Lung Cancer Clinical Trials Could See Boost in Enrollment

David Gerber, MD

Prior cancer history should not exclude patients with advanced lung cancer from participating in clinical trials because it does not impact clinical outcomes, according to a study led by researchers at the UT Southwestern Medical Center. The findings could help boost enrollment in lung cancer clinical trials.

“When it comes to clinical trial eligibility, a history of prior cancer should not count against you,” senior author David Gerber, MD, said in a statement. “For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.”

The NCI estimates that more than 14 million people in the United States have a history of cancer, but there are currently fewer than 5% of adults with cancer participating in clinical trials here.

Gerber, associate professor of Internal Medicine, Division of Hematology and Oncology, at the Harold C. Simmons Comprehensive Cancer Center, said that up to 18% of lung cancer patients are excluded from clinical trials solely based on the fact that they have a history of prior cancer.

“This longstanding and widespread practice reflects concerns that lung cancer patients with a prior cancer would have worse outcomes,” he said. “In the current study, these patients’ outcomes were as good—or even better—than those with no previous cancer diagnosis.”

For the study, which was published in the Journal of the National Cancer Institute, researchers analyzed 102,929 patients over the age of 65 who were diagnosed with stage IV lung cancer between1992 and 2009. Of these patients, 14.7% had a history of prior cancer.

Of those with a prior cancer, 76% were diagnosed at stages I, II, or III, and most were diagnosed less than 5 years prior to their lung cancer diagnosis. Among women analyzed in the study, the most common prior cancers were breast, gastrointestinal, and gynecologic whereas the most common prior cancers for men were prostate, other genitourinary cancers, and gastrointestinal cancers.

The study found that patients with prior cancer had 10% overall survival and 20% better lung cancer—specific survival than those with no previous cancer diagnosis.

Researchers hypothesized that the reason prior cancer patients had superior survival has to do with a lead-time bias rather than a biologic 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 Gerber.

Nonetheless, the knowledge from this study provides key data to help change clinical trial enrollment.

“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,” coauthor Ethan Halm, MD, chief of the William T. and Gay F. Solomon Division of General Internal Medicine, and chief of the Division of Outcomes and Health Services Research in the Department of Clinical Sciences at UT Southwestern, said in a statement.

Laccetti AL, Pruitt SL, Xuan L, et al. Effect of prior cancer on outcomes in advanced lung cancer: implications for clinical trial eligibility and accrual [published online February 9, 2015]. J Natl Cancer Inst. doi:10.1093/jnci/djv002.