Gemcitabine, carboplatin, and Epstein Barr virus-specific autologous cytotoxic T lymphocytes for recurrent or metastatic nasopharyngeal carcinoma: VANCE, an international randomized Phase 3 trial.

BACKGROUND: Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T cell immunotherapy generated from the blood of individuals and manufactured without genetic modification. In a previous Phase 2 trial of locally recurrent or metastatic nasopharyngeal cancer (R/M NPC) patients, first-line gemcitabine and carboplatin (GC) and EBV-CTL combination demonstrated objective anti-tumor EBV-CTL activity and a favorable safety profile. The present study explored whether this combined first-line chemo-immunotherapy strategy would produce superior clinical efficacy and better quality of life compared to conventional chemotherapy treatment. PATIENTS AND METHODS: This multicenter, randomized, Phase 3 trial evaluated the efficacy and safety of GC followed by EBV-CTL vs. GC alone as first-line treatment for R/M NPC patients. Thirty clinical sites in Singapore, Malaysia, Taiwan, Thailand, and the United States (US) were included. Subjects were randomized to first-line GC (4 cycles) and EBV-CTL (6 cycles) or GC (6 cycles) in a 1:1 ratio. The primary outcome was overall survival (OS) and secondary outcomes included progression-free survival, objective response rate, clinical benefit rate, quality of life, and safety. CLINICALTRIALS: gov identifier: NCT02578641. RESULTS: 330 subjects with NPC were enrolled. Most subjects in both treatment arms received ≥4 cycles of chemotherapy and most subjects in the GC+EBV-CTL group received ≥2 infusions of EBV-CTL. The central Good Manufacturing Practices (GMP) facility produced sufficient EBV-CTL for 94% of GC+EBV-CTL subjects. The median OS was 25.0 months in the GC+EBV-CTL group and 24.9 months in the GC group (hazard ratio = 1.19; 95% CI: 0.91, 1.56; P = 0.194). Only 1 subject experienced a Grade 2 serious adverse event related to EBV-CTL. CONCLUSION: GC+EBV-CTL in subjects with R/M NPC demonstrated a favorable safety profile but no overall improvement in OS vs. chemotherapy. This is the largest adoptive T cell therapy trial reported in solid tumors to date.

Nutritional supplement use among university athletes in Singapore.

INTRODUCTION: Nutritional supplements used by athletes can be classified as sports food, dietary supplements and ergogenic aids. The aim of this study was to examine the use of such supplements among university athletes in Singapore. METHODS: 82 athletes from 16 sport disciplines completed a questionnaire which sought information on demographical parameters, type of supplements, frequency of use, motivations, knowledge, expenditure and side effects. RESULTS: The prevalence of supplement use was 76.8 percent and 20 different products were used. Each individual consumed a mean and standard deviation of 3.18 +/- 1.7 products over a 12-month period. The mean number of products consumed daily was 2.1 +/- 1.2. Popular products included sports drinks, vitamin C, multivitamins and traditional/herbal preparations such as essence of chicken, bird's nest and ginseng. Before using a product, 65.9 percent sought information, usually from the media, the Internet, coaches and fellow athletes. However, many did not know where to obtain reliable information and 86.4 percent were also unaware that supplementation can have adverse effects. CONCLUSION: Although there is a high prevalence of supplement use in our study population, many do not have accurate information about these products. Hence, there is an urgent need to provide athletes with education and access to scientific and unbiased information.

Cartilage injury and repair: assessment with magnetic resonance imaging.

Articular cartilage damage plays a major role in joint degeneration and dysfunction. Accurate assessment of the morphology and degree of cartilage wear is important in diagnosis, prognosis and management, particularly as many of these patients are young or participate in high-performance sports. Magnetic resonance imaging is able to directly evaluate such injuries, due to its high spatial resolution and excellent soft-tissue contrast resolution. This pictoral essay aims to demonstrate normal and damaged articular cartilage on MR imaging, as well as surgically-repaired cartilage.