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When the Trial's the Thing

Winter 2004, Volume 16, Number 2 

Hopkins neurosurgeon-in-chief speaks out on the pros of brain tumor trials.

Henry Brem, M.D.
Neurosurgeon in Chief,
Henry Brem, M.D.

Each year, some 20,000 people in the United States leave a doctor's office knowing they have a primary brain tumor. More than half of those tumors are high-grade astrocytomas that kill: That's the stark truth that powers brain cancer research in this country. No small wonder, then, that Neurosurgeon in Chief Henry Brem, M.D., whose surgical practice gets worldwide referrals for brain tumors, says clinical trials stand out as his profession's best hope.

Brem not only advocates trials in principle, but his own approaches often come up for testing. At Hopkins, he reinstituted the Hunterian Neurosurgical Research Laboratory, originally begun by Harvey Cushing. The chemotherapy-laced, biodegradable wafer he helped develop and advance is the first FDA-approved local therapy-it's implanted on the surgical surface-to help brain tumor patients.

Brem's worked more than most to hasten therapy. In 1994, he and neuro-oncologist Stuart Grossman, M.D., started New Approaches to Brain Tumor Therapy (NABTT), an NIH-funded consortium of 11 top medical institutions that shares premier-quality trials for drugs, immune therapy and other approaches. Now, Brem uses his bully pulpit as head of Neurosurgery to advocate for trials.

Q. Patients are wary of clinical trials. Sometimes their doctors are as well. What could you say to convince them?
A. Start with the facts! Studies show patients in trials do better than those who aren't. Cancer patients in clinical studies have better outcomes, regardless of the treatment. They live longer with a better quality of life.

Q. Regardless of the treatment? Is that due to a placebo effect?
A. No, I think it's tied to human nature. People enrolled in trials get a standard of care that's beyond optimal. We believe our normal care is optimal. But because physicians in trials know people are observing the data, the quality of what they deliver is extremely high. Anybody does a bit more if the supervisor's in the room.

Q. Do we have many brain tumor trials ongoing?
A. Fifteen are still recruiting. Some are Hopkins-initiated and approved by our institutional review board. Others, like the NABTT studies, are part of larger, multicenter projects.

Q. You said a quandary surrounds the trials?
A. Yes. It can be difficult for patients to decide whether to participate. Say a patient gets a standard treatment drug. That patient may be excluded, then, from a trial of a new systemic agent as an initial therapy. True, the standard offers improved survival, but it's not a cure. So patient and physician must decide whether known benefits outweigh potential promise of a new treatment.
That creates a lot of tension in an institution! You find yourself saying, "We have to do better for patients," but still, there's that existing help, even though it's temporary.

Q. And most patients choose...
A. The treatment of known benefit. But there is an out. If the tumor recurs, they can still try a trial designed for recurring disease. That's why most new therapies first appear for clinical failure rather than the initial approach.

Q. What keeps you able to face patients with terminal tumors?
A. I alternate between two approaches. First, I feel it's my obligation to see patients get the best possible care, no matter what the probable outcome. That focuses my energy; it gives me drive.
But if that's all I did, it would be depressing. So I'm also obligated to try to improve their care through research. It gives hope, even in a dismal disease, to me as well as to patients. In the long run, it's the balance that keeps us all going.




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