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The common practice of excluding patients with a prior cancer diagnosis from lung cancer clinical trials may not be justified, according to a study by researchers from the University of Texas Southwestern Medical Center.

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Having previously had cancer did not have an impact on clinical outcomes in advanced lung cancer patients, and these patients therefore should be considered for inclusion in clinical trials seeking new therapies, according to the study, now available online ahead of print in the Journal of the National Cancer Institute (doi: 10.1093/jnci/djv002).


"When it comes to clinical trial eligibility, a history of prior cancer should not count against you," the senior author, David E. Gerber, MD, Co-Director of the Lung Cancer Disease Oriented Team and Co-leader of the Experimental Therapeutics Program at Simmons Comprehensive Cancer Center, said in a news release. "For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.


"Previous research by our team found that a substantial proportion of lung cancer patients-up to 18 percent-are excluded from clinical trial participation solely due to a history of prior cancer. This long-standing and widespread practice reflects concerns that lung cancer patients with a prior cancer would have worse outcomes. In the current study, these patients' outcomes were as good-or even better than-those with no previous cancer diagnosis."


Another 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 that modifying the policy for clinical trial inclusion could lead to faster accrual of patients, higher trial completion rates, and more generalizable trial results, with the result of helping more patients.


For the study (first author is Andrew L. Lacetti, MD), the researchers assessed 102,929 patients over age 65 who were diagnosed with stage IV lung cancer from 1992 to 2009. Of these patients, 14.7 percent had a history of prior cancer.


In the study, 76 percent of previous cancers were diagnosed at stages I, II or III, and most were diagnosed less than five years prior to the lung cancer diagnosis.


Among women, the most common prior cancers were breast, gastrointestinal, and gynecologic. For men, the most common prior cancers were prostate, other genitourinary, and gastrointestinal. Patients with prior cancer had 10 percent better overall survival and 20 percent better lung cancer-specific survival than those with no previous cancer diagnosis, the team reported.


The researchers noted that although the study was not designed to determine why prior cancer was associated with superior survival, it may be that the apparent benefit most likely reflects 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, and this shift leads to longer documented survival times," Gerber said.


The trial was supported by a National Cancer Institute Clinical Investigator Team Leadership Award, the Cancer Prevention Research Institute of Texas, and by the UT Southwestern Center for Patient-Centered Outcomes Research, Agency for Healthcare Research and Quality. Funding was also provided by the National Center for Advancing Translational Sciences, UT Southwestern Center for Translational Medicine.