Patients and physicians differ
significantly in their perceptions of phase I clinical trial outcomes and
the content of treatment discussions, according to a multicenter study presented
at the 38th annual meeting of the American Society of Clinical Oncology. Phase I
studies typically evaluate new drugs or drug combinations that have not yet been
tested in humans, and are offered to patients for whom a standard treatment
option does not exist.
"We conducted this study because we need to better
understand the decision-making process of this vulnerable group of cancer
patients," said Neal J. Meropol, MD, a medical oncologist at Fox Chase
Cancer Center in Philadelphia and principal investigator for the study.
A total of 328 cancer patients were surveyed after having
made a decision about whether to participate in a phase I trial. Of these 328
patients, 79% elected to enroll in a phase I trial. The physicians of 246 of
these patients (75%) also completed the survey.
Patients were asked about perceived life expectancy with
treatment as well as the potential for benefit and toxicity associated with
standard and experimental approaches; 71% thought they would survive more than 2
years with experimental therapy, whereas only 15% of their physicians predicted
that patients would survive more than 2 years. When asked to estimate
potential for benefit and harm under different treatment conditions (0%-100%),
patients predicted a greater likelihood of benefit and toxicity than did their
physicians. These findings applied to both experimental and standard treatment
"These results raise the possibility that patients do
not clearly recognize the likely outcomes from therapy," said Dr. Meropol.
"In addition, they may reflect a component of hope and optimism."
Although 95% of surveyed patients stated that quality of life
was at least as important as length of life, only 34% reported that
"changes in quality of life with treatment" were discussed with their
physician. In contrast, 79% of the surveyed physicians reported that this issue