Abstract
Introduction: Gefitinib, a tyrosine kinase inhibitor (TKI), is an epidermal growth factor receptor (EGFR)-blocking drug that is effective in the treatment of lung cancer with EGFR mutations; however, its benefits for head and neck cancers are uncertain. Therefore, this study aims to determine the efficacy of gefitinib and methotrexate in patients with advanced-stage or recurrent head and neck cancer.Methodology: Two hundred patients of age >18 years with advanced clinical stage either IVA or IVB and recurrent cases were included in this study. Patients were randomly allocated to the gefitinib (n=100) or methotrexate (n=100) group. Each patient was evaluated for demographic variables, addictions, comorbidities and history of cancer followed by clinical and radiological evaluation. Treatment response was evaluated with standard Response Evaluation Criteria in Solid Tumors (RECIST). The primary end point of the study was overall response rate (ORR). SPSS version 25 (IBM Corp., Armonk, NY, USA) was used to analyze data.Results: Overall response of therapy was partial 11% vs 8%, stable disease 52% vs 40%, and progressive disease 33% vs 40% in gefitinib and methotrexate groups respectively. Three patients were lost to follow up in the gefitinib group and one patient in the methotrexate group. Only one death was reported in the gefitinib group and four in the methotrexate group. In recurrent cases, six patients treated with gefitinib showed partial response whereas no case of partial response was reported in the methotrexate group (27.3% vs 0%). Similarly, in the methotrexate group significantly higher numbers of progressive and stable diseases were reported for recurrent cases than in the gefitinib group (p=0.045).Discussion: Gefitinib had marginally better results in terms of overall response and safety as compared to methotrexate, specifically in recurrent cases of head and neck cancer. This benefit for recurrent cases and ease of administration, leading to fewer hospital visits in the coronavirus disease 2019 (COVID-19) era, makes gefitinib superior to methotrexate.
Highlights
Gefitinib, a tyrosine kinase inhibitor (TKI), is an epidermal growth factor receptor (EGFR)blocking drug that is effective in the treatment of lung cancer with EGFR mutations; its benefits for head and neck cancers are uncertain
Six patients treated with gefitinib showed partial response whereas no case of partial response was reported in the methotrexate group (27.3% vs 0%)
In the methotrexate group significantly higher numbers of progressive and stable diseases were reported for recurrent cases than in the gefitinib group (p=0.045)
Summary
A tyrosine kinase inhibitor (TKI), is an epidermal growth factor receptor (EGFR)blocking drug that is effective in the treatment of lung cancer with EGFR mutations; its benefits for head and neck cancers are uncertain. Global cancer statistics show a rate of 48.4% incidence and 57.3% mortality from cancer in Asian countries, with 354,864 (2.0%) new cases and 177,384 (1.9%) deaths from carcinoma of the lip and oral cavity, 177,422 (1.0%) new cases and 94,771 (1.0%) deaths from carcinoma of the larynx, 129,079 (0.7%) new cases and 72,987 (0.8%) deaths from carcinoma of the nasopharynx, 92,887 (0.5%) new cases and 51,005 (0.5%) deaths from carcinoma of the oropharynx, and 80,608 (0.4%) new cases and 34,984 (0.4%) deaths from carcinoma of the hypopharynx [3]. A recent study from 2020 of head and neck cancer epidemiology reported an increasing incidence of oropharyngeal, hypopharyngeal, lip, and oral cavity carcinomas and a decreasing incidence of larynx and nasopharyngeal carcinomas throughout the world [4]. The majority of head and neck carcinomas (∼60.0%) are reported in an advanced stage of III or IV, whereas ∼40.0% are in stage I or II. Recommendations for stage I or II management include radiotherapy or surgery, whereas stages III and IV are managed with combined modality therapy [5]
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