Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma.

BACKGROUND: Preserving health-related quality of life (HRQOL) is an important goal during renal cell carcinoma treatment. We report HRQOL outcomes from a phase II trial (NCT03173560). PATIENTS AND METHODS: HRQOL data were collected during a multicenter, randomized, open-label phase II study comparing the safety and efficacy of 2 different starting doses of lenvatinib (18 mg vs. 14 mg daily) in combination with everolimus (5 mg daily), following one prior vascular endothelial growth factor-targeted treatment. HRQOL was measured using 3 different instruments-FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L-which were all secondary endpoints. Change from baseline was assessed using linear mixed-effects models. Deterioration events for time to deterioration (TTD) analyses were defined using established thresholds for minimally important differences in the change from baseline for each scale. TTD for each treatment arm was estimated using the Kaplan-Meier method. RESULTS: Baseline characteristics of the 343 participants randomly assigned to 18 mg lenvatinib (n = 171) and 14 mg lenvatinib (n = 172) were well balanced. Least-squares mean estimates for change from baseline were favorable for the 18 mg group over the 14 mg group for the FKSI-DRS and most EORTC QLQ-C30 scales, but differences between treatments did not exceed the minimally important thresholds. Median TTD was longer among participants in the 18 mg group than those in the 14 mg group for most scales. CONCLUSIONS: Participants who received an 18 mg lenvatinib starting dose had favorable HRQOL scores and longer TTD on most scales compared with those who received a 14 mg starting dose.

Health-related quality of life in long-term Caribbean prostate cancer survivors: comparisons with prostate cancer-free men.

PURPOSE: Prostate cancer (PCa) and its treatment can impact health-related quality of life (HRQoL). There are few studies of HRQoL in long-term PCa survivors of African ancestry from low- and middle-income countries. We examined the effect of PCa treatment on HRQoL of Jamaican PCa survivors compared with cancer-free controls and explored the effect of demographic and clinical factors on these outcomes. METHODS: PCa survivors (n = 64) treated with and without ADT along with PCa-free controls (n = 88) from a case-control study of 10 years post enrolment. HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30). Effects of demographic and clinical variables on HRQoL on PCa and type of therapy were evaluated in multivariable linear regression models. RESULTS: HRQoL of PCa survivors (overall and by treatment group) indicated a high quality of life, comparable to PCa-free men. However, ADT-treated survivors had lower physical functioning that was of small clinical relevance compared with those not on ADT. Symptom burden scores of PCa survivors and controls were similar excluding fatigue and dyspnoea which were highest in men on ADT and controls. In multivariable models, PCa was not an important determinant of overall HRQoL, functioning or symptom burdens. Underlying medical conditions and marital status were the main contributors to HRQoL in PCa survivors. CONCLUSION: PCa cancer status was not an independent determinant of long-term HRQoL in Jamaican men. Interventions addressing social factors and comorbid illnesses could improve HRQOL in long-term PCa survivors.

Underlying dimensions of the EORTC QLQ-C30 in a Cuban population of patients with advanced non-small cell lung cancer.

BACKGROUND: Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer (EORTC QLQ-C30) is one of the most used quality of life questionnaires in cancer studies. It provides scores for five functional scales, nine symptom scales, and two single items which assess overall health status and quality of life. However, high correlations among QLQ-C30 items suggest a reduced dimensionality for the scale. OBJECTIVE: To assess the dimensionality of the EORTC QLQ-C30 using item response theory (IRT) in a training sample and confirmatory factor analysis (CFA) in a test sample. METHODS: We analyzed responses to QLQ-C30 from 1,107 patients with advanced lung cancer who were included in five clinical trials of immunotherapy. We used non-parametric and parametric IRT models (Mokken, and Samejima's graded response) in a random training set (n = 332) for initial assessment of dimensions and item characteristics of the QLQ-C30. Finally, we used CFA in the test set (n = 775) to confirm the measurement domains. RESULTS: Mokken model showed that QLQ-C30 fits a unidimensional scale, whereas Samejima model showed that most QLQ-C30 items present adequate difficulty and discrimination. All items showed adequate scalability indexes with an overall scalability of 0.47 (medium scale). The QLQ-C30-reduced dimensionality was confirmed by CFA (comparative fit index = 0.98, root mean square error of approximation = 0.055) with all items presenting factorial loadings > 0.40. CONCLUSIONS: The EORTC QLQ-C30 fits a unidimensional latent construct identified with perceived quality of life in advanced lung cancer patients. TRIAL REGISTRATION: RPCEC00000161, RPCEC00000181 and RPCEC00000205.

Comparison of overall survival and quality of life between patients undergoing anal reconstruction and patients undergoing traditional lower abdominal stoma after radical resection.

BACKGROUND: Miles procedure is often necessary for patients with low rectal carcinoma. However, this operation often affects the quality of life of patients, to evaluate the advantages of improved operation (anal reconstruction), the quality of life and survival between patients undergoing anal reconstruction and patients undergoing traditional lower abdominal stoma after radical resection were analyzed. METHODS: The clinical data of 43 patients with low situated rectal carcinoma were retrospectively analyzed. 23 patients with left lower abdominal stoma after radical resection (Miles procedure) were divided into group A, and 20 patients with reconstruction of the anus in situ after radical resection were in group B. All patients were investigated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38 questionnaire, the clinical data are recorded. Independent sample T test was used to analyze the difference in quality of life between group A and group B at 3, 6, and 12 months after surgery, and Kaplan-Meier was used to compare the difference in overall survival between group A and group B. RESULTS: The results of T test showed that there were statistical significance in global health status and physical functioning between group A and group B at 3 and 6 months, but no statistical significance at 12 months (P = 0.024, P = 0.019, P = 0.115 for global health status; P = 0.004, P = 0.006, P = 0.065 for physical functioning, respectively). Emotional functioning and social functioning were also statistically significant between group A and group B at 3, 6, and 12 months (P = 0.041, P = 0.040, P = 0.034 for Emotional functioning; P = 0.020, P = 0.009, P = 0.032 for social functioning, respectively). This study also found that there was no statistical significance in body image and sexual functioning between group A and group B at 3 months, but there was statistical significance at 6 and 12 months(P = 0.098, P = 0.035, P = 0.045 for body image; P = 0.110, P = 0.048, P = 0.047 for sexual functioning, respectively). There were statistically significant about sexual enjoyment and defecation problems at 3, 6, and 12 months (P = 0.023, P = 0.028, P = 0.050 for sexual enjoyment; P = 0.013, P = 0.011, P = 0.050 for defecation problems, respectively).The results of Kaplan-Meier showed that the overall survival (OS) between group A and group B was not statistically significant (χ2 = 0.600, P = 0.439). CONCLUSIONS: There was no difference in survival time between group A and group B, but compared with the patients with left lower abdominal stoma(group A), the quality of life was better in patients with reconstruction of the anus in situ (group B). It is significant to improve the traditional lower abdominal stoma operation.

Quality of life of cancer patients living in Trinidad and Tobago.

PURPOSE: To determine quality of life (QoL) of cancer patients in The Republic of Trinidad and Tobago using the European Organization for Research and Treatment of Cancer Care Quality of Life Instrument (EORTC QLQ-C30) and examine relationships between QoL and socioeconomic and medical variables. METHOD: A cross-sectional study, consisting of 480 cancer patients being managed at the National Radiotherapy Centre, was conducted. One-way, multiple analysis of variance (MANOVA) with post hoc testing was used to analyze relationships between socioeconomic and medical variables and scales on the EORTC QLQ-C30. Stepwise linear regression was used to evaluate which independent variables contributed to the global QoL and function scores. RESULTS: Participants were of mean age 64.1 ± 12.1 years (males) and 56.7 ± 16.6 years (females). Mean values for global QoL and function scales were below 75. Persons in younger age groups had significantly better physical and cognitive function scores (p < 0.05). Males had higher emotional function scores than females (p < 0.05). Persons with higher income and education had better scores on all function scales, except social, and less symptoms (p < 0.05). Persons receiving chemotherapy had more nausea/vomiting, appetite loss, and constipation (p < 0.05). CONCLUSION: Age, income, education, and cancer treatment were factors most associated with scores on the EORTC QLQ-C30. Further research is required in this population to examine these variables in more depth and explore methods to improve QoL of cancer patients in this population.

Health-Related Quality of Life and Satisfaction With Health Care: Relation to Clinical Stage in Mexican Patients With Multiple Myeloma.

Multiple myeloma (MM) is characterized by bone pain, pathologic fractures, bone destruction, and secondary hypercalcemia, all these conditions impact on health-related quality of life of patients. The objective was to evaluate the global health state and health-related quality of life in a group of patients with MM who attended a tertiary health-care center of the Instituto Mexicano del Seguro Social in Mexico, through the questionnaires designed by European Organization for Research and Treatment of Cancer (EORTC) quality of life group. Exploratory cross-sectional study in patients with MM treated in a Department of Hematology in a High-Specialty Medical Unit was conducted. Patients older than 18 years of age, men and women, were selected, and their informed written consent was obtained. We included all consecutive cases treated from January 2012 to December 2014. Questionnaires EORTC QLQ-C30, EORTC QLQ-MY20, and EORTC IN-PATSAT-32 were used. We studied 37 patients, 19 (51%) men and 18 women. The mean age was 61.9 years. Twenty-two (59.46%) patients presented with clinical stage III. The mean time for diagnosis was 33.11 months. The most used first-line treatment schedule was melphalan/prednisone/thalidomide (15; 40%). The global health median was 66.67, and symptoms showed a median score of 22.22. Treatment side effects score was 16.67; for general satisfaction, the median score was 75. In conclusion, the patients showed an advanced clinical stage and poor prognosis but had scores higher than 50 in functional scales and lower than 50 for symptom scales. The scores for symptom scales were related to age, renal failure, and disease-free survival. Identification of quality of life and satisfaction of care markers allow for early therapeutic intervention and efficiency and enable a change in quality of life and perception of care in Health Services.

A cross-sectional assessment of quality of life of colorectal cancer patients in Saudi Arabia.

OBJECTIVE: In this cross-sectional study, we aimed to describe the quality of life of Saudi colorectal cancer (CRC) patients and identify the factors that may further improve health care for CRC survivors in Saudi Arabia (KSA). METHODS: A total of 106 CRC patients from five different private and public tertiary level hospitals in Saudi Arabia participated in this study. CRC patient was interviewed by a trained researcher between September and December 2014. All respondents answered a three-part questionnaire which includes demographic data and a validated Arabic version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life. RESULTS: Participants had a mean score for global health of 67.1 (95 % CI 62.55-71.71). Among the five scales of quality of life, social functioning and functional scales of CRC patients scored the highest [Mean 83.49 (95 % CI 78.64-86.33)] while the lowest scored was emotional scales [66.9 (95 % CI 61.81-71.98)]. Insomnia was considered the most distressing symptom on the symptom scales. Using the disease-specific tool, it was found that sexual interest scored the highest. On the symptom scale, dissatisfaction with stoma care problems scored the highest. CONCLUSION: Factors associated with a major reduction in all domains of quality of life included employment status and tumor location. This study identifies the factors and issues that affect the quality of life of CRC patients in KSA. Addressing these factors and issues may lessen the burden of cancer survivors in the KSA or may prolong their survival.