuals were assessed. Causes of death were categorized according to the Korean Standard Classification of Diseases. To compare the proportional mortality between the two groups, the P value for the ratio test was confirmed, and the Cochran-Armitage trend test and χ² test were performed to determine the cause of death according to the distance from the hypocenter. RESULTS: Diseases of the circulatory system were the most common cause of death (25.4%), followed by neoplasms (25.1%) and diseases of the respiratory system (10.6%) in atomic bomb survivors who died between 1992 and 2019. The proportional mortality associated with respiratory diseases, nervous system diseases, and other diseases among atomic bomb survivors was higher than that of the general population. Of the dead people between 1992 and 2019, the age at death of survivors who were exposed at a close distance was younger than those who were exposed at a greater distance. CONCLUSION: Overall, proportional mortality of respiratory diseases and nervous system diseases was high in atomic bomb survivors, compared with the general population. Further studies on the health status of Korean atomic bomb survivors are needed.

Evaluation of Temporal Trends of Lead Exposure in Korean Workers Using Workplace Monitoring Data.

BACKGROUND: Lead, which is widely used in various industrial settings, is a major health hazard for manufacturing workers. Therefore, control of lead exposure has been implemented in an effort to prevent lead-related health problems. In this study, our aim was to evaluate temporal trends in occupational lead exposure in Korean lead workers using data from monitoring of workplace exposure. METHODS: A nationwide work environment monitoring database, data from a work environment monitoring institution, and data extracted from a review paper were utilized. Different versions of standard industrial classification codes were aligned with the 10th Korean Standard Industrial Classification, which is generally consistent with the 4th revision of the International Standard Industrial Classification. The multiple data sources were combined and temporal trends over the period from 1994-2021 were estimated. In addition, separate estimation of temporal trends in the storage battery manufacturing industry over the period from 1987-2021 was also performed. RESULTS: A total of 444,296 personal airborne lead measurements were used for the estimation process. The temporal trends in occupational exposure to lead declined by -6% annually over the study period. In particular, levels of lead exposure in the storage battery manufacturing industry showed a steeper decline of -12% annually. CONCLUSIONS: Findings of our study showed that occupational exposure to lead declined over the period from 1994 to 2021 in Korea. However, adverse effects of exposure to lead on health should be regarded with caution. The results will be useful in conduct of epidemiological studies examining lead-related effects on health.

Association between long working hours and unmet dental needs in wage workers.

BACKGROUND: Many previous studies on the reasons behind unmet dental needs focus on economic issues. However, in this research, we aimed to investigate the relationship between long working hours and unmet dental needs while considering the influence of occupational factors in wage workers. METHODS: This study used data from the Korea National Health and Nutrition Examination Survey (2012-2018) and analyzed a sample of 12,104 wage workers. Unmet dental needs were defined as cases in which individuals did not receive dental care, despite their need for examination or treatment, within the last year. Long working hours were defined as exceeding 52 h per week, based on the standard working hours stipulated by the Labor Standards Act. A binomial model was applied to calculate the prevalence ratio through multivariate logistic regression analysis. RESULTS: The prevalence of unmet dental needs was observed in 3,948 cases (32.5%), among which 1,478 attributed their presence to lack of time. The prevalence of unmet dental needs showed an inverse relationship with the education level and household income. The wage workers who worked long hours had the highest prevalence of unmet dental needs. Long working hours were found to be 1.18 times (95% CI 1.07-1.29) more likely to result in unmet dental care compared to working less than 40 h. The relationship between long working hours and unmet dental needs were statistically significant only in men (PR 1.24, 95% CI 1.07-1.43). However, the relationship between long working hours and unmet dental needs owing to time were in both men and women (men: PR 1.59, 95% CI 1.20-2.11, women: PR 1.90, 95% CI 1.48-2.43). CONCLUSIONS: This study confirmed that long working hours and unmet dental needs are related when occupational factors are taken into consideration, despite the absence of oral health indicators. Using this study as a reference, further research is necessary to identify the underlying causes of unmet dental care and to improve access to dental services in the future.

Dementia in a Hearing-impaired Population According to Hearing Aid Use: A Nationwide Population-based Study in Korea.

BACKGROUND: Hearing loss is considered a potentially modifiable risk factor for dementia. However, the effect of use of a hearing aid on the development of dementia has not been clearly established. We aimed to assess the incidence of dementia in hearing-impaired individuals according to hearing aid use in a nationwide population-based cohort study with matched controls. METHODS: This was a retrospective, longitudinal, cohort study of South Korean national claims data for individuals newly registered with hearing disabilities (better ear ≥40 dBHL with worse ear ≥80 dBHL, or better ear ≥60 dBHL) between 2004 and 2008. The hearing aid cohort comprised individuals who received hearing aid subsidies from the National Health Insurance within a year from disability registration. The comparison cohort comprised individuals without a record of a hearing aid claim during the study period after 1:1 matching for audiologic and sociodemographic factors with the hearing aid cohort. The occurrence of dementia was followed up until 2018. RESULTS: Each cohort comprised 8780 individuals. Overall incidence of dementia in the hearing aid and comparison cohorts were 156.0 and 184.5 per 10,000 person-years, respectively (incidence rate ratio = 0.85, 95% confidence interval 0.79-0.91). In a multivariable analysis of the whole study populations, hearing aid use (hazard ratio = 0.75, 95% confidence interval 0.70-0.81) attenuated the risk of dementia. CONCLUSIONS: Dementia incidence in individuals with hearing disabilities was lower in hearing aid users than that in nonusers. Hearing rehabilitation with hearing aids should be encouraged for individuals with hearing loss.

Pregnancy loss and Income in the Republic of Korea using National Health Insurance Service Data, 2008-2014.

BACKGROUND: Although unintentional pregnancy loss is common, national representative statistics are lacking in high-income East Asian countries undergoing rapid demographic changes. It is necessary to confirm the income inequality of pregnancy loss even in universal national health insurance. METHOD: Using National Health Insurance Service data between 2008 and 2014, the annual prevalence of pregnancy loss was enumerated, and differences in pregnancy loss according to age and income levels were assessed by multivariable Poisson regression. Joint-point regression was used to examine the trend of pregnancy loss. RESULT: On average, there was a 15.0% annual pregnancy loss among 3,941,020 pregnancy cases from 2008 to 2014. Pregnancy loss inequality increased stepwise with income levels except for the highest income group. After adjusting for income levels, the annual percent change of age-standardized prevalence significantly increased by 2.6% every year since 2011. CONCLUSION: Even in high-income countries with universal national health insurance, income inequality in pregnancy loss is observed. Further appraisal is needed to explain the increasing trend of pregnancy loss between 2011 and 2014 even after adjusting income.

Association of coffee drinking with all-cause and cause-specific mortality in over 190,000 individuals: data from two prospective studies.

We examined the association of coffee drinking with all-cause and cause-specific mortality in a pooled analysis of two Korean prospective cohort studies: The Korea National Health and Nutrition Examination Survey and the Korean Genome and Epidemiology Study. We included 192,222 participants, and a total of 6057 deaths were documented. Cox proportional hazards model was used to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs), and the HRs were combined using a random-effects model. Coffee drinking was associated with a lower risk of all-cause mortality [HR (95% CI) = 0.84 (0.77-0.92), for ≥3 cups/day of coffee drinking versus non-drinkers; p for trend = 0.004]. We observed the potential benefit of coffee drinking for mortality due to cardiovascular disease, respiratory disease, and diabetes, but not for cancer mortality. Overall, we found that moderate coffee drinking was associated with a lower risk of death in population-based cohort analysis of Korean adults.

Increased risk of suicide after occupational injury in Korea.

OBJECTIVES: This study sought to investigate the association between occupational injury and subsequent risk of suicide in Korea. METHODS: We linked compensation data for 775 537 workers injured at work during 2003-2014 with National Death Registry through 2015. Suicide among injured workers was compared with the economically active population in Korea separately for men and women by calculating SMRs, with 95% CIs. RESULTS: Injured workers showed higher mortality from suicide for both men (SMR=2.22, 95% CI 2.14 to 2.31) and women (SMR=2.11, 95% CI 1.81 to 2.45) compared with the economically active population in Korea. CONCLUSIONS: Occupational injuries are associated with substantially elevated suicide risk in Korea. The results suggest the importance of social policies to protect and support injured workers as well as intensifying efforts to prevent workplace injuries.

Novel, user-friendly landmarks for localizing Baxter's nerve: A cadaveric study.

INTRODUCTION: Identification of Baxter's nerve (BN) has proven challenging for less experienced practitioners using ultrasonography due to a lack of adequate landmarks. This study aimed to establish novel, user-friendly anatomical landmarks and to describe useful structures to localize BN. MATERIALS AND METHODS: We examined 10 fresh cadaveric feet and identified the interobserver agreement of measuring three surface landmarks: the most medially protruded point on the medial malleolus (P), the navicular tuberosity (Q), and the center of the calcaneus (B). Next, 24 fresh cadaveric feet were used to identify the point of BN entry into the quadratus plantae (QP) muscle, which corresponds to the proximal BN impingement site. The rectangular coordinate system consisted of the origin (point P), X-axis, extension line P-Q, and Y-axis (the perpendicular line to the X-axis). To consider various foot sizes, the X and Y values were divided by the P-Q length and were designated as the ratios X and Y. RESULTS: Points P and Q showed smaller interobserver differences than that of point B. Ratios X and Y were 61.25 and 99.80%, respectively, for the QP. BN arose from the lateral plantar nerve in 20 of 24 specimens. The adjacent vessel was <3 mm from the entrapment site of BN in 20 of 24 specimens. CONCLUSION: New landmarks will improve the precision of localizing the entrapment site of BN and will provide advanced guidelines for podiatric patients.

Does increased body mass index lead to elevated prostate cancer risk? It depends on waist circumference.

BACKGROUND: We examined the association between obesity and prostate cancer based on both body mass index (BMI) and waist circumference (WC) using the National Health Insurance System (NHIS) database for the entire male population of Korea. METHODS: A total of 1,917,430 men who underwent at least one health examination in 2009 without a previous diagnosis of any other cancer were tracked through December 2015. The hazard ratio (HR) and 95% confidence interval (CI) value for the association between prostate cancer and obesity were analyzed using multiple Cox regression model. Since there was a statistically significant interaction between WC and BMI, a multiple HR for prostate cancer was estimated with stratifying both WC and BMI to control the interaction between WC and BMI. RESULTS: Without considering WC as an adjustment factor, very weak association between BMI and prostate cancer development risk was observed. When WC was considered as an adjustment factor, no significant change in the HRs for prostate cancer development beyond the reference BMI was observed in the group with WC < 85 cm in the multivariable-adjusted models. However, in the group with WC ≥ 85 cm, the HRs for prostate cancer increased as the BMI increased beyond the reference BMI. In addition, there was a discrepancy in the trend of prostate cancer development according to BMI among the groups with different categories for WC. CONCLUSION: In groups with abdominal obesity, a significant linear relationship was observed between increasing BMI and prostate cancer risk. Higher the WC category, the stronger was the association with BMI, signifying that the association of BMI with risk of prostate cancer development depends on abdominal obesity.

Sleep disturbance and next-day physical activity in COPD patients.

Physical inactivity and sleep disturbance are more problematic in patients with chronic obstructive pulmonary disease (COPD) than in healthy individuals. The purpose of the study was to identify impacts of nighttime sleep on next-day physical activity in COPD patients. The study included 52 COPD patients reporting disturbed sleep. Sleep and physical activity were measured using an accelerometer for 5 days. Increased sleep latency was associated with less next-day physical activity during the afternoon (4-6 p.m.). Greater waking duration/times were associated with less next-morning (6-8 a.m.) physical activity. Greater total sleep time was associated with less next-morning (12-9 a.m.) physical activity, and greater sleep efficiency was associated with less next-morning (1-3 a.m.) and more next-evening (6-7 p.m.) physical activity. Results suggest that sleep disturbance had varying influences on next-day hourly physical activity. These results support the potential value of sleep management in promoting physical activity in COPD patients.

Metabolically healthy and unhealthy obesity phenotypes and risk of renal stone: a cohort study.

BACKGROUND/OBJECTIVES: Although obesity is considered an independent risk factor of nephrolithiasis, little is known about the effect of obesity on nephrolithiasis according to metabolic health status. We investigated the association between body mass index (BMI) category and the incidence of nephrolithiasis in metabolically healthy and unhealthy individuals. SUBJECTS/METHODS: The cohort consisted of 270,190 Korean adults free of nephrolithiasis at baseline, who were followed-up annually or biennially for a median of 4.1 years. Nephrolithiasis were determined based on ultrasonographic findings. Being metabolically healthy was defined as not having any metabolic syndrome component. A parametric Cox model was used to estimate the adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). RESULTS: During 1,415,523.0 person-years of follow-up, 13,450 participants developed nephrolithiasis (incidence rate, 9.5 per 1000 person-years). Obesity was positively associated with an increased risk of incident nephrolithiasis in dose-response manner, but the association was stronger in metabolically healthy individuals. Among metabolically healthy individuals, the multivariable-adjusted HRs (95% CIs) for incident nephrolithiasis comparing BMIs 23-24.9, 25-29.9, and ≥30 with a BMI of 18.5-22.9 kg/m2 as the reference were 1.02 (0.95-1.10), 1.12 (1.03-1.22), and 1.72 (1.21-2.44), respectively, whereas corresponding HRs (95% CIs) in metabolically unhealthy individuals were 1.10 (1.04-1.17), 1.27 (1.20-1.34), and 1.36 (1.22-1.51), respectively. The association between obesity and incident nephrolithiasis was stronger in men and current smokers. CONCLUSIONS: Obesity was associated with a higher incidence of nephrolithiasis in both metabolically healthy and unhealthy individuals, indicating obesity per se as an independent risk factor for nephrolithiasis.

Epidemiology of ALS in Korea using nationwide big data.

OBJECTIVE: This study aimed to determine the incidence, prevalence and survival time of Korean patients with amyotrophic lateral sclerosis (ALS) using National Health Insurance Service (NHIS) data. METHODS: Using NHIS data, the Korean nationwide health dataset, we identified patients with motor neuron diseases who were first diagnosed with a KCD-6 code (G12.20-G12.28; modified from ICD-10 codes) between 2011 and 2015. ALS (G12.21 code) epidemiological characteristics, including annual incidence, prevalence, mortality rates and survival time, were analysed and compared with sociodemographic variables. RESULTS: New patients with ALS (n=3049) were enrolled over 5 years. The mean annual incidence was 1.20/100 000, and the sex ratio was 1.60 (male:female). The mean age at the time of diagnosis was 61.4 years. The prevalence rate was 3.43/100 000 in 2015. In this period, riluzole was prescribed to 53.6% of patients with ALS. Furthermore, 20.3% of patients with ALS underwent tracheostomy. When analysed for age and socioeconomic status, ALS prevalence rate was 10.71 in the aged group (≥60) in 2015 and was lowest in the middle-income group compared with that in the high-income and low-income groups. The estimated mean survival time in this population was 50.0 months, and the 3-year and 5-year mortality rates were 52.1% and 63.7%, respectively. CONCLUSIONS: This study is the first nationwide survey for epidemiological characteristics of ALS in Korea using national data. The use of these data substantially advances the understanding of Korean and Asian ALS epidemiology and its relationship with socioeconomic status, age and sex.

The relationship between hormone replacement therapy and periodontal disease in postmenopausal women: a cross-sectional study the Korea National Health and Nutrition Examination Survey from 2007 to 2012.

BACKGROUND: The purpose of this study was to investigate the relationship between hormone replacement therapy (HRT) and periodontal disease in postmenopausal women using data from the 4th and 5th Korea National Health and Nutrition Examination Survey (KNHANES). METHODS: The study included data from 5,482 postmenopausal women aged 45-74 years in the 2007-2012 KNHANES. The use of female HRT for at least one month was reclassified as HRT+/HRT-. The Community Periodontal Index of Treatment Needs (CPITN) was used to assess periodontal status. Propensity score matching (PSM) was used to control selection bias, and factors affecting education, family income, and age of menopause were used as covariates in PSM. A chi-square test was used to confirm the bivariate relationship between the variables. Binary logistic regression analysis was used to adjust for confounders (age, education, family income, body mass index, age of menopause, alcohol, smoking, dental clinic visits in the past one year, use of oral care products and frequency of tooth brushing per day). RESULTS: After adjusting for all covariates, HRT was associated with periodontal disease (OR: 0.79; 95% CI: 0.66-0.94). In particular, the relationship between HRT and periodontal disease was more evident in those with menopause under 45 years of age disease (OR: 0.55; 95% CI: 0.35-0.87). CONCLUSIONS: The results of this study supported that it is important that hormone therapy be actively considered in the policy towards postmenopausal women. Especially, health programs such as hormone replacement therapy, non-smoking, and use of oral care products are needed for women who undergo premature menopause.

Job Stress-attributable Burden of Disease in Korea.

BACKGROUND: As job stress is associated with various diseases and psychiatric conditions, we aimed to estimate the job stress-attributable burden of disease in Korea based on the concept of disability-adjusted life years (DALY). METHODS: We selected ischemic heart disease (IHD), stroke, major depressive disorder (MDD), and suicide as health outcomes from job stress, because of the ease of access to data estimating burdens and of important meaning of them in Korean occupational background. RESULTS: Our findings demonstrated that approximately 21% of Korean workers were exposed to high job strain, which was attributable for approximately 6.7% of IHDs, 6.9% of strokes, 13.6% of MDDs, and 4% of suicides. In terms of job stress-attributable DALY, the burdens of disease per 100,000 people were 38 for IHD, 72 for stroke, 168 for MDDs, and 44 for suicides. CONCLUSION: The present findings suggested that one-fifth of Korean workers were suffering from high job strain. Although the figures may not be accurate due to several assumptions, job stress is an important risk factor for health in working environment in Korea.

Evaluation of fatigability measurement: Integrative review.

Fatigability is defined as the extent of fatigue in the context of activity and differs from the term used in exercise literature to describe muscle endurance characteristics. Many fatigability measures are available, but no studies have thoroughly evaluated them for adequate incorporation of fatigability concepts. This integrative review provides an overall assessment of existing fatigability measures and then evaluates each in depth. A database search and hand search produced 14 studies for review. Fatigability measurement took three forms: self-reported fatigability, perceived fatigability (self-reported fatigue following a defined performance test), and performance fatigability (performance deterioration). Of 17 measures identified, validity and/or reliability was reported for six (35.3%), and no measure was used in more than one study. Fatigability measures have been correlated with clinical measures, indicating that fatigability should be measured during routine clinical health screening. Refinement of measures and additional fatigability data collection will improve understanding and treatment of fatigue.

A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer.

BACKGROUND: We investigated the efficacy of cetuximab when added to induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced head and neck squamous cell carcinoma. METHODS: Patients were randomized to receive three cycles of docetaxel and cisplatin (TP regimen) with or without cetuximab (TP plus cetuximab [CTP] vs. TP) as induction chemotherapy. Patients in the CTP arm received CCRT with cetuximab and cisplatin, whereas patients in the TP arm received cisplatin alone. The primary endpoint was the objective response rate (ORR) after induction chemotherapy. RESULTS: Overall, 92 patients were enrolled. The ORRs for induction chemotherapy in the CTP and TP arms were not different (81% vs. 82%). Adding cetuximab lowered the completion rate of induction chemotherapy and CCRT and resulted in more frequent dose reductions of the induction chemotherapy, although this did not reach statistical significance. In the CTP and TP arms, respectively, the 3-year progression-free survival (PFS) rates were 70% and 56% (p = .359), and the overall survival (OS) rates were 88% and 74% (p = .313). When limited to patients who completed induction chemotherapy, 3-year PFS rates of 78% and 59% (p = .085) and OS rates of 94% and 73% (p = .045) were observed in the CTP and TP arms, respectively. CONCLUSION: Adding cetuximab to sequential treatment did not increase the treatment efficacy and resulted in greater toxicity. In the intent-to-treat population, neither PFS nor OS was improved by the addition of cetuximab to sequential treatment; however, a suggestion of improved survival outcomes was observed in patients completing cetuximab-containing induction chemotherapy.