A new study from researchers at UT Southwestern Medical Center suggests that excluding patients from lung cancer clinical trials with prior cancer diagnosis might not be adequate and justified.
The study, published in the Journal of the National Cancer Institute and titled “Effect of Prior Cancer on Outcomes in Advanced Lung Cancer: Implication for Clinical Trial Eligibility and Accrual,” argues that the diagnosis of previous cancer does not influence the outcomes related to advanced lung cancer. As such, these patients should be considered for clinical trials.
The study’s senior author, Dr. David Gerber, who is a professor at the Harold C. Simmons Comprehensive Cancer Center, commented in a press release: “When it comes to clinical trial eligibility, a history of prior cancer should not count against you. For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.”
According to the National Cancer Institute (NCI), it is estimated that more than 14 million Americans have a record of cancer. However, less than 5 percent of adults with cancer in the United States enroll in clinical trials.
“Modifying the policy for clinical trial inclusion could lead to faster accrual of patients, higher trial completion rates, and more generalizable trial results that can help a greater number of patients, ultimately leading to better treatments,” stated Dr. Ethan Halm, the study’s co-author.
A total of 102,929 patients 65 years or older were diagnosed with the most advanced stage of lung cancer (stage IV) from 1992 to 2009, and of these patients, 14.7 percent had a previous history of lung cancer. Importantly, 76 percent of those previous cancers were diagnosed at stages I, II or III, and the majority were diagnosed less than 5 years before the lung cancer. The most common prior cancers diagnosed in women were breast, gynecologic and gastrointestinal cancers, while in men prostate, gastrointestinal and genitourinary cancers had the higher rates. Those who had previous cancers showed a 10% increase in overall survival and 20% increase in lung-cancer survival when compared to those with no previous cancer diagnosis.
The study was not conceived to determine whether prior cancer was associated with better survival outcomes, however, researchers think this improvement might have to do with lead-time bias rather than biological advantage. “The clinical and radiographic surveillance related to the prior cancer may result in earlier diagnosis of the stage IV lung cancer. This shift leads to longer documented survival times,” said Dr. Gerber.
