Riad Salem, MD, discusses data from the following presentation:

Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. (

EPOCH is the first positive phase 3 global study of Y-90 [Yttrium 90] TARE [Transarterial radioembolization] and chemotherapy in the second-line treatment of patients with colorectal liver metastases.

This study examined safety and efficacy in patients with unresectable unilobar or bilobar colorectal metastases who were able to receive second-line irinotecan- or oxaliplatin-based chemotherapy.

Patients were randomized 1:1 to receive Y-90 glass TARE and standard-of-care chemotherapy with or without targeted therapy (n=215) or standard of care chemotherapy with or without targeted therapy (n=213). Follow-up occurred every 8 weeks until disease progression or hepatic disease progression or death.

Primary end points were PFS [progression-free survival] and hPFS [hepatic PFS] adjudicated by BICR [blinded independent central review]. Secondary end points were OS [overall survival], ORR [overall response rate] by BICR, DCR [disease control rate] by BICR, TTSP [time to symptomatic progression], and TTDQoL [time to deterioration quality of life].

The addition of Y-90 TARE to chemotherapy increased PFS from 7.2 to 8.0 months and increased hPFS from 7.2 to 9.1 months; these increases were statistically significant, and the study success criteria were met (PFS: HR 0.69; 1-sided 

No significant differences were found in OS.

Overall response rate in the TARE-chemotherapy group was nominally better than the chemotherapy alone group.

Chemotherapy-related adverse events were comparable between the groups.

Y-90 did not compromise ability to receive additional chemotherapy.

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Expert Riad Salem, MD, MBA, highlights key data from the phase 3 EPOCH study, which evaluated TheraSphere in patients with mCRC and liver metastases who failed first line chemotherapy. 

Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial

Riad Salem, MD, vice chair for Image Guided Therapy, Department of Radiology, chief of Vascular and Interventional Radiology, the Department of Radiology, professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology), and Surgery (Organ Transplantation) at the Feinberg School of Medicine, discusses the history of TheraSphere™ Yttrium-90 (Y-90) in metastatic colorectal cancer (CRC).

Historically, Y-90 has been used for patients with CRC in the salvage setting after progression on chemotherapy, Salem explains. Several phase 2 clinical trials have examined the efficacy and safety of the agent in this space. Data with Y-90 demonstrated response rates of approximately 30% to 40% in patients with CRC and median overall survival (OS) of 12 to 14 months depending on the amount of prior chemotherapy a patient received, Salem explains. However, with newer agents emerging for the treatment of patients with CRC, patients are receiving more chemotherapy prior to the salvage setting and progressively longer delays have been seen regarding the use of Y-90, Salem adds.

Studies such as the SIRFLOX (NCT00724503) and the phase 3 FOXFIREGlobal (NCT01721954)trials, evaluated Y-90 as first-line treatment for patients with CRC, but failed to demonstrate an overall survival benefit with the agent, Salem says. As such, Y-90 remains a salvage option for patients who have no other available options, Salem concludes.

CAUTION: In the US Therasphere is under and investigational device exemption for treatment of patients with metastatic colorectal cancer. The safety and effectiveness for this treatment has not been established.

Riad Salem, MD, discusses the history of TheraSphere™ Yttrium-90 in metastatic colorectal cancer.

Dr. Salem on the Utility of Y-90 Glass Microspheres in CRC

Riad Salem, MD, vice chair for Image Guided Therapy, Department of Radiology, chief of Vascular and Interventional Radiology in the Department of Radiology, and professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology) and Surgery (Organ Transplantation) at the Feinberg School of Medicine, discusses outcomes with TheraSphere™ Yttrium-90 (Y-90) Glass Microsphere as a bridging therapy prior to transplantation in hepatocellular carcinoma (HCC).

The Northwestern University Feinberg School of Medicine hosted a large number of patients who underwent liver transplantation after being treated with Y-90 for downstaging or bridging, according to Salem. In an analysis that utilized pathology tissue, investigators examined both the explant and explant tumor to determine whether the amount of tumor could be quantified. Patients were followed for 10 to 15 years to see whether they experienced different outcomes following transplantation, Salem says.

Investigators found that if there was more necrosis present, it was easier to kill the tumor, Salem explains. Additionally, this patient population was found to have better outcomes following transplantation. Based on this, the goal of a locoregional therapy should be to maximize tumor kill and necrosis, as this will yield the best outcomes for patients following transplantation, Salem concludes.

Riad Salem, MD, discusses outcomes with TheraSphere™ Yttrium-90 Glass Microsphere as a bridging therapy prior to transplantation in hepatocellular carcinoma.

Dr. Salem on Outcomes With Y-90 as Bridging Therapy Prior to Transplant in HCC

Riad Salem, MD, vice chair for Image Guided Therapy, Department of Radiology, chief of Vascular and Interventional Radiology in the Department of Radiology, and professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology) and Surgery (Organ Transplantation) at the Feinberg School of Medicine, discusses considerations for selecting the appropriate treatment approach for patients with hepatocellular carcinoma.

Lesions that are visible via ultrasound, that are less than 3 cm, or are isolated from critical structures, are well suited to ablative therapy, according to Salem. However, if the lesion is more difficult to identify or is closer to adjacent structures, arterial locoregional therapy or external radiotherapy are recommended, Salem says.

If both options have failed, or the patient is not a candidate for these approaches, systemic therapies can be considered. Agents such as lenvatinib (Lenvima) are generating excitement in the downstaging setting due to the high response rates observed with its use, according to Salem. Although these agents need to be further studied and understood, these strategies are viable depending on the patient's clinical factors, Salem concludes.

Riad Salem, MD, discusses considerations for selecting the appropriate treatment approach for patients with hepatocellular carcinoma.

Dr. Salem on Selecting the Appropriate Treatment Approach in HCC

Riad Salem, MD, vice chair for Image Guided Therapy, Department of Radiology, chief of Vascular and Interventional Radiology in the Department of Radiology, and professor of Radiology (Vascular and Interventional Radiology), Medicine (Hematology and Oncology) and Surgery (Organ Transplantation) at the Feinberg School of Medicine, discusses the 

FDA approval of TheraSphere™ Yttrium-90 (Y-90) Glass Microsphere in March 2021 for the treatment of patients with hepatocellular carcinoma (HCC)

The approval stems from a collaboration between investigators, regulators, and the industry to generate a multicenter dataset that had demonstrated compelling outcomes, Salem says; these outcomes were strong enough to lead to approval of this approach. The regulatory decision possesses the potential to make Y-90 more widely available as a treatment option in more cancer centers, Salem notes.

Patients will benefit from having increased treatment options, Salem adds. Additionally, the approval of Y-90 is something that can be implemented in not only high-volume, highly specialized cancer centers, but also in other more low-volume centers that have the expertise to utilize Y-90 in a clinical setting, as well, Salem concludes.

Riad Salem, MD, discusses the FDA approval of TheraSphere™ Yttrium-90 Glass Microsphere in March 2021 for the treatment of patients with hepatocellular carcinoma.


Dr. Salem on the FDA Approval of Y-90 Glass Microspheres for HCC

Riad Salem, MD, professor of radiology, medicine, and surgery, vice chair, Image Guided Therapy, chief, Vascular Interventional Radiology, Department of Radiology, Northwestern University Feinberg School of Medicine, discusses the role of locoregional therapy in hepatocellular carcinoma (HCC).

Localized therapies include surgical resection, transplantation, ablation, stereotactic body radiotherapy, and embolization, says Salem.

Further refinement of which treatment modality is best suited for each patient is needed, explains Salem. Currently, treatment selection is largely based on an institution’s experience with 1 therapy versus another.

The majority of data regarding localized therapy in early-stage HCC is from phase II studies, explains Salem.

As such, utilizing a multidisciplinary approach to treat patients with localized therapy is important to develop the optimal treatment plan for each individual, concludes Salem.

Riad Salem, MD, discusses the role of locoregional therapy in hepatocellular carcinoma.



Dr. Salem on the Role of Locoregional Therapy in HCC

Riad Salem, MD, professor of radiology, medicine, and surgery, vice chair, Image Guided Therapy, chief, Vascular Interventional Radiology, Department of Radiology, Northwestern University Feinberg School of Medicine, discusses the utility of locoregional therapy versus systemic therapy in the treatment of patients with hepatocellular carcinoma (HCC).

The phase III IMbrave150 trial reported a 41% reduction in the risk of disease progression or death with the combination of bevacizumab (Avastin) and atezolizumab (Tecentriq) compared with sorafenib (Nexavar) in patients with newly diagnosed, unresectable HCC (HR, 0.59; 95% CI, 0.47-0.76; 

The majority of patients enrolled in IMbrave150 had extrahepatic metastases, says Salem. However, many patients in the real-world setting do not have extrahepatic metastases and may derive greater benefit from localized therapy rather than systemic therapy.

Locoregional therapy offers patients with localized disease a one-time treatment that maintains quality of life, says Salem. Systemic therapy should be considered for patients who progress on or become intolerant of localized therapy.

Among an influx of available treatment options in HCC, understanding how to best select treatment for patients is an ongoing challenge, concludes Salem.

Riad Salem, MD, discusses the utility of locoregional therapy versus systemic therapy in the treatment of patients with hepatocellular carcinoma.



Riad Salem, MD

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