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Title: Real-World Outcomes and Prognostic Factors in Patients Receiving Nivolumab Therapy for Recurrent or Metastatic Head and Neck Carcinoma
Authors: Hori, Ryusuke
Shinohara, Shogo
Kojima, Tsuyoshi
Kagoshima, Hiroki
Kitamura, Morimasa
Tateya, Ichiro
Tamaki, Hisanobu
Kumabe, Yohei
Asato, Ryo
Harada, Hiroyuki
Kitani, Yoshiharu
Tsujimura, Takashi
Honda, Keigo  kyouindb  KAKEN_id
Ichimaru, Kazuyuki
Omori, Koichi
Author's alias: 大森, 孝一
Keywords: Nivolumab; recurrent or metastatic head and neck carcinoma; squamous cell carcinoma; treatment-related adverse events; prognostic factor
Issue Date: Sep-2019
Publisher: MDPI AG
Journal title: Cancers
Volume: 11
Issue: 9
Abstract: 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.
Rights: © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (
DOI(Published Version): 10.3390/cancers11091317
PubMed ID: 31500103
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