LOBAR + PVT
Lobar + PVT: DOSISPHERE-01 Trial Summary
Level 1 evidence of 26.7 month overall survival for HCC patients treated with TheraSphere using personalized dosimetry compared to 10.7 months with standard single compartment dosimetry.
Study Objective Multi-center, prospective, randomized, investigator-sponsored phase II trial designed to compare the clinical outcomes of SIRT with TheraSphere in patients with advanced HCC using two pre-treatment dosimetry determination methods: (1) Standard, single-compartment dosimetry (SDA); defined as a uniform distribution of absorbed dose within the perfused volume – both tumor and normal liver or (2) Personalized dosimetry (PDA); defined as multi-compartment Y-90 distribution of absorbed dose within the perfused volume that accounts for preferential blood flow into the tumor compared with normal parenchyma.
Primary Endpoint Response rate of the index lesion at Month 3 according to EASL criteria using a mITT population* by investigator assessment.
Main Secondary Endpoints Overall Survival | PFS | Dose-response relationship | Safety
Multi-centre, randomized (1:1), prospective, phase II study
DOSISPHERE-01 Trial Summary
12 month results
Index Lesion Response Rate at 3 Months Using EASL in the mITT Population
* reasons for censoring: received another anti-cancer treatment before M3 evaluation (n=2), no evaluation at M3 evaluation (n=1) (10.7%)
** reasons for censoring: Early deaths (before M3) (n=2), no evaluation at M3 (n=1), start another anti-cancer treatment before M3 evaluation (n=1) (14.3%)
Liver Adverse Events
(Grade ≥3) Related to Y-90*
|PAD (n=35)||SDA (N=21)|
|Patients with ≥ 1 AE||3 (8.6%)||3 (14.3%)|
|Death||1 (2.9%)||1 (4.8%)|
|Liver AEs||4 (11.4%)||5 (23.8%)|
|Ascites||1 (2.9%)||1 (4.8%)|
|GI hemorrhage||0||2 (4.8%)|
|Bilirubin increase/jaundice||1 (2.9%)||2 (9.5%)|
|Hepatic failure||2 (5.7%)||0|