勃林格翰公司在2010 ESMO会议上公布了Afatinib在非小肺癌治疗中的数据

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New Afatinib (BIBW 2992) Data In Non-Small Cell Lung Cancer Patients Presented At The 2010 ESMO Congress

勃林格翰公司在2010 ESMO会议上公布了Afatinib在非小肺癌治疗中的数据

Boehringer Ingelheim Pharmaceuticals, Inc. announced results from two clinical trials for its investigational cancer compound afatinib (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

勃林格翰制药有限公司在意大利米兰市第35届欧洲肿瘤医学学会上宣布了来自研究性癌症化合物afatinib的两个临床实验结果。

In the phase IIb/III LUX-Lung 1 study, afatinib tripled the secondary endpoint of progression free survival (PFS) but did not extend the primary endpoint of overall survival (OS) in late-stage patients with non-small cell lung cancer (NSCLC).(1)

在IIb/III LUX-Lung 1期研究中，afatinib将无进展生存期的次要终点增加了三倍，但是没有延长非小细胞肺癌晚期患者总体生存率的主要终点。

Afatinib is an investigational orally administered irreversible inhibitor of both the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinases. Afatinib is under development in several solid tumors including NSCLC, breast and head and neck cancer.

Afatinib是表皮生长因子受体(EGFR)和人表皮生长因子受体-2(HER2) 酪氨酸激酶的研究性口服不可逆的抑制剂。Afatinib在一些包括非小细胞肺癌、乳腺癌和头颈癌等实体肿瘤中正处于研制开发阶段。

The LUX-Lung 1 trial compared afatinib to placebo in over 580 patients with advanced NSCLC who had received chemotherapy and a prior EGFR tyrosine kinase inhibitor (EGFR TKI; gefitinib or erlotinib);

LUX-Lung 1实验在超过580名伴已经接受化学治疗和优先接受表皮生长因子受体酪氨酸激酶抑制剂的晚期非小细胞肺癌患者中比较了afatinib和安慰剂 (表皮生长因子受体酪氨酸激酶抑制剂；吉非替尼或厄罗替尼)。

(1) results show:
-- Afatinib did not improve OS compared to placebo 10.78 months vs. 11.96 months, respectively (HR = 1.08, 95% CI 0.86 to 1.35)(1)

结果显示：
---与安慰剂相比，Afatinib没有改善总体生存率，分别为10.78个月比11.96个月（比率=1.08,95%可信区间0.86到1.35）。

-- As a secondary endpoint, afatinib extended PFS three-fold compared to placebo (3.3 months vs. 1.1 months) (HR = 0.38, 95% CI 0.31 to 0.48, p<0.0001). The improvement in PFS was apparent across all patient subgroups and has been confirmed by independent review(1)

作为次要终点，afatinib延长了无进展生存期3倍（3.3个月比1.1个月）（比率=0.38，95%可信区间0.31到0.48，P<0.0001）。无进展生存期的改善在所有亚组患者中是明显的，并且已经被独立性研究所证实。

-- At 8 weeks, there was a significantly higher disease control rate (stable disease and tumor shrinkage) in those patients who took afatinib (58%) vs. those taking placebo (19%), which was also independently verified (p<0.0001)(1)

---在第8周，在服用afatinib的那些患者中（58%）比服用安慰剂的患者中（19%）存在显著增高的疾病控制率（稳定的疾病和肿瘤缩小），这也被独立证实（p<0.0001)。

-- Improvement of the lung cancer-related symptoms of cough, dyspnea and pain was observed in the afatinib arm vs. placebo. In addition, the time to deterioration of cough, individual dyspnea items and chest pain was longer in the afatinib arm(2)

---与安慰机组比较，在afatinib组中观察到肺癌相关症状咳嗽、呼吸困难和疼痛的改善。另外，在afatinib组中，到咳嗽恶化、个人呼吸困难和胸痛的时间比较长。

-- The two most common side effects associated with treatment with afatinib were diarrhea (87% all grades, with 17% Grade 3) and rash/acne (79% all grades, with 14% Grade 3). These side effects were usually well-managed by supportive care and dose reduction(2)

---两个最常见的与afatinib治疗相关的副作用是腹泻（全部级别87%，3级17%)和皮疹/痤疮（全部级别79%，3级14%)。这些副作用一般通过支持护理和剂量减量很好地处理。

It is important to note that the overall study population, which included patients who received chemotherapy and one line of treatment with a first-generation EGFR inhibitor for at least 12 weeks, had a better performance status and lived longer than originally anticipated for patients with advanced NSCLC.

指出的总体研究人群比起初参加的晚期非小细胞肺癌患者有更好的体力状态和生活的更长是重要的，总体研究人群包括接受化学治疗和一直接受表皮生长因子受体酪氨酸激酶抑制剂治疗至少12周的患者。

This information warrants further investigation of subpopulations in treatment of advanced NSCLC.

这些信息使进一步调查晚期非小细胞肺癌治疗亚组成为有理由的。