本文選題：愛必妥 + 鼻咽癌�。� 參考：《廣西醫(yī)科大學(xué)》2010年碩士論文

【摘要】： 目的：評(píng)價(jià)愛必妥聯(lián)合同期放化療治療局部晚期鼻咽癌的近期臨床療效及安全性。 方法和材料：本次研究承擔(dān)了由中山大學(xué)腫瘤醫(yī)院牽頭的愛必妥聯(lián)合同期放化療治療鼻咽癌的開放性、單組Ⅱ期多中心臨床研究(A phase II study of cetuximab (Erbitux(?)) in NPC with ChemoRadiothErapy, ENCORE)的其中部分研究。多中心研究納入局部晚期鼻咽癌(Ⅲ～Ⅳb, UICC/AJCC,2002,6~(th))病人100例,采用統(tǒng)一標(biāo)準(zhǔn)對(duì)所有病人予以同期放化療／西妥昔單抗。本研究選取9例(多中心實(shí)驗(yàn)病人7例,非多中心實(shí)驗(yàn)病人2例)符合ENCORE研究納入標(biāo)準(zhǔn)的經(jīng)病理確診的初治局部晚期鼻咽癌患者進(jìn)入實(shí)驗(yàn)組,給予同期放化療／愛比妥治療,同期選取臨床資料具有可比性并且接受同樣放化療方案的21例患者進(jìn)入對(duì)照組。實(shí)驗(yàn)組予以同期順鉑80mg／m2,每3周1次,愛必妥第一周400 mg／m2,其后每周250 mg／m2,直至放療結(jié)束,并給予調(diào)強(qiáng)放療(intensity modulated radiotherapy,IMRT)(GTVnx、GTVnd、CTV1、CTV2處方劑量分別為66～75.9、66～70、64、54 Gy,1次／天,5天／周,共6～7周完成)。鼻咽和上頸部靶體積采用IMRT技術(shù)照射,下頸部靶體積采用下頸前野常規(guī)照射。對(duì)照組予的同步放化療方案同實(shí)驗(yàn)組。治療相關(guān)不良反應(yīng)按照NCI常見不良反應(yīng)標(biāo)準(zhǔn)第3版(Common Terminology Criteria for Adverse Events,CTCAE V3.0)分級(jí)評(píng)價(jià)。療效按照實(shí)體瘤療效反應(yīng)評(píng)價(jià)標(biāo)準(zhǔn)(Response Evaluation Criteria In Solid Tumors, RECIST)進(jìn)行評(píng)估。 結(jié)果： 療效：兩組病人的治療后3月的局部控制率均為100%,實(shí)驗(yàn)組和對(duì)照組的1年無(wú)遠(yuǎn)處轉(zhuǎn)移生存率分別為(5／7)71.4%、(18／21)85.7%,差異沒有統(tǒng)計(jì)學(xué)意義(P=0.367)；多中心研究結(jié)果顯示：全組病人治療結(jié)束后3月局部控制率為99%。 急性毒性反應(yīng)：除了黏膜反應(yīng)、痤瘡樣皮疹外,大部分急性毒性反應(yīng)均在1-2度,很少出現(xiàn)3度急性毒性反應(yīng),實(shí)驗(yàn)組和對(duì)照組的急性毒性反應(yīng)比較沒有明顯差異(P0.05)。多中心研究結(jié)果顯示：愛必妥配合同步放化療治療局部晚期鼻咽癌,患者耐受性好,不良反應(yīng)較輕,沒有4級(jí)不良反應(yīng)。 結(jié)論： (1)愛比妥配合同步放化療近期療效顯著,其長(zhǎng)期療效有待觀察。 (2)愛必妥配合同期放化療治療局部晚期鼻咽癌安全性較好,病人可以耐受。
[Abstract]:Objective: To evaluate the short-term efficacy and safety of IBI in combination with concurrent chemoradiotherapy in the treatment of locally advanced nasopharyngeal carcinoma.
Methods and materials: This study took part in the partial study of the A phase II study of cetuximab (Erbitux (Erbitux (?)) in NPC with ChemoRadiothErapy, ENCORE), which was led by the Cancer Hospital of the Cancer Hospital of the Zhongshan University, in partial study of the in NPC with ChemoRadiothErapy, ENCORE). 100 patients with advanced nasopharyngeal carcinoma (III ~ IV B, UICC/AJCC, 2002,6~ (th)) were treated with the same standard for concurrent chemoradiotherapy and cetuximab. This study selected 9 cases (7 cases of multi center experimental patients and 2 cases of non multicenter experimental patients), which were in conformity with the standard of ENCORE study for the primary locally advanced nasopharyngeal carcinoma patients. In the experimental group, 21 cases of cisplatin (cisplatin 80mg / m2, 1 times per 3 weeks, 400 mg / m2 per week, 250 mg / m2 per week) were given at the same time with the comparison of clinical data and the same chemotherapy regimen. The dosage of intensity modulated radiotherapy, IMRT) (GTVnx, GTVnd, CTV1, CTV2 was 66 ~ 75.9,66 ~ 70,64,54 Gy, 1 times / day, 5 days / week, for a total of 6~7 weeks). The target volume of the nasopharynx and upper neck was irradiated with IMRT technique and the lower neck target volume was routinely irradiated in the lower neck field. The synchronous radiotherapy and chemotherapy regimen given in the control group was the same as the experimental group. The treatment related adverse reactions were graded according to the standard third version of the common NCI adverse reaction standard (Common Terminology Criteria for Adverse Events, CTCAE V3.0). The curative effect was evaluated according to the evaluation criteria of the response to solid tumor response (Response Evaluation Criteria).
Result錛，

本文編號(hào)：1954072