山东大学耳鼻喉眼学报 ›› 2016, Vol. 30 ›› Issue (3): 10-14.doi: 10.6040/j.issn.1673-3770.0.2016.222

• 下咽肿瘤 • 上一篇    下一篇

新辅助化疗方案尼妥珠单抗联合奈达铂和5-氟尿嘧啶治疗下咽鳞癌初步临床分析

董频1,英信江1,陈歆维1,邓志宏2,张少强3,於子卫1,金斌1,孙臻峰1,谢晋1,祝江才1   

  1. 1.上海交通大学附属第一人民医院耳鼻咽喉头颈外科, 上海 200080;
    2.第四军医大学第一附属医院西京医院耳鼻咽喉头颈外科, 陕西 西安 710032;
    3.西安交通大学第一附属医院耳鼻咽喉头颈外科, 陕西 西安 710061
  • 收稿日期:2016-05-22 出版日期:2016-06-16 发布日期:2016-06-16
  • 作者简介:董频. E-mail:dongpin64@aliyun.com

Preliminary clinical analysis of neo-adjuvant chemotherapy with nimotuzumab plus nedaplatin and fluorouracil in hypopharyngeal squamous cell carcinoma.

DONG Pin1, YING Xinjiang1, CHEN Xinwei1, DENG Zhihong2, ZHANG Shaoqiang3, YU Ziwei1, JIN Bin1, SUN Zhenfeng1, XIE Jin1, ZHU Jiangcai   

  1. Department of Otolaryngology &Head and Neck Surgery, 1.Shanghai General Hospital of Shanghai Jiaotong University, Shanghai 200080, China;2.Xijing Hospital of Affiliated to The Forth Military Medical University, Xian 710032, Shaanxi, China;3.The First Affiliated Hospital of Xian Jiaotong University, Xian 710061, Shaanxi, China
  • Received:2016-05-22 Online:2016-06-16 Published:2016-06-16

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摘要： 目的 探讨尼妥珠单抗联合奈达铂和5-氟尿嘧啶(fluorouracil,5-Fu)新方案,作为新辅助化疗来治疗下咽鳞癌患者术前的疗效和安全性。 方法 对初治的91例下咽鳞癌患者以尼妥珠单抗(300 mg第1天)联合奈达铂(90 mg/m2第1天)和5-Fu(750 mg/m2第1~5天)3周方案作为新辅助化疗,两个周期后予以手术和术后放射治疗。主要研究终点为肿瘤缓解率,次要研究终点为病理完全缓解率、保喉率和化疗相关毒性。 结果 所有入组对象的总体肿瘤缓解率为86.8%(79/91),52例(57.1%)影像学降期,其中47例次(51.6%)达T降期,20例次(22.0%)达N降期。新辅助化疗(1或2个周期)后共88例行手术治疗,其中68例为保留喉功能的下咽癌根治性手术,保喉率为77.3%。8例术后原发灶病理完全缓解,占总入组患者数的8.8%(8/91)。29例(31.9%)出现中性粒细胞减少,26例(28.6%)出现恶心呕吐等胃肠道反应。 结论 尼妥珠单抗联合奈达铂和5-Fu方案作为新辅助化疗可提高下咽鳞癌患者的肿瘤缓解率,且对其毒性耐受良好,多数患者通过新辅助化疗保留喉功能。

关键词: 下咽癌,鳞状细胞癌, 新辅助化疗, 受体,表皮生长因子, 靶向

Abstract: Objective To investigate the safety and efficacy of nimotuzumab combined with nedaplatinand and fluorouracil(5-FU)as neo-adjuvant chemotherapy in the treatment of hypopharyngeal squamous cell carcinoma. Methods Between July 2012 and December 2014, we performed initial treatment on 91 cases of hypopharyngeal squamous cell carcinoma with the nimotuzumab(300 mg/m2 day 1)combined with nedaplatin(90 mg/m2 day 1)and 5-FU(750 mg/m2 day1-5)as neo-adjuvant chemotherapy, with one cycle for 3 weeks. Two cycles were followed by surgery and radiation therapy. The primary endpoint was tumor response rate, pathological complete response rate, the rate of laryngeal preservation and chemotherapy related toxicity. Results The response rate of tumor was 86.8%(79/91)after two cycles of neo-adjuvant chemotherapy. Fifty-two patients(57.1%)got downstage, with T downstage in 47(51.6%)cases and N downstage in 20(22.0%)cases. Eighty-eight patients got surgery after the neo-adjuvant chemotherapy, of which 68 patients(77.3%)preserved laryngeal function. The pathological complete response was 8.8%(8/91)of the total. The toxicity was mild and manageable. There were 29 cases of neutropenia(31.9%), 26 cases of nausea/vomiting(28.6%). Conclusion Nimotuzumab plus nedaplatin and 5-FU regimen as neo-adjuvant chemotherapy was highly effective for improving the hypopharyngeal carcinoma patients’ tumor response rate and preserving their organ function, while the toxicities were well tolerable.

Key words: Receptor, epidermal growth factor, Target, Neo-adjuvant Chemotherapy, Hypopharyngeal cancer, squamous cell carcinoma

中图分类号: 

  • R739.63
[1] 连欣, 季文樾. 97例下咽癌临床特点分析[J]. 临床耳鼻咽喉头颈外科杂志, 2015, 29(6):542-546. LIAN Xin, JI Wenyue. Clinical characteristics of 97 hypopharyngeal carcinoma cases[J]. Clin J Otorhinolarynol Head Neck Surg, 2015, 29(6):542-546.
[2] Lefebvre J L, Chevalier D, Luboinski B, et al. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase Ⅲ trial. EORTC Head and Neck Cancer Cooperative Group[J]. J Natl Cancer Inst, 1996, 88(13):890-899.
[3] Pointreau Y, Garaud P, Chapet S, et al. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation[J]. J Natl Cancer Inst, 2009, 101(7):498-506.
[4] Haddad R, ONeill A, Rabinowits G, et al. Induction chemotherapy followed by concurrent chemoradiotherapy(sequential chemoradiotherapy)versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer(PARADIGM): a randomised phase 3 trial[J]. Lancet Oncol, 2013, 14(3):257-264.
[5] Cohen E E, Karrison T G, Kocherginsky M, et al. Phase Ⅲ randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer[J]. J Clin Oncol, 2014, 32(25):2735-2743.
[6] Ongkeko W M, Altuna X, Weisman R A, et al. Expression of protein tyrosine kinases in head and neck squamous cell carcinomas[J]. Am J Clin Pathol, 2005, 124(1):71-76.
[7] 房树华,钱元霞. 奈达铂与其他铂类制剂药物不良反应的临床比较研究[J]. 中国药物警戒,2012,9(5):309-312. FANG Shuhua, QIAN Yuanxia. Compare Nedaplatin with other Platinum agents in clinical studies of adverse drug reaction [J]. Chin J Pharmacovigilance, 2012, 9(5):309-312.
[8] 邓颖,邓春美,胡洪林,等. 奈达铂或顺铂联合紫杉醇同步放化疗局部晚期鼻咽癌的疗效比较[J]. 实用癌症杂志,2011,26(2):175-177. DENG Ying, DENG Chunmei, HU Honglin, et al. Nedaplatin or Cisplatin plus Paclitaxel combined with radiotherapy for locally advanced nasopharyngeal carcinoma compared[J]. The Practical J Cancer, 2011, 26(2):175-177.
[9] Eisenhauer E A, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline(version 1.1)[J]. Eur J Cancer, 2009, 45(2):228-247.
[10] Posner M R, Haddad R I, Wirth L, et al. Induction chemotherapy in locally advanced squamous cell cancer of the head and neck: evolution of the sequential treatment approach[J]. SeminOncol, 2004, 31(6):778-785.
[11] Zhang L, Jiang N, Shi Y, et al. Induction chemotherapy with concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of head and neck: a meta-analysis[J]. Sci Rep, 2015, 4(5):10798.
[12] Qian X, Ma C, Hoffmann T K, et al. Taxane-cisplatin-fluorouracil as induction chemotherapy for advanced head and neck cancer: a meta-analysis of the 5-year efficacy and safety[J]. Springerplus, 2015, 1(4):208.
[13] Domenge C, Hill C, Lefebvre J L, et al. Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. French Grouped'Etude des Tumeurs de la Tête et du Cou(GETTEC)[J]. Br J Cancer, 2000, 83(12):1594-1598.
[14] Zorat P L, Paccagnella A, Cavaniglia G, et al. Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up[J]. J Natl Cancer Inst, 2004, 96(22):1714-1717.
[15] 杨蜜, 吴敬波. 实体瘤诱导化疗的应用进展[J]. 西南军医, 2014, 16(3):296-299. YANG Mi, WU Jingbo. Advances in the application of chemotherapy for solid tumors[J]. J Military Surg in Southwest China, 2014, 16(3):296-299.
[16] Vermorken J B, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer[J]. N Engl J Med, 2008, 359(11):1116-1127.
[17] Merlano M, Russi E, Benasso M, et al. Cisplatin-based chemoradiation plus cetuximab in locally advanced head and neck cancer: a phase II clinical study[J]. Ann Oncol, 2011, 22(3):712-717.
[18] 於子卫, 董频, 庞正.西妥昔单抗联合术后同步放化疗治疗晚期复发性头颈癌的初步观察[J].山东大学耳鼻喉眼学报,2010,24(6):44-46. YU Ziwei, DONG Pin, PANG Zheng. Clinical study of cetuximab combined with postoperative concurrent chemoradiotherapy on recurrent advanced squamous cell carcinoma of the head and neck[J]. J Otolaryngol Ophthal Shangdong Univ, 2010, 24(6):44-46.
[19] 赵晓莹, 郭晔, 朱永学, 等. 尼妥珠单抗联合顺铂和氟尿嘧啶方案诱导化疗治疗可切除的头颈部鳞癌初步临床分析[J]. 中华耳鼻咽喉头颈外科杂志, 2012, 47(7):536-539. ZHAO Xiaoying, GUO Ye, ZHU Yongxue, et al. Clinical analysis of nimotuzumab plus cisplatin and fluorouracil regimen as induction treatment in resectable head and neck squamous cell carcinoma[J]. Chin J Otorhinolarynol Head Neck Surg, 2012, 47(7):536-539.
[20] Rodríguez M O, Rivero T C, del Castillo Bahi R, et al. Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head and neck[J]. Cancer Biol Ther, 2010, 9(5):343-349.
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