Real-world 2-year long-term outcomes and prognostic factors in patients receiving nivolumab therapy for recurrent or metastatic squamous cell carcinoma of the head and neck |
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| Affiliation: | 1. Department of Otolaryngology, Tenri Hospital, Nara, Japan;2. Department of Otolaryngology - Head and Neck Surgery, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan;3. Department of Otolaryngology – Head & Neck Surgery, Kobe City Medical Center General Hospital, Hyogo, Japan;4. Department of Otolaryngology – Head & Neck Surgery, Kurashiki Central Hospital, Okayama, Japan;5. Department of Otolaryngology – Head & Neck Surgery, National Hospital Organization Kyoto Medical Center, Kyoto, Japan;6. Department of Head & Neck Surgery, Kanazawa Medical University, Ishikawa, Japan;7. Department of Otolaryngology – Head & Neck Surgery, Kokura Memorial Hospital, Fukuoka, Japan;8. Department of Otorhinolaryngology – Head & Neck surgery, Shizuoka General Hospital, Shizuoka, Japan;9. Department of Otolaryngology – Head & Neck Surgery, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan;10. Department of Otolaryngology – Head & Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan;11. Department of Otolaryngology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan;12. Department of Otolaryngology – Head & Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka, Japan;1. Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan;2. Department of Otolaryngology, Head and Neck Surgery, Kurashiki Central Hospital, Okayama, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan;1. Departments of Otorhinolaryngology, Teikyo University Chiba Medical Center, Chiba, Japan;2. Laboratory Medicine, Teikyo University Chiba Medical Center, Chiba, Japan;3. Department of Laboratory Medicine, Teikyo University School of Medicine, Tokyo, Japan;1. Department of Neurosurgery, Shanghai Jiaotong University School of Medicine, Xinhua Hospital, Shanghai, 20092, China;2. Department of Neurosurgery, Shanghai Jiaotong University School of Medicine, Xinhua Hospital Chongming Branch, Shanghai, 202150, China;1. Department of Otolaryngology-Head and Neck Surgery, Hyogo College of Medicine. 1-1 Nishinomiya, Hyogo 663-8501, Japan;2. Department of Otorhinolaryngology and Head and Neck Surgery, Nihon University School of Medicine. 30-1 Oyaguchikamicho Itabashi-ku, Tokyo 173-8610, Japan;3. Department of Otorhinolaryngology, Mie Chuo Medical Center, National Hospital Organization, 2158-5 Hisaimyojincyo, Tsu, Mie 514-1101, Japan;4. Department of Otorhinolaryngology, Kanazawa Medical University. 1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, Japan |
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| Abstract: | ObjectiveReal-world outcomes and prognostic factors in Japanese patients receiving nivolumab therapy for recurrent or metastatic head and neck carcinoma (RMHNC) with an observation period of 1 year have been previously reported. The 1-year follow-up data have been subsequently accumulated, and the long-term real-world outcomes have been analyzed. This study aimed to investigate the 2-year long-term outcomes and prognostic factors associated with the response to nivolumab.MethodsThis was a multi-institutional retrospective study. In total, 88 RMHNC Japanese patients with squamous cell carcinoma who received nivolumab between May 2017 and May 2018 were retrospectively reviewed. Overall survival (OS), progression-free survival (PFS), and best overall response (BOR) were evaluated. Univariate and multivariable analyses were performed to identify the prognostic factors.ResultsThe median follow-up periods for monitoring OS and PFS were 73.1 and 48.1 weeks, respectively. The median OS was 74.1 weeks, and the 2-year survival rate was 33.4%. The median PFS was 18.5 weeks, and the 2-year PFS rate was 22.5%. The BOR rate was 10.2%, 19.3%, 25.0%, and 44.3% in patients who achieved complete response, partial response, stable disease, and progressive disease (PD), respectively. Among the 88 patients with RMHNC, a total of 40 immune-related adverse events (irAEs) were reported in 30 patients. Four patients continued nivolumab, while 84 patients discontinued nivolumab at the data cut-off date. The most common reason for discontinuation was PD in 61 patients, irAEs in 14 patients, and patients’ wishes in 7 patients. Of the 61 patients who discontinued nivolumab because of PD, 28 patients received subsequent treatment. Statistical analyses revealed radiotherapy history, performance status, platinum-refractory carcinoma, irAEs, age, and post-nivolumab treatment as the important prognostic factors associated with OS in patients with RMHNC, and the magnitude of BOR was significantly associated with OS. Additionally, patients with subsequent treatment, including molecular targeted therapy and/or chemotherapy, had significantly prolonged OS compared to patients without subsequent treatment in cases with nivolumab discontinuation because of PD.ConclusionThese findings could be a useful guide for future treatment strategies for head and neck carcinoma. Considering the limitations of our cohort, further larger-scale studies with long-term follow-up are needed to substantiate the results of this study. |
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