特罗凯的新话题
请哪位大侠给大概地翻译一下：Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study
Original TextDr Federico Cappuzzo MD a , Tudor Ciuleanu MD b, Lilia Stelmakh MD c, Prof Saulius Cicenas MD d, Aleksandra Szczésna MD e, Erzsébet Juhász MD f, Emilio Esteban MD g, Olivier Molinier MD h, Wolfram Brugger MD i, Ivan Melezínek MUDr CSc j, Gaëlle Klingelschmitt MSc k, Barbara Klughammer PhD l, Prof Giuseppe Giaccone MD m, on behalf of the SATURN investigators
Summary
Background
First-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) is usually limited to four to six cycles. Maintenance therapy can delay progression and prolong survival. The oral epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib has proven efficacy and tolerability in second-line NSCLC. We designed the phase 3, placebo-controlled Sequential Tarceva in Unresectable NSCLC (SATURN; BO18192) study to assess use of erlotinib as maintenance therapy in patients with non-progressive disease following first-line platinum-doublet chemotherapy.
Methods
Between December, 2005, and May, 2008, 1949 patients were included in the run-in phase (four cycles of platinum-based chemotherapy). At the end of the run-in phase, 889 patients who did not have progressive disease were entered into the main study, and were randomly allocated using a 1:1 adaptive randomisation method through a third-party interactive voice response system to receive erlotinib (150 mg/day; n=438) or placebo (n=451) until progression or unacceptable toxicity. Patients were stratified by EGFR immunohistochemistry status, stage, Eastern Cooperative Oncology Group performance status, chemotherapy regimen, smoking history, and region. Co-primary endpoints were progression-free survival (PFS) in all analysable patients irrespective of EGFR status, and PFS in patients whose tumours had EGFR protein overexpression, as determined by immunohistochemistry. This study is registered with www.ClinicalTrials.gov, number NCT00556712.
Findings
884 patients were analysable for PFS; 437 in the erlotinib group and 447 in the placebo group. After a median follow-up of 11·4 months for the erlotinib group and 11·5 months for the placebo group, median PFS was significantly longer with erlotinib than with placebo: 12·3 weeks for patients in the erlotinib group versus 11·1 weeks for those in the placebo group (HR 0·71, 95% CI 0·62—0·82; p<0·0001). PFS was also significantly longer in patients with EGFR-positive immunohistochemistry who were treated with erlotinib (n=307) compared with EGFR-positive patients given placebo (n=311; median PFS 12·3 weeks in the erlotinib group vs 11·1 weeks in the placebo group; HR 0·69, 0·58—0·82; p<0·0001). The most common grade 3 or higher adverse events were rash (37 of 443 patients in the erlotinib group vs none of 445 in the placebo group) and diarrhoea (seven of 443 patients vs none of 445). Serious adverse events were reported in 47 patients (11%) on erlotinib compared with 34 patients (8%) on placebo. The most common serious adverse event was pneumonia (seven cases with erlotinib and four [<1%] with placebo).
Interpretation
Maintenance therapy with erlotinib for patients with NSCLC is well tolerated and significantly prolongs PFS compared with placebo. First-line maintenance with erlotinib could be considered in patients who do not progress after four cycles of chemotherapy.
Funding
F Hoffmann-La Roche Ltd. http://www.51qiji.com/thread-22151-1-1.html你可以找找robertzhang病友
[ 本帖最后由 阿孟的妈妈 于 2010-6-2 14:21 编辑 ]
回复 1# lvhuanran 的帖子
我用的是http://www.hao123.com/ss/fy.htm在线翻译软件，可供几十种语言翻译，而且是很快的，当然有些术语肯定不太准确，不过通过自己去分析，基本上也可以读通的。下面是原言的翻译结果，供参考。
埃罗替尼作为晚期非小细胞肺癌的维持治疗：一项多中心，随机，安慰剂控制的第三期临床试验
原TextDr费德里科Cappuzzo医师1，都铎丘莱亚努医师b，莉利亚斯捷利马赫医师ć，教授Saulius Cicenas医师研发，亚历山德拉Szczésna医师é，Erzsébet尤霍斯医师楼埃米利奥埃斯特班医师克，奥利维莫利尼耶医师小时，钨布鲁格医师我，伊凡梅莱齐内克穆德尔留学基金委j，Gaëlle Klingelschmitt硕士钾，芭芭拉Klughammer升博士，教授朱塞佩贾科医师米，对土星研究的代表
摘要
背景
一线晚期非小细胞肺癌（NSCLC）的化疗通常仅限于4至6个周期。维持治疗可延缓恶化，延长生存。口头表皮生长因子受体（EGFR）的酪氨酸激酶抑制剂erlotinib被证明在二线NSCLC的疗效和耐受性。我们设计的晚期非小细胞肺癌的第三阶段（土星，安慰剂控制的顺序特罗凯; BO18192）研究，以评估的维修与非进展性疾病患者使用厄洛替尼治疗后的第一线铂双峰化疗。
方法
12月至2005年5月，2008年，1949年34例，其中在第一阶段的运行（4铂为基础的化疗周期）。在磨合阶段，889例谁没有疾病恶化的主要研究进入到年底，被随机分配使用通过第三方交互式话音回应系统自适应随机化方法1:1获得埃罗替尼（ 150毫克/天; 438例）或安慰剂（n = 451），直到进展或不可接受的毒性。患者分层的EGFR免疫组化状态，阶段，东部肿瘤协作组的性能状态，化疗，吸烟史，和地区。合作的主要终点是无进展生存在所有不论地位可分析的患者表皮生长因子受体（加油站），并在病人的肿瘤有EGFR蛋白表达加油站，经免疫组织化学测定。这项研究是与www.ClinicalTrials.gov登记，编号NCT00556712。
发现
884例患者的油站可分析，在437和447的埃罗替尼组，安慰剂组。在平均后续的埃罗替尼组和11.5个月为11.4个月，安慰剂组，中位PFS为显着高于安慰剂组埃罗替尼再12.3个星期在埃罗替尼的病人：与11.1在安慰剂组周（0.71人力资源，95％CI为0.62 -0 ° 82，p <0.0001）。加油站也显着的EGFR阳性免疫组织化学与埃罗替尼治疗谁病患中（n = 307长）与给予安慰剂（n = 311表皮生长因子受体阳性的患者相比，比11.1个星期平均PFS12.3个星期在埃罗替尼组在安慰剂组，人力资源0.69，0.58 -0 ° 82，p <0.0001）。最常见的3级或更高的副作用是皮疹（37 在埃罗替尼组与445都不在安慰剂组）和腹泻（7 。严重不良反应报告47例（11％）的埃罗替尼相比，有34例（8％）的安慰剂。最常见的严重不良事件是肺炎（7宗 4 [<1％，与安慰剂]）。
解释
维修与埃罗替尼治疗非小细胞肺癌患者的耐受性好，与安慰剂相比显着延长油站。第一线的维修与埃罗替尼的患者，可以考虑谁不进步后4个周期的化疗。
资金
F霍夫曼罗氏有限公司 谢谢阿孟的妈妈和老伯。老伯的翻译还是有些怪怪的，我还是与robertzhang联系一下，翻译完成后供大家参考。 translate.google.com
的翻译也很不错的。
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