The significance of thymosin α1 and intravenous immunoglobulin in the prevention of pulmonary adverse events in B-cell lymphoma treated with R-CHOP: A prospective study

This prospective cohort study investigated whether adjunctive thymosin alpha 1 (Thα1) combined with intravenous immunoglobulin (IVIG), initiated 8–10 days after rituximab, could reduce pulmonary adverse events (PAEs) in 379 patients with B-cell lymphoma (BCL) receiving R-CHOP chemotherapy. Patients were assigned to either standard R-CHOP alone (n=164) or R-CHOP plus Thα1-IVIG (n=215); the study was conducted over approximately 11 years. The study found that the Thα1-IVIG group had a notably lower rate of overall PAEs (13.0% vs. 31.7%), with reductions in both infectious pulmonary events and interstitial pulmonary disease. Five-year event-free survival also appeared to favor the adjunctive group. Multivariable Cox proportional hazards models were used to identify independent risk and protective factors. Key limitations include the non-randomized, observational design (patients were not randomly assigned), potential for selection bias and confounding, the preprint status of the manuscript (not yet peer-reviewed), the single-study nature of the findings, and the lack of blinding. These factors substantially limit causal interpretation of the results, and findings should be considered hypothesis-generating pending confirmatory randomized controlled trials.

Why this grade: Despite a human cohort of 379 patients, the non-randomized prospective design, absence of blinding, high potential for selection bias, and preprint (non-peer-reviewed) status restrict the evidence to limited-human grade.