Yttrium-90 (Y-90) glass microspheres for HCC

Presented by

Prof. Robert Lewandowski, Northwestern University, Chicago, USA

Conference

ASCO GI 2021

Trial

LEGACY

Findings from the retrospective LEGACY trial showed that application of yttrium-90 (Y-90) glass microspheres in the neoadjuvant setting induced an overall response rate (ORR) of 72.2% per blinded independent central review (BICR), in 143 evaluable patients with unresectable hepatocellular carcinoma (HCC).

Prof. Robert Lewandowski (Northwestern University, Chicago, USA) presented the data from the single-arm LEGACY study (NCT01556490), in which 162 patients (mean age 66 years) with unresectable solitary HCC ≤8 cm were enrolled [1]. Of those, 143 patients were evaluable.

Patients received selective, lobar, or mixed administration of Y-90 glass microspheres at a median dose of 410 Gy, adjusted to liver volume. Most patients received the microspheres as stand-alone treatment, but they were also given as neoadjuvant therapy with the intent to bridge patients to transplant or resection as treatment. In total, 80.2% received 1 microsphere infusion, while the remainder of patients received at least 2 treatments. The primary efficacy endpoints included ORR and duration of response (DoR).

With a median follow-up of 29.9 months, ORR was 72.2% in all evaluable patients. Furthermore, of those patients who did respond, most had a good DoR ≥6 months (76.1%). Overall 3-year OS was 86.6%.

Y-90 microspheres were administered as neoadjuvant therapy for 45/162 (28%) of patients. Of those, 34 received a transplantation (21%) and 11 (7%) had resection. For neoadjuvant treatment, ORR was 80% (36/45), DoR ≥ 6 months was 31% (11/45), and 3-year OS was 93%. In total, 35 of the 45 patients (78%) receiving neoadjuvant microspheres achieved complete response (CR), while 1 achieved partial response (PR), and 9/45 (20%) were deemed not evaluable as they underwent surgery prior to the 6-month mark and did not have imaging assessments post-day 46. Histological assessment of those 9 censored participants, however, revealed that 7/9 (78%) achieved complete pathologic necrosis, 1/9 (11%) had extensive pathologic necrosis, and 1 (11%) had partial pathologic necrosis. The investigators concluded that the neoadjuvant application was effective in virtually all cases.

For the 117/162 (72%) patients who did not go on to surgical treatment, ORR was 92% (107/117), DoR ≥6 months was 73% (78/117), and 3-year OS was 84%.

Prof. Lewandowski concluded that treating solitary unresectable HCC with Y-90 glass microspheres provided robust response rates, good duration of response, and had a survival benefit, both as stand-alone treatment as well as in the neoadjuvant setting.

Lewandowski R, et al. Use of yttrium-90 (Y90) glass microspheres (TheraSphere) as neoadjuvant to transplantation/resection in hepatocellular carcinoma: Analyses from the LEGACY study. ASCO Gastrointestinal Cancers Symposium 2021, 15-17 January. Abstract 300.

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