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 options.
"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 was discussed.