Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

Abstract

Background We have previously reported the effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) in real-world clinical practice in Japan. Here, we report long-term outcomes from this study in the overall population and subgroups stratified by subsequent chemotherapy. Methods In this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R/M) HNC receiving nivolumab were followed up for 2 years. Effectiveness endpoints included overall survival (OS), OS rate, progression-free survival (PFS), and PFS rate. Safety endpoints included the incidence of immune-related adverse events (irAEs). Results Overall, 256 patients received a median of 6.0 doses (range: 1–52) of nivolumab over a median duration of 72.5 days (range: 1–736). Median OS was 9.5 months [95% confidence interval (CI) 8.2–12.0] and median PFS was 2.1 months (95% CI 1.8–2.7). A significant difference between 2-year survivors (n = 62) and non-2-year survivors was observed by median age (P = 0.0227) and ECOG PS (P = 0.0001). Of 95 patients who received subsequent chemotherapy, 54.7% received paclitaxel ± cetuximab. The median OS and PFS from the start of paclitaxel ± cetuximab were 6.9 months (95% CI 5.9–11.9) and 3.5 months (95% CI 2.3–5.5), respectively. IrAEs were reported in 17.2% of patients. Endocrine (7.0%) and lung (4.3%) disorders were the most common irAEs; kidney disorder (n = 1) was newly identified in this follow-up analysis. Conclusions Results demonstrated the long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up.

Chemotherapy following immune checkpoint inhibitors in recurrent or metastatic head and neck squamous cell carcinoma: clinical effectiveness and influence of inflammatory and nutritional factors

“…Compared to reports of patients receiving PTX + Cmab [ 14 ], we found no significant difference in OS, although PFS was slightly lower. In addition, there were no significant differences among the three groups by regimen, similar to the results reported by Yasumatsu et al [ 15 ]. Although the effects between regimens vary from report to report [ 12 – 15 , 40 – 43 ], all reports indicate that chemotherapy after ICI is effective.…”

“…In addition, there were no significant differences among the three groups by regimen, similar to the results reported by Yasumatsu et al [ 15 ]. Although the effects between regimens vary from report to report [ 12 – 15 , 40 – 43 ], all reports indicate that chemotherapy after ICI is effective. Our results also showed that chemotherapy was effective regardless of regimen, and the results were comparable to previous reports [ 14 , 15 , 41 ].…”

“…Immunotherapy, a breakthrough treatment for head and neck cancer, has become more widely used, and treatment outcomes and prognoses are gradually becoming clearer [ 10 , 15 , 38 ]. In addition, many studies have reported relatively better results with chemotherapy after ICI compared to conventional chemotherapy for RMHNSCC [ 12 , 13 , 15 , 39 ] Our department employs three regimens: PTX, PTX + Cmab, and S1, but the single agent, PTX regimen, is primarily used. However, this was because many patients had a history of cetuximab when nivolumab was started in our department, and we wanted to avoid duplication of cetuximab.…”

Pre-treatment Tumor Size and Tumor Growth Rate as Prognostic Predictors for Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Treated With Nivolumab

“…Patients with a low response rate to ICIs could benefit from prolonged survival with subsequent chemotherapy. However, patients with poor PS are generally not candidates for cytotoxic chemotherapy as salvage chemotherapy, resulting in no benefit from subsequent chemotherapy after ICI administration (23). This study also showed that R/M SCCHN patients with PD as a BOR had poorer survival, consistent with the results of previous studies demonstrating that a higher BOR was associated with improved survival in patients with R/M SCCHN or other malignancies (21,(24)(25)(26).…”

Prognostic Value of Inflammatory and Nutritional Biomarkers of Immune Checkpoint Inhibitor Treatment for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

“…With the widespread use of immunotherapy in the management of head and neck cancer, treatment outcomes and prognosis are being elucidated [ 5 , 33 , 34 , 35 , 36 , 37 , 38 ]. According to the results of this study, the ORR and DCR were 52.9% and 74.5%, respectively.…”