Study Assesses Clinical Trial Recruitment Difficulties in a Lymphoma Cohort

The REALYSA study has garnered an enrollment rate of 54%—higher than typical clinical trial inclusion rates, which remain at less than 10%, according to a study presented at the 2022 American Society of Hematology Annual Meeting.

REALYSA is a prospective, real-life, multicentric cohort study taking place in 35 hematology departments in France to assess the prognostic value of epidemiological, clinical, and biological factors, with a nine-year follow-up. Researchers assessed reasons of non-inclusion in the study to better understand “participation bias.”

Adult patients with newly diagnosed diffuse large B-cell, follicular, marginal zone, mantle cell, Burkitt, Hodgkin, and mature T-cell lymphomas were invited to participate by their hematologist. Patients who had already received anti-lymphoma treatment (except pre-phase) and those with HIV infection were excluded.

Among the 278 eligible patients, 159 (57%) were male, and the median age at diagnosis was 64 years (range, 18-96 years). Among the cohort, patients were diagnosed with diffuse large B-cell lymphoma (n=104; 37%), follicular lymphoma (n=56; 20%), Hodgkin lymphoma (n=46; 17%), marginal zone lymphoma (n=35; 13%), T-cell lymphoma (n=19; 7%), mantle cell lymphoma (n=16; 6%), and Burkitt lymphoma (n=2).

Curative treatment intent was decided for 251 patients (90%), “watch and wait” was selected for 19 (7%), and supportive care for eight (3%). Among all patients, 151 (54%) were included in the REALYSA program, and 27 (10%) were included in an interventional clinical trial.

The median inclusion rate by month was 55% (minimum, 37%; maximum, 74%). Among non-included patients, 39 (31%) refused to participate, for 20 patients (16%) treatment was started in emergency, for 12 patients (9%) the clinician judged inclusion not feasible, and for 56 patients (44%), the reason was unknown. Higher probability of inclusion was observed for those with advanced Ann Arbor stage (odds ratio [OR], 2.06; 95% CI, 0.98-4.31) and those treated with curative intent (OR, 4.98; 95% CI, 1.54-16.14).

“The analyses for continuous variables showed the trend for a lower probability of inclusion for older patients and patients with hypoalbuminemia and the trend for a higher probability of enrollment for patients who lived in semi-rural area,” the researchers noted of “interesting” in the findings.

Event-free survival was 50% (95% CI, 35-70) for those not included in the REALYSA study versus 61% (95% CI, 50-76) for those who were included (P=.32).

“This study is the first step to better understand recruitment bias in a real-world program to ensure generalizability of findings,” the researchers concluded. “This type of comparative study should be extended to a larger period and to other centers to have a better comprehensive understanding of the reasons of non-participation.”

Reference

Lan CLE, Belot A, Golfier C, et al. Evaluation of participation and recruitment bias in a prospective real-life multicentric cohort « Real World Data in Lymphoma and Survival in Adults » (REALYSA study) for newly diagnosed lymphoma patients over one year in a hematology department of teaching hospital. Abstract #2282. Presented at the 64th ASH Annual Meeting and Exposition; December 10-13, 2022; New Orleans, Louisiana.