One-Bag Protocol for Cancer Drug Hypersensitivity: A Meta-Analysis of Safety and Effectiveness.

Abstract

Background: Hypersensitivity reactions (HSRs) to essential chemotherapy create treatment barriers in cancer care globally. Conventional three-bag protocols (3BP) for rapid drug desensitization (RDD) present operational challenges that may inadvertently exacerbate healthcare disparities.

Objective: We aimed to systematically evaluate the safety, completion rates, and procedural duration of 1BP for chemotherapy and monoclonal antibody HSRs, and to compare these outcomes with those of conventional 3BP.

Methods: In this meta-analysis, we searched MEDLINE, Embase, Web of Science, and CENTRAL. We included studies describing 1BP for HSRs to chemotherapy and monoclonal antibodies. Four reviewers independently screened the studies and extracted the data. The primary outcome was the pooled completion rate of the 1BP protocols. Secondary outcomes compared safety, completion rates, and protocol duration between the 1BP and 3BP.

Results: Our analysis of 16 studies included 975 patients undergoing 4,473 RDD procedures. The pooled completion rate for 1BP was 99.7% (95% CI: 99.35-99.9%; Prediction Interval: 98-100%), remaining consistent across drug classes. While BTR occurred in 12% of RDDs, they were predominantly mild to moderate, with only 0.4% being severe. In studies comparing protocols, there was no significant difference in completion rates (Risk Difference: 0.00; p = 0.966).

Conclusion: One-bag RDD protocols demonstrate demonstrate consistent safety and completion rates. Our findings suggest that patient safety relies on the precise control of exposure kinetics rather than multiple dilution steps. By reducing procedural complexity and duration, 1BP provides a robust strategy to streamline workflows, optimize resource allocation, and enhance patient access to cancer therapies across diverse healthcare settings.

Prospero registration: CRD42024586580.