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【medical-news】Gemcitabine/Cisplatin Combo Improves Survival in Biliary Tract Cancers吉西他滨联合顺铂延长胆道癌生存期

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Gemcitabine/Cisplatin Combo Improves Survival in Biliary Tract Cancers
吉西他滨联合顺铂延长胆道癌生存期
Elsevier Global Medical News. 2009 May 14, K Wachter
The combination of cisplatin and gemcitabine improved overall survival and progression-free survival by 30% over gemcitabine alone in patients with advanced biliary tract cancers, offering what could become the standard of care for this difficult-to-treat cancer.
The results come from the phase III ABC-02 study involving 410 patients with advanced biliary tract, gallbladder, or ampullary carcinoma, which Dr. Juan W. Valle reported during a teleconference held May 14, by the American Society of Clinical Oncology.
Patients on the combination therapy had a 30% reduction in risk of death (Hazard ratio 0.70), compared with those who received gemcitabine (Gemzar) alone. Median survival for the combination therapy group reached 11.7 months, compared with 8.3 months for gemcitabine alone group (P = .002).
"We consider cisplatin and gemcitabine to now be the worldwide standard of care and the backbone for further studies of patients with advanced biliary tract cancers," said Dr. Valle, who is a senior lecturer and medical oncologist at the University of Manchester in the United Kingdom and the Christie NHS Foundation Trust in Manchester.
ASCO President Dr. Richard L. Schilsky, who co-moderated the session, welcomed the results. "As one who treats these patients in my own clinic, it's very comforting to now have a clear standard of care to offer," he said.
The combination therapy also significantly improved progression-free survival, reducing the risk of progression by 30%. The benefit of combining the two drugs comes without adding clinically significant toxicity, said Dr. Valle. Progression-free survival data will be presented along with toxicity data at the ASCO annual meeting.
For this study, patients had to be at least 16 years old with histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma. Intra- or extra-hepatic disease was allowed. Disease could be unresectable locally advanced, recurrent, or metastatic. Patients with brain metastases were excluded.
Patients had to have a life expectancy of least 3 months. At least 6 months had to have passed since prior adjuvant chemotherapy. Patients could not have had prior chemotherapy with gemcitabine or cisplatin.
Prior radiotherapy for localized disease was allowed provided there was clear evidence of disease progression afterward. Likewise, prior curative surgery was allowed provided there was evidence of nonresectable disease relapse requiring systemic chemotherapy.
Eligible patients were randomized to either treatment with gemcitabine alone (204 participants) or in combination with cisplatin (206). Patients were stratified by center, primary site, performance status, prior therapy, and locally advanced vs. metastatic disease.
In the gemcitabine-only arm, the drug was administered at a dose of 1,000 mg/m² on days 1, 8, and 15 out of a 28-day cycle. Patients in this arm underwent 6 cycles (24 weeks). Patients in the combination arm received 1,000 mg/m² gemcitabine and 25 mg/m² cisplatin on days 1 and 8 of a 21-day cycle. Patients in the combination arm underwent 8 cycles (24 weeks).
In both groups, management upon disease progression was at the clinician's discretion, though this was primarily supportive care.
Gemcitabine is manufactured by Eli Lilly and Co., and is indicated for the treatment of breast cancer, non-small cell lung, and pancreatic cancer. Cisplatin is indicated for the treatment of metastatic testicular tumors, metastatic ovarian tumors, and advanced bladder cancer.
The study was funded by Cancer Research UK, under the auspices of the National Cancer Research Network.
http://www.acep.org/ElsevierRSSfeed.aspx?feed=1

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2009-05-16 20:06 浏览 : 832 回复 : 2

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本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。

2009-05-26 08:20

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Gemcitabine/Cisplatin Combo Improves Survival in Biliary Tract Cancers
吉西他滨联合顺铂延长胆管癌生存期

Elsevier Global Medical News. 2009 May 14, K Wachter
爱思维尔全球医学新闻。2009年5月14日，K Wachter报道

The combination of cisplatin and gemcitabine improved overall survival and progression-free survival by 30% over gemcitabine alone in patients with advanced biliary tract cancers, offering what could become the standard of care for this difficult-to-treat cancer.
顺铂与吉西他滨的联合使用使得晚期胆管癌患者的总体生存率和疾病无进展生存率与单用吉西他滨的患者相比提高了30%。对于这种很难治疗的癌症，该治疗方法为人们提供了一个可以作为其治疗标准的处理方法。

The results come from the phase III ABC-02 study involving 410 patients with advanced biliary tract, gallbladder, or ampullary carcinoma, which Dr. Juan W. Valle reported during a teleconference held May 14, by the American Society of Clinical Oncology.
该结果是从一项包括了410例晚期胆管癌、胆囊或壶腹癌的患者的，称为“ABC-02”的三期试验得来的。该结果是由Juan W. Valle博士在5月14日举行的，由美国临床肿瘤学会召开的一个远程会议上公布的。

Patients on the combination therapy had a 30% reduction in risk of death (Hazard ratio 0.70), compared with those who received gemcitabine (Gemzar) alone. Median survival for the combination therapy group reached 11.7 months, compared with 8.3 months for gemcitabine alone group (P = .002).
与目前公认的单用吉西他滨（商品名：健择）相比，上述联合治疗方法使得死亡风险（危害比：0.70）减少了30%。联合治疗组的中位生存时间达到了11.7个月，而单用吉西他滨组只有8.3个月（P=0.002）。

"We consider cisplatin and gemcitabine to now be the worldwide standard of care and the backbone for further studies of patients with advanced biliary tract cancers," said Dr. Valle, who is a senior lecturer and medical oncologist at the University of Manchester in the United Kingdom and the Christie NHS Foundation Trust in Manchester.
英国联合王国的曼彻斯特大学和曼彻斯特Christie国家卫生局基金会的高级讲师、医学肿瘤学医师Valle博士说道：“我们认为顺铂与吉西他滨的联用现在已经是直接范围的治疗标准。同时它也是晚期胆管癌患者进一步治疗的主线。”

ASCO President Dr. Richard L. Schilsky, who co-moderated the session, welcomed the results. "As one who treats these patients in my own clinic, it's very comforting to now have a clear standard of care to offer," he said.
美国临床肿瘤学会的Richard L. Schilsky博士是该机构的合作协调人，他对该结果表示了欢迎。他说：“因为我在自己的诊所会遇到这样的患者，而现在有了这样一个值得参考的明朗的治疗标准，我感到非常欣慰。”

The combination therapy also significantly improved progression-free survival, reducing the risk of progression by 30%. The benefit of combining the two drugs comes without adding clinically significant toxicity, said Dr. Valle. Progression-free survival data will be presented along with toxicity data at the ASCO annual meeting.
该联合治疗方法同样显著地提高了疾病无进展生存率。疾病进展的风险减少了30%。Valle博士说道：“这两种药的联用带来了治疗效果的进步，而且这种进步不附带有临床可见的显著毒力的增加。”疾病无进展生存率的相关数据将与其相应的毒力数据一起在美国临床肿瘤学会的年会上汇报。

For this study, patients had to be at least 16 years old with histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma. Intra- or extra-hepatic disease was allowed. Disease could be unresectable locally advanced, recurrent, or metastatic. Patients with brain metastases were excluded.
在这项研究中，患者年龄都在16岁以上，每例患者都有组织学或细胞学确诊的胆管癌、胆囊或壶腹癌。可以伴有肝内或肝外的疾病。而那些因局部侵犯导致无法切除，复发患者，或者有脑转移的患者被剔除在外。

Patients had to have a life expectancy of least 3 months. At least 6 months had to have passed since prior adjuvant chemotherapy. Patients could not have had prior chemotherapy with gemcitabine or cisplatin.
这些患者至少要有3个月的预期寿命。至少离前期的辅助化疗有6个月。同时，这些患者既往不能有包含吉西他滨或者顺铂的化疗史。

Prior radiotherapy for localized disease was allowed provided there was clear evidence of disease progression afterward. Likewise, prior curative surgery was allowed provided there was evidence of nonresectable disease relapse requiring systemic chemotherapy.
当能证实疾病在进展后，前期的针对局部疾病的放射疗法是允许的。同样的道理，前期的根治性手术也是允许的，只要这种不能切除的疾病复发，需要全身性化疗就行。

Eligible patients were randomized to either treatment with gemcitabine alone (204 participants) or in combination with cisplatin (206). Patients were stratified by center, primary site, performance status, prior therapy, and locally advanced vs. metastatic disease.
这些满足适应症的患者被随机分至单用吉西他滨组（204例）和顺铂-吉西他滨联用组（206例）。患者通过中心、原发部位、身体状态、前期治疗和局部进展/转移情况来分层研究。

In the gemcitabine-only arm, the drug was administered at a dose of 1,000 mg/m² on days 1, 8, and 15 out of a 28-day cycle. Patients in this arm underwent 6 cycles (24 weeks). Patients in the combination arm received 1,000 mg/m² gemcitabine and 25 mg/m² cisplatin on days 1 and 8 of a 21-day cycle. Patients in the combination arm underwent 8 cycles (24 weeks).
单用吉西他滨组的患者于第1、8天和第15天给药。每次的量为1000毫克/平方米，28天为一疗程。患者经历6个疗程（24周）。联用组的患者在第1天和第8天接受1000毫克/平方米的吉西他滨和25毫克/平方米的顺铂。21天为一疗程。联用组的患者经历8个疗程（24周）。

In both groups, management upon disease progression was at the clinician's discretion, though this was primarily supportive care.
本试验对两组患者的疾病进展的处理是由临床医师慎重决定的。尽管该疗法是一个基本的支持性疗法。

Gemcitabine is manufactured by Eli Lilly and Co., and is indicated for the treatment of breast cancer, non-small cell lung, and pancreatic cancer. Cisplatin is indicated for the treatment of metastatic testicular tumors, metastatic ovarian tumors, and advanced bladder cancer.
本实验所用的药物吉西他滨是由礼来公司制造的。该药物适用于乳腺癌、小细胞肺癌和胰腺癌的治疗。顺铂适用于转移性睾丸癌、转移性卵巢肿瘤和晚期膀胱癌的治疗。

The study was funded by Cancer Research UK, under the auspices of the National Cancer Research Network.
该研究是由英国癌症研究所资助的。后者是由国家癌症研究网络赞助的。

编译：共1192字

吉西他滨联合顺铂延长胆管癌生存期

爱思维尔全球医学新闻。2009年5月14日，K Wachter报道

顺铂与吉西他滨的联合使用使得晚期胆管癌患者的总体生存率和疾病无进展生存率与单用吉西他滨的患者相比提高了30%。对于这种很难治疗的癌症，该治疗方法为人们提供了一个可以作为其治疗标准的处理方法。

该结果是从一项包括了410例晚期胆管癌、胆囊或壶腹癌的患者的，称为“ABC-02”的三期试验得来的。该结果是由Juan W. Valle博士在5月14日举行的，由美国临床肿瘤学会召开的一个远程会议上公布的。

与目前公认的单用吉西他滨（商品名：健择）相比，上述联合治疗方法使得死亡风险（危害比：0.70）减少了30%。联合治疗组的中位生存时间达到了11.7个月，而单用吉西他滨组只有8.3个月（P=0.002）。

英国联合王国的曼彻斯特大学和曼彻斯特Christie国家卫生局基金会的高级讲师、医学肿瘤学医师Valle博士说道：“我们认为顺铂与吉西他滨的联用现在已经是直接范围的治疗标准。同时它也是晚期胆管癌患者进一步治疗的主线。”

美国临床肿瘤学会的Richard L. Schilsky博士是该机构的合作协调人，他对该结果表示了欢迎。他说：“因为我在自己的诊所会遇到这样的患者，而现在有了这样一个值得参考的明朗的治疗标准，我感到非常欣慰。”

该联合治疗方法同样显著地提高了疾病无进展生存率。疾病进展的风险减少了30%。Valle博士说道：“这两种药的联用带来了治疗效果的进步，而且这种进步不附带有临床可见的显著毒力的增加。”疾病无进展生存率的相关数据将与其相应的毒力数据一起在美国临床肿瘤学会的年会上汇报。

在这项研究中，患者年龄都在16岁以上，每例患者都有组织学或细胞学确诊的胆管癌、胆囊或壶腹癌。可以伴有肝内或肝外的疾病。而那些因局部侵犯导致无法切除，复发患者，或者有脑转移的患者被剔除在外。

这些患者至少要有3个月的预期寿命。至少离前期的辅助化疗有6个月。同时，这些患者既往不能有包含吉西他滨或者顺铂的化疗史。

当能证实疾病在进展后，前期的针对局部疾病的放射疗法是允许的。同样的道理，前期的根治性手术也是允许的，只要这种不能切除的疾病复发，需要全身性化疗就行。

这些满足适应症的患者被随机分至单用吉西他滨组（204例）和顺铂-吉西他滨联用组（206例）。患者通过中心、原发部位、身体状态、前期治疗和局部进展/转移情况来分层研究。

单用吉西他滨组的患者于第1、8天和第15天给药。每次的量为1000毫克/平方米，28天为一疗程。患者经历6个疗程（24周）。联用组的患者在第1天和第8天接受1000毫克/平方米的吉西他滨和25毫克/平方米的顺铂。21天为一疗程。联用组的患者经历8个疗程（24周）。

本试验对两组患者的疾病进展的处理是由临床医师慎重决定的。尽管该疗法是一个基本的支持性疗法。

本实验所用的药物吉西他滨是由礼来公司制造的。该药物适用于乳腺癌、小细胞肺癌和胰腺癌的治疗。顺铂适用于转移性睾丸癌、转移性卵巢肿瘤和晚期膀胱癌的治疗。

该研究是由英国癌症研究所资助的。后者是由国家癌症研究网络赞助的。（丁香）

2009-05-27 12:44

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marcoai 编辑于 2009-05-28 07:00

• 临床要不要去做超声？超声科待遇怎么样？

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