Department of Medical Oncology/Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Int J Clin Oncol. 2020 Jul;25(7):1270-1277. doi: 10.1007/s10147-020-01669-y. Epub 2020 Apr 10.
Nivolumab improves overall survival (OS) in patients with platinum-refractory recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC). In one study, however, Kaplan-Meier OS and progression-free survival (PFS) curves for the nivolumab and cytotoxic agent arms crossed at 3-6 months, suggesting that patients with initial resistance to immunotherapy might have better outcomes with cytotoxic treatment. Here, we explored the conditions and candidates which are predictive of nivolumab outcomes in R/M HNSCC.
We retrospectively reviewed the clinical records of 27 consecutive R/M HNSCC patients treated with nivolumab from 2014 to 2018. Tumor size was evaluated by RECIST ver.1.1. Tumor growth rate (Gr) was defined as 3log(D/D)/t, where D and D are the sum of the diameters of the target lesions (SumTLs) at baseline and pre-baseline, and t is time, with 1t defined as 4 weeks.
Twenty-five patients were enrolled. Survival was significantly worse in patients with disease progression within 3 months. Outcomes appeared poorer in patients with higher pre-treatment Gr and bigger SumTLs at baseline. We therefore explored the association between prognosis, Gr and SumTLs. Recursive partitioning analysis showed that the characteristics of patients with disease progression after 3 months were Gr < 0.76 and SumTLs < 31.0 mm. Further, Gr < 0.76 and SumTLs < 31.0 mm was associated with significantly longer PFS (p = 0.01) and OS (p < 0.01).
These results suggest that Gr and SumTLs at baseline are significantly associated with OS and PFS in R/M HNSCC patients treated with nivolumab.
纳武利尤单抗可改善铂类耐药复发性和转移性头颈部鳞状细胞癌（R/M HNSCC）患者的总生存期（OS）。然而，在一项研究中，纳武利尤单抗组和细胞毒药物组的 Kaplan-Meier OS 和无进展生存期（PFS）曲线在 3-6 个月时交叉，这表明对免疫治疗最初有抵抗的患者接受细胞毒治疗可能会有更好的结果。在这里，我们探讨了预测 R/M HNSCC 患者纳武利尤单抗治疗结局的条件和候选因素。
我们回顾性分析了 2014 年至 2018 年期间接受纳武利尤单抗治疗的 27 例连续 R/M HNSCC 患者的临床记录。采用 RECIST ver.1.1 评估肿瘤大小。肿瘤生长率（Gr）定义为 3log(D/D)/t，其中 D 和 D 是基线和基线前靶病变总和直径（SumTLs），t 为时间，1t 定义为 4 周。
共纳入 25 例患者。3 个月内疾病进展的患者生存明显更差。治疗前 Gr 较高和基线时 SumTLs 较大的患者结局较差。因此，我们探讨了预后、Gr 和 SumTLs 之间的关系。递归分区分析显示，3 个月后疾病进展患者的特征为 Gr<0.76 和 SumTLs<31.0mm。此外，Gr<0.76 和 SumTLs<31.0mm 与显著更长的 PFS（p=0.01）和 OS（p<0.01）相关。
这些结果表明，R/M HNSCC 患者接受纳武利尤单抗治疗时，基线时的 Gr 和 SumTLs 与 OS 和 PFS 显著相关。
