文档介绍：Phase Ill. Randomized Double-Blind
Controlled Trial: Study Design
Letrozole mg daily
Placebo
No pror teatment for MBC D
letrozole mg
Lapatinib 1500
N=1286 (including n=219
Age Distribution
Data from Shanghai Cancer Institute
5-yr disease-free
5-yr recurrence
Gain from adjuvant chemotherapy
70
700
10200
Risk reduction: 30%/0>20%, 10/30=33%
e Absolute benefit: 10%
70% always free
20%o always recurred
超过2/3的乳腺癌复发为远处转移
对侧乳腺癌
(9%-11%)
%
局部复发
(16%-28%)
远处转移
%
%
BIG= Breast International Group
Baum et al. Lancet. 2002 359 :2131
Thurlimann et al N Eng/ Med. 2005: 363: 2747.
晚期乳腺癌治疗目的
控制疾病,缓解症状
提高患者的生活质量,延长高质量的生存期
DIagnosIs Of MBC
全面评估
内
分泌
化疗
First
rapy
-N resp
Sasond-line chemotherapy
Thircl-ll
Progress
Supportive Care
乳腺癌的分子分型与内科治疗方法
Luminar A/B
ER(+)和/或PR(+)
Her-2阳性
靶向
内分地
化疗
所有类型MBC
受体三阴性
全身化疗
针对所有类型的晚期乳腺癌
晚期乳腺癌的化疗发展史
Approved specifically
for first-line use in MBC
Trastuzumab
Docetaxel Capecitabine
Lapatinib
Methotrexate
1996
1998
Gemcitabine 2006
1971
2004
Nab paclitaxel
Cyclophosphamide Doxorubicin Paclitaxel
2005
1959
1974
1994
Platinums
Ixabepilone
5-FU
2007
196
evaclzuma
2008
1955
1965
19751985
1995
2005
2015
Accessed on-line at fda. gov/cder/cancer/druglistframe htm
晚期乳腺癌化疗适应证
病变发展迅速
内脏转移,如肝、肺广泛转移
无病生存期(DFS)<2年
ER和PR阴性
既往内分泌治疗无效