Patients with head and neck cancer enrolled in randomized clinical trials evaluating interventions to improve outcome are much younger and have a very good performance status compared to patients seen in clinical practice, according to a recently published systematic review by investigators in the Netherlands (JAMA Otolaryngol Head Neck Surg. May 19, 2022. Published online ahead of print. doi:10.1001/jamaoto.2022.0890).
“Physicians should be critical about results of randomized trials and pay attention to the characteristics of the study population before they implement results from studies in daily practice,” said the lead author of the study, J.H.A.M. Kaanders, MD, PhD, a professor in the department of radiation oncology at Radboud University Medical Center in The Netherlands.
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Based on a review of 87 randomized clinical trials with a total of 34,241 patients with head and neck cancer, Dr. Kaanders and his colleagues found that nearly half of the patients enrolled in the studies were younger than age 57 years and that 70% had a very good performance status as represented by the World Health Organization performance score of 0 to 1 or a Karnofsky performance status of 90 to 100. In clinical practice, head and neck patients are typically older, with half of them older than 64 years according to national cancer registries that were used to provide reference data.
Although it’s known that patients in trials differ from patients in daily clinical practice, Dr. Kaanders said that the difference was larger than expected. He also said that the extremely low accrual rate for participating centers indicated selectivity in recruiting patients in the trials. The yearly accrual per participating center in more than 50% of the trials was fewer than six patients.
Of the 87 trials reviewed, half included all major head and neck sites, and these trials had a median accrual of 5.4 patients per center each year. One-third of the trials included only nasopharynx cancers, with a median accrual per center each year of 39.7 patients. The median sample size of all the trials was 332 patients, and the median duration of accrual was 4.6 years.