The Risks and Benefits of Cancer Trials
Reported March 4, 2005
(Ivanhoe Newswire) — For patients with advanced cancer, enrolling in a cancer trial may make sense as an attempt to fight the disease. However, some critics contend enrollment of patients with advanced disease is risky research and may cause more harm than benefit.
A team of researchers from the National Institutes of Health, Memorial Sloan-Kettering Cancer Center, and the National Cancer Center in Tokyo has published a new study examining the risks and benefits involved in phase 1 cancer trials.
Phase 1 cancer trials enroll patients with advanced cancer. These trials are often designed to evaluate the safety and toxicity of new therapeutic agents and help to determine safe doses.
For this study, adult phase 1 cancer trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute were analyzed. Researchers analyzed 460 trials involving 11,935 participants enrolled in trials between 1991 and 2002. Researchers calculated the rates of response to treatment and death rates, related and unrelated to the treatment.
Upon analyzing the data, researchers found response to treatment was higher than previously reported, as 10.6 percent of the participants had either a partial or complete response to therapy. The researchers also found toxicity-related deaths have not increased over time.
The study authors say that reliance on a single estimate of the response rate or the toxicity related death for phase 1 oncology trials is misleading, since the rates of response and toxicity vary according to the type of trial. Furthermore, they recommend that potential patients and their families, physicians, and others be aware of the complexity and variety of such trials, know the details about the trial they are considering, and carefully evaluate all relevant risks and benefits.
SOURCE: New England Journal of Medicine, 2005;352:895-904
