Irshad Razia, Haider Ghulam, Hashmi Madiha, Hassan Anusha
Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, PAK.
Cureus. 2021 Jun 4;13(6):e15451. doi: 10.7759/cureus.15451. eCollection 2021 Jun.
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.
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.
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).
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.
吉非替尼是一种酪氨酸激酶抑制剂（TKI），是一种表皮生长因子受体（EGFR）阻断药物，对治疗具有EGFR突变的肺癌有效；然而，其对头颈部癌的益处尚不确定。因此，本研究旨在确定吉非替尼和甲氨蝶呤对晚期或复发性头颈部癌患者的疗效。
本研究纳入了200例年龄大于18岁、临床分期为IVA期或IVB期的晚期患者以及复发病例。患者被随机分配到吉非替尼组（n = 100）或甲氨蝶呤组（n = 100）。对每位患者进行人口统计学变量、成瘾情况、合并症和癌症病史评估，随后进行临床和影像学评估。采用实体瘤疗效评价标准（RECIST）评估治疗反应。本研究的主要终点是总缓解率（ORR）。使用SPSS 25版（美国纽约州阿蒙克市IBM公司）分析数据。
吉非替尼组和甲氨蝶呤组治疗的总体反应分别为部分缓解11%对8%、疾病稳定52%对40%、疾病进展33%对40%。吉非替尼组有3例患者失访，甲氨蝶呤组有1例患者失访。吉非替尼组仅报告1例死亡，甲氨蝶呤组报告4例死亡。在复发病例中，6例接受吉非替尼治疗的患者出现部分缓解，而甲氨蝶呤组未报告部分缓解病例（27.3%对0%）。同样，对于复发病例，甲氨蝶呤组报告的疾病进展和稳定病例数明显高于吉非替尼组（p = 0.045）。
与甲氨蝶呤相比，吉非替尼在总体反应和安全性方面略胜一筹，特别是在头颈部癌的复发病例中。在2019冠状病毒病（COVID - 19）时代，这种对复发病例的益处以及给药方便，导致就诊次数减少，使得吉非替尼优于甲氨蝶呤。
