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肺癌靶向药物

ID #1039

索坦(舒尼替尼)中文说明书

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  舒尼替尼(索坦)——肾癌、胃肠间质瘤、非小细胞肺癌、肝癌新药。索坦(苹果酸舒尼替尼)
  ★ 舒尼替尼:最新靶向治疗药物,双通道、多靶点酪氨酸激酶抑制剂
  ★ 舒尼替尼:抑制癌细胞生长、阻断肿瘤生长所需血液和营养物质供给
  ★ 舒尼替尼:显著延长总体生存期、有效改善主客观症状和体征
  ★ 舒尼替尼:广泛用于肾细胞癌、胃肠间质瘤、肺癌、肝癌等实体瘤
  ★ 舒尼替尼:作用强、起效快、依从性好、不良反应轻、口服方便
  舒尼替尼(Sunitinib,Sutent)是一种新型多靶向性的治疗肿瘤的口服药物。舒尼替尼的首要开发目标为,用于治疗对标准疗法没有响应或不能耐受之胃肠道基质肿瘤和转移性肾细胞癌。舒尼替尼能选择性地靶向某些蛋白的受体,后者被认为在肿瘤生长过程中起着一种分子开关样的作用。舒尼替尼的上述适应证已在美国获得了FDA授予的“快通道”审批地位。
  舒尼替尼是一类能够选择性地靶向多种受体酪氨酸激酶的新型药物中的第一个药物。抑制受体酪氨酸激酶被认为可经阻断肿瘤生长所需的血液和营养物质供给而“饿死”肿瘤并具同时杀死肿瘤细胞活性,即舒尼替尼结合了中止向肿瘤细胞供应血液的抗血管形成和直接攻击肿瘤细胞的抗肿瘤这两种作用机制。
  舒尼替尼可能代表了新一轮靶向疗法的问世,它既能直接攻击肿瘤、又无常规化疗的毒副反应,其临床优势是显而易见的。舒尼替尼已于2005年8月在美提出了新药申请;同年9月又向欧美药政当局提交了批准申请。辉瑞公司目前正在等待欧美批准舒尼替尼用于标准治疗无效或不能耐受的胃肠道基质肿瘤和肾细胞癌患者。Ⅲ期临床试验证实,舒尼替尼能够大大延长已对伊马替尼治疗耐药或不能耐受的胃肠道基质肿瘤患者的肿瘤进展时间(分别为6.3个月对安慰剂组的1.5个月),并显著性降低他们50%的死亡风险。舒尼替尼也已在用于治疗转移性乳腺癌和神经内分泌肿瘤等的Ⅱ期临床试验中显现出令人鼓舞的结果。舒尼替尼现正在进行单用或合用其他抗肿瘤药物用于治疗许多其他类型实体瘤,包括乳腺癌、肺癌、前列腺癌和结肠直肠癌等的大量研究。
  舒尼替尼(Sunitinib,Sutent)是一类能够选择性地靶向针对多种受体酪氨酸激酶的新型药物中的第一个药物。它通过阻断肿瘤生长所需的血液和营养物质供给和直接攻击肿瘤细胞这两种作用机制来对抗肿瘤,因此其临床优势是显而易见的。它可能代表了新一轮靶向疗法的问世。
  治疗转移性肾细胞癌
  已有非对照研究显示舒尼替尼对转移性肾细胞癌(mRCC)患者有效。2006年ASCO会议上美国纽约Memorial Sloan-Kettering癌症中心Motzer等报告,在一项针对mRCC患者的随机Ⅲ期试验中,和干扰素(IFN)-α相比,舒尼替尼作为一线疗法证实对患者无进展生存期(PFS)和目标缓解率(ORR)都有明显改善作用。第三方评估的舒尼替尼组的中位无进展生存期(11个月)显著长于IFN-α 组(5个月),相应的风险比是0.42(95%可信区间为0.32~0.54,P<0.001)。
  在2007年ASCO会议上,Motzer等提供了来自这一试验的最新结果和有关预后因素的一个分析报告。研究纳入未经治疗的患有透明细胞mRCC的750例患者,并按1∶1的比例(舒尼替尼与IFN-α组均为375例)将患者随机分组以便接受舒尼替尼(每天50 mg 口服,连用4周,休息2周,6周为1个周期)或IFN-α(9 MU 皮下注射,每周3次)治疗。主要终点是PFS。治疗的中位持续时间是舒尼替尼11个月,IFN-α 4个月。
  研究者评估的最新客观肿瘤缓解率(ORR)是:舒尼替尼组44% (95% CI:39~49),IFN-α组 11%(95% CI:8~15)。舒尼替尼组4例完全缓解,IFN-α组 2例。舒尼替尼组中位PFS为10.8个月(95%CI:10.6~12.6),IFN-α组为 4.1个月(95% CI:3.8~5.3) (图1)。经舒尼替尼治疗的0风险因子的患者(n=112)中位PFS 是14.8个月(95% CI:13.0~19.3);具有1个风险因子的患者(n=169)则是10.8个月(95% CI:8.7~12.6);≥2个风险因子的患者(n=94)则是8.0个月(95% CI:4.0~8.6)。
  在所有的美国癌症中心纽约纪念医院(MSKCC)预后因子组中均可发现舒尼替尼有PFS获益(HR= 0.488;95% CI:0.406~0.586)。舒尼替尼组中预测更长PFS的基线特征(通过研究者评估)是血红蛋白处于正常值低限(P=0.0043),校正钙=10 mg/dl (P=0.001),ECOG评分为0(P=0.0005),转移灶数量为0 或 1 (P=0.0064),从诊断到治疗的时间为1年(P=0.0002)。
  治疗胃肠道间质瘤
  会议上还报告了舒尼替尼在许多其他类型肿瘤的治疗上所显现出的令人鼓舞的结果。在伊马替尼抵抗或无法耐受的胃肠道间质瘤(GIST)患者中,初步研究显示:循环中KIT水平可能是TTP的一个标记,可溶性KIT(sKIT)水平的降低可能预示着伊马替尼和舒尼替尼治疗有效。研究中期分析显示,舒尼替尼组与安慰剂组相比TTP显著延长,中位TTP为27.3周对6.4周(HR=0.33,P<0.0001)(图2)。舒尼替尼持续每日给药似乎是伊马替尼抵抗或无法耐受的GIST患者的一个安全且有效的给药策略。
  治疗非小细胞肺癌
  一项Ⅱ期试验显示,对化疗无效的晚期非小细胞肺癌(NSCLC)患者,舒尼替尼单药治疗能缩小肿瘤或阻止肿瘤生长,提示其有望在肺癌治疗中占一席之地。既往接受过治疗的患者接受舒尼替尼连续给药方案治疗时,安全性可接受。同时有初步的有效性证据:1例PR,中位PFS 12.1周。
  治疗肝细胞癌
  有研究者设计了一个Ⅱ期临床试验来评估舒尼替尼治疗进展期肝细胞肝癌(HCC)的有效性和毒性。结果显示,在密切监护下,患者接受目前的剂量(37.5 mg口服,每天一次治疗,连用4周休息2周,6周为一个周期)是安全的。初步观察到抗肿瘤活性证据,并且治疗后血管源性参数及血中标志物发生了改变。
  商品名:索坦
  通用名:苹果酸舒尼替尼
  分子结构名:苹果酸舒尼替尼
  英文名:sunitinib malate(Sutent)
  规格:12.5mg×28粒/盒
  用法:每天4粒,一次顿服4粒,服用4周后需停药观察2周后继续服用
  疗程:6周/疗程
  适应症:胃肠道间质瘤、肾癌
  生产厂家:Pfizer 辉瑞公司
  适应症:除了胃肠道间质肿瘤,抑制晚期肾细胞癌,现在临床证明还可以治疗非小细胞肺癌,治疗肝细胞癌。

==== 汉译英 ====

Sunitinib (sautin) - renal cell carcinoma, gastrointestinal stromal tumors, non-small cell lung cancer, liver cancer drug. Sautin (sunitinib malate)
★ Sunitinib: The latest targeted therapy drugs, dual-channel, multi-target tyrosine kinase inhibitor
★ Sunitinib: inhibiting growth of cancer cells, block tumor growth of blood and nutrients needed to supply
★ Sunitinib: overall survival was significantly prolonged period, effectively improve the subjective and objective signs and symptoms of
★ Sunitinib: widely used in renal cell carcinoma, gastrointestinal stromal tumor, lung cancer, liver cancer and other solid tumors
★ sunitinib: the role of strong, fast onset of action, good compliance, adverse reactions of light, to facilitate oral
Sutent (Sunitinib, Sutent) is a novel multi-targeted treatment of tumors of the oral drug. Sunitinib the primary development goal for the treatment of standard therapy did not respond to or can not tolerate the gastrointestinal stromal tumor and metastatic renal cell carcinoma. Sunitinib can selectively target certain protein receptors, which are considered in the process of tumor growth plays a molecular switch-like effect. Sunitinib the above-mentioned indications received in the United States FDA granted "fast-track" approval status.
Sunitinib is a kind of be able to selectively target a variety of receptor tyrosine kinases in the first new drug in a drug. Inhibit receptor tyrosine kinase is thought to be required for tumor growth by blocking the blood and nutrient supply, while "starving" tumor and kill tumor cells with the same time, activity, namely, suspension of sunitinib combined with the supply to the tumor cells blood anti-angiogenic and direct anti-tumor attack on tumor cells, these two mechanisms.
Sunitinib may represent a new round of the advent of targeted therapies, it not only directly attack the tumor, nor conventional chemotherapy toxicity, its clinical advantage is obvious. Sunitinib was in August 2005 in the United States submitted a new drug application; Youxiang in September the same year, the political authorities in Europe and the United States submitted the drug for approval. Pfizer Europe and the United States is currently awaiting approval of sunitinib for the invalid or can not tolerate the standard treatment of gastrointestinal stromal tumors and renal cell carcinoma. Phase Ⅲ clinical trials confirm that sunitinib has been able to significantly extend the treatment of imatinib-resistant or intolerant gastrointestinal stromal tumor patients with tumor progression (6.3 months, respectively for the placebo group 1.5 months), and significantly reduce their risk of death 50%. Sunitinib has also been used for the treatment of metastatic breast cancer and neuroendocrine tumors such as Phase Ⅱ clinical trials, demonstrating encouraging results. Sunitinib is currently being used alone or in combination of other anticancer drugs for the treatment of many other types of solid tumors, including breast, lung, prostate and colon cancer such as a large number of studies.
Sutent (Sunitinib, Sutent) is a class can be selectively targeted for a variety of receptor tyrosine kinases in the first new drug in a drug. It does this by blocking tumor growth in the blood and nutrients needed to supply and direct attacks on these two mechanisms of tumor cells to fight cancer, so its clinical advantages are obvious. It may represent the advent of a new round of targeted therapies.
The treatment of metastatic renal cell carcinoma
Have been non-controlled studies have shown that sunitinib for metastatic renal cell carcinoma (mRCC) patients effectively. 2006 ASCO meeting in New York Memorial Sloan-Kettering Cancer Center, Motzer and other reports, for mRCC patients in a randomized phase Ⅲ trial, and interferon (IFN)-α compared with sunitinib as first-line therapy confirmed progression-free survival for patients (PFS) and objective response rate (ORR) has a significant improvement. Third-party evaluation of sunitinib group, the median progression-free survival period (11 months) was significantly longer than IFN-α group (5 months), the corresponding hazard ratio was 0.42 (95% confidence interval 0.32 ~ 0.54, P <0.001).
In 2007 ASCO meeting, Motzer and so provides the latest results from this trial and the related prognostic factors in an analysis. Studies into untreated 750 with clear cell mRCC patients, according to a 1:1 ratio (sunitinib and IFN-α group were 375 cases) to patients randomized to receive sunitinib ( 50 mg per day orally qd for 4 weeks, rest 2 weeks, 6 weeks of a cycle), or IFN-α (9 MU subcutaneously 3 times per week) treatment. The primary endpoint was PFS. The median treatment duration was 11 months of sunitinib, IFN-α 4 months.
The researchers assessed the latest objective tumor response rate (ORR) is: sunitinib group 44% (95% CI: 39 ~ 49), IFN-α group 11% (95% CI: 8 ~ 15). Sunitinib group of four cases of complete remission, IFN-α group 2 patients. Sunitinib The median PFS of 10.8 months (95% CI: 10.6 ~ 12.6), IFN-α group was 4.1 months (95% CI: 3.8 ~ 5.3) (Figure 1). After sunitinib treatment for patients with 0 risk factors (n = 112) median PFS was 14.8 months (95% CI: 13.0 ~ 19.3); with a risk factor in patients (n = 169) was 10.8 months (95% CI: 8.7 ~ 12.6); ≥ 2 and risk factors of patients (n = 94) was 8.0 months (95% CI: 4.0 ~ 8.6).
In all the United States, New York Memorial Hospital Cancer Center (MSKCC) prognostic factor groups can be found in a PFS benefit of sunitinib (HR = 0.488; 95% CI: 0.406 ~ 0.586). Sunitinib group predicted a longer PFS baseline characteristics (assessed by the researchers) is the hemoglobin in the normal lower limit (P = 0.0043), corrected calcium = 10 mg / dl (P = 0.001), ECOG score of 0 ( P = 0.0005), metastasis number of 0 or 1 (P = 0.0064), time from diagnosis to treatment for 1 year (P = 0.0002).
Treatment of gastrointestinal stromal tumor
Meeting, sunitinib also reported in many other types of tumors as demonstrated in the treatment of the encouraging results. In the imatinib resistance or can not be tolerated gastrointestinal stromal tumors (GIST) patients, preliminary studies have shown that: cycle KIT levels may be a marker for TTP, soluble KIT (sKIT) may indicate a lower level of the Iraqi Imatinib and Sunitinib effective treatment. The interim analysis showed that sunitinib group and the placebo group was significantly prolonged compared with TTP, with a median TTP of 27.3 weeks against 6.4 weeks (HR = 0.33, P <0.0001) (Figure 2). Continuous daily administration of sunitinib appears to imatinib resistance or can not be tolerated in GIST patients with a safe and effective drug delivery strategies.
Treatment of non-small cell lung cancer
A phase Ⅱ trials have shown that ineffective chemotherapy of advanced non-small cell lung cancer (NSCLC) patients, sunitinib monotherapy to shrink tumors or prevent tumor growth, suggesting that its is expected to account for a place in the treatment of lung cancer. Past received treatment for patients receiving continuous administration of sunitinib in the treatment, the security of acceptability. At the same time the validity of the preliminary evidence: one cases of PR, the median PFS 12.1 Zhou.
Treatment of hepatocellular carcinoma
There the researchers designed a phase Ⅱ clinical trial to evaluate sunitinib treatment of advanced hepatocellular carcinoma (HCC) the effectiveness and toxicity. The results showed that in close custody, the patients receiving the current dose (37.5 mg oral, once daily treatment, used in conjunction 4 weeks rest 2 weeks, 6 weeks for a cycle) is safe. Preliminary evidence of antitumor activity was observed, and after the treatment of vascular-derived parameters and blood markers changed.
Product Name: sautin
Common name: sunitinib malate
Molecular Structure Name: sunitinib malate
English name: sunitinib malate (Sutent)
Size: 12.5mg × 28 pills / Box
Usage: 4 tablets per day, a Dayton clothing 4, taking 4 weeks after the withdrawal be observed 2 weeks after the continued use
Duration of treatment: 6 weeks / treatment
Indications: gastrointestinal stromal tumors, renal cell carcinoma
Manufacturer: Pfizer Pfizer Inc
Indications: Apart from gastrointestinal stromal tumors, inhibit advanced renal cell carcinoma, and now also can be treated clinically proven non-small cell lung cancer, treatment of hepatocellular carcinoma.

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更新日期: 2014-06-27 09:11
作者: : mcyclub
修订: 1.2

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