Ryan Hickey, MD, discusses data from the following presentation: Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomized, multicentre, open-label phase 2 trial (Garin E, ASCO GI 2021, Interventional Radiologist Perspective)

The objective of this study is to report outcomes from the randomized, phase 2 DOSISPHERE-01 trial (NCT02582034), which compared standard dosimetry with personalized dosimetry in patients with hepatocellular carcinoma.

Patients enrolled in the trial were randomly assigned 1:1 to receive standard dosimetry (120 ± 20 Gy targeted to the perfused lobe) or personalized dosimetry (≥205 Gy targeted to the index lesion).

The primary end point was investigator-assessed objective response rate in the index lesion, according to European Association for the Study of Liver criteria, at 3 months after selective internal radiation therapy.

The intent-to-treat population included 28 patients in the standard dosimetry arm and 28 in the personalized dosimetry arm.

The objective response rate at 3 months was 71% in the personalized dosimetry arm and 36% in the standard dosimetry arm.

Progression-free survival (PFS) was 6.0 months in the personalized dosimetry arm and 3.4 months in the standard dosimetry arm.

Median overall survival (OS) was 26.6 months in the personalized dosimetry arm and 10.7 months in the standard dosimetry arm (HR, 0.421; P = .0096).

The strong response rate but short PFS as well as the prolonged OS suggest that there may be a benefit of combining personalized dosimetry with systemic drugs.

There was no degradation of the safety profile. Serious treatment-related adverse events were seen in 9% of patients who received personalized dosimetry and 14% of patients who received standard dosimetry. Any adverse events of grade ≥3 affected 60% of patients who received personalized dosimetry and 76% of those who received standard dosimetry.

Patient selection criteria included good liver function, possibility to spare a sufficient volume of liver from treatment for transarterial radioembolization (TARE) or transarterial chemoembolization (TACE), and 99mTc macroaggregated albumin (MAA) dosimetry used as a screening tool.

Biomarkers in this study included MAA dosimetry (tumor dose, normal liver dose, portal vein thrombosis (PVT) targeting, for TARE), immunoproofing, and tumor size. Tumors larger than 5 cm have previously been correlated with poor response rates. With personalized dosimetry, larger tumor size did not correlate with lack of response.

Videos

Ryan Hickey, MD, presents data from the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium on results of the phase 2 DOSISPHERE-01 trial of personalized vs standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma.

Rapid Readouts: Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomized, multicentre, open-label phase 2 trial

Ryan Hickey, MD, New York University Langone Health

Articles

Rapid Readouts: Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomized, multicentre, open-label phase 2 trial