文档介绍：Chandra P. Belani MD
Professor of Medicine
University of Pittsburgh School of Medicine
Co-Director, Lung & Thoracic Cancer Program
University of Pittsburgh Cancer Institute
非小细胞肺癌(NSCLC)目前治疗进展及未来发展方向
NSCLC:诊断时分期及生存
Mountain. Chest. 1997;1710-1717.
Stage I
Stage II
Stage III
Stage IV
0
20
40
60
80
100
生存比例
诊断时分期
St I
St II
St IIIA
St IIIB
St IV
两药方案一线治疗晚期NSCLC的合理性
Good PS 患者
1990s: 含铂方案是治疗标准NSCLC Collaborative Group BMJ. 1995;311:899-909
目前ASCO指南:
含铂两药方案或非铂两药方案是具有较佳PS晚期NSCLC的治疗标准Pfister et al. J Clin Oncol. 2004;22:330-353
ECOG 1594: 研究设计
分层:
分期: IIIB vs IV
PS: 0–1 vs 2
体重降低: 5% vs 5%
CNS 转移: no vs yes
Arm A: 顺铂+ 泰素
泰素: 135 mg/m2/24 h Day 1
顺铂: 75 mg/m2 day 2
q3wk
Arm D: 卡铂+ 泰素
泰素: 225 mg/m2/3 h Day 1
卡铂: AUC 6 Day 1
Arm C: 顺铂+ 多西他赛
多西他赛: 75 mg/m2 Day 1
顺铂: 75 mg/m2 Day 1
Arm B: 顺铂+ 双氟胞苷
双氟胞苷: 1000 mg/m2 Days 1, 8, 15
顺铂: 100 mg/m2 Day 1
q4wk
q3wk
q3wk
Schiller JH, et al. Proc ASCO 36th Annual Meeting. 2000;19:abstr 2.
Schiller JH, et al. N Engl J Med. 2002;346:92-98.
R
A
N
D
O
M
I
Z
E
E1594
TAX326 研究设计
RANDOMIZE
分层因素:
疾病分期
IIIB vs. IV
和
区域
US/Canada
South America
Europe/Lebanon
Israel
SouthAfrica/AustraliaNew Zealand
Response assessment every 2 cycles
多西他赛 75mg/m2 IV 卡铂 AUC 6 IV Q 3 wks
去甲长春花碱 25mg/m2 IV D 1, 8, 15 & 22顺铂 100mg/m2 IV D 1Q 4 wks
多西他赛 75mg/m2 IV顺铂 75mg/m2 IV Q 3 wks
vs.
or
TAX 326 总生存
Fossella et al. J . 2003;21:3016-3024.
100
80
60
40
20
0
Survival (%)
0
3
6
9
12
15
18
21
24
27
30
33
Time (months)
TC
VC
100
80
60
40
20
0
Survival (%)
0
3
6
9
12
15
18
21
24
27
30
33
Time (months)
P = .657, adjustedlog-rank test
TCb
VC
1-y survival 46% vs 41% with VC
2-y survival 21% vs 14% with VC
Median survival: vs mo
P = .044, adjusted log-rank test
1-y survival 38% vs 40% with VC
2-y survival 18% vs 14% with VC
«
R
A
N
D
O
M
I
Z
E
方案设计
分层
前6个月体重降低:
<5% vs ≥5%
疾病分期:
湿性IIIB,
IV
是否脑转移:
双氟胞苷 1000 mg/m2 d 1,8
泰素 200 mg