Reported Hospitalization Rate in Patients Receiving Systemic Therapy for Metastatic NSCLC Much Higher in Real-World vs Clinical Trial Setting
- Hospitalization rates were 51% in observational studies and 16% in clinical trials.
- Observational study patients were older.
In a study reported in JAMA Oncology, Prince et al found that the hospitalization rate among patients receiving systemic therapy for metastatic non–small cell lung cancer (NSCLC) was much higher in observational studies vs clinical trials among studies reporting hospitalization rates.
A systematic literature review identified 10 studies reporting hospitalization rates among patients receiving chemotherapy, all published after 2004, consisting of 5 clinical trials (N = 3962) and 5 observational studies (real-world cohort, N = 8624). Chemotherapy regimens included doublet therapy or single-agent therapy or were unspecified.
The real-world cohort was older (mean age = 71 vs 63 years). Three observational studies reported comorbidities using the Charlson comorbidity index, and two reported common comorbidities. All studies reported Eastern Cooperative Oncology Group performance status.
The aggregate hospitalization rate was 51% among real-world patients vs 16% among clinical trial patients (odds ratio = 7.7, P < .001). Only one study reported rate of rehospitalization and length of hospital stay. No studies reported timing of hospitalization in relation to chemotherapy cycle number.
Four of five clinical trials assessed potential hospitalization risk factors, including age, performance status, tumor histology, and type of chemotherapy regimen, with poor performance status and type of chemotherapy being associated with risk of hospitalization. Two of five observational studies evaluated potential risk factors, including age, sex, weight loss, comorbidity index, performance status, falls, activities of daily living, instrumental activities of daily living, anemia, hypoalbuminemia, histology, brain metastases, and type of chemotherapy regimen; only type of chemotherapy regimen was significantly associated with risk.
The investigators concluded: “Clinical trials in [metastatic] NSCLC consistently report significantly lower rates of hospitalization than reports of real-world cohorts of patients undergoing similar therapies. However, very few clinical trials report hospitalization information.”
The authors had no research funding to acknowledge and reported no conflicts of interest.
Monika K. Krzyzanowska, MD, MPH, FRCPC, of Princess Margaret Cancer Centre, is the corresponding author for the Journal of Clinical Oncology article.