Multicentre, retrospective study of the efficacy and safety of nivolumab for recurrent and metastatic salivary gland carcinoma

Niwa, Kazutomo; Kawakita, Daisuke; Nagao, Toshitaka; Takahashi, Hideaki; Saotome, Takashi; Okazaki, Masanori; Yamazaki, Keisuke; Okamoto, Isaku; Hirai, Hideaki; Saigusa, Naoto; Fushimi, Chihiro; Masubuchi, Tatsuo; Miura, Kouki; Okazaki, Satoshi; Matsui, Hiroki; Okada, Takenori; Iwaki, Sho; Matsuki, Takashi; Hanyu, Kenji; Tsukahara, Kiyoaki; Tada, Yuichiro

doi:10.1038/s41598-020-73965-6

Cited by 37 publications

(36 citation statements)

References 58 publications

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“…Regarding the primary tumor site, while we performed nivolumab therapy in patients not included in the CheckMate 141 trial, such as nasopharyngeal cancer, clinical outcomes were comparable to those included in the CheckMate 141 trial 1,7 . In patients excluded from the CheckMate 141 trial, the efficacy of nivolumab therapy has been reported with primary tumors at other sites, including the nasopharynx, while its efficacy is limited in the salivary gland cancer 5,[26][27][28] . However, there is insufficient evidence for the optimal systematic therapy for HNC other than squamous cell carcinoma (SCC).…”

Section: Discussionmentioning

confidence: 99%

Novel Prognostic Score for recurrent or metastatic head and neck cancer patients treated with Nivolumab

Minohara

Matoba

Kawakita

et al. 2021

Sci Rep

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Although several prognostic factors in nivolumab therapy have been reported in recurrent or metastatic head and neck cancer (RM-HNC) patients, these factors remain controversial. Here, we conducted a multicenter retrospective cohort study to investigate the impact of clinico-hematological factors on survival in RM-HNC patients treated with nivolumab. We reviewed 126 RM-HNC patients from seven institutes. We evaluated the prognostic effects of clinico-hematological factors on survival. The median overall survival (OS) was 12.3 months, and the 1 year-OS rate was 51.2%. Patients without immune-related adverse events, lower relative eosinophil count, worse best overall response, higher performance status, and higher modified Glasgow Prognostic Score had worse survival. The score, generated by combining these factors, was associated with survival. Patients with score of 4–5 had worse survival than those with score of 2–3 and 0–1 [adjusted HR for PFS: score of 4–5, 7.77 (3.98–15.15); score of 2–3, 3.44 (1.95–6.06), compared to score of 0–1], [adjusted HR for OS: score of 4–5, 14.66 (4.28–50.22); score of 2–3, 7.63 (2.29–25.37), compared to score of 0–1]. Our novel prognostic score utilizing clinico-hematological factors might be useful to establish an individual treatment strategy in RM-HNC patients treated with nivolumab therapy.

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Section: Discussionmentioning

confidence: 99%

Novel Prognostic Score for recurrent or metastatic head and neck cancer patients treated with Nivolumab

Minohara

Matoba

Kawakita

et al. 2021

Sci Rep

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“…Nivolumab was approved for recurrent or metastatic head and neck cancer (R/M HNC) after platinum drug administration in Japan in March 2017. Further evidence of efficacy has since been obtained [ 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

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

Matsuki

Okamoto

Fushimi

et al. 2020

Cancers

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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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“…Recent studies showed that pembrolizumab demonstrated promising antitumor activity and a manageable safety profile in patients with advanced, PD-L1positive SGC [ 50 , 51 ]. Other recent studies showed the effectiveness and safety of nivolumab for the treatment of SGC [ 26 , 52 ]. All of these findings suggest that immune checkpoint inhibitors have clinical efficacy in patients with SGC.…”

Section: Discussionmentioning

confidence: 99%

Prognostic role of PD-L1 expression in patients with salivary gland carcinoma: A systematic review and meta-analysis

Jiang

Zhu

et al. 2022

PLoS ONE

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Background Although programmed cell death-ligand 1 (PD-L1) has been recognized as a potential marker in several cancers, the relationship between PD-L1 expression and survival in patients with salivary gland carcinoma (SGC) has remained unclear. We aimed to evaluate the association of PD-L1 expression with clinicopathological features and prognosis in SGC patients. Methods The databases Ovid Medline, PubMed, Scopus, and EMBASE were searched for relevant studies that detected PD-L1 expression in SGC. The meta-analysis was performed according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA), and the reporting recommendations for tumor marker prognostic studies (REMARK) was used to assess the quality of research eligible for this meta-analysis. Included studies were assessed using the Quality in Prognosis Studies (QUIPS) tool. Odds ratios (ORs) with 95% confidence interval (CI) were calculated to estimate the correlation between PD-L1 expression and clinicopathological features. Hazard ratios (HRs) with 95% CI were applied to assess the association between PD-L1 expression and survival outcomes of patients. Results A total of ten studies (including 952 patients with SGC) were evaluated. The meta-analysis showed that positive PD-L1 expression in SGC was significantly associated with male patients, older age, Tumor stage, lymph node metastasis, high pathological grade, and non-adenoid cystic carcinoma subtype. The pooled data demonstrated that high PD-L1 expression was associated with poor overall survival and disease-free survival. There was no significant correlation between PD-L1 expression and progression-free survival or disease-specific survival of SGC patients. Conclusion According to the meta-analysis, positive PD-L1 expression may play an important role as an effective marker of poor prognosis in patients with SGC. However, large-scale, prospective investigations are still needed to confirm the findings. The assessment of PD-L1 expression may aid in the personalized management of SGC.

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Multicentre, retrospective study of the efficacy and safety of nivolumab for recurrent and metastatic salivary gland carcinoma

Cited by 37 publications

References 58 publications

Novel Prognostic Score for recurrent or metastatic head and neck cancer patients treated with Nivolumab

Novel Prognostic Score for recurrent or metastatic head and neck cancer patients treated with Nivolumab

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

Prognostic role of PD-L1 expression in patients with salivary gland carcinoma: A systematic review and meta-analysis

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