Table 4.
Summary of the published clinical findings deriving from the prospective studies completed so far
References | Study | Na | Lesion type | Main finding |
---|---|---|---|---|
Reinders-Hut et al. [28] | HEPAR primary | 31 | HCC (87% multifocal disease) | 166Ho-radioembolization is a safe treatment option for HCC patients with |
Unacceptable toxicity related to study treatment occurred in 10% of patients | ||||
Complete or partial response for: | ||||
54% of the target liver lesions at 3-month follow-up | ||||
84% of the target liver lesions at 6-month follow-up | ||||
Median overall survival was 14.9 months | ||||
Van Roekel et al. [27] | SIM | 21 | Liver metastases (mCRC) | Between anti-reflux and standard microcatheter |
No difference in tumor targeting | ||||
No difference in infusion efficiency | ||||
No influence on the dose–response rate | ||||
Confirmed safety and efficacy in mCRC | ||||
Braat et al. [25] | HEPAR PLuS | 30 | Liver metastases (NET) | 166Ho radioembolization, as an adjunct to peptide receptor radionuclide therapy is safe and efficacious, with |
Response (complete or partial) in the liver, according to RECIST 1.1 | ||||
43% at 3 months | ||||
47% at 6 months | ||||
Acceptable toxicity | ||||
No loss in quality of life | ||||
Prince et al. [24] | HEPAR II | 37 | Liver metastases (different origins) | 166Ho radioembolization-induced a tumor response and acceptable toxicity profile in salvage patients with |
Complete response, partial response or stable disease of the target lesion obtained in 73% of population at 3-month follow-up | ||||
Median overall survival of 14.5 months | ||||
Smits et al. [23] | HEPAR I | 15 | Liver metastases (different origins) | The maximum tolerated radiation dose was identified as 60 Gy (averaged over the perfused volume) |
Stable disease or partial response regarding target lesions achieved: | ||||
In 93% population at 6-week follow-up | ||||
In 64% population at 12-week follow-up |
T/N tumor to non-tumor ratio, RECIST response evaluation criteria in solid tumors, HCC hepatocellular carcinoma, MCRC metastatic colorectal cancer, NET neuroendocrine tumor
aNumber of subjects included in the referred article analyzing the mentioned study