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Background An important issue for patients with cancer treated with novel therapeutics is how they weigh the effects of treatment on survival and quality of life (QOL). We compared QOL in patients enrolled to SWOG S1400I, a substudy of the LungMAP biomarker-driven master protocol. Methods SWOG S1400I was a randomized phase III trial comparing nivolumab plus ipilimumab vs nivolumab for treatment of immunotherapy-naïve disease in advanced squamous cell lung cancer. The primary endpoint was the MD Anderson Symptom Inventory–Lung Cancer severity score at week 7 and week 13 with a target difference of 1.0 points, assessed using multivariable linear regression. A composite risk model for progression-free and overall survival was derived using best-subset selection. Results Among 158 evaluable patients, median age was 67.6 years and most were male (66.5%). The adjusted MD Anderson Symptom Inventory–Lung Cancer severity score was 0.04 points (95% confidence interval [CI] = −0.44 to 0.51 points; P = .89) at week 7 and 0.12 points (95% CI = −0.41 to 0.65; P = .66) at week 13. A composite risk model showed that patients with high levels of appetite loss and shortness of breath had a threefold increased risk of progression or death (hazard ratio [HR] = 3.06, 95% CI = 1.88 to 4.98; P Conclusions We found no evidence of a benefit of ipilimumab added to nivolumab compared with nivolumab alone for QOL in S1400I. A risk model identified patients at high risk of poor survival, demonstrating the prognostic relevance of baseline patient-reported outcomes even in those with previously treated advanced cancer.

Objective The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) module is a widely used instrument for measuring symptom burden and interference of daily activities in brain tumor patients. This study aims to develop and validate its Japanese version (MDASI-BT-Japanese). Methods Following forward and backward translation of the original MDASI-BT into Japanese, understandability and feasibility were assessed by cognitive debriefing. Subsequently, patients with brain tumors were asked to fill out MDASI-BT-Japanese and European Quality of Life-5 Dimensions (EQ-5D). Feasibility, reliability and validity of MDASI-BT-Japanese were assessed. Results Cognitive debriefing confirmed overall ease of completion and good understandability. The study population composed of 140 patients with brain tumors (most commonly gliomas). The mean symptom severity score and mean interference score were 1.9 ± 1.7 and 2.8 ± 2.7, respectively. The top items included distress and drowsiness for symptom severity and general activity and work for interference. The median time required was 4 minutes (range, 0.5–30), and missing values were seen in 1%. Internal consistency was proven by excellent Cronbach’s coefficient alpha (0.94 for symptom severity, 0.92 for interference). Test–retest reliability was assessed with acceptable intra-class correlation coefficient (mean, 0.76). Correlation efficient ranged between 0.7 and 0.9 for convergent validity. Known-group validity was confirmed by significantly different mean symptom severity score and mean interference score among patients with different performance status. As evidence of concurrent validity, MDASI-BT-Japanese correlated with EQ-5D in the hypothesized magnitude and direction. Conclusions The newly developed MDASI-BT-Japanese has demonstrated feasibility, reliability and validity in evaluation of clinical benefit in Japanese-speaking brain tumor patients.

Background The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) reporting system is widely used by clinicians to measure patient symptoms in clinical trials. The European Organization for Research and Treatment of Cancer's Quality of Life core questionnaire (EORTC QLQ-C30) enables cancer patients to rate their symptoms related to their quality of life. We examined the extent to which patient and clinician symptom scoring and their agreement could contribute to the estimation of overall survival among cancer patients. Methods We analyzed baseline data regarding six cancer symptoms (pain, fatigue, vomiting, nausea, diarrhea, and constipation) from a total of 2279 cancer patients from 14 closed EORTC randomized controlled trials. In each trial that was selected for retrospective pooled analysis, both clinician and patient symptom scoring were reported simultaneously at study entry. We assessed the extent of agreement between clinician vs patient symptom scoring using the Spearman and kappa correlation statistics. After adjusting for age, sex, performance status, cancer severity, and cancer site, we used Harrell concordance index (C-index) to compare the potential for clinician-reported and/or patient-reported symptom scores to improve the accuracy of Cox models to predict overall survival. All P values are from two-sided tests. Results Patient-reported scores for some symptoms, particularly fatigue, did differ from clinician-reported scores. For each of the six symptoms that we assessed at baseline, both clinician and patient scorings contributed independently and positively to the predictive accuracy of survival prognostication. Cox models of overall survival that considered both patient and clinician scores gained more predictive accuracy than models that considered clinician scores alone for each of four symptoms: fatigue (C-index = .67 with both patient and clinician data vs C-index = .63 with clinician data only; P

BACKGROUND Patient reporting of the severity and impact of symptoms is an essential component of cancer symptom management and cancer treatment clinical trials. In multinational clinical trials, cultural and linguistic variations in patient-reported outcomes instruments could confound the interpretation of study results. METHODS The severity and interference of multiple symptoms in 1433 cancer patients with mixed diagnoses and treatment status from the United States, China, Japan, Russia, and Korea were measured with psychometrically validated language versions of the M. D. Anderson Symptom Inventory (MDASI). Mixed-effect ordinal probit regression models were fitted to the pooled data to compare the magnitude of the effect of "country" (nation and linguistic factors) with between-subjects effects on symptom reporting, adjusted for patient and clinical factors (age, sex, performance status, and chemotherapy status). RESULTS For the pooled sample, fatigue, disturbed sleep, distress, pain, and lack of appetite were the most severe patient-reported MDASI symptoms. The magnitude of the variance of the country random effects was only one-fourth to one-half of the interpatient variation (sigma(2) = 0.23-0.46) for all symptoms, except nausea and vomiting. CONCLUSIONS Cultural and linguistic variations in symptom reporting among the five language versions of the validated MDASI were limited. Ordinal probit modeling provided a simple mechanism for accounting for cultural and linguistic differences in patient populations. The equivalence among MDASI translations in this study suggests that symptom ratings collected from various cultural and language groups using the MDASI can be interpreted in a similar way in oncology practice, clinical trials, and clinical research.

Cancer-related neuropathic pain syndromes are common and serious complications of a patient's primary malignancy or its treatment, whether by surgery, radiation, or chemotherapy. They may compromise the patient's quality of life as well as their ability to receive effective treatment. In many patients, there may be more than one coexistent neuropathic pain syndrome, posing a diagnostic dilemma that, if unresolved, may result in the institution of therapies that are of limited scope or not targeted at the primary underlying pathophysiology. There is no single adequate diagnostic method that has been established to reliably diagnose or follow patients with cancer-related neuropathic pain syndromes. Clinical assessment of cancer-related neuropathic pain poses some important challenges diagnostically as well as in defining a clear and reliable endpoint assessment in controlled clinical trials. Many different approaches have been applied to the development of assessment or diagnostic tools. Careful review of these methods has been helpful in developing a clearer vision for the future design and refinement of more reliable tools, and more importantly, validation of the clinical utility as well as the reliability of such tools when employed as endpoints in clinical trials focused on prevention, mitigation, or treatment of cancer neuropathic pain.

Cancer and its treatment produce multiple symptoms that significantly distress patients and impair function. Symptoms caused by treatment may delay treatment or lead to premature treatment termination, and residual treatment-related symptoms often complicate posttreatment rehabilitation. When treatment is no longer possible, symptom control becomes the focus of cancer care. Patient ratings of symptom severity and impact are important patient-reported outcomes (PROs) in cancer clinical trials and comprise a subset of a larger domain of PROs generally referred to as health-related quality of life (HRQOL). Symptoms rarely occur in isolation; rather, there is now ample evidence that symptoms frequently occur in clusters. The impact of these multiple symptoms upon the patient can be described as "symptom burden," a concept that encompasses both the severity of the symptoms and the patient's perception of the impact of the symptoms. The distress caused by symptoms is a subject of much investigation, and several validated measures of the severity and impact of multiple symptoms are now available. Symptom measures are generally brief, thereby reducing respondent burden, and can be administered repeatedly during a trial to give a relatively fine-grained picture of the patient's status across time. In many instances, information on trial-related changes in symptom burden, or comparison of symptom burden between arms in a clinical trial, may provide sufficient self-report data for clinical trial consumers (patients, clinicians, and regulators) to make treatment choices or to evaluate new therapies, without measuring other HRQOL domains.

Administration of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or statins, to ambulatory patients is associated with a lower incidence of long-term adverse cardiovascular events, including death, myocardial infarction, stroke, atrial fibrillation, and renal dysfunction. However, increasing clinical evidence suggests that statins, independent of their effects on serum cholesterol levels, may also play a potential role in the prevention and treatment of cancer. Specifically, statins have been shown to exert several beneficial antineoplastic properties, including decreased tumor growth, angiogenesis, and metastasis. The feasibility and efficacy of statins for the prevention and treatment of cancer is reviewed.

Pain is one of the most frequent and deleterious symptoms in cancer patients. This study was carried out to investigate the adequacy of pain management at the National Cancer Center Hospital East, Japan.The available data were obtained from 138 ambulatory cancer patients with pain. The data included pain severity, which patients reported using the Japanese version of the M. D. Anderson Symptom Inventory, along with such medical information as cancer and treatment information and currently prescribed analgesics. Adequacy of pain management was assessed using the Pain Management Index, which revealed whether prescribed analgesic drugs were congruent with pain severity.Physicians undertreated pain in 70% of patients. Patients with non-advanced cancer (local cancer or no evidence of any recurrent cancer) were more likely to receive inadequate treatment than those with advanced cancer [P = 0.009, odds ratio = 0.18, Exp (95% CI) lower = 0.05, higher = 0.64] in the exploratory logistic regression analysis. Additionally, we found significant differences among physicians in ability to manage cancer pain, unrelated to a physician's years of experience as an oncologist.This study suggests that cancer pain management is insufficient at the investigated institute. Remedial action should be taken, including increasing awareness of symptom management in medical staff and incorporating existing knowledge into routine clinical practice.

background. Pain and fatigue are common debilitating symptoms reported by both patient and community-dwelling populations. However, population-based studies typically focus on psychosocial variables as correlates of fatigue, with little effort toward assessing pain as a risk factor. This study examines the specific relationship between pain and fatigue and the importance of mood and sleep as covariates of fatigue in a community-dwelling sample of adults. We also assessed the prevalence of mild, moderate, and severe fatigue for this sample. methods. Data were collected using self-administered questionnaires assessing demographic characteristics and symptoms, including pain, fatigue, mood, and sleep disturbance, in a sample (N=274) of community-dwelling adults. results. Regression analyses showed pain, mood, and sleep as significantly associated with fatigue, with pain being the most highly correlated. However, while pain accounted for the largest proportion of the variability in fatigue, mood modified the relationship between pain and fatigue. We also found that 9% of the sample reported no fatigue, 41% reported mild fatigue, 42% reported moderate fatigue, and 8% reported severe fatigue. conclusions. Our findings provide empirical support of the importance of assessing pain as an important risk factor of fatigue and examining mood as a covariate in population-based studies of fatigue.

BACKGROUND: It has been recognized that symptom burden reported as a patient-reported outcome is valuable in assessment of both disease and treatment-related symptoms and should be incorporated into evaluation of clinical benefit of novel therapies. MDASI-BT is a widely-used instrument for measuring symptom burden in brain tumor patients, and its Japanese version (MDASI-BT-J) has recently been validated linguistically. The purpose of this study is to psychometrically validate MDASI-BT-J. METHODS: Patients with brain tumors who were undergoing oncologic treatments in The University of Tokyo Hospital or National Cancer Center Hospital between 2014 and 2015 were asked to fill out MDASI-BT-J and the Japanese version of European Quality of Life-5 Dimensions (EQ-5D-J). Feasibility, reliability, and validity of MDASI-BT-J were assessed. RESULTS: One-hundred-and-forty patients (72 men) including 63 patients with gliomas participated in the study. The median age was 54 years, and the median Karnofsky Performance Status (KPS) score was 90. The mean symptom severity score (MSS) and mean interference score (MIS) were 1.9 ± 1.7 and 2.8 ± 2.7, respectively. The median amount of time required to complete the form was 4 minutes (range, 0-30), and missing values were seen in 1%. Internal consistency using Cronbach's coefficient alpha was 0.94 and 0.92 for symptom severity and interference, respectively. Test-retest reliability was assessed in 30 patients with acceptable intra-class correlation coefficient (mean, 0.74). Known-group validity confirmed a significant difference in MSS (1.6 versus 2.3, P = 0.007) and MIS (2.0 versus 3.9, P = 0.007) between patients with KPS score >= 90 and those with KPS score