Mortality Risks Decline for Patients in Phase I Cancer Drug Trials
The risk of death related to treatment for cancer patients participating in phase I clinical trials has decreased over the past 12 years, according to a study published in the November 3 Journal of the American Medical Association (JAMA). Dr. Thomas G. Roberts, Jr., of Massachusetts General Hospital and Harvard Medical School and his colleagues analyzed data from abstracts and journal articles reporting early trial results originally submitted to annual meetings of the American Society of Clinical Oncology (ASCO) from 1991-2002.
The researchers reviewed data from 213 studies involving 6,474 cancer patients. The overall toxic (treatment-related) death rate was 0.54 percent; treatment-related death rates decreased over the study period from 1.1 percent over the first 4 years to 0.06 percent over the last 4 years. After adjusting for the characteristics of the experimental trials and investigational agents, the chances of a patient dying from an experimental treatment while participating in a trial in the last 4 years of the study period were less than one-tenth those of a patient participating in a trial during the first 4 years.
"This is an encouraging finding," said Dr. James Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis and chair of the National Cancer Institute (NCI) Clinical Trials Working Group. "Almost half of the trials involved molecular targeted agents - another indicator of the potential of targeted therapies to improve outcomes while reducing the often debilitating toxicities of cancer treatment." Read more
Improving the Efficacy of Pediatric Cancer Trials
One of the most challenging aspects of conducting clinical trials in pediatric populations is making decisions about which of the many new anticancer agents under development to test. Although treatment of childhood cancers is one of the most remarkable success stories in all of medicine - nearly 80 percent of children diagnosed with cancer survive 5 years or more - if we are to expand on that progress and ensure that every child who develops cancer has a legitimate chance of survival, we must address this issue.
That's why I am so enthusiastic about a new, first-of-its-kind program being launched by NCI: the Pediatric Preclinical Testing Program (PPTP). This program will systematically test 10-15 agents or combinations of agents annually in preclinical models of common childhood cancers. The program's goal is to generate the kind of information that will allow pediatric oncology researchers to make educated, reliable decisions on which new agents should be tested in children with specific cancers. This is critically important because only a limited number of clinical trials can be conducted for any given type of childhood cancer. If we are to provide more effective treatments for pediatric cancer patients, we must test the agents with the best chance of success.
The PPTP, which will begin testing its first set of agents in early 2005, is supported by an NCI research contract with St. Jude Children's Research Hospital (SJCRH), with Dr. Peter Houghton as the principal investigator. Testing will occur at SJCRH and other sites with expertise in specific childhood cancers. Dr. Malcolm Smith, of the Cancer Therapy Evaluation Program, is the NCI project officer. Read more