Dexamethasone is non-inferior to antihistamine plus dexamethasone premedication in preventing ramucirumab plus nab-paclitaxel infusion-related reactions in gastric cancer: a multicenter retrospective study

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2024年10月7日

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Yutaka Negoro,
Taichi Maeda,
Hiroyuki Igarashi,
Mina Shigemori,
Toshihiro Tanaka,
Yukio Ito,
Norihiko Tanizawa,
Shota Nishikawa,
Jyunya Ogawa,
Yukio Kamitani,
Kyohei Watanabe,
Hitoshi Tsukamoto,
Nobuyuki Goto

摘要

Purpose

Ramucirumab (RAM) is recommended as premedication with H₁-receptor antagonists (H₁RA) to prevent infusion-related reactions (IRRs). However, RAM is a human antibody with a low incidence of IRRs. We evaluated the noninferiority of non-H₁RA (dexamethasone [DEX] alone) premedication to H₁RA (plus DEX) premedication in terms of IRRs in patients with gastric cancer receiving RAM plus nanoparticle albumin-bound paclitaxel (nab-PTX).

Methods

This was a noninferiority, multicenter, retrospective trial conducted in three Japanese centers to assess the incidence of IRRs in patients receiving RAM plus nab-PTX for gastric cancer between 2018 and 2023. Patients with gastric cancer receiving RAM plus nab-PTX were divided into groups with and without H₁RA premedication. The incidence of IRRs was compared between the two groups.

Results

Ninety patients were evaluated, with non-H₁RA and H₁RA premedications in 43 and 47 cases, respectively. After the first dose of RAM, IRRs were not observed in either group. IRRs during the overall doses were 0% for non-H₁RA premedication and 2.1% for H₁RA premedication (90% confidence interval (CI): –5.6%–1.3% for each comparison). The upper limit of the 90% CI (1.3%) did not exceed the noninferiority margin (Δ) of + 10% and therefore met the noninferiority criteria.

Conclusion

RAM plus nab-PTX for gastric cancer with DEX premedication may be possible without H₁RA premedication.