This news release responsibly describes a small safety trial for the use of image-guided injections of an immunotherapy approved for melanoma in advanced liver cancer. The study involving a genetically modified version of the herpes virus called talimogene laherparepvec (T-VEC) was presented at the Society of Interventional Radiology’s Annual Scientific Meeting. The news release provides caveats and doesn’t try to imply that the treatment has been proven effective. We would have liked to see a more detailed description of side effects and cost data.
Liver cancer has been on the rise, and it is particularly deadly. Fewer than one in five people diagnosed with liver cancer live more than five years, according to the National Cancer Institute, and the survival rate is lower for people with advanced forms that have invaded other parts of the body.
As the lead author of this study notes, “Advanced stage liver tumors, including ones that have spread from other locations, have limited treatment options because the patients can be in poor health; further, the complex structure of the organ can make it difficult to target with standard approaches.”
That scarcity of options might lead some patients to participate in clinical trials for unproven therapies such as this one. Many experimental treatments don’t pan out, raising false hopes and putting trial participants through unproductive procedures. It’s important that news releases temper expectations about their potential.
There was no discussion of how much this therapy might cost. The reported cost of T-VEC for a round of melanoma therapy has been $65,000.
The trial was not designed to test the effectiveness of this therapy, so we don’t expect the news release to describe any benefits.
The news release stated, “Researchers found the patients tolerated the treatment well with expected side effects, including temporary flu-like symptoms.”
Since this was a safety trial, we expected more detail on what those expected side effects were.
Were “expected side effects” the same as those observed in patients getting T-VEC for melanoma? Are the flu like symptoms the worst?
The news release stated that the findings involved “14 advanced-stage cancer patients with liver metastases, including those with cirrhosis.”
It mentions caveats: “The authors note several limitations of the current study, including the preliminary nature of the results, as well as the number of patients tested.”
There was no disease mongering. However, the news release didn’t add any context about the scope and impact of liver cancer.
The American Cancer Society estimates there will be 42,220 new cases of liver cancer diagnosed in 2018, and about 30,200 deaths.
The release identified Amgen, the pharmaceutical company that makes T-VEC, as a sponsor of the trial.
The news release rightly quotes the study’s lead author saying that there are “limited treatment options” for patients with advanced liver cancer. It notes researcher’s future plans to combine the therapy with a checkpoint inhibitor to activate a stronger immune response.
There’s no cure for advanced liver cancer, although chemotherapy and low-dose radiation may be used to slow its spread and relieve pain. The drug sorafenib (Nexavaris) has been shown to improve survival.
Radiofrequency ablation (RFA), transarterial chemoembolization (TACE), and the targeted therapy sorafenib (Nexavar) may be other options for select patients with liver cancer. For patients whose cancer originated elsewhere and spread to the liver, chemotherapy specific to the primary cancer may be appropriate.
The news release made it clear that this therapy is still being tested and people with liver cancer should not expect to access it soon except through a clinical trial:
As part of the study, researchers will follow patients for up to two years, and new trials to investigate the effectiveness of the drug in treating advanced cancer in the liver are being planned. Additional investigation is also planned to test the therapy in combination with a checkpoint inhibitor to activate a stronger immune response.
“Image-guided treatments have expanded the options available for patients with liver cancer from innovative approaches to biopsies to resections to chemo,” said Raman. “This is an exciting way to look to the future, but patients living with advanced liver cancer should understand that this treatment will not be available for several years, except through clinical trials.”
The lead researcher was quoted saying, “This minimally invasive treatment offers patients a novel way to directly and indirectly attack the cancer cells.”
The idea of deploying natural occurring viruses to selectively kill cancer cells has been around for decades but research has taken off in recent years, according to a 2016 paper. It states: “Many clinical trials using T‐VEC are currently performed worldwide by the (Amgen) pharmaceutical company in order to expand its application and also to expand countries for marketing.”
The news releases used restrained language.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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