The group had previously shown that the same treatment delayed progression in primary liver cancer, which the FDA approved for humanitarian use in unresectable liver cancers. A similar Y-90 treatment was FDA approved for inoperable colorectal cancer as well.
The results in metastatic liver cancer weren't surprising, but were still important as the first prospective multicenter data on the strategy, commented co-author and program chair William Rilling, MD, of the Medical College of Wisconsin in Milwaukee.
The results in metastatic liver cancer weren't surprising, but were still important as the first prospective multicenter data on the strategy, commented co-author and program chair William Rilling, MD, of the Medical College of Wisconsin in Milwaukee.
By Crystal Phend, Senior Staff Writer, MedPage Today
Published: March 30, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
CHICAGO -- Targeted radiation delivered intra-arterially to refractory liver metastases among patients with metastatic colorectal cancer, neuroendocrine tumors, or other metastatic cancers appears to halt progression with little toxicity, according to results of an open-label phase II study.
Treatment with microscopic pellets of yttrium-90 (Y-90, TheraSphere) yielded a partial response or stable disease in 69.2% of these patients who failed prior chemotherapy regimens, Riad Salem, MD, MBA, of Northwestern University in Chicago, and colleagues found.
While the experimental therapy didn't eradicate any tumors, no severe adverse effects were seen in more than 1% of patients with intra-arterial Y-90, Salem's group reported here at the Society of Interventional Radiology meeting.
Mild fatigue and nausea were the most common side effects of the treatment, with grade 3 events limited to a 6% rate of pain and of elevated alkaline phosphatase levels indicating liver function problems.Action Points
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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Explain that targeted radiation delivered intra-arterially to refractory liver metastases among patients with metastatic colorectal cancer, neuroendocrine tumors, or other metastatic cancers appears to halt progression with little toxicity.
Note that no severe adverse effects were seen in more than 1% of patients with intra-arterial yttrium-90, and mild fatigue and nausea were the most common side effects of the treatment.
The group had previously shown that the same treatment delayed progression in primary liver cancer, which the FDA approved for humanitarian use in unresectable liver cancers. A similar Y-90 treatment was FDA approved for inoperable colorectal cancer as well.
The results in metastatic liver cancer weren't surprising, but were still important as the first prospective multicenter data on the strategy, commented co-author and program chair William Rilling, MD, of the Medical College of Wisconsin in Milwaukee.
Intra-arterial delivery of radiation -- akin to seed radiation implants for prostate cancer, but smaller and higher dose -- could change the standard of care for liver tumors, Salem suggested.
"We can do these sorts of very high level very potent therapies on an outpatient basis -- really a change in paradigm of cancer therapy compared with long infusions," he said at a press conference here.
His group conducted a single-arm, prospective, open-label trial in 151 patients with unresectable liver metastases refractory to or inappropriate for other systemic or targeted therapies. Most of these patients had primary colorectal (n=61) or neuroendocrine (n=44) cancers.
In the month prior to treatment, patients got imaging to map out the volume of tumor that would need to be treated and determine dose and catheterization route for delivery.
Patients got a total of 120 Gy of radiation in one or two doses from the glass encased microspheres, which Salem said did not travel beyond the liver in any cases.
The median progression-free survival was 2.8 months among colorectal cancer patients and 14.6 months among neuroendocrine cancer patients. Overall survival came in at a median 9.4 and 24.0 months, respectively.
Response rates in the overall study population were:
9.2% for partial response
60.0% for stable disease
30.8% for progressive disease
0.0% for complete response
Five deaths occurred among study participants, but none were judged to be treatment related.
Grade 4 adverse events included:
Four cases of elevated bilirubin
Five cases of liver dysfunction
Four cases of infection
Four cases of lymphopenia
Four cases of pain
Four cases of platelet abnormalities
Fatigue topped the list as the most common adverse event overall, at rates of 18% for grade 2 and 39% for grade 1. Salem called these "excellent tolerability and safety" results.
International multicenter phase III randomized controlled trials are getting under way with the treatment, he noted, including STOP-HCC in primary liver cancer to compare the sequence with sorafenib (Nexavar) to sorafenib alone and EPOCH in second-line treatment of liver metastases.
The study was sponsored by MDS Nordion.
Salem reported being a consultant for Nordion.
Rilling reported being a consultant for Navilyst, Cook Medical, DBO Innovations, B. Braun Medical, and Siemens Healthcare.
Primary source: Society of Interventional Radiology
Source reference:
Benson A, et al "Safety, response and survival outcomes of 90y radioembolization for liver metastases: Results from a 151-patient investigational device exemption multi-institutional study" SIR 2011;
Abstract 1.
Abstract 1.
