Why a Clinical Trial May Be a Sarcoma Patient’s Best Option — Not Their Last

A Keck Medicine of USC medical oncologist explains why clinical trials are valuable opportunities for many sarcoma patients.

A sarcoma is a rare type of cancer that develops in connective tissues, fat, muscle and bone — as opposed to more common organ-based cancers such as lung cancer and breast cancer. Sarcomas can occur anywhere in the body, including in bone, fat, blood vessels, lymph vessels, nerves, muscles, tendons, ligaments and cartilage.

If you’ve been diagnosed with a sarcoma, all of a sudden you’re facing intensive treatment, and the future feels uncertain. So it’s reasonable to wonder if signing up for a clinical trial might add to that uncertainty: Will I be protected? Will I still get the standard of care?

Mark Agulnik, MD, a medical oncologist and co-leader of the USC Sarcoma Program, part of the USC Norris Comprehensive Cancer Center and Keck Medicine of USC, understands those concerns. But, as he points out, “It’s easy to forget that the standard of care we use in sarcoma treatment today was established because of clinical trials.”

Dr. Agulnik shares five reasons why he thinks sarcoma patients should consider enrolling in a clinical trial.

Clinical trials advance sarcoma care.

“Sarcomas are a very rare tumor,” Dr. Agulnik explains. “They affect only about 1% of adult cancer patients.”

As such, they don’t attract the same research funding as cancers that affect more people, like breast, colon and prostate cancer. Because of this, drugs are often first approved for use in these more common cancers. But clinical trials give researchers a chance to find out if these drugs have indications for sarcoma treatment as well, and to “bring the drugs into the sarcoma world,” Dr. Agulnik says.

For instance, he notes, “We currently have two first-line clinical trials underway at USC Norris Comprehensive Cancer Center for untreated sarcoma patients, and both add an FDA-approved drug to the standard of care.”

Clinical trials provide the standard of care, plus.

That raises another important point: Sarcoma patients participating in clinical trials never receive less than the standard of care.

In fact, Dr. Agulnik says, “Clinical trials often give patients access to cutting-edge treatments that wouldn’t otherwise be available — whether targeted therapies, immunotherapies or novel drug combinations. We hope to find that the ‘plus’ therapy either improves outcomes or is equivalent to the standard.”

And for sarcoma patients who fear being assigned to a placebo group that receives no additional treatment, Dr. Agulnik offers reassurance: “The only time we use a placebo is if an absence of therapy would be considered standard of care. There are some situations like that, but for the most part that’s not what patients encounter.”

Clinical trials respect sarcoma patients’ right and protections.

Enrolling in a clinical trial can call to mind thoughts of being a “guinea pig” in an experiment. But this, too, doesn’t reflect reality.

Clinical trials are highly regulated, monitored at every stage and designed with patient safety the top priority. Further, Dr. Agulnik adds, “Clinical trials are partnerships where patients are fully aware of what they’re getting.”

They receive a comprehensive consent form that’s not a binding contract, he says, and they have the right to exit the trial if and when they wish. “Everything is aimed at the patient’s wellbeing, the efficacy of the new therapies and improving outcomes in the future,” he says.

Clinical trials give sarcoma patients wraparound support.

Of course, finding, enrolling and participating in a clinical trial is a complex process. But it’s not a solo journey.

“If a patient comes to the USC Sarcoma Program,” Dr. Agulnik says, “we act as their advocates and try very hard to match them to the best therapies we have, including standard of care and clinical trials.”

Once enrolled in a trial, USC Sarcoma Program patients have an entire team looking out for them. “Orthopedic, radiation and surgical oncologists, pathologists, radiologists — all of us comprehensively evaluate our sarcoma patients and tailor treatment toward them,” Dr. Agulnik says.

Clinical trials are not sarcoma patients’ last resort.

A final misunderstanding that Dr. Agulnik wants to dispel is the notion that clinical trials are what’s left when no other treatment options remain.

On the contrary, he says, physicians will often introduce clinical trials as a first treatment to ensure optimal early outcomes. “This can help to guide future treatments,” he says. “And in that sense, I feel clinical trials are an opportunity for sarcoma patients, rather than something they should view with apprehension.”

All of which is why he encourages patients to discuss clinical trials with their doctors: “Whether the patient brings it up first or the physician does, any way they can get more information is going to benefit them,” he says.

And if the patient still has doubts, that’s okay, too. “There’s more than one path to the finish line,” Dr. Agulnik concludes. “Patients need to feel comfortable with what they’re doing, so I tell them to trust their gut. We’ll meet you where you are, and we’ll find a treatment that sits well with you.”

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