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

Thymosin alpha 1 combined with intravenous immunoglobulin may significantly reduce pulmonary adverse events in B-cell lymphoma patients receiving R-CHOP therapy, but further research is needed to confirm these findings.

Summary and findings

This study evaluated the impact of adjunctive thymosin alpha 1 (Thα1) combined with intravenous immunoglobulin (IVIG) on pulmonary adverse effects in 379 patients with B-cell lymphoma undergoing R-CHOP therapy. The primary endpoint was the incidence of pulmonary adverse events (PAEs), which was significantly lower in the Thα1-IVIG group compared to the R-CHOP alone group. Five-year event-free survival (EFS) was also reported to be higher in the Thα1-IVIG group.

Abstract

<title>Abstract</title> <p>Background Rituximab based chemotherapy regimens, particularly R-CHOP, are highly effective for the treatment of B-cell lymphoma (BCL) but are frequently complicated by pulmonary adverse effects (PAEs) that may disrupt therapy and adversely affect outcomes. This prospective study evaluated whether adjunctive thymosin alpha 1 (Thα1) combined with intravenous immunoglobulin (IVIG) reduces RCHOP associated pulmonary toxicity and improves survival. Methods In this prospective cohort study, 379 patients with histologically confirmed BCL and no pre-existing respiratory disease received R-CHOP therapy between February 2008 and October 2019 and had no prior history of respiratory disease. Exclusion criteria were primary pulmonary pathology, significant comorbidities, and pregnancy or lactation. Participants received either standard R‑CHOP alone (n = 164) or R‑CHOP plus adjunctive Thα1‑IVIG (n = 215), initiated 8–10 days after rituximab administration. The primary endpoint was the incidence of PAE. Secondary endpoints included infectious pulmonary events (IP), interstitial pulmonary disease (IPD), and 5‑year event‑free survival (EFS). Multivariable Cox proportional hazards models were used to identify independent risk and protective factors. Results Among 379 patients, the Thα1-IVIG therapy was associated with a significantly lower overall PAE (13.0% vs. 31.7%, P < 0.001) and IP (4.2% vs. 19.5%, P < 0.001), whereas the incidence of IPD was not significantly different (8.8% vs. 12.2%, P = 0.286) between the two groups. Five‑year event-free survival (EFS) was higher in the Thα1‑IVIG group (77.7% vs. 61.0%, P < 0.001). Multivariate modeling identified extra nodal involvement as a risk factor for PAEs (HR = 1.79, 95% CI 1.14–2.82, P = 0.011), and Thα1‑IVIG therapy appeared to be independently protective (HR = 0.40, 95% CI 0.25–0.64, P < 0.001). Conclusion Thα1-IVIG prophylaxis is a safe, and cost-efficient strategy to reduce pulmonary toxicity, improve treatment adherence and improvement EFS in patients receiving R-CHOP.</p>

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