吉非替尼、甲氨蝶呤以及甲氨蝶呤联合5-氟尿嘧啶用于复发性头颈部鳞状细胞癌的姑息治疗
Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma.
作者信息
Kushwaha Vandana Singh, Gupta Seema, Husain Nuzhat, Khan Huma, Negi M P S, Jamal Naseem, Ghatak Ashim
机构信息
a Department of Radiotherapy ; King George's Medical University ; Lucknow , India.
出版信息
Cancer Biol Ther. 2015;16(2):346-51. doi: 10.4161/15384047.2014.961881.
Abstract
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.
摘要
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。
相似文献
1
Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma.吉非替尼、甲氨蝶呤以及甲氨蝶呤联合5-氟尿嘧啶用于复发性头颈部鳞状细胞癌的姑息治疗
Cancer Biol Ther. 2015;16(2):346-51. doi: 10.4161/15384047.2014.961881.
2
Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected].吉非替尼与静脉注射甲氨蝶呤治疗复发性头颈部鳞状细胞癌的III期研究[校正后]
J Clin Oncol. 2009 Apr 10;27(11):1864-71. doi: 10.1200/JCO.2008.17.0530. Epub 2009 Mar 16.
3
Phase III randomized, placebo-controlled trial of docetaxel with or without gefitinib in recurrent or metastatic head and neck cancer: an eastern cooperative oncology group trial.多西他赛联合或不联合吉非替尼治疗复发性或转移性头颈部癌的 III 期随机、安慰剂对照试验：东部肿瘤协作组试验。
J Clin Oncol. 2013 Apr 10;31(11):1405-14. doi: 10.1200/JCO.2012.45.4272. Epub 2013 Mar 4.
4
Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial.阿法替尼对比甲氨蝶呤用于铂类治疗后进展的复发性或转移性头颈部鳞状细胞癌患者的二线治疗（LUX-Head & Neck 1）：一项开放标签、随机、III 期研究。
Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.
5
Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: a Southwest Oncology Group study.顺铂加氟尿嘧啶与卡铂加氟尿嘧啶对比甲氨蝶呤治疗晚期头颈部鳞状细胞癌的随机对照研究：西南肿瘤协作组研究
J Clin Oncol. 1992 Aug;10(8):1245-51. doi: 10.1200/JCO.1992.10.8.1245.
6
Capecitabine and lapatinib for the first-line treatment of metastatic/recurrent head and neck squamous cell carcinoma.卡培他滨和拉帕替尼用于转移性/复发性头颈部鳞状细胞癌的一线治疗。
Cancer. 2016 Aug 1;122(15):2350-5. doi: 10.1002/cncr.30067. Epub 2016 May 19.
7
Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial.阿法替尼与甲氨蝶呤用于老年二线复发和/或转移性头颈部鳞状细胞癌患者的疗效比较：LUX-Head & Neck 1试验的亚组分析
Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.
8
Systemic chemotherapy with cisplatin plus 5-FU (PF) for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): efficacy and safety of a lower dose of PF (80/800) at a single institution in Japan.顺铂联合5-氟尿嘧啶（PF）用于复发性或转移性头颈部鳞状细胞癌（R/M SCCHN）的全身化疗：日本一家机构采用较低剂量PF（80/800）的疗效和安全性
Jpn J Clin Oncol. 2009 Apr;39(4):225-30. doi: 10.1093/jjco/hyp002. Epub 2009 Feb 10.
9
Carboplatin/5-fluorouracil as an alternative to cisplatin/5- fluorouracil for metastatic and recurrent head and neck squamous cell carcinoma and nasopharyngeal carcinoma.卡铂/5-氟尿嘧啶作为顺铂/5-氟尿嘧啶的替代方案用于转移性和复发性头颈部鳞状细胞癌及鼻咽癌。
Asian Pac J Cancer Prev. 2013;14(2):1121-6. doi: 10.7314/apjcp.2013.14.2.1121.
10
Rationale and design of LUX-Head & Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who progressed after platinum-based therapy.LUX-头颈1研究的原理与设计：一项针对铂类治疗后进展的复发和/或转移性头颈部鳞状细胞癌患者，比较阿法替尼与甲氨蝶呤的随机III期试验。
BMC Cancer. 2014 Jun 28;14:473. doi: 10.1186/1471-2407-14-473.
引用本文的文献
1
Exploring the Therapeutic Implications of Co-Targeting the EGFR and Spindle Assembly Checkpoint Pathways in Oral Cancer.探索联合靶向表皮生长因子受体（EGFR）和纺锤体组装检查点通路在口腔癌中的治疗意义
Pharmaceutics. 2024 Sep 11;16(9):1196. doi: 10.3390/pharmaceutics16091196.
2
Enduring Efficacy and Clinical Outcomes of Combined Palliative Chemotherapy With Gefitinib, Methotrexate, and Cyclophosphamide in Advanced Oral Cancer: A 3.5-Year Case Study of Carcinoma in the Buccal Mucosa and Hard Palate.吉非替尼、甲氨蝶呤和环磷酰胺联合姑息化疗在晚期口腔癌中的持久疗效和临床结果：一项关于颊黏膜和硬腭癌的3.5年病例研究
Cureus. 2023 Oct 7;15(10):e46661. doi: 10.7759/cureus.46661. eCollection 2023 Oct.
3
Comparison of Second-Line Treatments for Patients with Platinum-Resistant Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Systematic Review and Bayesian Network Meta-Analysis.铂耐药复发或转移性头颈部鳞状细胞癌患者二线治疗的比较：一项系统评价和贝叶斯网络荟萃分析
Cancers (Basel). 2022 Sep 15;14(18):4472. doi: 10.3390/cancers14184472.
4
Efficacy of Gefitinib and Methorexate in Patients With Advanced Stage and Recurrent Head and Neck Cancer.吉非替尼与甲氨蝶呤治疗晚期及复发性头颈癌患者的疗效
Cureus. 2021 Jun 4;13(6):e15451. doi: 10.7759/cureus.15451. eCollection 2021 Jun.
5
Overview of Evidence-Based Chemotherapy for Oral Cancer: Focus on Drug Resistance Related to the Epithelial-Mesenchymal Transition.口腔癌循证化疗概述：重点关注上皮-间质转化相关的耐药性。
Biomolecules. 2021 Jun 16;11(6):893. doi: 10.3390/biom11060893.
6
Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort.双功能融合蛋白靶向 TGF-β和 PD-L1 的 Bintrafusp alfa 治疗头颈部鳞状细胞癌的 I 期队列研究结果。
J Immunother Cancer. 2020 Jul;8(2). doi: 10.1136/jitc-2020-000664.
7
Overview of Dual-Acting Drug Methotrexate in Different Neurological Diseases, Autoimmune Pathologies and Cancers.双作用药物甲氨蝶呤在不同神经疾病、自身免疫性疾病和癌症中的概述。
Int J Mol Sci. 2020 May 14;21(10):3483. doi: 10.3390/ijms21103483.
8
Methotrexate plus or minus cetuximab as first-line treatment in a recurrent or metastatic (R/M) squamous cell carcinoma population of the head and neck (SCCHN), unfit for cisplatin combination treatment, a phase Ib-randomized phase II study Commence.在不适合顺铂联合治疗的复发或转移性（R/M）头颈部鳞状细胞癌（SCCHN）人群中，作为一线治疗，甲氨蝶呤联合或不联合西妥昔单抗，一项 Ib 期随机 II 期研究开始。
Head Neck. 2020 May;42(5):828-838. doi: 10.1002/hed.26053. Epub 2020 Jan 6.
9
Approach to the Patient with Recurrent/Metastatic Disease.复发性/转移性疾病患者的处理方法。
Curr Treat Options Oncol. 2019 Jun 25;20(8):65. doi: 10.1007/s11864-019-0664-z.
10
Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials.吉非替尼治疗晚期头颈部鳞状细胞癌患者的疗效与安全性：一项随机对照试验的荟萃分析
J Oncol. 2019 May 23;2019:6273438. doi: 10.1155/2019/6273438. eCollection 2019.
本文引用的文献
1
Current treatment options for metastatic head and neck cancer.转移性头颈部癌的当前治疗选择。
Curr Treat Options Oncol. 2012 Mar;13(1):35-46. doi: 10.1007/s11864-011-0176-y.
2
Management of recurrent head and neck cancer: recent progress and future directions.复发性头颈部癌症的管理：最新进展与未来方向。
Drugs. 2011 Aug 20;71(12):1551-9. doi: 10.2165/11592540-000000000-00000.
3
Randomized phase III trial (GORTEC 98-03) comparing re-irradiation plus chemotherapy versus methotrexate in patients with recurrent or a second primary head and neck squamous cell carcinoma, treated with a palliative intent.随机 III 期试验（GORTEC 98-03）比较了再放疗加化疗与甲氨蝶呤在姑息性治疗的复发性或第二原发头颈部鳞状细胞癌患者中的疗效。
Radiother Oncol. 2011 Jul;100(1):70-5. doi: 10.1016/j.radonc.2011.06.025. Epub 2011 Jul 7.
4
Optimal treatment for recurrent/metastatic head and neck cancer.复发性/转移性头颈部癌的最佳治疗方法。
Ann Oncol. 2010 Oct;21 Suppl 7:vii252-61. doi: 10.1093/annonc/mdq453.
5
Cetuximab in metastatic or recurrent head and neck cancer: the EXTREME trial.西妥昔单抗治疗转移性或复发性头颈癌：EXTREME试验
Expert Rev Anticancer Ther. 2009 Oct;9(10):1421-8. doi: 10.1586/era.09.113.
6
Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected].吉非替尼与静脉注射甲氨蝶呤治疗复发性头颈部鳞状细胞癌的III期研究[校正后]
J Clin Oncol. 2009 Apr 10;27(11):1864-71. doi: 10.1200/JCO.2008.17.0530. Epub 2009 Mar 16.
7
Increased epidermal growth factor receptor gene copy number is associated with poor prognosis in head and neck squamous cell carcinomas.表皮生长因子受体基因拷贝数增加与头颈部鳞状细胞癌的不良预后相关。
J Clin Oncol. 2006 Sep 1;24(25):4170-6. doi: 10.1200/JCO.2006.07.2587.
8
Epidermal growth factor receptor biology in head and neck cancer.头颈部癌中的表皮生长因子受体生物学
J Clin Oncol. 2006 Jun 10;24(17):2666-72. doi: 10.1200/JCO.2005.04.8306.
9
Chemotherapy options for patients with metastatic or recurrent squamous cell carcinoma of the head and neck.转移性或复发性头颈部鳞状细胞癌患者的化疗选择。
J Clin Oncol. 2006 Jun 10;24(17):2644-52. doi: 10.1200/JCO.2005.05.3348.
10
Gefitinib (ZD1839, Iressa) as palliative treatment in recurrent or metastatic head and neck cancer.吉非替尼（ZD1839，易瑞沙）用于复发性或转移性头颈癌的姑息治疗。
Br J Cancer. 2006 Mar 13;94(5):631-6. doi: 10.1038/sj.bjc.6602999.
Zotero 插件