ABSTRACT
AIM: To assess the prognostic role of interim 18FFDGPET/CT in pediatric patients with Hodgkin's lymphoma (PHL). METHODS: Prospective analysis of 254 Saudi patients with pathologically proven PHL, they underwent interim 18F-FDG-PET/CT after 2 cycles of ABVD with baseline study, analysis of interim 18F-FDG-PET/CT was done visually according to the Deauville score (5-point score) as well as semi-quantitative analysis using maximum standardized uptake value (SUVmax), average SUV (SUVmean2.5 and SUVmean40). The parameters were calculated as absolute values and as percentages of difference between the initial and the interim hottest residual lesion. Follow-up was done for period of 2.9 years (range, 0.9 to 5.2 years). clinical outcomes were obtained from medical records. RESULTS: two hundred and twenty out of 254 children showed PET-ve interim while 34 were still PET+ve. Univariate analysis showed that the risk stratification, qualitative analysis of interim 18F-FDG-PET/CT were significant predictors for total actuarial survival (TAS) and disease free survival (DFS). Among the semiquantitative parameters, ΔSUVmean2.5 has the highest hazard ratio. In multivariate analysis, the current study revealed that the three above factors were important prognostic factors that can predict TAS and DFS. However, visual assessment of interim PET canceled the prognostic impact of ΔSUVmean2.5. CONCLUSIONS: visual assessment of early interim 18F-FDG-PET/CT after 2 cycles of ABVD in PHL showed a very significant role in prediction ofTAS and DFS.
ABSTRACT
BACKGROUND: No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. AIM: To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. METHODS: This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). RESULTS: The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. CONCLUSIONS: This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group.
