By Admin at 30 Sep 2016, 15:17 PM

Patients enrolling in phase 1 cancer clinical trials may have unrealistic expectations about the outcomes, according to new research published in the journal Cancer.

Phase 1 trials are primarily used to evaluate the safety of an intervention, as well as determine the maximum dose of a drug or other treatment that can be safely given, along with identify potential side effects.

Those who enroll in phase 1 trials often have advanced cancer that cannot be effectively treated with standard treatments, and the median survival time of patients in such trials is six months.

The study revealed that more than 80 percent of the patients who enroll in early-phase clinical cancer trials are motivated to do so because they believe they’ll benefit. About half of participants said they expected their tumor to shrink while about one-tenth believed they may be cured.

In reality, past studies suggest phase 1 trials only have a beneficial effect in 4 percent to 20 percent of patients, thus revealing that many patients have misconceptions about how the trial may influence the course of their cancer.

Part of the issue is that such trials often start at very low drug dosages, then slowly increase them until a recommended dose is established. Phase 2 trials are then used to test the newly discovered recommended dose.

At the other end of the spectrum, patients in phase 1 trials may also be exposed to dangerously high doses of drugs that could cause serious side effects. Researchers explained:

“ … patients in phase 1 trials can receive subtherapeutic doses with little realistic chance of efficacy or an excessively high drug dose with a risk of serious toxicity.”

The so-described “misconceptions” may not be so much a matter of misinformation as a display of human hope, however.

Even after a consultation to explain the benefits and risks of enrolling in a phase 1 clinical trial, most patients’ perceptions of the trial remained largely unchanged. The researchers pointed out the importance of care providers explaining clinical information without downplaying a person’s hope.

“Given the late stage in their cancer journey, more than half of the patients had not ruled out a cure; 14% believed that a cure was possible, and 37% were unsure. This likely represents human hope …

… phase 1 physicians have to walk a fine line between reiterating a patient's poor prognosis, which may be seen as patronizing, and not disregarding the importance of human hope.”

The willingness of many advanced-stage cancer patients to enroll in phase 1 trials provides a benefit to cancer research as a whole, as well as to future and current cancer patients.

Those considering joining such a trial should discuss the decision with their health care team and family and carefully weigh the likelihood of benefit against the potential for harm.

Sources:
Cancer September 26, 2016
U.S. News & World Report September 26, 2016

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