中美两国头颈部肿瘤规范化诊疗差异浅析
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摘要
通过从中美两国头颈部肿瘤诊疗指南入手,对比中美头颈部肿瘤发病原因、多学科团队构成、诊断原则、证据级别和推荐级别、常见头颈肿瘤治疗原则及随访要求等方面差异,并探讨形成差异的原因和对我国肿瘤专业临床医师的启示。未来肿瘤治疗的方向强调个体化治疗和精准治疗,任何指南均不能作为临床诊疗的唯一标准。美国NCCN指南给我们提供了很好的循证医学范例,参考NCCN指南对于规范我国肿瘤治疗能起到积极作用。同时,我国仍属于发展中国家,地区经济、医疗发展不均衡,我们在强调肿瘤诊疗规范化的同时,也需要根据地区经济条件、医疗水平以及患者个人综合情况进行精准施治。
Based on the latest clinical practice guidelines of China and the United States, which were named the Chinese Society of Clinical Oncology(CSCO) guideline by CSCO and the National Comprehensive Cancer Network(NCCN) guideline by NCCN, we compared the differences of multidisciplinary team constitutive requirement, the levels of evidence and recommendation, the diagnostic principles, the treatment principles of common head and neck tumors and follow-up requirements, and explored the causes of the differences and their implications for Chinese oncologists. The NCCN guideline provides us a good example of evidence-based medicine, and plays an impressive role in regulating cancer treatment in China. At the same time, China is still a developing country with unbalanced regional economic and medical development, individualized and precise treatment should be recommended according to the regional economic environment, medical condition and the individual situation of patients while standardization was emphasized.
Based on the latest clinical practice guidelines of China and the United States, which were named the Chinese Society of Clinical Oncology(CSCO) guideline by CSCO and the National Comprehensive Cancer Network(NCCN) guideline by NCCN, we compared the differences of multidisciplinary team constitutive requirement, the levels of evidence and recommendation, the diagnostic principles, the treatment principles of common head and neck tumors and follow-up requirements, and explored the causes of the differences and their implications for Chinese oncologists. The NCCN guideline provides us a good example of evidence-based medicine, and plays an impressive role in regulating cancer treatment in China. At the same time, China is still a developing country with unbalanced regional economic and medical development, individualized and precise treatment should be recommended according to the regional economic environment, medical condition and the individual situation of patients while standardization was emphasized.
引文
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[3] Argiris A, Karamouzis MV, Raben D, et al. Head and neck cancer[J].Lancet,2008, 371(9625):1695-1709.
[4] Lee YA, Li S, Chen Y, et al. Tobacco smoking, alcohol drinking, betel quid chewing, and the risk of head and neck cancer in an East Asian population[J]. Head Neck,2019,41(1):92-102.
[5] Gillison ML, Chaturvedi AK, Anderson WF, et al. Epidemiology of human papillomavirus-positive head and neck squamous cell carcinoma[J]. J Clin Oncol,2015, 33(29):3235-3242.
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[13] O'Brien CJ, Lauer CS, Fredricks S, et al. Tumor thickness influences prognosis of T1 and T2 oral cavity cancer--but what thickness[J]. Head Neck, 2003,25(11):937-945.
[14] Chone CT, Magalhes RS, Etchehebere E, et al. Predictive value of sentinel node biopsy in head and neck cancer[J]. Acta Otolaryngol,2008,128(8):920-924.
[15] Cooper JS, Zhang Q, Pajak TF, et al. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck[J]. Int J Radiat Oncol Biol Phys,2012, 84(5):1198-1205.
[16] Bernier J, Cooper JS, Pajak TF, et al. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501)[J]. Head Neck, 2005,27(10):843-850.
[17] Lim YC, Koo BS, Lee JS, et al. Distributions of cervical lymph node metastases in oropharyngeal carcinoma: therapeutic implications for the N0 neck[J]. Laryngoscope,2006, 116(7):1148-1152.
[18] Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival[J]. Lancet Oncol,2010,11(1):21-28.
[19] Lorch JH, Goloubeva O, Haddad RI, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial[J]. Lancet Oncol,2011,12(2):153-159.
[20] Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck[J]. Ann Oncol,2014, 25(11):2101-2115.
[21] Warner L, Chudasama J, Kelly CG, et al. Radiotherapy versus open surgery versus endolaryngeal surgery (with or without laser) for early laryngeal squamous cell cancer[J]. Cochrane Database Syst Rev, 2014(12):CD002027.
[22] Forastiere AA, Zhang Q, Weber RS, et al. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer[J]. J Clin Oncol,2013,31(7):845-852.
[23] Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer[J]. N Engl J Med,2003,349(22):2091-2098.
[24] Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck[J]. N Engl J Med,2006,354(6):567-578.
[25] Popovtzer A, Burnstein H, Stemmer S, et al. Phase II organ-preservation trial: Concurrent cisplatin and radiotherapy for advanced laryngeal cancer after response to docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy[J]. Head Neck,2017, 39(2):227-233.
[26] Janoray G, Pointreau Y, Garaud P, et al. Long-term results of a multicenter randomized phase III trial of induction chemotherapy with Cisplatin, 5-fluorouracil, +/- Docetaxel forlarynx preservation[J]. J Natl Cancer Inst, 2016,108(4).
[27] Forastiere AA, Ismaila N, Wolf GT. Use of larynx-preservation strategies in the treatment of laryngeal cancer: American Society of Clinical Oncology Clinical Practice Guideline Update Summary[J]. J Oncol Pract, 2018,14(2):123-128.
[28] Martin A, Jackel MC, Christiansen H, et al. Organ preserving transoral laser microsurgery for cancer of the hypopharynx[J]. Laryngoscope,2008,118(3):398-402.
[29] Rabbani A, Amdur RJ, Mancuso AA, et al. Definitive radiotherapy for T1-T2 squamous cell carcinoma of pyriform sinus[J]. Int J Radiat Oncol Biol Phys,2008,72(2):351-355.
[30] 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.
[31] Lefebvre JL, Pointreau Y, Rolland F, et al. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study[J]. J Clin Oncol,2013,31(7):853-859.
[32] Gibson MK, Li Y, Murphy B, et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group[J]. J Clin Oncol,2005,23(15):3562-3567.
[33] Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy[J]. J Clin Oncol,2007,25(16):2171-2177.
[34] Argiris A, Ghebremichael M, Gilbert J, et al. 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[J]. J Clin Oncol,2013,31(11):1405-1414.
[35] Stewart JS, Cohen EE, Licitra L, et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected][J]. J Clin Oncol, 2009,27(11):1864-1871.
[36] Harrington KJ, Ferris RL, Blumenschein GJr, et al. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial[J]. Lancet Oncol,2017,18(8):1104-1115.
[37] Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression[J]. Oral Oncol, 2018, 81:45-51.
[38] Adelstein DJ, Li Y, Adams GL, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer[J]. J Clin Oncol,2003, 21(1):92-98.
[39] Kurzweg T, Mockelmann N, Laban S, et al. Current treatment options for recurrent/metastatic head and neck cancer: a post-ASCO 2011 update and review of last year's literature[J]. Eur Arch Otorhinolaryngol, 2012,269(10):2157-2167.
[40] Price KA, Cohen EE. Current treatment options for metastatic head and neck cancer[J]. Curr Treat Options Oncol,2012,13(1):35-46.
[41] de Andrade DA, Machiels JP. Treatment options for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who progress after platinum-based chemotherapy[J]. Curr Opin Oncol,2012,24(3):211-217.
[42] Guardiola E, Peyrade F, Chaigneau L, et al. Results of a randomised phase II study comparing docetaxel with methotrexate in patients with recurrent head and neck cancer[J]. Eur J Cancer, 2004,40(14):2071-2076.
[43] Burtness B, Goldwasser MA, Flood W, et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study[J]. J Clin Oncol,2005,23(34):8646-8654.
[44] Colevas AD. Chemotherapy options for patients with metastatic or recurrent squamous cell carcinoma of the head and neck[J]. J Clin Oncol,2006,24(17):2644-2652.
[45] 张程,尹梅. 中美肿瘤患者姑息治疗的对比研究[J]. 中国医学伦理学,2018, 31(3):346-351. Zhang C,Yin M. Comparative study on palliative treatment of cancer patients between China and the United States[J]. Chinese Medical Ethics,2018,31(3):346-351.
[2] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018[J]. CA Cancer J Clin, 2018,68(1):7-30.
[3] Argiris A, Karamouzis MV, Raben D, et al. Head and neck cancer[J].Lancet,2008, 371(9625):1695-1709.
[4] Lee YA, Li S, Chen Y, et al. Tobacco smoking, alcohol drinking, betel quid chewing, and the risk of head and neck cancer in an East Asian population[J]. Head Neck,2019,41(1):92-102.
[5] Gillison ML, Chaturvedi AK, Anderson WF, et al. Epidemiology of human papillomavirus-positive head and neck squamous cell carcinoma[J]. J Clin Oncol,2015, 33(29):3235-3242.
[6] Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirus and rising oropharyngeal cancer incidence in the United States[J]. J Clin Oncol, 2011,29(32):4294-4301.
[7] Guo L, Yang F, Yin Y, et al. Prevalence of human papillomavirus type-16 in head and neck cancer among the Chinese population: a meta-analysis[J]. Front Oncol,2018,8:619.
[8] Wang Z, Xia RH, Ye DX, et al. Human papillomavirus 16 infection and TP53 mutation: two distinct pathogeneses for oropharyngeal squamous cell carcinoma in an eastern Chinese population[J]. PLoS One, 2016,11(10):e0164491.
[9] Meng HX, Miao SS, Chen K, et al. Association of p16 as prognostic factors for oropharyngeal cancer:evaluation of p16 in 1470 patients for a 16 year study in northeast China[J]. Biomed Res Int,2018,2018:9594568.
[10] Huang SH, Hwang D, Lockwood G, et al. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies[J]. Cancer,2009,115(7):1489-1497.
[11] International Consortium for Outcome Research in Head and Neck Cancer, Ebrahimi A, Gil Z, et al. Primary tumor staging for oral cancer and a proposed modification incorporating depth of invasion: an international multicenter retrospective study[J]. JAMA Otolaryngol Head Neck Surg,2014, 140(12):1138-1148.
[12] Schilling C, Stoeckli SJ, Haerle SK, et al. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer[J]. Eur J Cancer,2015,51(18):2777-2784.
[13] O'Brien CJ, Lauer CS, Fredricks S, et al. Tumor thickness influences prognosis of T1 and T2 oral cavity cancer--but what thickness[J]. Head Neck, 2003,25(11):937-945.
[14] Chone CT, Magalhes RS, Etchehebere E, et al. Predictive value of sentinel node biopsy in head and neck cancer[J]. Acta Otolaryngol,2008,128(8):920-924.
[15] Cooper JS, Zhang Q, Pajak TF, et al. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck[J]. Int J Radiat Oncol Biol Phys,2012, 84(5):1198-1205.
[16] Bernier J, Cooper JS, Pajak TF, et al. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501)[J]. Head Neck, 2005,27(10):843-850.
[17] Lim YC, Koo BS, Lee JS, et al. Distributions of cervical lymph node metastases in oropharyngeal carcinoma: therapeutic implications for the N0 neck[J]. Laryngoscope,2006, 116(7):1148-1152.
[18] Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival[J]. Lancet Oncol,2010,11(1):21-28.
[19] Lorch JH, Goloubeva O, Haddad RI, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial[J]. Lancet Oncol,2011,12(2):153-159.
[20] Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck[J]. Ann Oncol,2014, 25(11):2101-2115.
[21] Warner L, Chudasama J, Kelly CG, et al. Radiotherapy versus open surgery versus endolaryngeal surgery (with or without laser) for early laryngeal squamous cell cancer[J]. Cochrane Database Syst Rev, 2014(12):CD002027.
[22] Forastiere AA, Zhang Q, Weber RS, et al. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer[J]. J Clin Oncol,2013,31(7):845-852.
[23] Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer[J]. N Engl J Med,2003,349(22):2091-2098.
[24] Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck[J]. N Engl J Med,2006,354(6):567-578.
[25] Popovtzer A, Burnstein H, Stemmer S, et al. Phase II organ-preservation trial: Concurrent cisplatin and radiotherapy for advanced laryngeal cancer after response to docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy[J]. Head Neck,2017, 39(2):227-233.
[26] Janoray G, Pointreau Y, Garaud P, et al. Long-term results of a multicenter randomized phase III trial of induction chemotherapy with Cisplatin, 5-fluorouracil, +/- Docetaxel forlarynx preservation[J]. J Natl Cancer Inst, 2016,108(4).
[27] Forastiere AA, Ismaila N, Wolf GT. Use of larynx-preservation strategies in the treatment of laryngeal cancer: American Society of Clinical Oncology Clinical Practice Guideline Update Summary[J]. J Oncol Pract, 2018,14(2):123-128.
[28] Martin A, Jackel MC, Christiansen H, et al. Organ preserving transoral laser microsurgery for cancer of the hypopharynx[J]. Laryngoscope,2008,118(3):398-402.
[29] Rabbani A, Amdur RJ, Mancuso AA, et al. Definitive radiotherapy for T1-T2 squamous cell carcinoma of pyriform sinus[J]. Int J Radiat Oncol Biol Phys,2008,72(2):351-355.
[30] 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.
[31] Lefebvre JL, Pointreau Y, Rolland F, et al. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study[J]. J Clin Oncol,2013,31(7):853-859.
[32] Gibson MK, Li Y, Murphy B, et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group[J]. J Clin Oncol,2005,23(15):3562-3567.
[33] Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy[J]. J Clin Oncol,2007,25(16):2171-2177.
[34] Argiris A, Ghebremichael M, Gilbert J, et al. 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[J]. J Clin Oncol,2013,31(11):1405-1414.
[35] Stewart JS, Cohen EE, Licitra L, et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected][J]. J Clin Oncol, 2009,27(11):1864-1871.
[36] Harrington KJ, Ferris RL, Blumenschein GJr, et al. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial[J]. Lancet Oncol,2017,18(8):1104-1115.
[37] Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression[J]. Oral Oncol, 2018, 81:45-51.
[38] Adelstein DJ, Li Y, Adams GL, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer[J]. J Clin Oncol,2003, 21(1):92-98.
[39] Kurzweg T, Mockelmann N, Laban S, et al. Current treatment options for recurrent/metastatic head and neck cancer: a post-ASCO 2011 update and review of last year's literature[J]. Eur Arch Otorhinolaryngol, 2012,269(10):2157-2167.
[40] Price KA, Cohen EE. Current treatment options for metastatic head and neck cancer[J]. Curr Treat Options Oncol,2012,13(1):35-46.
[41] de Andrade DA, Machiels JP. Treatment options for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who progress after platinum-based chemotherapy[J]. Curr Opin Oncol,2012,24(3):211-217.
[42] Guardiola E, Peyrade F, Chaigneau L, et al. Results of a randomised phase II study comparing docetaxel with methotrexate in patients with recurrent head and neck cancer[J]. Eur J Cancer, 2004,40(14):2071-2076.
[43] Burtness B, Goldwasser MA, Flood W, et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study[J]. J Clin Oncol,2005,23(34):8646-8654.
[44] Colevas AD. Chemotherapy options for patients with metastatic or recurrent squamous cell carcinoma of the head and neck[J]. J Clin Oncol,2006,24(17):2644-2652.
[45] 张程,尹梅. 中美肿瘤患者姑息治疗的对比研究[J]. 中国医学伦理学,2018, 31(3):346-351. Zhang C,Yin M. Comparative study on palliative treatment of cancer patients between China and the United States[J]. Chinese Medical Ethics,2018,31(3):346-351.