恩度联合卡培他滨治疗晚期乳腺癌的临床观察(1)
【摘要】 目的 评价重组人血管内皮抑制素注射液(恩度)联合卡培他滨治疗晚期乳腺癌的有效性和安全性。方法 经病理学确定的Ⅳ期乳腺癌患者6例，其中浸润性导管癌4例，浸润性小叶癌1例，髓样癌1例，均接受恩度联合卡培他滨的治疗。恩度15 mg加生理盐水500 ml匀速缓慢静脉滴注1～14 d，间歇7 d，重复给药；卡培他滨每日2 500 mg/m2 分早、晚2次 口服，于饭后半小时用水吞服， 1～14 d，休息7 d， 21 d为一周期。按照RECIST标准评价近期疗效，参照Kamofsky评分(KPS)变化评价生活质量(QOL)。按照NCI.CTC3.0版标准评价毒性反应，用药1周期即可评价毒性，2周期后方可评价疗效。结果 6例患者均可评价客观疗效和安全性。共完成26个周期，平均为4.3个周期，获得CR 1例、PR 2例、SD 2例、PD 1例。客观有效率(RR)(3/6)，疾病控制率(DCR)(5/6)，生活质量改善者4例、稳定1例、下降1例。C3/4级毒性主要与化疗药物有关，白细胞下降1例，血小板下降1例，恶心、呕吐1例。结论 恩度联合卡培他滨治疗晚期乳腺癌具有协同作用，疗效好，毒性低，安全性好，可改善患者的生活质量，值得进一步研究观察。
, http://www.100md.com
【关键词】 重组人血管内皮抑制素(恩度)；卡培他滨；乳腺癌；化疗
Clinical observation of therapeutic effect Rh-endostatin(Edostar,YH-16) and capecitabine on terminal breast cancel SONG -Shijun,JIA Liang The Third AffiliatedHospital of Xinxiang Medical College，Henan 453003,China
【Abstract】 Objective To evaluate the validity and drug safety of Edostar and capecitabine on terminal breast canner. Methods Six stage Ⅳ breast cancer patients by pathological were observed. 4 cases of breast infiltrative ductal carcinoma, one case of breast invasive lobular carcinom and one case ofbreast medullary carcinoma were treated with Edostar and Capecitabine. Capecitabine(2500 mg/m2,twice per day) was performed with orally administration in the first 14 days in one course of treatment (21 days). Edostar (15 mg in 500 ml saline) was injected intravenously in the first 14 days too. Then evaluated the effection by RECIST,the live quality by KPS and adverse reaction by NCL.CTC3.0. The adverse reaction was evaluated after two courses of treatment. Results 26 cycles of treatment was performed to the six patients. CR,PR,SD and PD took place in one case,two cases, two cases and one case respectively. The RR was (3/6) and the DCR was (5/6).Having good quality life, stable life and bad quality life was four cases, one case and one case respectivaly.
, 百拇医药
The stage G 3/4 adverse reactionwas correlate to Edostar and cappcitabine. The decreasing levels of interleukin ,platelet were took place in two patients respectively. And nausea and vomit was took place in one patients.Conclusions The Edostar and Capecitabine on terminal breast cancer has advantages including good therapeutic effects, less adverse reaction and high quality live for the patients and it worth further study.
【Key words】 Rh-endostatin(Edostar,YH-16)；Capecitabine；Breast cancer ；Chemotherapy
, http://www.100md.com
重组人血管内皮抑制素注射液(YH-16.Endostar，恩度)是我国学者自主创新研发的新产品，实验研究，其能够强烈抑制血管内皮增殖和肿瘤生长。Ⅰ、Ⅱ期临床研究证实其有有效性和 安全性。Ⅲ期临床研究中恩度与NP方案联合治疗晚期非小细胞肺癌(NSCLC).显著提高客观疗效，延长生存时间并改善患者的生活质量[1] 。已被2006年NCCN 、NSCL临床实践指南(中国版)推荐为一线治疗药物。但恩度应用在晚期乳腺癌的治疗尚未见报道，我们从2007年以来应用恩度联合卡培他滨治疗晚期乳腺癌6例效果好，现报告如下。
1 资料和方法
1.1 病例资料 6例患者均为术后经病理组织学确诊者，曾接受过一种或多种方案的联合治疗，出现进展的Ⅳ期患者。比例均为女性，年龄36～52岁，平均43.8岁，KPS60分者2例、KPS<60分者4例，具有CT或MRI可测量的客观病灶及ECT检查结果、血常规，肝、肾功能及心脏功能检查结果。4例预期生存期3个月，2例预期生存期<3个月，患者及家属自愿要求接受恩度治疗，并与患者和家属签订协议书。
1.2 治疗方案 6例患者均采用恩度加卡培他滨治疗，恩度(山东烟台先声麦得 津生物工程有限公司生产)国药准字S20050088 )剂量为15 mg/次 加入生理盐水500 ml中，缓慢静脉滴注，时间为3~4 h， 1~14 d，间歇7 d后进行第2周期治疗；卡培他滨(上海罗氏公司)每日2 500 mg/m2 分早、晚2次 口服，于饭后半小时用水吞服， 1~14 d，休息7 d， 21 d为1个周期。治疗1周后即可评价毒性、2周后方可评价疗效，对于稳定和有效者继续应用该方案治疗至4~6个周期。
, 百拇医药(宋士军 贾 良)
, http://www.100md.com
【关键词】 重组人血管内皮抑制素(恩度)；卡培他滨；乳腺癌；化疗
Clinical observation of therapeutic effect Rh-endostatin(Edostar,YH-16) and capecitabine on terminal breast cancel SONG -Shijun,JIA Liang The Third AffiliatedHospital of Xinxiang Medical College，Henan 453003,China
【Abstract】 Objective To evaluate the validity and drug safety of Edostar and capecitabine on terminal breast canner. Methods Six stage Ⅳ breast cancer patients by pathological were observed. 4 cases of breast infiltrative ductal carcinoma, one case of breast invasive lobular carcinom and one case ofbreast medullary carcinoma were treated with Edostar and Capecitabine. Capecitabine(2500 mg/m2,twice per day) was performed with orally administration in the first 14 days in one course of treatment (21 days). Edostar (15 mg in 500 ml saline) was injected intravenously in the first 14 days too. Then evaluated the effection by RECIST,the live quality by KPS and adverse reaction by NCL.CTC3.0. The adverse reaction was evaluated after two courses of treatment. Results 26 cycles of treatment was performed to the six patients. CR,PR,SD and PD took place in one case,two cases, two cases and one case respectively. The RR was (3/6) and the DCR was (5/6).Having good quality life, stable life and bad quality life was four cases, one case and one case respectivaly.
, 百拇医药
The stage G 3/4 adverse reactionwas correlate to Edostar and cappcitabine. The decreasing levels of interleukin ,platelet were took place in two patients respectively. And nausea and vomit was took place in one patients.Conclusions The Edostar and Capecitabine on terminal breast cancer has advantages including good therapeutic effects, less adverse reaction and high quality live for the patients and it worth further study.
【Key words】 Rh-endostatin(Edostar,YH-16)；Capecitabine；Breast cancer ；Chemotherapy
, http://www.100md.com
重组人血管内皮抑制素注射液(YH-16.Endostar，恩度)是我国学者自主创新研发的新产品，实验研究，其能够强烈抑制血管内皮增殖和肿瘤生长。Ⅰ、Ⅱ期临床研究证实其有有效性和 安全性。Ⅲ期临床研究中恩度与NP方案联合治疗晚期非小细胞肺癌(NSCLC).显著提高客观疗效，延长生存时间并改善患者的生活质量[1] 。已被2006年NCCN 、NSCL临床实践指南(中国版)推荐为一线治疗药物。但恩度应用在晚期乳腺癌的治疗尚未见报道，我们从2007年以来应用恩度联合卡培他滨治疗晚期乳腺癌6例效果好，现报告如下。
1 资料和方法
1.1 病例资料 6例患者均为术后经病理组织学确诊者，曾接受过一种或多种方案的联合治疗，出现进展的Ⅳ期患者。比例均为女性，年龄36～52岁，平均43.8岁，KPS60分者2例、KPS<60分者4例，具有CT或MRI可测量的客观病灶及ECT检查结果、血常规，肝、肾功能及心脏功能检查结果。4例预期生存期3个月，2例预期生存期<3个月，患者及家属自愿要求接受恩度治疗，并与患者和家属签订协议书。
1.2 治疗方案 6例患者均采用恩度加卡培他滨治疗，恩度(山东烟台先声麦得 津生物工程有限公司生产)国药准字S20050088 )剂量为15 mg/次 加入生理盐水500 ml中，缓慢静脉滴注，时间为3~4 h， 1~14 d，间歇7 d后进行第2周期治疗；卡培他滨(上海罗氏公司)每日2 500 mg/m2 分早、晚2次 口服，于饭后半小时用水吞服， 1~14 d，休息7 d， 21 d为1个周期。治疗1周后即可评价毒性、2周后方可评价疗效，对于稳定和有效者继续应用该方案治疗至4~6个周期。
, 百拇医药(宋士军 贾 良)