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The Patient Centered Outcomes Research Institute has awarded Kaiser Permanente $14.4 million to compare strategies for active surveillance of current and former smokers to scan for potentially cancerous small growths in the lungs, including more versus less intensive strategies.
The Patient Centered Outcomes Research Institute (PCORI) has awarded Kaiser Permanente $14.4 million to compare strategies for active surveillance of current and former smokers.
The grant will allow Kaiser to scan for potentially cancerous small growths in the lungs, including more versus less intensive strategies.
Current guidelines recommend that smokers and former smokers undergo lung cancer screening, which can identify these small growths (or pulmonary nodules) so they can be scanned to determine if they are cancerous. However, the optimal frequency of such scans has not been determined. Beginning April 1, the study will compare more intensive versus less intensive protocols for monitoring these pulmonary nodules.
The study is said to be the first controlled trial of different approaches to surveillance involving patients with these small, commonly encountered growths, and which until recently were not actively monitored among current and former smokers as a potential symptom of lung cancer.
“Specifically, it addresses how to best evaluate small pulmonary nodules-a question that comes up commonly in primary care and specialty settings,” says Michael K. Gould, MD, MS, of Kaiser Permanente Southern California who is also the principal investigator for the study. “We estimate that over 1 million nodules are identified on chest computed tomography [CT] scans each year. Most nodules are harmless, but about 5% turn out to be cancer."
NEXT: Active surveillance
Furthermore, says Gould, while most lung cancer is not curable, cancerous nodules are treatable and potentially curable. "However," he adds, "it's often difficult to distinguish the cancerous ones from the benign ones." This is especially true for small nodules, those that measure </=10 mm in diameter, according to Dr. Gould.
"These nodules are difficult or too risky to biopsy and not reliably characterized by other imaging tests like PET scans, so the default option for evaluation is to use time as a diagnostic test by doing repeat chest CT scans to check for growth,” he says. “We call this ‘active surveillance.’ If the nodule grows, it is presumptive evidence of cancer and more intensive evaluation follows. If there is no growth over 2 years, the nodule is usually considered benign.”
Physicians, says Dr. Gould, have been using active surveillance for years and several guidelines make recommendations for how frequently to repeat the CT scan, but the guidelines are based on expert opinion-not evidence-and it’s unknown what frequency is best.
“In theory, more frequent surveillance will identify cancerous nodules sooner, but less-frequent surveillance minimizes inconvenience, anxiety, radiation exposure, costs, false alarms and downstream complications of invasive testing among those who have false alarms,” he says.
NEXT: Study methadology
The study will compare two options for active surveillance, both supported by existing guidelines and therefore consistent with current standards of care. The study is expected to enroll 47,000 patients from 26 hospitals in 14 different health systems. The primary outcome is the proportion of cancerous nodules that grow to a less-treatable stage. The secondary outcomes include time to cancer diagnosis, survival and all of the other considerations mentioned above-anxiety, radiation exposure, etc.
“The study is important to health systems because they will be able to give doctors and patients better information about the tradeoffs involved and improve patient-centered care,” Dr. Gould says. “If our hypothesis is correct that the less-frequent surveillance protocol does not result in more cases of cancer progression, the study will improve affordability by showing that it is safe to do fewer CT scans-about one-third fewer.”