【作者】 佟仲生； 任秀宝； 李淑芬； 任宝柱； 汪旭； 曹水； 王忱； 何丽宏； 戴荣增； 张乃宁； 史业辉； 郝春芳； 巴一； 郝希山；

【Author】 Tong Zhong-Sheng Ren Xiu-Bao Li Shu-Fen Ren Bao-Zhu Wang Xu Cao Shui Wang Chen He Li-Hong Dai Rong-Zeng Zhang Nai-Ning Shi Ye-Hui Hao Chun-Fang Ba Yi Hao Xi-Shan Department of chemotherapy second, Tianjin medical university cancer hospital, Tianjin 300060, P.R.China

【机构】 天津医科大学附属肿瘤医院内二科；

【摘要】 目的:观察大剂量化疗联合自体造血干细胞支持方案和标准剂量化疗方案对乳腺癌术后生存期的影响。方法:人组为1998—2001年于我院经手术确诊为原发乳腺癌患者,腋窝淋巴结转移数目大于4枚伴ER(-)或局部晚期,或淋巴结超过10个以上阳性,且没有远处转移。采用非随机、配对方法,分为两组:①大剂量化疗联合干细胞移植组(试验组) ;②标准剂量化疗组(对照组)。两组病人均先行常规CAF 化疗三个周期,然后试验组接受C C E方案大剂量化疗 (CBP1000mg／m2,VP～16 1000mg／m2,CTX 120mg／KG), 对照组则接受三个周期的常规剂量化疗(CBP400mg／m2, VP～16 200mg／m2,CTX 500mg／m2)。移植后在骨髓无功能期给予输注血小板悬液及去白浓集红细胞等对症处理,并给予支持治疗及预防性抗生素处理,两组化疗结束后若雌激素和／或孕激素受体阳性,以三苯氧胺辅助内分泌序贯治疗, 20mg／d,共口服5年。并进行长期随访。结果:共入组30 对即60例,其中29对即58例可评价。所有病例无移植相关性死亡。经统计显示试验组第1-5年的无病生存率分别为 96．55％、79．31％、68．97％、58．62％和41．38％,而对照组的第1-5年的无病生存率93．10％、82．76％、62．07％、 51．72％和37．93％,经x2检验无统计学意义,但除了第二年以外,试验组均高于对照组。试验组的1-5年的总生存率分别为100．0％,100．0%,93．10％、79．31％、68．97％,而对照组的1-5年总生存率则分别为96．55％、86．21％、65．52％、 51．72％和41．38％,经x2检验后五年的生存率均存在统计学意义,试验组优于对照组。讨论:大剂量化疗联合干细胞移植治疗术后的高危乳腺癌可以提高患者的5年总生存率, 优于常规剂量组,但并不能改善患者的5年无病生存率。更多还原

【Abstract】 Objective: Investigation of high-dose ehemotherapy(HD-CT) followed by autologous hemato-poietic stem-cell support compared with standard-dose chemotherapy(SD-CT) as adjuvant treatment in patients with primary breast cancer and 4 or more positive axillary lymph nodes. Methods: Between 1998-20013 patients were randomized to receive (following three cycles of standard-dose C AF regimens either HD-CT of cyclo-phosphamide 120mg/kg, Carboplatin 1000mg/m2,and etoposide 1000mg/m2, intravenously for 4 consecutive days followed by stem-cell support,or SD-CT in three cycles of cyclophosphamide 500mg/mg2, Carboplatin 400mg/m2, and etoposide 200mg/m2, every 28 days. The primary end point was disease-free survival and overall survival. Results: After a median follow of 5.6 years, Disease- free survival have been observed no difference(HD-CT: 96.55%, 79.31%, 68.97%, 58.62% 和 41.38%, SD-CT: 93.10%, 82.76%, 62.07%, 51.72% 和 37.93%) between lst-5th years, however over all survival have been observed significance(p<0.05) (HD-CT: 100.0%,100.0%, 93.10%, 79.31%, 68.97%, SD-CT: 96.55%, 86.21%, 65.52%, 51.72% 和41.38%) between 1st-Sth years. Conclusion: our finding of significant improvement in overall survival for HD-CT compared with SD-CT, Futher follow-up and a meta-analysis of all randomized studies will reveal the effert of HD-CT as compared eith SD-CT as adjuvant treatment in high-risk breast cancer.更多还原