Researchers from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle investigated the relationship between participation in a clinical trial and overall survival in patients with advanced non–small cell lung cancer (NSCLC). Cristina Merkhofer, MD, MHS, will present the results of this research at the ASCO Quality Care Symposium (Abstract 137). Dr. Merkhofer is a hematology-oncology fellow at Fred Hutchinson and the University of Washington.
Patients with metastatic NSCLC enrolled in a clinical trial had a median survival that was nearly double that of those not enrolled, according to the new research. Further, patients enrolled in a clinical trial had an almost 50% lower risk of death.
Data on the benefits of enrollment in therapeutic trials for patients with advanced lung cancer have been inconsistent. To more conclusively answer the question, the researchers used a clinically enriched database that contained clinical and patient-level characteristic, which are often unavailable in larger registry-level studies or national databases.
Characteristics of Clinical Trials Vary
“Our study accounts for some important clinical variables that other studies have not included, such as the molecular features of the cancer, and we also have some unique data regarding the study participants,” said Dr. Merkhofer, who was the lead author of the study. “For example, we have data on clinical trial phase, whether the trial was randomized or not, whether the agents studied were later approved by the U. S. Food and Drug Administration [FDA], and the classes of agents studied. This allows us to look at the survival difference that we found through some other lenses and see whether there were specific trial characteristics that may have contributed to it.”
Of a group of 371 patients who met eligibility criteria for clinical trials, 118 (32%) enrolled in at least one. The majority of patients (89%) were in phase I/II trials. For the patients who enrolled, 51% were in clinical trials for drugs that were later approved by the FDA.
The researchers found that median survival in clinical trial enrollees was 838 days, as compared with 454 days for those not enrolled. After the investigators adjusted for sex, Eastern Cooperative Oncology Group score, smoking, histology, EGFR and ALK status, and presence of brain metastases, clinical trial enrollees had a 47% lower risk of death relative to those not enrolled.
Further Study Warranted
The authors hypothesized that both the access to new treatments and the enhanced supportive care offered through clinical trials are equally important but noted that their data could only begin to examine the former by looking at the aspect of access to promising agents. However, the role of enhanced supportive care received by trial patients is much more difficult to capture in a database.
"We must work to better understand factors associated with trial enrollment so the prospective benefits can be made accessible to all who are eligible.”— Merry-Jennifer Markham, MD, FACP
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This research is part of a larger study to investigate areas of uncertainty surrounding clinical trial participation. In upcoming subgroup analyses, the authors plan to evaluate whether specific trial design characteristics are associated with a survival benefit. “The study can support research evaluating health-care policies or research that looks at incentives for patient participation in trials, such as financing transportation or lodging,” said Dr. Merkhofer. “It can help with research that addresses some of these important barriers to trial participation,” she added.
Merry-Jennifer Markham, MD, FACP, ASCO expert and Chair of the Quality Care Symposium News Planning Team, offered this perspective: “It is our duty as oncologists to enroll our patients in clinical trials when appropriate. Research from this year’s meeting finds that participation in clinical trials is associated with longer overall survival in patients with advanced lung cancer. We must work to better understand factors associated with trial enrollment so the prospective benefits can be made accessible to all who are eligible.” ■
DISCLOSURE: For disclosure information for all study authors, visit coi.asco.org.