Real-World Outcomes and Prognostic Factors in Patients Receiving Nivolumab Therapy for Recurrent or Metastatic Head and Neck Carcinoma
Real-World Outcomes and Prognostic Factors in Patients Receiving Nivolumab Therapy for Recurrent or Metastatic Head and Neck Carcinoma
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DOI：
10.3390/cancers11091317
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发表时间：
2019-09-01
期刊：
影响因子：
5.2
通讯作者：
Omori, Koichi
中科院分区：
文献类型：
--
作者：
Hori, Ryusuke;Shinohara, Shogo;Omori, Koichi
最近，一项全球III期研究表明，nivolumab显著改善了复发或转移性头颈癌(RMHNC)的患者预后。然而，nivolumab对不符合临床试验条件的患者的疗效尚不清楚。我们研究了尼伏卢单抗在真实患者中的疗效以及与尼伏卢单抗疗效相关的预后因素。这项研究是在京都大学及其附属医院-头颈肿瘤学集团的11个研究所进行的。总共对2017年5月至2018年5月期间接受nivolumab治疗的93名RMHNC患者进行了回顾。客观评价有效率(ORR)、总生存期和无进展生存期(PFS)。进行单变量和多变量分析以确定预后因素。鳞癌和非鳞癌患者的ORR分别为21.8%和0%。鳞癌和非鳞癌患者的1年生存率分别为28.7%和8.9%。发生PFS事件(鳞癌与非鳞癌)的危险比(HR)为2.28(95%可信区间：1.21~4.1.对数列p=0.007)。单因素和多因素分析显示，放疗史、铂类难治性癌和治疗相关不良事件(TRAE)是与鳞癌患者PFS相关的重要预后因素。在现实生活中，非鳞状细胞癌和铂类难治癌预后较差，原发灶有放疗史，TRAE的发生与较好的预后相关。这些发现可能对临床医生和患者在选择治疗策略时有用。
Recently, a global phase III study demonstrated that nivolumab markedly improved patient outcomes in recurrent or metastatic head and neck carcinoma (RMHNC). However, the efficacy of nivolumab in patients who are ineligible for clinical trials is unknown. We investigated nivolumab efficacy in real-world patients and prognostic factors associated with the response to nivolumab. This study was conducted at 11 institutes associated with Kyoto University and its Affiliated Hospitals-Head and Neck Oncology Group. In total, 93 patients with RMHNC who received nivolumab between May 2017 and May 2018 were retrospectively reviewed. Objective response rate (ORR), overall survival, and progression-free survival (PFS) were evaluated. Univariate and multivariate analyses were performed to identify prognostic factors. The ORRs in patients with squamous cell carcinoma (SCC) and non-SCC were 21.8% and 0%, respectively. In patients with SCC and non-SCC, the 1-year PFS rates were 28.7% and 8.9%, respectively. The hazard ratio (HR) for risk of PFS events (SCC versus non-SCC) was 2.28 (95% confidence interval: 1.21-4.1; log-rank p = 0.007). Univariate and multivariate analyses revealed radiotherapy history, platinum-refractory carcinoma, and treatment-related adverse events (TRAEs) as important prognostic factors associated with PFS in patients with SCC. In a real-world setting, non-SCC and platinum-refractory carcinoma were associated with a poorer prognosis, and a history of radiotherapy to the primary tumor, and the occurrence of TRAEs were associated with a better prognosis. These findings could be useful for clinicians and patients when selecting a treatment strategy.