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 So-called phase 1 trials of experimental treatments are intended to
test the drug's safety. Just 4 percent to 20 percent of participants
may see their cancer respond to the drug, the authors write in the
journal Cancer.
But among cancer patients surveyed while they were considering
taking part in an early drug trial, between 40 percent and 50
percent of patients thought their tumors would shrink. That was true
both before and after talking with doctors, researchers found.
These expectations don't correspond to what cancer patients
typically experience during those early cancer trials, write Saoirse
Dolly, of the Royal Marsden NHS Foundation Trust in London, and
colleagues in the journal Cancer.
Phase 1 trials are typically conducted among people who have
advanced cancers that haven't responded to other treatment, the
study team writes.
"Usually the goal is not to provide efficacy to a patient," said Dr.
Paul Barr, who leads the Clinical Trials Office at the Wilmot Cancer
Institute of the University of Rochester Medical Center in New York.
He was not involved with the new study.
Then, in phase 2 trials, more people are given the treatment to
again test its safety and begin to test its effectiveness. Finally,
the treatment is tested in a phase 3 trial in a large group of
people and its effectiveness is compared against other treatments.
For the new study, researchers surveyed people at one medical center
who were being considered for a phase 1 trial.
Before their visit with a doctor to talk about the trial, 396 people
completed the questionnaire. About three quarters of those surveyed
were willing to participate in the trial. About 43 percent also
thought their tumors would shrink as a result of the trial.
"This is more than double the reported response rates and represents
a large discrepancy between expectations and what phase 1 trials
offer," the researchers write.
The discussion with doctors did little to lower patients'
expectations regarding a benefit.
After they visited with a doctor to discuss the trial, 301
prospective participants filled out a second questionnaire. The
proportion of those willing to take part in the study increased to
84 percent, and the proportion expecting their tumors to shrink rose
to about 47 percent.
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The researchers also found that after talking with a doctor, 14
percent expected their cancers to be cured. Another 37 percent were
unsure if their cancers could be cured.
Barr told Reuters Health the high expectations of cancer patients
are likely the result of them not wanting to lose hope.
"A lot of people would say patients are misinformed, and I think a
lot of it is patients don’t want to lose hope," he said. "Even the
best communicator in the world can’t change that rate."
He also cautioned that people who were very sick or not as
optimistic may have been less likely to answer the second survey.
The researchers echo that caution in their report, noting that
people who didn't return the second survey were likely not eligible
to take part in the phase 1 trial due to another health condition.
Barr said people thinking about taking part in a phase 1 trial
receive a lot of information and should bring a family member to the
initial visit. They should also take notes and take the consent
documents home to examine and consider.
"The point is to think about it and see if it’s best for you," he
said.
Additionally, he said people need to realize that the potential
benefit from phase 1 trials is usually low, but it's not zero.
"There is hope," said Barr. "People want to hear that and they need
to hear that."
SOURCE: http://bit.ly/2dewhhE Cancer, online September 26, 2016.
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