Tarceva for patients over 70

Susan

http://patient.cancerconsultants.com/CancerNews.aspx?DocumentId=39447

According to results recently published in the Journal of Clinical Oncology, treatment with the single agent Tarceva® (erlotinib) is active and well tolerated when used as initial therapy for patients 70 years of age or older with advanced non–small cell lung cancer who have not received prior chemotherapy.

Lung cancer remains the leading cause of cancer deaths in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from the lung to other sites in the body. Because long-term survival for patients with advanced NSCLC remains suboptimal, treatment is aimed at extending the duration of survival for patients while maintaining an optimal quality of life.

Elderly patients often cannot tolerate standard treatment including chemotherapy and radiation therapy, particularly if they have other existing medical conditions. Furthermore, patients may not wish to receive additional chemotherapy or radiation therapy if they have already undergone treatment with these modalities and have experienced a cancer recurrence.

Tarceva is a targeted agent that may be used for treatment of patients with NSCLC that has stopped responding to prior therapies. It works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication and when mutated or altered, excessive replication of cells can occur. Tarceva reduces the uncontrolled replication and growth of cancer cells by blocking mutated EGFR pathways. Study results have indicated that patients with specific mutations and/or disease characteristics may respond better to Tarceva than patients without these mutations and characteristics. Research continues to determine specifically which patients may derive the greatest benefit from treatment with Tarceva. Furthermore, Tarceva is not associated with the side effects of chemotherapy and/or radiation therapy, giving some patients who are not eligible for standard therapies because of their side effects an effective treatment alternative.

Researchers from the Dana-Farber Cancer Center recently conducted a clinical trial to further evaluate Tarceva in the treatment of elderly patients with advanced NSCLC. This trial included 80 patients with a median age of 75 years. Forty percent of patients had received prior surgery and/or radiation therapy; however, no patients had received prior chemotherapy.

Partial regression of cancer (partial response) occurred in 10% of patients.
41% of patients had a stabilization of their disease for at least two months.
The median survival time was nearly 11 months.
At one year nearly half (46%) of patients were still alive.
At two years nearly 20% of patients were still alive.
All patients with EGFR mutations achieved a partial response or disease stabilization and had improved survival over patients without EGFR mutations.
The researchers concluded that treatment with Tarceva appears to be an effective treatment choice for some patients with NSCLC, particularly those with EGFR mutations. Further research is needed to clearly identify which patients will gain optimal benefit from Tarceva. The researchers stated, “Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients.”

Reference: Jackman DM, Yeap BY, Lindeman NI, et al. Phase II clinical trial of chemotherapy-naïve patients >70 years of age treated with erlotinib for advanced non-small-cell lung cancer. Journal of Clinical Oncology. 2007;25:760-766.

伊豆子

看着SUSAN的文章就心急要看，越急越看不明白，唉。

darklessness

According to results recently published in the Journal of Clinical Oncology, treatment with the single agent Tarceva® (erlotinib) is active and well tolerated when used as initial therapy for patients 70 years of age or older with advanced non–small cell lung cancer who have not received prior chemotherapy.

发表在Clinical Oncology（临床肿瘤学）杂志上的结果表明：对于70岁以及70岁以上高龄的预先未接受过化疗的晚期非小细胞肺癌患者而言，单药Tarceva® (erlotinib)的治疗是有效而且容易耐受的初始治疗方法。

Lung cancer remains the leading cause of cancer deaths in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from the lung to other sites in the body. Because long-term survival for patients with advanced NSCLC remains suboptimal, treatment is aimed at extending the duration of survival for patients while maintaining an optimal quality of life.

 在美国，肺癌仍然处于癌症导致死亡的首要位置，而非小细胞肺癌(NSCLC) 大约占了肺癌的75-80%。晚期非小细胞肺癌的癌细胞已经从肺转移到了身体的其他部位而且晚期非小细胞肺癌的长期生存率差强人意，因此，该治疗旨在维持患者良好生活质量的同时提高其生存时间。

Elderly patients often cannot tolerate standard treatment including chemotherapy and radiation therapy, particularly if they have other existing medical conditions. Furthermore, patients may not wish to receive additional chemotherapy or radiation therapy if they have already undergone treatment with these modalities and have experienced a cancer recurrence.

年老的患者通常不能耐受标准治疗方法包括化疗和放疗，尤其是如果他们患有其他疾病的条件下。此外，患者在已经进行过标准治疗却发生癌症复发的时候，他们也不希望接受额外的化疗和放疗。 

Tarceva is a targeted agent that may be used for treatment of patients with NSCLC that has stopped responding to prior therapies. It works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication and when mutated or altered, excessive replication of cells can occur. Tarceva reduces the uncontrolled replication and growth of cancer cells by blocking mutated EGFR pathways. Study results have indicated that patients with specific mutations and/or disease characteristics may respond better to Tarceva than patients without these mutations and characteristics. Research continues to determine specifically which patients may derive the greatest benefit from treatment with Tarceva. Furthermore, Tarceva is not associated with the side effects of chemotherapy and/or radiation therapy, giving some patients who are not eligible for standard therapies because of their side effects an effective treatment alternative.

Tarceva作为靶向药物可以用来治疗对先前标准治疗出现抗药性的非小细胞肺癌患者。它的作用机理是可抑制人表皮生长因子受体（EGFR）的信号传导途径。表皮生长因子受体（EGFR）通道将会阻止细胞变异或者改变的时过渡的细胞的生长和复制。通过抑制表皮生长因子受体（EGFR）的信号传导途径，Tarceva减少了非受控的癌细胞的复制和生长。 研究结果显示，具有特异Study results have indicated that patients with specific mutations and/or disease characteristics may respond better to Tarceva than patients without these mutations and characteristics继续研究Research continues to determine specifically which patients may derive the greatest benefit from treatment with Tarceva. Furthermore, Tarceva is not associated with the side effects of chemotherapy and/or radiation therapy, giving some patients who are not eligible for standard therapies because of their side effects an effective treatment alternative

Researchers from the Dana-Farber Cancer Center recently conducted a clinical trial to further evaluate Tarceva in the treatment of elderly patients with advanced NSCLC. This trial included 80 patients with a median age of 75 years. Forty percent of patients had received prior surgery and/or radiation therapy; however, no patients had received prior chemotherapy.

Partial regression of cancer (partial response) occurred in 10% of patients.
41% of patients had a stabilization of their disease for at least two months.
The median survival time was nearly 11 months.
At one year nearly half (46%) of patients were still alive.
At two years nearly 20% of patients were still alive.
All patients with EGFR mutations achieved a partial response or disease stabilization and had improved survival over patients without EGFR mutations.
The researchers concluded that treatment with Tarceva appears to be an effective treatment choice for some patients with NSCLC, particularly those with EGFR mutations. Further research is needed to clearly identify which patients will gain optimal benefit from Tarceva. The researchers stated, “Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients.”

Reference: Jackman DM, Yeap BY, Lindeman NI, et al. Phase II clinical trial of chemotherapy-naïve patients >70 years of age treated with erlotinib for advanced non-small-cell lung cancer. Journal of Clinical Oncology. 2007;25:760-766.

darklessness

特罗凯常见问题解答

特罗凯是什么？

特罗凯是一种进展性及转移性NSCLC患者化疗失败后可选用的新治疗药物。它是一种口服片剂，每日仅需服用一次，对多种实体肿瘤有着良好的疗效。特罗凯已在2004年11月及2005年9月先后通过了美国以及欧盟的认证许可。特罗凯可以阻断一种位于肿瘤细胞表面、可诱导细胞生长分裂的受体；籍此减慢和阻止肿瘤生长，显著改善患者生存期。

 

特罗凯的作用机理是什么？

　　特罗凯的作用途径与化疗不同，是一种靶向治疗药物，可特异性地针对肿瘤细胞作用，抑制肿瘤的形成和生长。它是一种小分子化合物，可抑制人表皮生长因子受体（EGFR）的信号传导途径；是表皮生长因子（又可称HER1）信号传导通路的关键组分，在多种肿瘤细胞的形成及生长中都扮演了重要的角色。特罗凯的通过抑制酪氨酸激酶的活性的方式来抑制肿瘤生长，酪氨酸激酶是EGFR细胞内的重要组成部分之一。

 

特罗凯的疗效如何？

　　特罗凯是目前唯一一种已经研究证实治疗肺癌具有生存期优势的EGFR抑制剂。在标志性的核心研究BR.21研究中，针对731名进展性 NSCLC患者进行了研究，研究证实：服用特罗凯的患者较对照组显著提高了生存期，中位生存期改善42.5%（总生存期：6.7个月对4.7个月）。特罗凯组31%的患者生存期超过1年，而对照组仅为22%。特罗凯组患者肿瘤相关症状的控制稳定情况也长于对照组，可以显著改善生活质量及躯体功能。 

    在另一项针对569名进展性或转移性胰腺癌患者进行的随机Ⅲ期临床研究（PA.3）中，数据显示：

•特罗凯联合吉西他滨治疗进展性胰腺癌，可较吉西他滨单药治疗显著延长生存期（23%）；

　　•特罗凯联合吉西他滨组24%的患者生存期超过1年，而对照组仅为19%；

　　•特罗凯联合吉西他滨组患者无进展生存期显著延长；

　　•特罗凯/吉西他滨联合方案的耐受性好，未增加造血系统不良反应；

　　•在其他同类研究中也证实特罗凯/吉西他滨联合方案的安全性。

 

患者能够从哪些方面得益呢？

　　特罗凯耐受性良好并能提高生活质量。对患者来说，每日服用一次药片远较去医院接受输液更为便利。此外，特罗凯还能有效避免恶心、呕吐、脱发、神经病变等一系列化疗相关不良反应。

    特罗凯在很多亚组中的疗效亦十分显著。它不仅仅为准备接受再次化疗的患者提供了一个替代的治疗方案，也为那些一般情况差、不能接受二、三线化疗的患者提供了治疗的希望。

 

特罗凯是否会对某些类型的患者疗效特别显著？

　　BR.21研究的数据显示特罗凯在很多亚组中的疗效亦十分显著。在EGFR阴性的肿瘤患者中未发现生存期优势。但EMEA适应症中不推荐患者预先进行特异性EGFR免疫组化检测。

 

特罗凯有哪些不良反应？

    临床研究数据显示，特罗凯的总耐受性良好。特罗凯不会导致化疗药物常见的不良反应，如恶心、呕吐、脱发或周围神经病变等。BR.21研究的数据显示：最常见的不良反应为轻到中度皮疹（76%）及轻到中度腹泻（55%）。严重的肺不良事件发生率低，实验组和对照组间相似；特罗凯组中5%患者因不能耐受不良反应而退出，安慰剂组中退出比例为2%。特罗凯的疗效同化疗相似，但更重要的是耐受性良好并能提高生活质量。

 

特罗凯是否会引起化疗常见的不良反应？禁忌症？

　　特罗凯是一种小分子化合物，可抑制人表皮生长因子受体（EGFR）的信号传导途径；这一作用方式与传统的化疗截然不同，因此不会导致化疗中常见的不良反应。仅禁用于对特罗凯及辅料严重过敏的患者。

 

特罗凯何时得到了美国和中国食品药品管理局（FDA）的许可？　

    美国FDA于2004年11月19日批准特罗凯用于治疗既往化疗失败的局部进展性或转移性NSCLC患者。　中国FDA于2006年4月6日批准。

 

经批准的特罗凯治疗适应症是什么？

    至少两种化疗无效局部晚期或转移性的晚期NSCLC的三线治疗

    当开具特罗凯处方时，还应考虑到其余可能对生存期产生影响的因素。在EGFR阴性的肿瘤患者中未发现生存期优势。但EMEA适应症中不推荐患者预先进行特异性EGFR免疫组化检测。

 

特罗凯是否还有其他适应症？

    FDA已于2005年11月2日批准特罗凯＋吉西他滨联合方案治疗既往未经治疗、难以手术切除的局部进展性、转移性胰腺癌。

 

目前是否正就特罗凯针对其他类型肿瘤的疗效进行研究？

　　目前有一项OSI制药、基因泰克以及罗氏公司联合进行的临床项目，针对特罗凯对早期NSCLC的疗效进行研究。此外，还有实验正在研究特罗凯＋贝伐单抗联合方案对NSCLC等多种肿瘤的疗效。特罗凯对卵巢癌、支气管肺泡细胞癌、结直肠癌、胰腺癌、头颈部癌以及胶质瘤疗效的研究正在进行中。

 

特罗凯的价格如何？是否能够得到医疗保险的报销呢？

　　由中华人民共和国国家发展和改革委员会价格司审核批准的特罗凯（盐酸厄洛替尼片）零售价格为：

　　150毫克×30片：人民币19,800.00元

　　100毫克×30片：人民币14,800.00元

有关其是否能够进入医疗保险报销目录的问题需要依据每个国家具体情况不同而定。

伊豆子

谢谢    darklessness，真厉害！！

咱们论坛还真是藏龙卧虎啊！！

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