Efficacy and Safety of Pembrolizumab Monotherapy for Recurrent/Unresectable/Metastatic Oral Squamous Cell Carcinoma: A Single-Center Study in China

Abstract

Background. Although pembrolizumab is recommended as a first-line treatment for advanced recurrent/unresectable/metastatic (R/U/M) head and neck squamous carcinoma, the differences in its efficacy among different populations need to be investigated. Methods. We reviewed 15 consecutive patients with R/U/M oral squamous cell carcinoma (OSCC) treated with pembrolizumab monotherapy at the Affiliated Hospital of Qingdao University between February 2021 and May 2022. All the 15 patients had known programmed death-ligand 1 expression and received multiple cycles of pembrolizumab monotherapy as first-line treatment. We evaluated and analyzed patients’ basic characteristics, time to first remission, the clinical efficacy of pembrolizumab monotherapy, and treatment-related adverse reactions. Results. The objective response rate of the 15 patients was 60%. Six patients (40.0%) achieved partial response, while three patients (20.0%) achieved complete response. In our study, the objective response status of the patients was observed in two to five cycles (mean, 3.6 cycles). For patients who responded well to immunotherapy, the mean Karnofsky Performance Status (KPS) score after treatment was significantly higher than that before treatment ( P < 0.001 ). The progression-free survival rates were 66.9% and 50.1% at 6 months and 1 year, respectively. Eight adverse events were observed, comprising four cases of rash and one case each of hypothyroidism, interstitial pneumonia, cheilitis, and cerebral thrombosis. Conclusion. Our study suggests that pembrolizumab is beneficial to the most responsive patients with R/U/M OSCC in our single-center study and may shed light on the management of OSCC.

Vascular events in patients with head and neck cancer: A systematic review and meta‐analysis

“…A total of 146 studies were ultimately included in our meta‐analysis 9,24–167 . A PRISMA diagram outlining our search is shown in Figure 1.…”

First‑line programmed cell death 1 inhibitor plus chemotherapy vs. standard treatment in patients with recurrent or metastatic oral squamous cell carcinoma: A retrospective cohort study

“…Available evidence suggests that the use of PD-1 inhibitors is effective for certain tumor types. In recent years, the efficacy of the PD-(L)1 inhibitors (including camrelizumab, nivolumab, pembrolizumab and durvalumab) in OSCC has been reported in several studies (10)(11)(12)(13)(14). For instance, a previous study has shown that nearly 60% of patients with recurrent/unresectable/metastatic OSCC treated with pembrolizumab achieve objective response (10).…”

“…In recent years, the efficacy of the PD-(L)1 inhibitors (including camrelizumab, nivolumab, pembrolizumab and durvalumab) in OSCC has been reported in several studies (10)(11)(12)(13)(14). For instance, a previous study has shown that nearly 60% of patients with recurrent/unresectable/metastatic OSCC treated with pembrolizumab achieve objective response (10). An additional study has revealed that the 1-year progression-free survival (PFS) rate is 25.4% in nivolumab-treated patients with R/M OSCC (11).…”

“…Another study showed that durvalumab was able to achieve numerically higher 12-, 18-and 24-month survival rates compared to standard of care in R/M head and neck squamous cell carcinoma (HNSCC) (lacking statistical significance) (13). However, certain patients do not have a durable clinical benefit and the efficacy of the PD-1 inhibitors can be improved by rational combination with other therapies, which results in overcoming potential resistance (10,11,(15)(16)(17)(18).…”

“…Another study showed that durvalumab was able to achieve numerically higher 12-, 18- and 24-month survival rates compared to standard of care in R/M head and neck squamous cell carcinoma (HNSCC) (lacking statistical significance) ( 13 ). However, certain patients do not have a durable clinical benefit and the efficacy of the PD-1 inhibitors can be improved by rational combination with other therapies, which results in overcoming potential resistance ( 10 , 11 , 15 – 18 ). To date, only one study has suggested that PD-1 inhibitor combined with concurrent chemoradiotherapy treatment is able to achieve satisfactory efficacy [median overall survival (OS), 19 months] for Chinese patients with R/M HNSCC ( 19 ).…”