Purpose: To evaluate therapeutic efficacy of ultrasound (US)-guided high-intensity focused ultrasound (HIFU) ablation for treatment of needle-track seeding of hepatocellular carcinoma (HCC).Materials and methods: Nine patients with needle-track seeding of HCC were treated as outpatients using US-guided HIFU ablation. The mean size of the lesion was 1.8 cm (range 1.1 to 2.6 cm), two lesions were located on the abdominal wall, seven lesions were located on the chest wall. An acoustic power of 200 to 400 W was used determined by the echo changes after energy exposures, intermittent HIFU exposures of 1 to 2 s were used during treatment. Treatment was considered complete when the entire nodule and a surrounding 0.5 cm margin become hyperechoic on US. The outcome of HIFU ablation was observed by US and contrast-enhanced magnetic resonance imaging during follow up.Results: HIFU ablation was performed smoothly in all patients, the treatment lasted for 6 to 21 min (mean 12 min). No major complications occurred. During a mean follow up of 10.3 months (range 7–15 months), persistent absence of lesion enhancement was seen in eight patients, one patient developed a recurrent lesion near the treated area, which was successfully treated by a repeat HIFU ablation.Conclusions: US-guided HIFU ablation may be an effective treatment for needle-track seeding of HCC.
9040 Background: Pembrolizumab is approved for treating advanced MEL that progressed following IPI and, if BRAFV600 mutant, a BRAF inhibitor. In KEYNOTE-002 (NCT01704287), pembrolizumab significantly prolonged PFS compared with chemotherapy in IPI-R advanced MEL (P < .0001) and was associated with a lower rate of grade 3-5 AEs. Herein, we present the PRO analysis. Methods: Pts with advanced MEL that progressed within 6 mo after ≥2 IPI doses and, if BRAFV600 mutant, following a BRAF/MEK inhibitor, were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 wk or investigator’s choice of chemotherapy. Primary end points were PFS and OS. PROs were an exploratory end point with prespecified analysis. The EORTC QLQ-C30 was collected at baseline, wk 3, 6, 12, 24, 36, treatment discontinuation, and safety follow-up. The key PRO end points are the score change from baseline and the proportions of improvement/deterioration at wk 12 of the global health status score. A constrained longitudinal data analysis model assessed between-arm differences in all pts with ≥1 PRO assessment. Results: 520 of 540 enrolled pts were included in the PRO analysis. Baseline global health status scores were similar across treatment arms. Pembrolizumab-treated pts had significantly lesser decreases from baseline in the global health status scale score compared with control (Table). At wk 12, the proportion of pts with a ≥10-point decrease in global health status was 38% for control, 32% for pembrolizumab 2 mg/kg, and 27% for pembrolizumab 10 mg/kg. Pembrolizumab-treated pts had consistently lesser score changes from baseline for the different function and symptoms scales. Conclusions: In KEYNOTE-002, quality of life was maintained to a greater degree with pembrolizumab versus chemotherapy in IPI-R MEL. Clinical trial information: NCT01704287. Global Health Status Scale Score Baseline Wk 12 Change From Baseline, Least Squares Mean (95% CI) Mean SD Mean SD Control (n = 167) 64.0 21.9 59.0 23.2 –9.1 (–12.9, –5.4) Pembro 2 mg/kg (n = 176) 66.2 22.1 66.3 23.0 –2.6 (–6.2, 1.0)* Pembro 10 mg/kg (n = 177) 63.0 23.6 64.3 22.9 –2.6 (–6.0, 0.9)* *P = .01 versus control.
The aim of this review is to evaluate the value of ultrasound (US)-guided high intensity focused ultrasound (HIFU) ablation in the treatment of primary malignant tumours of the bony pelvis.Eleven patients with primary malignant tumours of the bony pelvis received US-guided HIFU ablation. The maximum tumour size ranged from 5.6 to 25.0 cm (median 10.5 cm). Treatment was curative in four patients and palliative in seven patients. During follow-up, the effectiveness of HIFU ablation was assessed by contrast-enhanced magnetic resonance (MR).Significant coagulative necrosis was obtained in all patients after scheduled HIFU ablations; the volume ablation ratio was 86.7% ± 12.5% (range 65-100%). Complete tumour necrosis was achieved in all patients receiving curative HIFU ablation. No major complications were encountered. No patients died of local tumour progression during follow-up.US-guided HIFU ablation may be a safe and effective minimally invasive technique for the local treatment of primary malignant tumours of the bony pelvis.
Abstract Venous stenosis, secondary to venous neointimal hyperplasia ( VNH ), at the arteriovenous anastomosis ( AV ) is a major etiology of vascular access failure in AV fistulas ( AVF ) and AV grafts ( AVG ). Recently, our group has reported that severe VNH also occurs prior to vascular access placement. The objective of this study was to perform a comparison of the cellular phenotypes within the neointima from veins collected from subjects at the time of new vascular access creation and stenotic veins from subjects with failed AVG s and AVF s. Vein samples, collected at the time of new access surgery, and stenotic vein segments, collected at access revision, were evaluated for expression of α ‐smooth muscle actin ( SMA ), vimentin, and desmin within the neointima, and quantified using semiquantitative scoring. Within the neointima, the majority of cells from vein samples collected at the time of new access surgery were contractile smooth muscle cells, and veins from stenotic AVF and AVG were predominately myofibroblasts. Our results suggest the possibility of different mechanistic pathways in response to vascular injury that occurs prior to vascular access creation vs. after access creation, and that divergent therapeutic approaches may be needed for treating vascular injury in these two settings.