使用西妥昔单抗治疗的局部晚期头颈部肿瘤患者三年生存率:来自随机对照研究的中等质量证据显示了西妥昔单抗治疗局部晚期头颈部肿瘤的优势。先给予一次西妥昔单抗400 mg/m^2 的负荷计量,随后在常规或超分割放疗 (70-72 Gy)过程中给予250 mg/m^2的每周剂量。单纯放疗三年生存率为45%,放疗联合西妥昔单抗为55%。除痤疮样皮疹,西妥昔单抗治疗的耐受性良好。[61]Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006;354:567-578.http://www.nejm.org/doi/full/10.1056/NEJMoa053422#t=articlehttp://www.ncbi.nlm.nih.gov/pubmed/16467544?tool=bestpractice.com
证据 B 提高局部晚期的IVB期及不可手术切除头颈部癌的生存率和局部控制:随机研究的中等质量证据证明,同步放化疗比单纯放疗有更好的生存率和局部控制率。[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com[78]Staar S, Rudat V, Stuetzer H, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy: results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50:1161-1171 (erratum in: Int J Radiat Oncol Biol Phys 2001;51:569).http://www.ncbi.nlm.nih.gov/pubmed/11483325?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com[83]Pignon JP, le Maitre A, Maillard E, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4-14.http://www.ncbi.nlm.nih.gov/pubmed/19446902?tool=bestpractice.com化疗作为放疗增敏剂。最常见的组合是氟尿嘧啶和顺铂,[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com氟尿嘧啶和卡铂,[78]Staar S, Rudat V, Stuetzer H, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy: results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50:1161-1171 (erratum in: Int J Radiat Oncol Biol Phys 2001;51:569).http://www.ncbi.nlm.nih.gov/pubmed/11483325?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com以及氟尿嘧啶和丝裂霉素。[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com联合治疗的三年生存率为40%~55%,局部控制为58%到70%。[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com然而,在5年时,随着局部控制下降,生存率下降到22%至28%,远处转移上升至50%。[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com一项 meta 分析证实,在放疗中添加化疗可提高生存率。[83]Pignon JP, le Maitre A, Maillard E, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4-14.http://www.ncbi.nlm.nih.gov/pubmed/19446902?tool=bestpractice.com放疗剂量范围为70Gy(每日1次)到75Gy(每日2次)。 系统评价或者受试者>200名的随机对照临床试验(RCT)。提高局部晚期的IVB期及不可手术切除头颈部癌的生存率和局部控制:随机研究的中等质量证据证明,同步放化疗比单纯放疗有更好的生存率和局部控制率。[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com[78]Staar S, Rudat V, Stuetzer H, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy: results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50:1161-1171 (erratum in: Int J Radiat Oncol Biol Phys 2001;51:569).http://www.ncbi.nlm.nih.gov/pubmed/11483325?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com[83]Pignon JP, le Maitre A, Maillard E, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4-14.http://www.ncbi.nlm.nih.gov/pubmed/19446902?tool=bestpractice.com化疗作为放疗增敏剂。最常见的组合是氟尿嘧啶和顺铂,[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com氟尿嘧啶和卡铂,[78]Staar S, Rudat V, Stuetzer H, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy: results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50:1161-1171 (erratum in: Int J Radiat Oncol Biol Phys 2001;51:569).http://www.ncbi.nlm.nih.gov/pubmed/11483325?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com以及氟尿嘧啶和丝裂霉素。[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com联合治疗的三年生存率为40%~55%,局部控制为58%到70%。[77]Bensadoun RJ, Benezery K, Dassonville O, et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006;64:983-994.http://www.ncbi.nlm.nih.gov/pubmed/16376489?tool=bestpractice.com[81]Calais G, Alfonsi M, Bardet E, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-2086.http://jnci.oxfordjournals.org/cgi/content/full/91/24/2081http://www.ncbi.nlm.nih.gov/pubmed/10601378?tool=bestpractice.com[82]Brizel DM, Albers ME, Fisher SR, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-1804.http://content.nejm.org/cgi/content/full/338/25/1798http://www.ncbi.nlm.nih.gov/pubmed/9632446?tool=bestpractice.com然而,在5年时,随着局部控制下降,生存率下降到22%至28%,远处转移上升至50%。[76]Budach V, Stuschke M, Budach W, et al. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial. J Clin Oncol. 2005;23:1125-1135.http://jco.ascopubs.org/cgi/content/full/23/6/1125http://www.ncbi.nlm.nih.gov/pubmed/15718308?tool=bestpractice.com[79]Semrau R, Mueller RP, Stuetzer H, et al. Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006;64:1308-1316.http://www.ncbi.nlm.nih.gov/pubmed/16464538?tool=bestpractice.com[80]Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant chemoradiotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69-76.http://jco.ascopubs.org/cgi/content/full/22/1/69http://www.ncbi.nlm.nih.gov/pubmed/14657228?tool=bestpractice.com一项 meta 分析证实,在放疗中添加化疗可提高生存率。[83]Pignon JP, le Maitre A, Maillard E, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4-14.http://www.ncbi.nlm.nih.gov/pubmed/19446902?tool=bestpractice.com放疗剂量范围为70Gy(每日1次)到75Gy(每日2次)。
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