替吉奥同步放疗治疗局部晚期和复发性胰腺癌的Ⅱ期临床试验  

Phase Ⅱ trial of low dosage S-1 concurrent with radiotherapy in patients with locally advanced or recurrent pancreatic cancer

作　　者：吴莉莉[1] 楼文晖 曾昭冲[1] 曾蒙苏 李婷婷[1] 姬巍[1] 

机构地区：[1]复旦大学附属中山医院放疗科,上海200032 [2]普外科 [3]影像科

出　　处：《上海医学》2011年第5期367-370,共4页Shanghai Medical Journal

摘　　要：目的探讨低剂量替吉奥同步放疗治疗局部晚期和复发性胰腺癌的疗效和安全性。方法收集16例经病理检查证实或符合临床诊断标准的局部晚期胰腺癌患者或术后复发患者，应用15MV直线加速器，肿瘤大体靶区（GTV）为肿瘤组织和转移淋巴结，临床靶区（CTV）=GTV，淋巴引流区不行预防性照射。计划靶区（PTV）=GTV＋1．0em，95％PTV接受总放疗剂量50．4Gy·28次^-1·5．5周。（单次剂量为1．8Gy）外放疗。同时予替吉奥40rag／次，每天1次，治疗前2．5～3．5h（中位数为3h）口服，1周5d。放疗结束4周后复查CT测量病灶体积改变，检测肿瘤标志物水平，用实体瘤疗效反应的评价标准（response evaluation criteria in solid tumors，RECIST）评价治疗效果，根据国立癌症研究所的常规毒性判定标准（NCICTCAE3．0）评价毒副反应。结果共入组16例患者，均完成放化疗。治疗有效率为3／16，肿瘤控制率为12／16。最常见的毒副反应为恶心（13／16）。无3度及以上骨髓抑制。所有毒副反应均属能够耐受范围。结论对局部晚期和复发胰腺癌，低剂量替吉奥同步放疗增敏是一种安全的同步选择。其毒副反应少，局控效果较好，但远期效果还有待观察。Objective To evaluate the efficacy and safety of low dosage S-1 concurrent with radiotherapy for treatment of patients with locally advanced or recurrent pancreatic cancer. Methods Eligibility criteria were pathologically confirmed or clinically diagnosed locally advanced or recurrent pancreatic cancer. S-1 was administered orally at a dose of 40 mg once daily 3 h before radiotherapy （5 days per week）. A total dose of 50.4 Gy was applied by daily fractions of 1.8 Gy, 5 days per week using a 15 MV linear accelerator. The gross tumor volume （GTV） was confined to the primary tumor and metastatic lymph nodes. Clinical target volume （CTV） = GTV, no prophylactic nodal irradiated, PTV= CTV ＋ 1.0 cm, and 95% PTV was encompassed within the isodose line. Toxicities were evaluated using the NCI CTCAE 3.0 （response evaluation criteria in solid tumors）. Tumor response was assessed using multidetector CT according to RECIST 4 weeks after treatment. Results A total of 16 patients were included for evaluation of efficacy and toxicity, The response rate and disease control rate were 3/16 and 12/16, respectively. The most common toxic reaction during concurrent radiotherapy was nausea （13/16）. There was no grade 3 or above myelosuppression, and all toxicities were tolerable and transient. Conclusions Low dose S-1 concurrent with radiotherapy shows favorable efficacy against locally advanced or recurrence pancreatic cancer, and it is well tolerated, but the long-term results still need to be further observed. （Shanghai Med J, 2011, 34.. 367-370）

关 键 词：胰腺癌 同步放化疗 替吉奥 局部晚期 

分 类 号：R735.9[医药卫生—肿瘤]