PATIENTS AND METHODS: This multicenter, randomized, phase III trial evaluated the efficacy and safety of GC followed by EBV-CTL versus GC alone as first-line treatment of R/M NPC patients. Thirty clinical sites in Singapore, Malaysia, Taiwan, Thailand, and the USA were included. Subjects were randomized to first-line GC (four cycles) and EBV-CTL (six cycles) or GC (six 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: A total of 330 subjects with NPC were enrolled. Most subjects in both treatment arms received four or more cycles of chemotherapy and most subjects in the GC + EBV-CTL group received two or more 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% confidence interval 0.91-1.56; P = 0.194). Only one subject experienced a grade 2 serious adverse event related to EBV-CTL.
CONCLUSIONS: GC + EBV-CTL in subjects with R/M NPC demonstrated a favorable safety profile but no overall improvement in OS versus chemotherapy. This is the largest adoptive T-cell therapy trial reported in solid tumors to date.
METHOD: A retrospective data collection was conducted using the clinical records of patients who were histopathologically diagnosed with NPC at the Otolaryngology-Head & Neck Clinic and the Radiotherapy & Oncology Clinic at Sarawak General Hospital.
RESULT: The study comprised a total of 892 patients from 2010 to 2020. Males outnumbered females 3-to-1, with a mean age of 51 years (standard deviation: 13.9). The largest groups of patients were the Iban (34%) and the Bidayuh (21%), followed by the Chinese (19%) and the Malay (15%). The Bidayuh had the highest incidence rate with 81 cases per 100,000. Only 10% of the study population had a family history of NPC. The most common presentation was a neck lump (64.5%). Distant metastasis was discovered in 20% of patients. 82% of the cases were stage 3 or 4 at the time of presentation. The histological types of the 892 cases were mainly undifferentiated carcinoma (73%). Eighty-six patients developed recurrence, with 83% experiencing local recurrence, 10% developing distant metastasis, and 7% developing regional recurrence. Treatment for recurrence included nasopharyngectomy, neck dissection, and chemotherapy.
CONCLUSION: The study highlights a significant incidence of NPC among the Bidayuh. Emphasis on screening and early detection is crucial for better outcomes, with lifelong follow-up recommended.
METHODS: A systematic search was conducted across six databases, including PubMed, to identify randomized controlled trials (RCTs) that satisfied the specified inclusion and exclusion criteria. The intervention measure consisted of Internet-based self-help interventions.
RESULTS: A total of 23 randomized controlled trials (RCTs) were included in this analysis. Meta-analysis indicated that Internet-based self-help therapies significantly reduced depression scores in adolescents and young adults. (OR = -0.68, 95%CI [-0.88, -0.47], P
METHODS: A Markov model was developed to compare the cost effectiveness of various biologic sequential treatments in a hypothetical cohort of moderate to severe psoriasis patient in Malaysia over a lifetime horizon. The model simulated the progression of patients through three lines of active biologic therapy, before transitioning to best supportive care. Costs and effects were discounted annually at a rate of 3%.
RESULTS: First line secukinumab has produced lowest incremental cost effectiveness ratios (ICERs) when compared to first line systemic [ICERs value; US$152,474 (first set analysis) and US$110,572 (second set analysis)] and first line phototherapy [ICERs value; US$147,057 (first set analysis) and US$107,616 (second set analysis)]. However, these values were slightly higher than the Malaysian based threshold of three times gross domestic product per capita, US$104,337. A 40% reduction in the unit costs of reference biologics renders most of the evaluated treatment sequences cost-effective.
CONCLUSION: Adding biosimilar to the current treatment sequence could achieve cost savings ranging from 4.3% to 10.8% without significant loss of effectiveness. Given the significant impact of comorbidities and the resulting decline in quality of life among individuals with psoriasis, it may be justifiable to establish a threshold of up to US$184,000 per quality-adjusted life year (QALY) for the provision of therapies in the context of Malaysia.