Purpose
To investigate the relationships between tumor absorbed dose (TAD) or normal tissue absorbed dose (NTAD) and clinical outcomes in hepatocellular carcinoma (HCC) treated with yttrium-90 glass microspheres.
Methods
TARGET was a retrospective investigation in 13 centers across eight countries. Key inclusion criteria: liver-dominant HCC with or without portal vein thrombosis, < 10 tumors per lobe (at least one ≥ 3 cm), Child–Pugh stage A/B7, BCLC stages A–C, and no prior intra-arterial treatment. Multi-compartment pre-treatment dosimetry was performed retrospectively. Primary endpoint was the relationship between ≥ grade 3 hyperbilirubinemia (such that > 15% of patients experienced an event) without disease progression and NTAD. Secondary endpoints included relationships between (1) objective response (OR) and TAD, (2) overall survival (OS) and TAD, and (3) alpha fetoprotein (AFP) and TAD.
Results
No relationship was found between NTAD and ≥ grade 3 hyperbilirubinemia, which occurred in 4.8% of the 209 patients. The mRECIST OR rate over all lesions was 61.7%; for the target (largest) lesion, 70.8%. Responders and non-responders had geometric mean total perfused TADs of 225.5 Gy and 188.3 Gy (p = 0.048). Probability of OR was higher with increasing TAD (p = 0.044). Higher TAD was associated with longer OS (HR per 100 Gy increase = 0.83, 95% CI: 0.71–0.95; p = 0.009). Increased TAD was associated with higher probability of AFP response (p = 0.046 for baseline AFP ≥ 200 ng/mL).
Conclusion
Real-world data confirmed a significant association between TAD and OR, TAD and OS, and TAD and AFP response. No association was found between ≥ grade 3 hyperbilirubinemia and NTAD.
Trial registration number
NCT03295006.
Purpose In light of recently published clinical reports and trials, the TheraSphere Global Dosimetry Steering Committee (DSC) reconvened to review new data and to update previously published clinical and dosimetric recommendations for the treatment of hepatocellular carcinoma (HCC). Methods The TheraSphere Global DSC is comprised of health care providers across multiple disciplines involved in the treatment of HCC with yttrium-90 (Y-90) glass microsphere-based transarterial radioembolization (TARE). Literature published between January 2019 and September 2021 was reviewed, discussed, and adjudicated by the Delphi method. Recommendations included in this updated document incorporate both the results of the literature review and the expert opinion and experience of members of the committee. Results Committee discussion and consensus led to the expansion of recommendations to apply to five common clinical scenarios in patients with HCC to support more individualized efficacious treatment with Y-90 glass microspheres. Existing clinical scenarios were updated to reflect recent developments in dosimetry approaches and broader treatment paradigms evolving for patients presenting with HCC. Conclusion Updated consensus recommendations are provided to guide clinical and dosimetric approaches for the use of Y-90 glass microsphere TARE in HCC, accounting for disease presentation, tumor biology, and treatment intent.
Patients with hepatic STS treated with TARE demonstrated a high rate of DC and a median OS of 30 months, which suggests a role for TARE in the palliation of hepatic STS.
Transjugular intrahepatic portosystemic shunt (TIPS) creation is most commonly performed for patients with refractory ascites or variceal hemorrhage. While TIPS have also been created prior to planned abdominal operation to decrease morbidity related to portal hypertension, there are limited data supporting its effectiveness in that indication. The goal of this study was to determine if preoperative TIPS creation allows for successful abdominal operation with limited morbidity. Methods: A retrospective review of records of 22 consecutive patients who underwent TIPS creation for the specific indication of improving surgical candidacy, between 2011 and 2016, was performed. Clinical and serologic data were obtained for 21 patients (one patient was excluded since she was completely lost to follow up after TIPS creation). The primary endpoint was whether patients underwent planned abdominal operation following TIPS. Operative outcomes and reasons that patients failed to undergo planned operation were examined as secondary endpoints. The mean age was 56.4 ± 8.8 years, and the mean Child-Pugh and Model for End-Stage Liver Disease (MELD) scores were 7.2 ± 1.5 and 11.9 ± 4.3, respectively. Results: TIPS creation was performed in all 21 patients with a thirty-day mortality rate of 9.5%. Eleven patients (52.4%) subsequently underwent abdominal operation after which the thirty-day postoperative mortality rate was 0%. One patient (9.1%) had major perioperative morbidity related to portal hypertension and presented with surgical wound dehiscence and infection requiring drain placement and antibiotic therapy. Conclusions: In this population, TIPS allowed successful abdominal operation in the majority of patients, with thirty-day TIPS mortality of 9.5%, no perioperative mortality, and 9.1% major postoperative morbidity attributable to portal hypertension.
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