The pooled #HOPE4LIVER trials demonstrated the safety and technical success of the HistoSonics System for the destruction of liver tumors using histotripsy, a non-thermal, mechanical process of focused US.
Objective: To evaluate the 1-year clinical outcomes of patients enrolled in the #HOPE4LIVER trial of hepatic histotripsy. Background: Histotripsy is a novel noninvasive, non-thermal–focused ultrasound therapy that liquefies tissue at the focal point of the transducer. Following diagnostic ultrasound targeting, an automated treatment is performed through a robotic arm to treat a user-defined volume of tissue. Methods: Forty-seven patients were enrolled at 14 sites in the United States and Europe. Included patients were ineligible for or had opted out of standard therapies. Tumor control was evaluated through a core laboratory with a primary assessment at each time point and a post hoc assessment performed following the completion of each time point to allow for a learning curve of interpreting imaging findings of this novel therapy. Overall survival and freedom from local tumor progression were evaluated through the Kaplan-Meier method. Results: Nineteen patients with hepatocellular carcinoma and 28 with metastatic disease were enrolled, of whom 89.5% (17/19) and 96.4% (27/28) had multifocal hepatic tumors at the time of treatment. Fifty-two tumors were treated. The 1-year local control rate was 63.4% using the primary assessment method and 90% using the post hoc method. There were 6 serious adverse device-related effects within 30 days of treatment. Only one nonserious adverse device-related effect was observed after 30 days of treatment. Overall survival at 1-year was 73.3% for patients with hepatocellular carcinoma and 48.6% for patients with metastatic disease. Conclusions: Histotripsy results in local control of liver tumors at 1 year, which is consistent with current locoregional therapies. The safety profile is favorable, and survival at 1 year is comparable with other therapies for similar disease stages.
Sarcopenia is defined as skeletal muscle loss and can be assessed by cross-sectional imaging. Our aim was to establish the effect of sarcopenia on relevant outcomes in patients with pancreatic ductal adenocarcinoma (PDAC) in curative and palliative settings based on a large patient sample. MEDLINE library, EMBASE and SCOPUS databases were screened for the associations between sarcopenia and mortality in patients with PDAC up to March 2022. The primary endpoint of the systematic review was the hazard ratio of Sarcopenia on survival. 22 studies were included into the present analysis. The included 22 studies comprised 3958 patients. The prevalence of sarcopenia was 38.7%. Sarcopenia was associated with a higher prevalence in the palliative setting (OR 53.23, CI 39.00-67.45, p<0.001) compared to the curative setting (OR 36.73, CI 27.81-45.65, p<0.001). Sarcopenia was associated with worse OS in the univariable (HR 1.79, CI 1.41-2.28, p<0.001) and multivariable analysis (HR 1.62, CI 1.27-2.07, p<0.001) in the curative setting. For the palliative setting the pooled hazards ratio showed that sarcopenia was associated with overall survival (HR 1.56, CI 1.21-2.02, p<0.001) as well as in multivariable analysis (HR 1.77, CI 1.39-2.26, p<0.001). Sarcopenia was not associated with a higher rate of post-operative complications in univariable analysis (OR 1.10, CI 0.70-1.72, p = 0.69). Sarcopenia occurs in 38.7% of patients with pancreatic cancer, significantly more in the palliative setting. Sarcopenia is associated with overall survival in both settings. The assessment of sarcopenia is therefore relevant for personalized oncology. Sarcopenia is not associated with postoperative complications.
16 April 2025 in Journal of Cancer Research and Clinical Oncology
Background: Body composition analysis, particularly the assessment of sarcopenia and myosteatosis, has emerged as a potential prognostic tool in oncology. However, the clinical implication of body composition parameters remains inconsistent, largely due to the variability in cutoff values used across studies. This study examines the influence on prevalence and prognostic influence of different cutoff values for sarcopenia and myosteatosis in patients in a standardized cohort from a large clinical trial (SORAMIC). Methods: This study included 179 patients with unresectable liver cancer from the palliative arm of the SORAMIC trial. Skeletal muscle index (SMI) was calculated by measuring the cross-sectional area of skeletal muscle at the third lumbar vertebra (L3) on baseline CT scans. We then applied 14 published cutoff definitions for sarcopenia (SMI) and 7 for myosteatosis (muscle attenuation) to determine their prevalence in this cohort. Cox regression models were used to analyze the relationship between sarcopenia, myosteatosis, and OS. Results: The prevalence of sarcopenia ranged from 8.9% (Van der Werf et al.) to 69.8% (Lanic et al.). Overall, 3 of the 14 cutoffs [Van Vledder et al. (HR = 1.53, p = 0.03), Coelen et al. (HR = 1.46, p = 0.03), and Derstine et al. (HR = 1.47, p = 0.04)] showed a relevant association with OS. Other cut off values were not associated with OS. The prevalence of myosteatosis varied between 10.1% (Nachit et al.) and 53.1% (Zhang et al.). One of the 7 cutoffs (Chu et al.) demonstrated a relevant association with OS (HR = 1.53, p = 0.03). Conclusion: The large variability in prevalence and prognostic impact observed across different cutoff definitions underscores the urgent need for standardized, cancer-specific cutoff values for SMI and muscle attenuation. Establishing uniform criteria will enhance the reliability and clinical applicability of body composition metrics as prognostic tools in oncology. Further research should focus on refining these cutoffs and validating them across diverse cancer populations.
28 February 2023 in Computers in Biology and Medicine