UTSW. US: 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 UT Southwestern Medical Center.
Having previously had cancer did not impact 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, appearing in the Journal of the National Cancer Institute.
“When it comes to clinical trial eligibility, a history of prior cancer should not count against you,” said senior author Dr. David Gerber, Associate Professor of Internal Medicine in the Division of Hematology and Oncology in the Harold C. Simmons Comprehensive Cancer Center.
“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 National Cancer Institute (NCI) estimates that more than 14
million people in the U.S. have a history of cancer. Currently fewer
than 5 percent of adults with cancer in the U.S. participate in clinical
trials.
“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,” said Dr.
Gerber, Co-Director of the Lung Cancer Disease Oriented Team and co-leader of the Experimental Therapeutics Program. “In the current study, these patients’ outcomes were as good – or even better than- those with no previous cancer diagnosis.”
“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,” said co-author Dr. Ethan Halm,
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. Dr.
Halm is holder of the Walter Family Distinguished Chair in Internal
Medicine in Honor of Albert D. Roberts, M.D.
The researchers studied 102,929 patients over age 65 who were
diagnosed with stage IV lung cancer – the most advanced stage − from
1992 to 2009. Of these patients, 14.7 percent had a history of prior
cancer.
In the study, about three-quarters of previous cancers (76 percent)
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.
Although the study was not designed to determine why prior cancer was
associated with superior survival, the research team hypothesizes 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. This shift leads to longer documented survival times,”
said Dr. Gerber.
Other UT Southwestern researchers involved include Dr. Sandi Pruitt,
Assistant Professor of Clinical Science; Dr. Andrew Laccetti, resident
in Department of Internal Medicine; and Lei Xuan, biostatistical
consultant in Clinical Sciences.
This trial was supported by a National Cancer Institute (NCI)
Clinical Investigator Team Leadership Award, the Cancer Prevention
Research Institute of Texas (CPRIT), 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.
UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center
is one of just 68 NCI-designated cancer centers in the nation. The
Simmons Cancer Center includes 13 major cancer care programs with a
focus on treating the whole patient with innovative treatments, while
fostering groundbreaking basic research that has the potential to
improve patient care and prevention of cancer worldwide. In addition,
the Center’s education and training programs support and develop the
next generation of cancer researchers and clinicians.
In addition, the Simmons Cancer Center is among only 30 U.S. cancer
research centers to be named a National Clinical Trials Network Lead
Academic Participating Site, a prestigious new designation by the NCI,
and the only Cancer Center in North Texas to be so designated. The
designation and associated funding is designed to bolster the cancer
center’s clinical cancer research for adults and to provide patients
access to cancer research trials sponsored by the NCI, where promising
new drugs often are tested.
About UT Southwestern Medical CenterUT Southwestern, one
of the premier academic medical centers in the nation, integrates
pioneering biomedical research with exceptional clinical care and
education. The institution’s faculty includes many distinguished
members, including six who have been awarded Nobel Prizes since 1985.
Numbering approximately 2,800, the faculty is responsible for
groundbreaking medical advances and is committed to translating
science-driven research quickly to new clinical treatments. UT
Southwestern physicians provide medical care in 40 specialties to about
92,000 hospitalized patients and oversee approximately 2.1 million
outpatient visits a year.