Based on a comparison of hospitalization rates reported in real-world, observational studies and randomized control trials (RCTs), patients receiving systemic therapy for metastatic non-small cell lung cancer (mNSCLC) outside of clinical trials are hospitalized significantly more often than RCTs would lead one to expect.
Researchers at Toronto’s Princess Margaret Cancer Centre reported in JAMA Oncology that the hospitalization rate in observational studies was almost 8 times higher than that in RCTs.1
Monika K. Krzyzanowska, MD, MPH, MRCPC, lead author on the study, explained that the impetus for this systematic review was her experience with patients, which suggested they were hospitalized more frequently than expected based on RCTs of the therapies involved.
“We had a hunch that we would see this, but there were no data. Now, we see it is real. Our patients do end up in the hospital often, and we need to think about why and what we can do differently to help keep them out of the hospital.”
Patients with mNSCLC were chosen because the researchers could identify 5 observational studies and 5 RCTs that allowed a direct comparison. Overall, these studies included 12,586 patients who received systemic chemotherapy.
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While patient characteristics and treatment histories generally were similar in the observational and randomized trials, patients in the real-world studies were considerably older (mean age of 71 years vs 63 years). The rate of hospitalization in observational studies was 51%, compared with 16% in RCTs (odds ratio, 7.7; 95% CI: 7.0-8.4; P<.001).
“When making treatment decisions, we focus on the cost of the drugs,” Dr. Krzyzanowska said in an interview, “but hospitalization is also very expensive, and we need to consider all the costs involved.”