He was impressed by the results of a small safety study, now published
in the journal Proceedings of the National Academy of Sciences. "Not
only was it found to be safe in the pilot study, it was found that it
did improve survival," says Engelhard, who was not involved in any of
the device's early studies. In the pilot study in Europe, researchers led by Yoram Palti of the Technion-Israel Institute of Technology
tested their prototype device in ten patients with recurrent GBM. While
the purpose of the trial was to look for side effects, the authors
compared the subjects' time to progression (how long until their cancer
progressed), PFS6 (percent that survive six months with no progression)
and overall survival with compiled statistics from clinical trials of
the best available treatments for recurrent GBM. The treatment exceeded
the historical outcomes in all of these measures, more than doubling
the expected survival time on average. That
led the researchers to ask the US Food and Drug Administration to
approve a Phase III efficacy trial without first conducting a large
Phase II safety trial. Palti, who invented the device, has formed a
company called NovoCure that's funding the research.
The Phase III trial, which is still recruiting patients, is a
randomized controlled study-- to tell if the device is truly effective,
only half of the patients are randomly selected to use the new device.
Patients who aren't randomly assigned to the device get the most
advanced available treatments. Quatrano feels fortunate that he has the device.
"Ever since I've been in this research I've been doing better, okay? So
here we are, I feel good, I don't have all the reactions from chemo and
radiation. And it's working out."
Engelhard says new treatments for GBM are badly needed because the
disease is so insidious and, in fact, isn't really a tumor at all. "It
might show up on the MRI scan as a circle or a ball, but really, by the
time it's seen on the MRI scan, individual cells have gone deep into
the brain. So glioblastoma multiforme is really cancer of the brain,
and it's very, very difficult to treat," he says. "Once the tumor does
not respond to radiation therapy and chemotherapy-- because surgery
can't remove it all-- then one does have a very short time left on
average."
While Englehard acknowledges that the device is "cumbersome," he
regards it as a prototype that could be refined if it's proved to work.
He also says it's unknown whether it has any long-lasting effects.
Quatrano doesn't care if he needs to wear the device for the rest of
his life. His advice to others diagnosed with this vicious opponent? "Fight--
don't believe what they say about the six months and all that because
in that time you go through a lot of drama in your head," Quatrano
says. "And this thing is okay." This research was published in PNAS Early Edition, June 5, 2007 and funded by NovoCure, Ltd.
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