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在日本复发性或转移性头颈癌患者中,纳武单抗的疗效受先前使用西妥昔单抗和颈部清扫术的影响:一项真实世界环境中的回顾性观察研究结果

Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting.

作者信息

Kariya Shin, Shimizu Yasushi, Hanai Nobuhiro, Yasumatsu Ryuji, Yokota Tomoya, Fujii Takashi, Tsukahara Kiyoaki, Yoshida Masafumi, Hanyu Kenji, Ueda Tsutomu, Hirakawa Hitoshi, Takahashi Shunji, Ono Takeharu, Sano Daisuke, Yamauchi Moriyasu, Watanabe Akihito, Omori Koichi, Yamazaki Tomoko, Monden Nobuya, Kudo Naomi, Arai Makoto, Yonekura Shuji, Asakage Takahiro, Fujiwara Akinori, Yamada Takayuki, Homma Akihiro

机构信息

Department of Otolaryngology, Head and Neck Surgery, Okayama University Hospital, Okayama, Japan.

Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.

出版信息

Int J Clin Oncol. 2021 Jun;26(6):1049-1056. doi: 10.1007/s10147-021-01900-4. Epub 2021 Apr 8.

DOI:10.1007/s10147-021-01900-4
PMID:33830342
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8134300/
Abstract

BACKGROUND

To examine the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab, we conducted a large-scale subgroup analysis in Japanese patients with recurrent/metastatic head and neck cancer.

METHODS

Data on the effectiveness of nivolumab were extracted from patient medical records. All patients were analyzed for effectiveness by prior cetuximab use. In the analyses for prior neck dissection, only patients with locally advanced disease were included.

RESULTS

Of 256 patients analyzed, 155 had received prior cetuximab. Nineteen of 50 patients with local recurrence underwent neck dissection. The objective response rate was 14.7 vs 17.2% (p = 0.6116), median progression-free survival was 2.0 vs 3.1 months (p = 0.0261), and median overall survival was 8.4 vs 12 months (p = 0.0548) with vs without prior cetuximab use, respectively. The objective response rate was 23.1 vs 25.9% (p = 0.8455), median progression-free survival was 1.8 vs 3.0 months (p = 0.6650), and median overall survival was 9.1 vs 9.9 months (p = 0.5289) with vs without neck dissection, respectively.

CONCLUSIONS

These findings support the use of nivolumab for patients with recurrent/metastatic head and neck cancer regardless of prior cetuximab use or neck dissection history.

TRIAL REGISTRATION NUMBER

UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).

摘要

背景

为了研究先前使用西妥昔单抗和颈部清扫术对纳武单抗疗效的影响,我们对日本复发性/转移性头颈癌患者进行了大规模亚组分析。

方法

从患者病历中提取纳武单抗疗效的数据。所有患者均根据先前是否使用西妥昔单抗进行疗效分析。在先前颈部清扫术的分析中,仅纳入局部晚期疾病患者。

结果

在分析的256例患者中,155例先前接受过西妥昔单抗治疗。50例局部复发患者中有19例行颈部清扫术。先前使用西妥昔单抗与未使用西妥昔单抗相比,客观缓解率分别为14.7%和17.2%(p = 0.6116),无进展生存期中位数分别为2.0个月和3.1个月(p = 0.0261),总生存期中位数分别为8.4个月和12个月(p = 0.0548)。有颈部清扫术与无颈部清扫术相比,客观缓解率分别为23.1%和25.9%(p = 0.8455),无进展生存期中位数分别为1.8个月和3.0个月(p = 0.6650),总生存期中位数分别为9.1个月和9.9个月(p = 0.5289)。

结论

这些发现支持对于复发性/转移性头颈癌患者使用纳武单抗,无论其先前是否使用过西妥昔单抗或有无颈部清扫术史。

试验注册号

UMIN-CTR(UMIN000032600),Clinicaltrials.gov(NCT03569436)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6cf/8134300/667a2c04023e/10147_2021_1900_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6cf/8134300/87656828ccd1/10147_2021_1900_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6cf/8134300/667a2c04023e/10147_2021_1900_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6cf/8134300/87656828ccd1/10147_2021_1900_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6cf/8134300/667a2c04023e/10147_2021_1900_Fig2_HTML.jpg

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