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
by
, , ,
Takashi Matsuki
1
,
Isaku Okamoto
2,
Chihiro Fushimi
3,
Hideaki Takahashi
4,
Takuro Okada
2,
Takahito Kondo
5,
Hiroki Sato
2,
Tatsuya Ito
2,
Kunihiko Tokashiki
2,
Kiyoaki Tsukahara
2,
Kenji Hanyu
3,
Tatsuo Masubuchi
3,
Yuichiro Tada
3,
Kouki Miura
3,
Go Omura
6,
Michi Sawabe
7,
Daisuke Kawakita
7 and
Taku Yamashita
1,* 1
Department of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan
2
Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University School of Medicine, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan
3
Department of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, 1-4-3 Mita, Minato-ku, Tokyo 108-8329, Japan
4
Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
5
Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, 1163 Tatemachi, Hachioji, Tokyo 193-0998, Japan
6
Department of Head and Neck Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
7
Department of Otorhinolaryngology, Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
*
Author to whom correspondence should be addressed.
Cancers 2020, 12(11), 3427; https://doi.org/10.3390/cancers12113427
Submission received: 20 October 2020
/
Revised: 8 November 2020
/
Accepted: 17 November 2020
/
Published: 18 November 2020
(This article belongs to the Section Cancer Therapy)
Simple Summary
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.
Abstract
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.
