Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study

Abstract

Background This study aimed to analyze the clinical outcomes associated with patients with recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) who received cetuximab-based chemotherapy in a real-world clinical setting. Methods Clinical data were extracted from RM HNSCC patients diagnosed between 2016 and 2019. Kaplan–Meier survival estimates and Cox proportional hazards model were used for survival analyses. Results Of 106 RM HNSCC patients (mean age = 55.1 years), 38.7% exhibited recurrent disease and 61.3% had metastatic disease. The majority of patients showed a habit of addictive substance use, including alcohol (67.0%), betel nuts (71.7%), or tobacco (74.5%). The primary tumor sites included the oral cavity (64.1%), hypopharynx (19.8%), and oropharynx (16.0%). The median number of cetuximab cycles for the 106 patients was 11 (2–24). The disease control rate (DCR) was 48.1%, and the overall response rate (ORR) was 28.3%. The median progression-free survival (PFS) and overall survival (OS) were 5.0 and 9.23 months, respectively. Patients treated with more than 11 cycles of cetuximab exhibited a longer median PFS and median OS than did patients treated with less than 11 cycles (median PFS: 7.0 vs. 3.0 months, p < 0.001; OS: 12.43 vs. 4.46 months, p = 0.001). Patients without previous concurrent chemoradiotherapy (CRT) had a better median PFS than did those with previous CRT (6.0 vs. 4.0 months, p = 0.046). Multivariable analysis revealed that perineural invasion and fewer cycles of cetuximab (<11 cycles) were independent risk factors associated with disease progression. In addition, the reduction in treatment cycles of cetuximab and advanced lymph node metastasis were independent prognostic factors predicting poorer overall survival. Conclusion Our study provides important real-world data regarding cetuximab-containing treatment in RM HNSCC. Consistent administration of cetuximab could be associated with more favorable outcomes in RM HNSCC in endemic carcinogen exposure areas.

Monoclonal antibodies for the treatment of squamous cell carcinoma: A literature review

“… 43 , 44 Among Anti‐EGFR Mabs, cetuximab (a highly studied Mab in SCC treatment) such as zalutumumab and panitumumab has shown favorable outcomes in locoregionally advanced, recurrent, or metastatic HNSCC, specifically HPV‐negative SCCs. 49 , 50 , 53 , 55 , 56 , 57 , 58 , 60 , 171 , 172 , 173 Cetuximab is also helpful in sensitizing the tumor to radiotherapy. 45 , 46 , 47 Cetuximab showed some grade 3 and 4 adverse effects such as folliculitis, anemia, trichomegaly, 48 acneiform rash and infusion, 45 neutropenia, 50 and hyper transaminasemia 174 with different doses of chemo‐ and radiotherapy.…”

“…The most potent Mabs in HNSCC are EGFR antagonists and checkpoint inhibitors, especially PD‐L1 antagonists. 49 , 50 , 53 , 55 , 56 , 57 , 58 , 60 , 116 , 117 , 128 , 130 , 131 , 142 , 143 , 148 , 165 , 171 , 172 , 173 Mabs have also been approved by FDA for treating HNSCC, including cetuximab and pembrolizumab. Cetuximab was approved as monotherapy or in combination with chemotherapy in locally or regionally advanced and recurrent or metastatic HNSCC after treatment with platinum‐based therapy.…”

“…Most HNSCCs express high levels of EGFR 43,44 . Among Anti‐EGFR Mabs, cetuximab (a highly studied Mab in SCC treatment) such as zalutumumab and panitumumab has shown favorable outcomes in locoregionally advanced, recurrent, or metastatic HNSCC, specifically HPV‐negative SCCs 49,50,53,55–58,60,171–173 . Cetuximab is also helpful in sensitizing the tumor to radiotherapy 45–47 .…”

“…Mabs are considered excellent options in locally advanced, recurrent, and metastatic HNSCCs. The most potent Mabs in HNSCC are EGFR antagonists and checkpoint inhibitors, especially PD‐L1 antagonists 49,50,53,55–58,60,116,117,128,130,131,142,143,148,165,171–173 . Mabs have also been approved by FDA for treating HNSCC, including cetuximab and pembrolizumab.…”

The role of the genomic mutation signature and tumor mutation burden on relapse risk prediction in head and neck squamous cell carcinoma after concurrent chemoradiotherapy

“…The treatment response of patients was evaluated using RECIST 1.1-measurable lesions and classified into four categories: complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD), as reported in a previous study 19 . After disease progression, further treatments and survival status were documented every 3 months.…”