Outcomes of a Undiluted, One-Bag Desensitization Protocol for Chemotherapeutic Agents

Abstract

Background Hypersensitive reactions (HSRs) often require that the provoking medication be discontinued but chemotherapeutic drugs are often essential for the treatment of the disease. Rapid drug desensitization is a procedure that induces temporary tolerance to the drug allowing continuation of treatment in patients who have presented HSRs. Most of the desensitization protocols use 3 bags with sequential dilutions of the drug, which are infused in gradual steps. However, it has not been sufficiently investigated whether dilution is essential for successful desensitization. Objective The objective of this study was to evaluate the efficacy and safety of a new one-bag desensitization protocol which uses a single solution of 1 mg/mL throughout the procedure allowing to reduce time and simplifying the desensitization procedure. Methods Retrospective observational study was carried out in adult patients with HSRs to chemotherapy agents who received a new nondilution one-bag desensitization protocol between 2016 and 2021. Results A total of 130 desensitization procedures with an undiluted one-bag protocol were performed on 17 patients with HSRs to chemotherapy. One hundred and seven (82.3%) were for desensitization to CBDCA, 15 (11.5%) for oxaliplatin, 4 (3.1%) for paclitaxel and 4 (3.1%) for brentuximab. All of the 130 procedures were successfully accomplished, and all patients could receive their target dose. No breakthrough reactions (BTRs) occurred in 77% (100/130) of desensitizations, and only mild reactions (grade 1) with skin symptoms were observed in 23% (30/130) of desensitizations. Conclusion and Relevance The undiluted one-bag desensitization protocol was safe and effective and has been adopted as the standard of care at our institution in treating patients with HSRs to chemotherapeutic drugs as it requires less time and simplifies the desensitization procedure, optimizing risk management.

Carboplatin desensitization – simplified 4-step 2-bag method

“…2,4,9 Effective desensitization is accomplished by controlled and uninterrupted carboplatin administration that delivers an increasing intensity of drug exposure to ultimately administer the regimen-based dose. 10 Approaches to carboplatin and chemobiotherapy desensitization are often based on a 4-step 4-bag, 2,3,12–14 12-step 3-bag, 4,9,11 12- or 16-step 1-bag, 15,16 or similar strategy starting with a less than or equal to 1:1000 dilution equivalent. Determination of superior effectiveness and safety for one method in comparison to another is outside the scope of this publication.…”

“…Desensitization schemas that use a single admixture to deliver all planned titrations start at a rate of 0.1 mL/hr. 15,16 Infusion devices routinely used to treat our adult oncology patients can be programed to an administration rate of 0.5 to 999 mL/hr with rate accuracy of ±5%; accuracy improves with infusion rate of at least 2 mL/hr. 17 The decision to prepare a separate Bag A was intended to facilitate administration of the most dilute step as a pharmaceutically stable product in a tolerable fluid volume at an accurate rate using a system-standard equipment and supplies.…”