CAJ | 학술논문

目的：评价重组人血管内皮抑制素(恩度)联合DP方案治疗远处转移鼻咽癌的临床疗效及安全性。方法：收集2009年1月至2010年12月在本科治疗的远处转移鼻咽癌患者62例,均接受恩度联合DP方案行姑息性化疗。恩度剂量为30 mg/d,加入生理盐水500 mL静滴3~4 h,第1天~第14天,休息一周,重复给药；多西紫杉醇70 mg/m2,每天加生理盐水500 mL静滴,第1天；顺铂80~100 mg/m2,加生理盐水500 mL静滴,第1天。21 d为1周期。以RECIST标准评价近期疗效,NCI CTC 3.0评价毒性反应,采用SPSS 13.0软件进行统计分析,Kaplan Meier法计算生存率,用Log rank进行检验。结果：62例患者中,肝转移28例,肺转移17例,骨转移9例,多器官转移8例。所有患者均可评价毒副作用,60例患者可评价疗效,共完成280个周期,中位数为4个周期。完全缓解( CR)18例,部分缓解( PR)31例,稳定(SD)9例,疾病进展(PD)2例。客观缓解率为81.7％(49/60),疾病控制率为96.7％(58/60)。中位随访25个月,1、2年总生存率分别为69.2％、40.8％,中位生存期和中位无进展生存期分别为18.5个月和10.5个月。主要不良反应为脱发、骨髓抑制、胃肠道反应和神经毒性,多为1~2级,且与化疗相关。结论：恩度联合DP方案一线治疗远处转移鼻咽癌的疗效较好,毒性低,安全可靠。
목적：평개중조인혈관내피억제소(은도)연합DP방안치료원처전이비인암적림상료효급안전성。방법：수집2009년1월지2010년12월재본과치료적원처전이비인암환자62례,균접수은도연합DP방안행고식성화료。은도제량위30 mg/d,가입생리염수500 mL정적3~4 h,제1천~제14천,휴식일주,중복급약；다서자삼순70 mg/m2,매천가생리염수500 mL정적,제1천；순박80~100 mg/m2,가생리염수500 mL정적,제1천。21 d위1주기。이RECIST표준평개근기료효,NCI CTC 3.0평개독성반응,채용SPSS 13.0연건진행통계분석,Kaplan Meier법계산생존솔,용Log rank진행검험。결과：62례환자중,간전이28례,폐전이17례,골전이9례,다기관전이8례。소유환자균가평개독부작용,60례환자가평개료효,공완성280개주기,중위수위4개주기。완전완해( CR)18례,부분완해( PR)31례,은정(SD)9례,질병진전(PD)2례。객관완해솔위81.7％(49/60),질병공제솔위96.7％(58/60)。중위수방25개월,1、2년총생존솔분별위69.2％、40.8％,중위생존기화중위무진전생존기분별위18.5개월화10.5개월。주요불량반응위탈발、골수억제、위장도반응화신경독성,다위1~2급,차여화료상관。결론：은도연합DP방안일선치료원처전이비인암적료효교호,독성저,안전가고。
Objective:To evaluate the efficacy and safety of recombinant human endostatin ( endostar) plus docetaxol and cisplatin (DP) as a first line therapy for the treatment of distant metastatic nasopharyngeal cancer. Methods: Between January 2009 and December 2010, 62 patients with distant metastatic nasopharyngeal cancer, recruited from Center for Oncology, The First Affiliated Hospital of Guangdong Medical University, were treated with palliative chemotherapy based on endostar plus DP. Endostar 30mg/d, solved in 500 mL saline, was administered intravenously for 3 to 4 h from day 1 to day 14, which was repeated following 1 week intervals. Docetaxel 70mg/m2, solved in 500mL saline, was administered intravenously on day 1. Cisplatin at the dose of 80~100 mg/m2, diluted with 500mL saline, was administered intravenously on day 1. All individual protocols were based on a cycle of 21 days. The short term effects and toxicity were evaluated according to the RECIST criteria and the NCI CTC 3. 0 criteria, respectively. The statistical analysis was performed using SPSS 13. 0 software. Survival analyses were estimated using Kaplan Meier method and compared by the Log rank test. Results:Of the 62 patients, 28 had liver metastasis, 17 lung metastasis, 9 bone metastasis and 8 multiple organ metastasis. All patients were evaluable for toxicity and 60 patients for efficacy. A total of 280 cycles were completed (median:4 cycles). Complete remission (CR), partial remission (PR), stable (SD) and disease progression ( PD) was achieved in 18, 31, 9 and 2 patients, respectively. The objective response rate was 81.7%(49/60) and the disease control rate 96.7% (58/60). The median duration of follow up was 25 months. The 1 and 2 year overall survival rates were 69.2% and 40.8%, respectively. The median survival and progression free survival duration was 18.5 and 10.5 months, respectively. Major adverse events, rated as grades 1 and 2, and were consisted of alopecia, bone marrow suppression, gastrointestinal reactions and neurotoxicity and were mainly related to chemotherapy.Conclusion:The first line protocol of endostar plus DP is characterized by effectiveness and low toxicity for the treatment of distant metastatic nasopharyngeal cancer.