Predicting the treatment outcome of nivolumab in recurrent or metastatic head and neck squamous cell carcinoma: prognostic value of combined performance status and modified Glasgow prognostic score

Ueki, Yushi; Takahashi, Takeshi; Ota, Hisayuki; Shodo, Ryusuke; Yamazaki, Keisuke; Horii, Arata

doi:10.1007/s00405-020-05945-5

Cited by 17 publications

(29 citation statements)

References 16 publications

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“…The incidence of irAEs (33%) in this study was similar to those in previous reports (35.9-38.1%) [4,5]. Severe irAEs are likely to occur within 6 months after the initiation of nivolumab treatment [2]; in fact, in this study, 70% of severe irAEs (Grade 3 or more) occurred within this period.…”

Section: Discussionsupporting

confidence: 89%

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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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Section: Discussionsupporting

confidence: 89%

“…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: 98%

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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“…Of note, only 27 Japanese patients participated in this study; therefore, the effects of prior cetuximab use in Japanese patients were not investigated. Several studies have investigated the association between the outcome of nivolumab treatment and prior cetuximab use as one of the possible prognostic factors in Japanese patients with R/M HNC [6,[14][15][16]. However, the sample sizes of these studies were small.…”

Section: Introductionmentioning

confidence: 99%

“…Here, we analyzed the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab in Japanese patients with R/M HNC in a real-world clinical setting by using a larger sample size compared with previous reports [6,[14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting

et al. 2021

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Background To examine the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab, we conducted a large-scale subgroup analysis in Japanese patients with recurrent/metastatic head and neck cancer. Methods Data on the effectiveness of nivolumab were extracted from patient medical records. All patients were analyzed for effectiveness by prior cetuximab use. In the analyses for prior neck dissection, only patients with locally advanced disease were included. Results Of 256 patients analyzed, 155 had received prior cetuximab. Nineteen of 50 patients with local recurrence underwent neck dissection. The objective response rate was 14.7 vs 17.2% (p = 0.6116), median progression-free survival was 2.0 vs 3.1 months (p = 0.0261), and median overall survival was 8.4 vs 12 months (p = 0.0548) with vs without prior cetuximab use, respectively. The objective response rate was 23.1 vs 25.9% (p = 0.8455), median progression-free survival was 1.8 vs 3.0 months (p = 0.6650), and median overall survival was 9.1 vs 9.9 months (p = 0.5289) with vs without neck dissection, respectively. Conclusions These findings support the use of nivolumab for patients with recurrent/metastatic head and neck cancer regardless of prior cetuximab use or neck dissection history. Trial registration number UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436)

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“…To identify inflammation predictive biomarkers, there is accumulated literature on peripheral blood leukocytes and acute phase proteins such as elevated neutrophils, monocytes, platelets, and C-reactive proteins have been closely associated with reducing survival rates in different tumor models including OSCC (de Ruiter et al, 2017;Wojtukiewicz et al, 2017;Zhang et al, 2012).Conversely, higher lymphocyte infiltration indicates a better prognosis (de Ruiter et al, 2017). In addition, the parameters of inflammation status and immune response failure have been combined as new prognostic indicators such as lymphocyte-to-monocyte ratio (LMR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) or Glasgow Prognostic Score (GPS) (assessed by the Creactive protein and albumin levels) (Nakashima et al, 2016;Ong et al, 2017;Ueki et al, 2020).…”

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confidence: 99%

The systemic inflammation response index predicts the survival of patients with clinical T1‐2N0 oral squamous cell carcinoma

et al. 2021

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Statistical analysis has shown that the new cases and deaths worldwide for oral cancer ranked 18th and 15th among all malignant tumors in 2018 (Bray et al., 2018). As one of the most common and representative types of oral cancer, oral squamous cell carcinoma (OSCC) has become a growing health concern. The survival outcome of OSCC is remaining poor, and existing reports show that its 5-year survival is about 50% (Zhang et al., 2015). Even in the early stage (cT1-2N0), OSCC patients are prone to occur local-regional recurrence and distant metastasis, which may lead to poor prognosis (Zhan et al., 2018). It has been reported that the 5-year survival rate for early-stage OSCC after surgery is approximately 70% (Ellis et al., 2017;Sowder et al., 2017). To improve patient survival, it is necessary to investigate new noninvasive and easily accessible biomarkers for predicting the prognosis of cT1-2N0 OSCC and guiding their treatment.In 1863, Rudolf Virchow firstly explained the relationship between inflammation and cancer. Over the past few decades, we had an understanding of the inflammatory microenvironment of malignant tissues and utilized the link between cancer and inflammation for tumor prevention and treatment (Balkwill & Mantovani, 2001).

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Predicting the treatment outcome of nivolumab in recurrent or metastatic head and neck squamous cell carcinoma: prognostic value of combined performance status and modified Glasgow prognostic score

Cited by 17 publications

References 16 publications

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

Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting

The systemic inflammation response index predicts the survival of patients with clinical T1‐2N0 oral squamous cell carcinoma

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