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Few Patients Enroll in Clinical Trials of First-Line Therapies


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Patient enrollment in clinical trials as the first course of treatment after cancer diagnosis is low, despite the fact that enrollment may increase life expectancy, according to research published by Zaorsky et al in JNCCN–Journal of the National Comprehensive Cancer Network. Researchers also found that white males with private health insurance and metastatic cancers treated at academic medical centers are more likely than other groups to enroll in clinical trials.

Nicholas G. Zaorsky, MD

Nicholas G. Zaorsky, MD

Nicholas G. Zaorsky, MD, Assistant Professor of Radiation Oncology at Penn State College of Medicine, led a team who analyzed data from the National Cancer Database on more than 12 million patients with 46 different types of cancer between 2004 and 2015.

Results

Of 12,097,681 patients listed in the analysis, only 11,576 (0.1%) were enrolled in clinical trials as their first course of therapy following diagnosis.

According to Niraj J. Gusani, MD, FACS, Professor of Surgery at Penn State and senior author of the study, the low rate of enrollment is troubling because clinical trials may be beneficial for patients.

“Major advances in cancer treatment have been supported by clinical trials,” said Dr. Gusani. “By volunteering to participate in a trial, patients may help further the field of research and gain access to new treatments.”

The team also found that patients with cancer treated in clinical trials, when matched and compared to similar patients not treated on trials, lived longer—at a median follow-up of 64 months, those enrolled in a clinical trial had improved overall survival in univariate and stratified analyses, with a median survival of 60.0 vs 52.5 months (hazard ratio = 0.876, 95% confidence interval = 0.845–0.907, P < .0001).

KEY POINTS

  • Of 12,097,681 patients listed in the analysis, only 11,576 (0.1%) were enrolled in clinical trials as their first course of therapy following diagnosis.
  • The team also found that patients with cancer treated in clinical trials, when matched and compared to similar patients not treated on trials, lived longer.
  • Patients who enrolled in clinical trials at first course of therapy tended to be white males with private insurance, metastatic disease, who had no other chronic medical conditions, and who were treated at academic medical centers.

According to Dr. Zaorsky, previous evaluations of whether clinical trials improved survival compared patients who were enrolled in trials against those not enrolled in trials, but didn’t account for factors like age, race, sex, and cancer type.

The researchers also performed a stratified analysis in which they matched each patient who participated in a clinical trial with another patient who was not enrolled in a trial that had 10 similar characteristics—including cancer type, age, race, insurance type, disease stage, and whether or not surgery or chemotherapy were part of the treatment plan. While the survival trend was evident across cancer types, the researchers said that this may not necessarily be true for the general population. In their analysis, they determined that the patients who enrolled in clinical trials at first course of therapy tended to be white males with private insurance, metastatic disease, who had no other chronic medical conditions, and who were treated at academic medical centers.

“If clinical trials are going to be used to determine standards of care for the general population, then the study participants need to be representative of the general population—and this study shows that often this isn’t the case,” explained Dr. Gusani.

The authors concluded, “Enrollment in clinical trials at the first line of therapy in the United States is exceedingly low (0.1% of patients at the first course of therapy) and favors young, healthy, white patients with metastatic disease and private insurance who are treated at academic medical centers. Patients with cancer treated in clinical trials live substantially longer than those not treated in trials.”

Disclosure: For full disclosures of the study authors, visit jnccn.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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