Y-90 Resin Microspheres Show Favorable Safety, Reinforcing Role in HCC

In an interview highlighting the significance of the FDA’s approval of SIR-Spheres Y-90 resin microspheres for patients with unresectable hepatocellular carcinoma (HCC), Armeen Mahvash, MD, discussed the safety profile observed with Y-90 and how the treatment was tolerated in patients administered the agent during the DOORwaY90 trial (NCT04736121). He also expanded on considerations for its use in clinical practice and the importance of a multidisciplinary approach for the treatment of this patient population.1

In the first portion of the interview, Mahvash detailed the efficacy data from DOORwaY90 trial that helped support the FDA’s approval of Y-90.2

Mahvash is an interventional radiologist in the Department of Interventional Radiology within the Division of Diagnostic Imaging at The University of Texas MD Anderson Cancer Center in Houston.

OncLive: What should clinicians know about the safety profile of Y-90?

Mahvash: [In] the safety profile demonstrated in this study, most AEs were grade 1 or 2, which are acceptable. We had 4 grade 3 AEs: 2 [instances] of abdominal pain, 1 of nausea, and 1 of radiation-induced liver disease.

Looking at abdominal pain as an AE, the challenge is that even a one-night hospitalization due to abdominal pain is considered a grade 3 AE. [The same] applies to nausea—if hospitalization occurs, it is automatically considered grade 3. Regarding the patient who developed radiation-induced liver disease, looking back at that patient, we recognized that the planned treatment area and the actual executed area did not fully match. [That discrepancy helps explain] why the patient developed radiation-induced liver disease. Overall, the treatment was very well tolerated. [In the] 4 patients who had grade 3 AEs, 3 were reversible, and the patient with radiation-induced liver disease eventually had liver function improve to some extent.

Most AEs were temporary. No patients had grade 4 or grade 5 AEs from the study treatment itself, including no deaths. [Some patients] died for other reasons—not from the study itself.

What should clinicians know about using Y-90 in clinical practice?

In the possibility that patients recur at the tumor site, you can always retreat these patients. You can retreat patients with Y-90 to maintain transplant eligibility, especially those for whom chemoembolization historically was not as successful. For transplant-eligible patients, this is a paradigm shift. [Patients in the United States] who are transplant eligible, realistically, should be getting radioembolization. Obviously, there are some financial [considerations since] radioembolization as a single treatment is more expensive than chemoembolization, but its efficacy has now been demonstrated to be better. In Texas, for example, Medicaid patients are ineligible for radioembolization, but in other states, Medicaid patients are [eligible]. Otherwise, it is included in both the NCCN and BCLC guidelines for treatment of patients [with HCC].

We treated patients with multifocal disease, not just solitary lesions. Getting patients to transplant or surgery who were not initially surgical candidates may become eligible through downstaging.

We demonstrated 1-year tumor control, which is outstanding, [making Y-90] excellent for local tumor control. Patients who progress outside the treatment field can be retreated. Patients who are not transplanted will likely transition to systemic therapy, which remains an option since liver function is preserved following [Y-90].

What key takeaways or final messages would you like to share with clinicians regarding coverage and access to this therapy?

I work in a tertiary care cancer center, and we do a lot of multidisciplinary care in our practice. That’s the key to implementing this therapy effectively in all practices. There are data showing that multidisciplinary care for cancer treatment improves patient outcomes and survival. Interventional radiologists applying [Y-90] must collaborate closely with hepatologists and oncologists. We need to apply what we’ve learned from this study into practice. That’s my goal, to educate people so they can apply these things to their practices. Historically, interventional radiologists have worked in their [space] and do a lot of procedures. However, [interventional radiology] has evolved as a practice, especially in the past 10 years, and we interact a great deal with the clinicians with lots of multidisciplinary care, and that is the key to applying [Y-90] to a myriad of patients who can really benefit.

I have close relationships with my oncologist [colleagues], and [I encourage] oncologists to reach out to their local interventional radiologists to incorporate [Y-90] into their paradigm of care.

References

Sirtex Medical’s SIR-Spheres Y-90 resin microspheres receive FDA approval for the treatment of unresectable hepatocellular carcinoma. News release. Sirtex Medical. July 7, 2025. Accessed October 23, 2025. https://www.sirtex.com/us/news/press-releases/news-item?id=11510

DiEugenio J. FDA approval of Y-90 resin microspheres marks a new chapter for radioembolization in unresectable HCC. OncLive.com. October 23, 2025. Accessed October 23, 2025. https://www.onclive.com/view/fda-approval-of-y-90-resin-microspheres-marks-a-new-chapter-for-radioembolization-in-unresectable-hcc