Fayette Jérôme, Even Caroline, Digue Laurence, Geoffrois Lionnel, Rolland Fréderic, Cupissol Didier, Guigay Joel, Le Tourneau Christophe, Dillies Anne Françoise, Zanetta Sylvie, Bozec Laurence, Borel Christian, Couchon-Thaunat Sophie, Costes-Martineau Valérie, Sudaka-Bahadoran Anne, Jallut Isabelle, Garic Florence, Lardy-Cleaud Audrey, Chabaud Sylvie
Medicine Department, Centre Leon Berard, Lyon, France.
University of Lyon, Lyon, France.
BMJ Oncol. 2023 Oct 30;2(1):e000065. doi: 10.1136/bmjonc-2023-000065. eCollection 2023.
Salivary gland cancers (SGC) are rare cancers with currently no standard treatment for recurrent/metastatic disease. Based on checkpoint inhibitors benefit in a broad range of tumours, NIvolumab in Salivary gland CArcinoma of the Head and Neck (NISCAHN) evaluated nivolumab efficacy in SGC.
In this phase II single-stage Fleming design, patients with SGC with a progressive disease progression within 6 months prior to entering the study, were divided into ACC (adenoid cytic carcinoma) and non-ACC. All received nivolumab for a maximum of 12 months. The primary endpoint was the non-progression rate at 6 months (NPR) according to Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), tumour growth rate, safety and quality of life (health-related quality of life).
46 patients with ACC and 52 patients without ACC were enrolled over 1 year. Median follow-up was respectively 29.2 months and 16.9 months for patients with ACC and non-ACC. In the ACC cohort, with 15/45 patients non-progressive at 6 months, the primary endpoint was met (33.3%; 95% CI 21.8 to NE). Nivolumab failed to demonstrate efficacy in the non-ACC cohort (NPR: 14.0%; 7/50 patients). ORR, PFS and OS were 8.7% (95% CI 2.4 to 20.8), 5.3 (95% CI 3.2 to 5.6) and 17.2 months (95% CI 12.5-NE) in the ACC cohort, and 3.8% (95% CI 0.5 to 13.2), 1.8 (95% CI 1.7 to 3.5) and 11.5 months (95% CI 7.5 to 14.8) in the non-ACC cohort. Nivolumab safety profile was consistent with previous reports.
Nivolumab has limited efficacy in SGC. Differential results were observed in the two cohorts. The primary endpoint was met in the ACC cohort and no new safety signals were identified.
EudraCT number: 2016-001794-32/NCT03132038.
唾液腺癌（SGC）是罕见癌症，目前对于复发/转移性疾病尚无标准治疗方案。基于检查点抑制剂在多种肿瘤中显示出的获益，头颈部唾液腺癌的纳武利尤单抗（NISCAHN）研究评估了纳武利尤单抗在唾液腺癌中的疗效。
在这项II期单阶段弗莱明设计研究中，入组前6个月内疾病进展的唾液腺癌患者被分为腺样囊性癌（ACC）组和非ACC组。所有患者均接受纳武利尤单抗治疗，最长治疗12个月。主要终点是根据实体瘤疗效评价标准V.1.1得出的6个月时的无进展率（NPR）。次要终点包括无进展生存期（PFS）、总生存期（OS）、总缓解率（ORR）、肿瘤生长率、安全性和生活质量（健康相关生活质量）。
1年多时间里共入组46例ACC患者和52例非ACC患者。ACC组和非ACC组患者的中位随访时间分别为29.2个月和16.9个月。在ACC队列中，15/45例患者在6个月时无疾病进展，达到主要终点（33.3%；95%CI 21.8至无上限）。纳武利尤单抗在非ACC队列中未显示出疗效（NPR：14.0%；7/50例患者）。ACC队列中的ORR、PFS和OS分别为8.7%（95%CI 2.4至20.8）、5.3（95%CI 3.2至5.6）和17.2个月（95%CI 12.5 - 无上限），非ACC队列中的分别为3.8%（95%CI 0.5至13.2）、1.8（95%CI 1.7至3.5）和11.5个月（95%CI 7.5至14.8）。纳武利尤单抗的安全性与既往报告一致。
纳武利尤单抗在唾液腺癌中的疗效有限。两个队列观察到不同结果。ACC队列达到主要终点，未发现新的安全信号。
欧洲临床试验数据库编号：2016 -
001794 - 32/NCT03132038 。
