Sato Yasuyoshi, Fukuda Naoki, Wang Xiaofei, Urasaki Tetsuya, Ohmoto Akihiro, Nakano Kenji, Yunokawa Mayu, Ono Makiko, Sato Yukiko, Mitani Hiroki, Tomomatsu Junichi, Takahashi Shunji
Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.
Pathology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.
Cancer Manag Res. 2020 Jun 3;12:4161-4168. doi: 10.2147/CMAR.S249393. eCollection 2020.
In the CheckMate-141 trial, nivolumab conferred a survival benefit in patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC). Here, we examined the efficacy of nivolumab in patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial.
This was a retrospective analysis of data collected prospectively from 97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution. The patients were assigned to three groups based on HNC primary site: 1) oral cavity, pharynx, and larynx, which were included in CheckMate-141 (n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14). Survival outcomes and nivolumab treatment response were compared between the primary site and histological subgroups.
The median number of nivolumab treatments was 7 cycles (range, 1-53 cycles) and the median follow-up time was 9.1 months (range, 0.66-33.0 months). There were no significant differences in response rates between the three primary site subgroups (CheckMate-141 sites 22%, nasopharynx 43%, others 18%; p=0) or the two histological subtype subgroups (SCC 25%, non-SCC 7%, p=0). Similarly, overall survival and progression-free survival were comparable for patients stratified by primary site or histological subtype.
No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial. These data provide a potential rationale for nivolumab therapy for all HNC patients in clinical practice.
在CheckMate-141试验中，纳武单抗可使复发性或转移性难治性头颈部鳞状细胞癌（HNC）患者获益。在此，我们研究了纳武单抗在CheckMate-141试验未纳入的HNC组织学亚型或原发部位患者中的疗效。
这是一项回顾性分析，数据前瞻性收集自我院97例接受纳武单抗治疗复发性或转移性HNC的患者。根据HNC原发部位，患者被分为三组：1）口腔、咽和喉，纳入CheckMate-141试验（n = 68）；2）鼻咽癌（未纳入CheckMate-141试验，n = 7）；3）其他未纳入CheckMate-141试验的原发部位（n = 22）。根据组织学亚型分为两组：1）鳞状细胞癌（SCC，纳入CheckMate-141试验，n = 83）；2）非鳞状细胞癌（所有部位均未纳入CheckMate-141试验，n = 14）。比较原发部位和组织学亚组之间的生存结果和纳武单抗治疗反应。
纳武单抗治疗的中位数为7个周期（范围1 - 53个周期），中位随访时间为9.1个月（范围0.66 - 33.0个月）。三个原发部位亚组（CheckMate-141试验部位22%，鼻咽癌43%，其他部位18%；p = 0）或两个组织学亚型亚组（SCC 25%，非SCC 7%，p = 0）之间的缓解率无显著差异。同样，按原发部位或组织学亚型分层的患者总生存期和无进展生存期相当。
在CheckMate-141试验中，接受纳武单抗治疗的HNC患者，其纳入与未纳入的原发部位和组织学亚型之间，在缓解率或生存结果上未检测到显著差异。这些数据为临床实践中所有HNC患者使用纳武单抗治疗提供了潜在依据。
