Real-world data on efficacy/safety and economic impact of nivolumab administered every 2 and 4 weeks among Japanese patients

IF 1.4 4区 医学 Q4 ONCOLOGY
Yoshihiko Tasaki, Nanami Ito, Yoshihisa Mimura, Yosuke Sugiyama, Ryo Ogawa, Takaya Shimura, Motoki Nakamura, Daisuke Kawakita, Shuzo Hamamoto, Takehiro Uemura, Keisuke Yokota, Moeko Iida, Kunihiro Odagiri, Yuka Kimura, Yuji Hotta, Hirokazu Komatsu, Katsuhiro Okuda, Akio Niimi, Takahiro Yasui, Shinichi Iwasaki, Akimichi Morita, Hiromi Kataoka, Shuji Takiguchi, Yoko Furukawa-Hibi
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引用次数: 0

Abstract

Aim

A new treatment interval for nivolumab administration at 480 mg every 4 weeks, in addition to 240 mg every 2 weeks, was approved in Japan in 2020. Using model-based evaluation, it was speculated that the effects or safety of nivolumab do not differ between the two treatment intervals; however, real-world data on nivolumab efficacy, safety, and economic impact are lacking. Accordingly, we aimed to examine the effects of nivolumab treatment intervals (2 weeks vs. 4 weeks) in terms of efficacy, safety, and economic impact in Japanese patients with cancer.

Methods

We retrospectively analyzed 126 patients treated with nivolumab. The patients were divided into two groups depending on whether they received nivolumab at 240 mg every 2 weeks (2-week group) or 480 mg every 4 weeks (4-week group).

Results

Efficacy results found no significant difference between the 4- and 2-week groups considering median overall survival (p = 0.70) and median progression-free survival (p = 0.57). The incidence of any grade and ≥  grade 3 immune-related adverse events did not differ between the 4-week and 2-week groups (any grade, p = 0.13; ≥  grade 3, p = 0.36). Excluding drug costs, the 4-week group had significantly lower medical costs than the 2-week group (2-week vs. 4-week: mean, 94,659 JPY [679.0 USD] vs. 58,737 JPY [421.3 USD]; p < 0.05).

Conclusion

Collectively, our findings suggest that nivolumab 480 mg every 4 weeks may be more effective than nivolumab 240 mg every 2 weeks in terms of economic impact.

Abstract Image

日本患者每 2 周和 4 周使用 nivolumab 的疗效/安全性和经济影响的真实数据
目的日本于2020年批准了一个新的治疗间隔,在每2周240毫克的基础上,每4周480毫克服用尼夫单抗。通过基于模型的评估,推测两种治疗间隔的尼夫单抗疗效或安全性没有差异;然而,缺乏有关尼夫单抗疗效、安全性和经济影响的真实世界数据。因此,我们旨在研究 nivolumab 治疗间隔(2 周与 4 周)对日本癌症患者疗效、安全性和经济影响的影响。结果疗效结果显示,在中位总生存期(p = 0.70)和中位无进展生存期(p = 0.57)方面,4 周组和 2 周组没有显著差异。任何等级和≥3级免疫相关不良事件的发生率在4周组和2周组之间没有差异(任何等级,p = 0.13;≥3级,p = 0.36)。总之,我们的研究结果表明,就经济影响而言,每 4 周使用 480 毫克 nivolumab 可能比每 2 周使用 240 毫克 nivolumab 更有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
175
审稿时长
6-12 weeks
期刊介绍: Asia–Pacific Journal of Clinical Oncology is a multidisciplinary journal of oncology that aims to be a forum for facilitating collaboration and exchanging information on what is happening in different countries of the Asia–Pacific region in relation to cancer treatment and care. The Journal is ideally positioned to receive publications that deal with diversity in cancer behavior, management and outcome related to ethnic, cultural, economic and other differences between populations. In addition to original articles, the Journal publishes reviews, editorials, letters to the Editor and short communications. Case reports are generally not considered for publication, only exceptional papers in which Editors find extraordinary oncological value may be considered for review. The Journal encourages clinical studies, particularly prospectively designed clinical trials.
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