NSCLC辅助及晚期化疗

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Chemotherapy
No chemotherapy
935
932
61%
61%
39%
39%
44.5%
40.4% P <
0.03
39.4%
34.4%
50.8
44.4
40.2
30.5
44.5%vs 40.4%
Adjuvant chemotherapy with a cisplatin-based regimen should be considered in patients who maintain a good performance status after surgical resection.
Trial
Stage IA Stage IB Stage II Stage IIIA
IALT[6] NCIC[7] CALGB[8] ANITA[9]
Negative Not tested Not tested Not tested
Negative Negative Positive Negative
%
Value
44.5
< .03
Winton et al[7] (JBR.10) 2004
Strauss et al[8] (CALGB 9633) 2004
Rosell et al[9] (ANITA) 2005
OBS
40.4
482 Cisplatin-Vinorelbine
69
.03
OBS
54
344 Carboplatin-Paclitaxel 71 (4 years) .028
总例数:344例 5-y生存:59%:57% P=0.375
ANITA: phase III adjuvant vinorelbine (N) and cisplatin (P) versus observation in completely resected (stage I-III) non-small cell lung cancer Rosell R 2005
ANITA: Rosell R 2005
Subset analysis of the ANITA trial demonstrated that significant improvement in survival was restricted to stage II and IIIA patients, and no benefit was observed in stage IB disease. The investigators recommend cisplatin-vinorelbine as standard of care after total resection for stages IIA, IIB, and IIIA.
840 patients IB (T2N0),
II, IIIA
R
A
cisplatin 100 mg/m2 day 1
N
vinorelbine 30 mg/m2/week
every 4 weeks
D
O
M
I
observation
Z end point: 2-year survival
E secondary end point:relapse-free survival
NSCLC辅助及晚期化疗
600,000 500,000 400,000 300,000 200,000 100,000
0
332,286 261,839

2000
2005
497wenku.baidu.com908 381,487
165,622 119,648


Standard of care for early-stage disease depends upon whether the patient is a candidate for surgery. With surgical resection, the 5-year survival rate for patients with stage IB NSCLC is 57% and less than 50% for patients with stage II disease. While local disease recurs in approximately one third of patients following surgical resection, distant disease is the primary cause of death for patients with early-stage NSCLC.
ANITA: Rosell R 2005
70 months follow-up : median survival : 65.8 months vs 43.7 months
Five-year survival
stage
adjuvant therapy arm
OBS
I
62%
63%
II
52%
39%
III
OBS 840 Cisplatin-Vinorelbine
59 (4 years) 51
.0131
OBS
43
IALT Trial Results
N Stage I and II disease Stage III disease 5-year OS
5-year DFS Median survival (months) Median DFS (months)
Author and Year Published Arriagada et al[6] (IALT) 2004
# Pts Treatment Groups
1867 Cisplatin and either: Etoposide Vinorelbine Vindesine Vinblastine
5-Year Survival P
42%
26%
ANITA: Rosell R 2005
Grade 3/4 toxicities in the experimental arm :
neutropenia
86%,
febrile neutropenia
8.5%,
nausea-vomiting
27%,
constipation
5%,
peripheral neuropathy 3%.
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