Kushwaha Vandana Singh, Gupta Seema, Husain Nuzhat, Khan Huma, Negi M P S, Jamal Naseem, Ghatak Ashim
a Department of Radiotherapy ; King George's Medical University ; Lucknow , India.
Cancer Biol Ther. 2015;16(2):346-51. doi: 10.4161/15384047.2014.961881.
This study compared the efficacy and toxicity of Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil (5-FU) in patients of recurrent squamous cell carcinoma of head and neck (SCCHN) treated with palliative intent. Patients with recurrent SCCHN not amenable to curative treatment were randomly assigned to Gefitinib, Methotrexate or Methotrexate plus 5-FU arm. The primary end point was overall survival. Secondary end points of interest were objective response rate, toxicity and quality of life. Total 117 patients were analyzed. Median overall survival and objective response rates were 8.8 months, 7.8 months and 8.1 months and 7.7%, 5.0% and 7.9% in Gefitinib, Methotrexate and Methotrexate plus 5-FU arms respectively with no statistically significant difference between 3 arms. Gefitinib had different toxicity profile compared with other arms. Majority of toxicities were Grade 1 or Grade 2. Gefitinib had significant improvement in quality of life during initial months over Methotrexate. There was no suggestion that Gefitinib significantly prolonged overall survival compared with Methotrexate and Methotrexate plus 5-FU. However, improved Quality of Life with manageable toxicities was observed.
本研究比较了吉非替尼、甲氨蝶呤以及甲氨蝶呤联合5-氟尿嘧啶（5-FU）对复发性头颈部鳞状细胞癌（SCCHN）患者进行姑息治疗的疗效和毒性。将不适于根治性治疗的复发性SCCHN患者随机分配至吉非替尼组、甲氨蝶呤组或甲氨蝶呤联合5-FU组。主要终点为总生存期。感兴趣的次要终点为客观缓解率、毒性和生活质量。共分析了117例患者。吉非替尼组、甲氨蝶呤组和甲氨蝶呤联合5-FU组的中位总生存期分别为8.8个月、7.8个月和8.1个月，客观缓解率分别为7.7%、5.0%和7.9%，三组之间无统计学显著差异。与其他组相比，吉非替尼具有不同的毒性特征。大多数毒性为1级或2级。在最初几个月中，吉非替尼组的生活质量较甲氨蝶呤组有显著改善。没有迹象表明吉非替尼与甲氨蝶呤及甲氨蝶呤联合5-FU相比能显著延长总生存期。然而，观察到生活质量有所改善且毒性可控。
