Involved field irradiation (IFI) versus elective nodal irradiation (ENI) in combination with concurrent chemotherapy for esophageal thoracic squamous cell cancer:a prospective,randomized,multicenter,controlled study
Lyu Jiahua, Abulimiti·Yisikandaer, Li Tao, Zhang Xiaozhi, Tian Zhongge, Wang Xiaohu, Chen Long, Lu Bing, Chen Hong, Yang Jie, Wang Qifeng, Zhang Jinrong, Ma Youguo, Liu Rui, Liu Ruifeng, Ayiguli· Hare, Lang Jinyi
Sichuan Cancer Hospital Institute/Sichuan Cancer Center/School of Medicine,University of Electronic Science and Technology of China,Chengdu 610041,China (Lyu JH,Li T,Wang QF,Lang JY);The Affiliated Tumor Hospital of Xinjiang Medical University,Wulumuqi 830000,China (Abulimiti. Y,Zhang JR,Ayiguli H); The First Affiliated Hospital of Xi′an Jiaotong University,Xi An 710061,China (Zhang XZ, Liu R;Wu Wei Tumor Hospital,Wu Wei 116011,China (Tian ZG,Ma YG);Gansu Cancer Hospital,Lanzhou 730050,China (Wang XH,Liu RF);Guangxi Tumor Hospital,The Affiliated Hospital of Guangxi Medical University,Nanning 530021,China (Chen L);Guizhou Cancer Hospital, Guiyang 550000,China (Lu B);Kunming General Hospital Of Military Region, Kunming 650118,China (Chen H);Xinjiang Renmin Hospital,Wulumuqi 830001,China (Yang J)
Abstract：Objective This study was conducted to evaluate treatment-related toxicities,the patterns of failure,overall survival (OS) and progression-free survival (PFS) by comparing IFI with ENI in combination with chemotherapy. Methods Eligible patients were treated with concurrent chemoradiotherapy and randomized into either an IFI or ENI arm. The primary end points wereacute treatment-related toxicities. The secondary end points were patterns of failure,OS and PFS. Kaplan-Meier survival rate of the method for calculating the Logrank test difference method. Results Between April 2012 and October 2016,a total of 228 patients were enrolled from nine centers in china. Grade≥3,Grade≥2 radiation esophagitis and pneumonitis in the IFI arm were significantly lower than that of the ENI arm (P=0.018,0.027).No significant differences were observed in overall failure rates,loco-regional failure,distant failure rates,in-field and out-field lymph node failure between the two arms (P=0.401,0.561,0.510,0.561,0.681).The 1-,2-,3-,4-yearand median OS in the ENI arm and IFI arm were 84.1%,57.3%,39.4%,31.6%,28 months and 83.6%,62.1%,44.5%,31.5%,32 months (P=0.654),respectively. The 1-,2-,3-yearand median PFS in the ENI arm and IFI arm were 71.9%,42.3%,32.7%,20 months and 70.1%,45.0%,35.9%,22 months (P=0.885),respectively. Conclusions Compared to ENI,IFI resulted in decreased radiation pneumonitis and esophagitis without sacrificing loco-regional lymph nodal control,PFS and OS in thoracic ESCC.Clinical Trial Registry Chinese Clinical trail registry,registration number:NCT01551589.
Lyu Jiahua,Abulimiti·Yisikandaer,Li Tao et al. Involved field irradiation (IFI) versus elective nodal irradiation (ENI) in combination with concurrent chemotherapy for esophageal thoracic squamous cell cancer:a prospective,randomized,multicenter,controlled study[J]. Chinese Journal of Radiation Oncology, 2018, 27(3): 245-249.
[1] Button MR,Morgan CA,Croydon ES,et al. Study to determine adequate margins in radiotherapy planning for esophageal carcinoma by detailing patterns of recurrence after definitive chemoradiotherapy[J].Int J Radiat Oncol Biol Phys,2009,73(3):818-823.DOI:10.1016/j.ijrobp.2008.04.062. [2] Zhao KL,Ma JB,Liu G,et al. Three-dimensional conformal radiation therapy for esophageal squamous cell carcinoma:is elective nodal irradiation necessary?[J]. Int J Radiat Oncol Biol Phys,2010,76:446-451. DOI:10.1016/j.ijrobp.2009.02.078. [3] Zhang XL,Li MH,Meng X,et al. Involved-field irradiation in definitive chemoradiotherapy for locally advanced esophageal squamous cell carcinoma[J]. Radiat Oncol,2014,9(1):64. DOI:10.1186/1748-717X-9-64. [4] 李多杰,李红伟,何斌,等.食管癌适形调强放疗累及野和扩大野的比较研究[J].中国肿瘤临床,2013,40(20):1248-1251.DOI:10.3969/j.issn.1000-8179.20130671. Li DJ,Li HW,He B,et al. Comparison of involved field radiotherapy and extended field ra-diotherapy of definitive radiotherapy in patients with esophageal squamous cell carcinoma[J].Chin J Clin Oncol,2013,40(20):1248-1251. DOI:10.3969/j.issn.1000-8179.20130671. [5] Jing W,Zhu H,Guo HB,et al. Feasibility of elective nodal irradiation (ENI) and involved field irradiation (IFI) in radiotherapy for the elderly patients (aged≥ 70 years) with esophageal squamous cell cancer:a retrospective analysis from a single institute[J/OL].PLoS One,2015,10(12):e0143007.DOI:10.1371/journal.pone.0143007. [6] 祝淑钗,董辉,沈文斌,等.食管癌调强放疗淋巴引流区预防同期对照研究[J].中华放射医学和防护杂志,2014,34(10):758-762. DOI:10.3760/cma.j.issn.0254-5098.2014.10.009. Zhu SC,Dong H,Shen WB,et al. The concurrent control study of elective nodal prophylactic irradiation with intensity modulated radiotherapy for esophageal carcinoma[J].Chin J Radio Med Prot,2014,34(10):758-762. DOI:10.3760/cma.j.issn.0254-5098.2014.10.009. [7] Liu MN,Zhao KL,Chen Y,et al. Evaluation of the value of ENI in radiotherapy for cervical and upper thoracic esophageal cancer:a retrospective analysis[J].Radiat Oncol,2014,9:232.DOI:10.1186/s13014-014-0232-4. [8] Welsh J,Settle SH,Amini A,et al. Failure patterns in patients with esophageal cancer treated with definitive chemoradiation[J].Cancer,2012,118(10):2632-2640.DOI:10.1002/cncr.26586. [9] Minsky BD,Pajak TF,Ginsberg RJ,et al. INT 0123(radiation therapy oncology group 94-05) phase Ⅲ trial of combined-modality therapy for esophageal cancer:high-dose versus standard-dose radiation therapy[J].J Clin Oncol,2002,20(5):1167-1174.DOI:10.1002/JCO.2002.20.5.1167. [10] Cooper JS,Guo MD,Herskovic A,et al. Chemoradiotherapy of locally advanced esophageal cancer:long-term follow-up of a prospective randomized trial (RTOG 85-01)[J].JAMA,1999,281(17):1623-1627.DOI:10.1001/jama.281.17.1623. [11] 罗毅君,王晓莉,于金明,等.食管鳞癌累及野放疗的理论和实践[J].中华放射肿瘤学杂志,2017,26(8):965-968.DOI:10.3760/cma.j.issn.1004-4221. Luo YJ,Wang XL,Yu JM,et al. Theory and practice of involved-field radiotherapy for esophageal squamous cell carcinoma[J].Chin J Radiat Oncol,2017,26(8):965-968.DOI:10.3760/cma.j.issn.1004-4221. [12] Yamashita H,Takenaka R,Omori M,et al. Involved-field radiotherapy (IFRT) versus elective nodal irradiation (ENI) in combination with concurrent chemotherapy for 239 esophageal cancers:a single institutional retrospective study[J].Radiat Oncol,2015,10:171.DOI 10.1186/s13014-015-0482-9. [13] Ma JB,Song YP,Yu JM,et al. Feasibility of involved-field conformal radiotherapy for cervical and upper-thoracic esophageal cancer[J]. Onkologie,2011,34(11):599-604.DOI:10.1159/000334194. [14] Ji K,Zhao LJ,Yang CW,et al. Three-dimensional conformal radiation for esophageal squamous cell carcinoma with involved-field irradiation may deliver considerable doses of incidental nodal irradiation[J].Radiat Oncol,2012,7:200.DOI:10.1186/1748-717X-7-200 [15] Lee Y,Auh SL,Wang Y,et al. Therapeutic effects of ablative radiation on local tumor require CD8+ T cells:changing strategies for cancer treatment[J].Blood,2009,114(3):589-595.DOI:10.1182/blood-2009-02-206870. [16] Formenti SC,Demaria S.Systemic effects of local radiotherapy[J].Lancet Oncol,2009,10(7):718-726.DOI:10.1016/S1470-2045(09)70082-8. [17] Ahmed MM,Guha C,Hodge JW,et al. Immunobiology of radiotherapy:new paradigms[J].Radiat Res,2014,182(2):123-125.DOI:10.1667/RR13849.1.
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