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Background: Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide. We tested megestrol acetate (MA) against placebo in the treatment of advanced HCC. Methods: From 2002 through 2007, this randomised double-blind trial enrolled 204 patients with treatment-naive advanced HCC (Eastern Cooperative Oncology Group (ECOG) performance rating of 0-3) from specialist care centres in six Asia-Pacific nations. Patients received placebo or MA (320 mg day−1). End points were overall survival (OS) and quality of life. Results: An adverse but not statistically significant difference in OS was found for MA vs placebo: median values 1.88 and 2.14 months, respectively (hazard ratio (HR)=1.25, 95% CI=0.92–1.71, P=0.16). However, OS was similar among patients of good functional status (Child-Pugh A and ECOG 0, 1 or 2) (44.3%) in both treatment groups, with the adverse effect of MA confined to those of poor status. Megestrol acetate patients had a worse global health status (not statistically significant) but reduced levels of appetite loss and nausea/vomiting. Conclusion: Megestrol acetate has no role in prolonging OS in advanced treatment-naive HCC. Overall survival with placebo differed markedly from that in similar trials conducted elsewhere, suggesting therapeutic outcomes may be strongly dependent on ECOG status and Child-Pugh score.

To investigate the relationship between body mass and health-related quality of life (HRQOL) among Singaporean adolescents. Variation in this relationship by age, gender and ethnicity, and association of HRQOL with change in body mass over time and with demographic, socioeconomic and health variables were also assessed.HRQOL was assessed for Singaporean adolescents aged 11-18 from their own (N=1,249) and their parent’s (N=948) perspective using PedsQLTM 4.0 generic core scales. Body mass, measured as body mass index z-score based on the WHO Reference 2007, was categorized as thin, healthy weight, overweight and obese. Multiple linear regression models assessed the relationship between current body mass and HRQOL, adjusting for demographic, socioeconomic and health variables. Differences between adolescent and parent-proxy reported HRQOL were also investigated.Obese adolescents (and their parents) reported significantly lower HRQOL, overall and in most domains, compared to healthy weight adolescents. Parents tended to report lower HRQOL for their adolescents than the adolescents did themselves; however, this difference was much larger and statistically significant for obese adolescents.Obesity is associated with reduced HRQOL among adolescents. The effect in these Singaporean adolescents is similar to that in populations with higher rates of obesity. Awareness of this relationship can make it easier for health professionals, teachers, parents and peers to be supportive of obese adolescents.

Purpose To determine the impact of visual impairment on health-related quality of life (QoL) measures in adolescents. Design School-based, cross-sectional study. Methods Adolescents aged 11 to 18 years from the Singapore Cohort Study of the Risk Factors for Myopia were analyzed. QoL scores were determined using parallel child-self and parent proxy-report of PedsQL 4.0 Generic Core Scales. Refractive error was measured using the table-mounted autorefractor (model RK5 Canon Inc, Ltd, Tochigiken, Japan) and habitual distance logarithm of the minimal angle of resolution (logMAR) visual acuity charts were used. Results Data on 1,249 adolescents and 948 parents were analyzed. The prevalence of better eye presenting visual impairment > 0.3 logMAR was 5.7%. The mean (standard deviation) total, physical, and psychosocial health scores of all adolescents were 83.6 (11.8), 89.9 (11.8), and 80.3 (13.7). Healthy adolescents with visual impairment reported statistically but not clinically lower total (−3.8; 95% confidence interval [CI], −7.1 to −0.5; P = .03), psychosocial (−4.2; 95% CI, −8.1 to −0.3; P = .03), and school functioning scores (−5.5, 95% CI, −10.2 to −0.9; P = .02) than those with normal vision. However, no significant difference was observed in the parent proxy-reported scores between the two groups. Differences in total scores between high (1.9; 95% CI, −0.6 to 4.4) and low-myopes (0.2; 95% CI, −1.3 to 1.6) compared with nonmyopes were not significant. Comparable scores were also reported by hyperopes, astigmatism, and their counterparts, as well as their parents. Concordance between child and parent proxy-report was Conclusion Healthy adolescents with visual impairment experienced statistically though not clinically impaired health related QoL, but refractive errors did not appear to have an impact on QoL.

Health-related quality of life instruments tend to include a great many items. This imposes a burden on the respondents as well as undermining response rate and data quality. In this study we developed a shortened version of the Functional Living Index-Cancer (FLIC), now called Quick-FLIC, and examined its measurement properties. A questionnaire package, self-administered by 140 patients, included the FLIC and the Functional Assessment of Cancer Therapy-General. A factor analysis and clinical judgement were used to shorten the FLIC, which included 22 items. Each subscale of FLIC was shortened to include two or three items only. The Quick-FLIC included a total of only 11 items. Nevertheless, the measurement properties of the Quick-FLIC and its subscales were comparable to those of the original FLIC. It is concluded that the shortening of established health-related quality of life instruments is viable in oncology research.

Background The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279) was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC) not amenable to curative therapies. Methods Sorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (90Y) resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR) using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD]) and overall survival (OS). Results Twenty-nine patients with Barcelona Clinic Liver Cancer (BCLC) stage B (38%) or C (62%) HCC received a median of 3.0 GBq (interquartile range, 1.0) 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months). Twenty eight patients experienced ≥1 toxicity; 15 (52%) grade ≥3. Best ORR was 25%, including 2 (7%) CR and 5 (18%) PR, and 15 (54%) SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7%) had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively. Conclusions This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib. Trial Registration ClinicalTrials.gov NCT00712790.