Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients.
Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients.
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DOI：
10.3390/cancers12113427
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发表时间：
2020-11-18
期刊：
影响因子：
5.2
通讯作者：
Yamashita T
中科院分区：
文献类型：
--
作者：
Matsuki T;Okamoto I;Fushimi C;Takahashi H;Okada T;Kondo T;Sato H;Ito T;Tokashiki K;Tsukahara K;Hanyu K;Masubuchi T;Tada Y;Miura K;Omura G;Sawabe M;Kawakita D;Yamashita T
目前尚未报道nivolumab免疫治疗复发性或转移性头颈部鳞状细胞癌（R/M SCCHN）的真实世界长期结局。此外，该疗法的最佳总体缓解（BOR）的预后影响仍不清楚。我们对这种疗法的长期疗效和安全性进行了多机构队列研究。我们还评估了BOR与生存率之间的关系。中位随访时间为25.9个月。中位总生存期（OS）为9.6个月，2年生存率为25.0%。总有效率为18%，疾病控制率为48%。对于免疫相关不良事件（irAE），在29例患者中检测到38例irAE。irAE的发生和更好的BOR与更长的生存期显著相关。这些发现证明了纳武单抗治疗R/M SCCHN在现实世界中的长期疗效和安全性。BOR的幅度和irAE的发生可能是有用的生存替代标志物。目前尚未报道nivolumab免疫治疗复发性或转移性头颈部鳞状细胞癌（R/M SCCHN）的真实世界长期结局。此外，该疗法的最佳总体缓解（BOR）的预后影响仍不清楚。我们进行了一项多机构的队列研究，研究这种疗法的长期疗效和安全性，并调查了与生存相关的预后因素。此外，我们还评估了BOR与生存率之间的关系。中位随访时间为25.9个月。中位总生存期（OS）为9.6个月，2年生存率为25.0%。中位无进展生存期（PFS）为3.7个月，2年PFS率为19.6%。BOR被评估为6%的患者完全缓解（CR），13%的患者部分缓解（PR），30%的患者疾病稳定（SD），52%的患者疾病进展（PD）。总有效率为18%，疾病控制率为48%。对于免疫相关不良事件（irAE），在29例患者中检测到38例irAE。在多变量分析中，irAE的发生与更好的OS和PFS显著相关。更好的BOR与更长的OS和PFS显著相关。这些发现证明了纳武单抗治疗R/M SCCHN在现实世界中的长期疗效和安全性。BOR的幅度和irAE的发生可能是有用的生存替代标志物。
No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy. We also evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. The development of irAEs and better BOR were significantly associated with longer survival. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival. No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy and investigated prognostic factors associated with survival. Further, we evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Median progression-free survival (PFS) was 3.7 months, and two-year PFS rate was 19.6%. BOR was assessed as complete response (CR) in 6%, partial response (PR) in 13%, stable disease (SD) in 30%, and progressive disease (PD) in 52% of the patients. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. On multivariate analysis, the development of irAEs was significantly associated with better OS and PFS. Better BOR was significantly associated with longer OS and PFS. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.
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