研究者介绍了4组cetuximab对晚期 CLC患者的治疗活性的临床结果。1)在一项随机II期临床试验中，Erbitux联合顺铂(Ci latin)和长春瑞宾(vinorelbine)，响应率由32.3%提高到了53.3%。2)在一项对61位未化疗的 CLC患者的IB/IIA临床试验中，Erbitux 吉西他滨(gemcitabine) 卡铂(Carboplatin)联合治疗，部分响应率为28.6%。疾病稳定率为60%，疾病控制率为88.6%。3)在一项对31位预先未治患者的I/II期临床试验中，Erbitux 紫杉醇(paclitaxel) 卡铂联合方案，部分响应率为29%，疾病稳定率为35.5%，疾病控制率为 64.5%，中位生存期为472天。4)在对47例对化疗有复发或者抵抗的患者的II期临床试验中，Erbitux 多烯紫杉醇(Docetaxel)方案，完全响应率为1.9%，部分响应率为20.4%，疾病稳定率为33.3%，疾病控制率达55.6%。以上试验中最常见的非血液毒性包括痤疮状皮疹，感染及疲劳。
克罗拉多大学癌症中心教授Bu PA指出，这些早期研究数据表明cetuximab与化疗联合可以获得比单独化疗更好的治疗效果。更多的试验将用来评估cetuximab的具体疗效。
ERBITUX(C225、Cetuximab)英文说明书
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ERBITUXTM Rx only
1
(Cetuximab) 2
For intravenous use only. 3
WARNING 4
Infusion Reactio : Severe infusion reactio
occurred with the administration of 5
ERBITUX in a roximately 3% of patients, rarely
with fatal outcome (<1 in 1000). 6
A roximately 90% of severe infusion reactio
were a ociated with the first infusion of 7
ERBITUX. Severe infusion reactio are
characterized by rapid o et of airway 8
o truction (broncho asm, stridor, hoarsene ),
urticaria, and hypote ion (see 9
WARNINGS and ADVERSE REACTIO ). Severe infusion
reactio require 10
immediate interruption of the ERBITUX infusion and
permanent discontinuation from 11
further treatment. (See WARNINGS: Infusion
Reactio and DOSAGE AND 12
ADMINISTRATION: Dose Modificatio .) 13
DESCRIPTION 14
ERBITUXTM (Cetuximab) is a recombinant,
human/mouse chimeric monoclonal 15
antibody that binds ecifically to the
extracellular domain of the human epidermal 16
growth factor receptor (EGFR). ERBITUX is composed
of the Fv regio of a murine 17
anti-EGFR antibody with human IgG1 heavy and ka a
light chain co tant regio and 18
has an a roximate molecular weight of 152 kDa.
ERBITUX is produced in mammalian 19
(murine myeloma) cell culture. 20
ERBITUX is a sterile, clear, colorle liquid of
pH 7.0 to 7.4, which may contain a small 21
amount of easily visible, white, amorphous,
Cetuximab particulates. Each single-use, 22
50-mL vial contai 100 mg of Cetuximab at a
concentration of 2 mg/mL and is 23
formulated in a preservative-free solution
containing 8.48 mg/mL sodium chloride, 24
1.88 mg/mL sodium pho hate dibasic heptahydrate,
0.42 mg/mL sodium pho hate 25
monobasic monohydrate, and Water for Injection,
U . 26
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CLINICAL PHARMACOLOGY 27
General 28
ERBITUX binds ecifically to the epidermal growth
factor receptor (EGFR, HER1, 29
c-Er -1) on both normal and tumor cells, and
competitively inhibits the binding of 30
epiderm
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