Prajapati Raju, Singh Om P, Ghori Hameeduzzafar, Jatav Jagannath, Narwariya Abhinav, Yogi Vineeta, Elbadawy Ismail Essam, Shaikh Mohammad Habeebur Raheman, Moosa Shajiya Sarwar, Begum Yousuf
Department of Radiation Oncology, Shyam Shah Medical College and Sanjay Gandhi Memorial Hospital, Rewa, IND.
Department of Radiation Oncology, Mahaveer Institute of Medical Sciences and Research, Bhopal, IND.
Cureus. 2022 Dec 14;14(12):e32532. doi: 10.7759/cureus.32532. eCollection 2022 Dec.
The treatment of locally advanced head and neck carcinoma has been a combination of chemotherapy and radiation. The higher incidences of recurrence and metastasis warrant the search for an alternative therapy for better patient outcomes. This study was designed to evaluate the effect of gefitinib in conjunction with concurrent chemoradiation in locally advanced stages III and IV head and neck cancer.
The patients were equally divided into two groups: Group I received cisplatin 100 mg/m2 on the first, 22nd, and 43rd days together with the radiation, whereas Group II was given the same treatment as Group I together with oral doses of gefitinib 250 mg on a daily basis, starting two weeks prior to radiotherapy and continuing until the completion of it. The dose of radiotherapy was 2 Gray (Gy) per fraction given over a period of five days per week to a maximum of 70 Gy in locally higher grades of head and neck neoplasms. The evaluation was performed in accordance with the RECIST (Response Evaluation Criteria in Solid Tumors) criteria, which include stable disease (SD), progressing disease (PD), partial response (PR), and complete response (CR). Salvage chemotherapy, potential surgical intervention, or palliative care was presented to patients with remaining or recurring diseases. The grading of the patients for acute and chronic radiation morbidity was done according to the Radiation Therapy Oncology Group (RTOG) criteria for toxicity during radiation treatment and at each subsequent follow-up. Parameters such as site, nodal involvement, stage, tumor status, and Eastern Cooperative Oncology Group (ECOG) were recorded.
On comparing the patient characteristics, no statistical significance was observed. The overall response was seen in 24 (80%) and 28 (83.33%) patients in Group I and Group II, respectively (p = 0.08). All patients in Group I and Group II reported xerostomia as an acute/chronic adverse event of chemotherapy. Similarly, mucositis, dysphagia, and diarrhea were observed in all the patients, and no statistical difference was observed. Seventeen (56.67%) patients in Group II had complaints of skin rashes, while four (13.33%) patients in Group I had similar complaints (p = 0.01).
The study concludes that encouraging results were observed in comparing overall response after the addition of oral gefitinib to the traditional treatment of locally advanced head and neck neoplasms.
局部晚期头颈癌的治疗一直是化疗与放疗相结合。复发和转移的较高发生率促使人们寻找能改善患者预后的替代疗法。本研究旨在评估吉非替尼联合同步放化疗在局部晚期III期和IV期头颈癌中的疗效。
患者被平均分为两组：第一组在第1、22和43天接受顺铂100mg/m²，同时进行放疗；而第二组在放疗前两周开始每天口服吉非替尼250mg，并与第一组接受相同治疗，持续至放疗结束。对于局部高级别头颈肿瘤，放疗剂量为每周5天，每次2格雷（Gy），最大剂量为70Gy。评估按照实体瘤疗效评价标准（RECIST）进行，包括疾病稳定（SD）、疾病进展（PD）、部分缓解（PR）和完全缓解（CR）。对残留或复发疾病的患者给予挽救性化疗、潜在的手术干预或姑息治疗。根据放射肿瘤学组（RTOG）的放疗毒性标准，在放疗期间及随后每次随访时对患者的急性和慢性放射损伤进行分级。记录部位、淋巴结受累情况、分期、肿瘤状态和东部肿瘤协作组（ECOG）等参数。
比较患者特征时，未观察到统计学差异。第一组和第二组分别有24例（80%）和28例（83.33%）患者出现总体缓解（p = 0.08）。第一组和第二组的所有患者均报告口干是化疗的急性/慢性不良事件。同样，所有患者均出现黏膜炎、吞咽困难和腹泻，未观察到统计学差异。第二组有17例（56.67%）患者主诉皮疹，而第一组有4例（13.33%）患者有类似主诉（p = 0.01）。
该研究得出结论，在局部晚期头颈肿瘤的传统治疗中添加口服吉非替尼后，比较总体缓解情况时观察到了令人鼓舞的结果。
