| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | A phase II trial of nivolumab for patients with platinum-refractory recurrent or metastatic salivary gland cancer. |
| 掲載誌名 | 正式名：Japanese journal of clinical oncology 略 称：Jpn J Clin Oncol ISSNコード：14653621/03682811 |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Yoshiaki Nagatani, Naomi Kiyota, Tomoko Yamazaki, Yukinori Asada, Masaaki Higashino, Hironaga Satake, Shogen Boku, Ari Nishimura, Hirokazu Uemura, Ichiro Ota, Katsunari Yane, Kaoru Tanaka, Takuma Onoe, Yuji Hirayama, Takahiro Tsujikawa, Hajime Fujiwara, Hikari Shimoda, Ken-Ichi Nibu, Yoshinori Imamura, Shiro Kimbara, Taiji Koyama, Yohei Funakoshi, Hironobu Minami |
| 発行年月 | 2025/12 |
| 概要 | BACKGROUND:Salivary gland cancer (SGC) is rare and has various histological types. This rarity and heterogeneity have hindered elucidation of the therapeutic contribution of systemic therapy, including immune checkpoint inhibitors, to recurrent or metastatic SGC (RM-SGC). The purpose of this trial was to investigate the efficacy and safety of nivolumab for platinum-refractory RM-SGC.METHODS:This phase II trial for platinum-refractory RM-SGC was conducted at nine centers. Nivolumab 240 mg was administered intravenously every 2 weeks. The primary endpoint was the objective response rate (ORR), and secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.RESULTS:Twenty-four patients were enrolled between March 2018 and January 2022. The main histological types were salivary duct carcinoma (n = 10), adenoid cystic carcinoma (n = 6), and adenocarcinoma not otherwise specified (n = 5). The ORR was 8.3% (2/24, 80% CI, 2.2-20.6), with two partial responses in patients with salivary duct carcinoma. The DCR was 29.2% (7/24), while all of the other 17 patients (70.8%) showed progressive disease on first disease evaluation at 12 weeks. With a median follow-up of 21.2 months, median PFS and OS were 3.0 months (95% CI, 2.8-3.2) and 25.0 months (95% CI, 10.9-39.1), respectively. There were no new safety concerns with nivolumab monotherapy.CONCLUSIONS:This phase II trial of nivolumab for patients with platinum-refractory RM-SGC did not meet its primary endpoint of ORR. Although nivolumab may be worth further development in salivary duct carcinoma, these results may raise concerns over nivolumab monotherapy for RM-SGC. |
| DOI | 10.1093/jjco/hyaf192 |
| PMID | 41342548 |