Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohistochemical expression: a Gynecologic Oncology Group study.
Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohistochemical expression: a Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2011.01.030
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发表时间：
2011-05-01
影响因子：
4.7
通讯作者：
Lankes HA
中科院分区：
文献类型：
--
作者：
Farley J;Sill MW;Birrer M;Walker J;Schilder RJ;Thigpen JT;Coleman RL;Miller BE;Rose PG;Lankes HA
本研究的目的是评价西妥昔单抗(C225)与顺铂联合应用的安全性和有效性，并探讨EGFR蛋白表达与患者人口学特征或临床结果的关系。患有晚期、持续性或复发性宫颈癌的妇女符合条件。这些妇女接受顺铂30 mg/m2，第1天和第8天，西妥昔单抗负荷量为400 mg/m2，然后是250 mg/m2，第1天，第8天，第15天，21天为一个周期。不良事件用CTCAE v3.0进行评估。疗效的主要衡量标准是RECIST的肿瘤反应。这项研究根据先前的化疗(CT)进行了分层。免疫组织化学方法检测治疗前肿瘤组织中EGFR蛋白的表达。2004年9月至2008年3月期间，共有76名患者入选。其中，69人合格和可评价；44人(%)接受过化疗。化疗前和未化疗组各有4例有效，分别为9%和16%。4级毒性包括贫血(1例)、过敏(1例)、代谢(1例)和血管(1例)。最常见的3级毒性是代谢(15例)、皮肤病(8例)、疲劳(6例)和胃肠道(6例)。EGFR蛋白在47/48(98%)的肿瘤中表达，细胞表达的中位数为81%。探索性分析揭示了表达EGFR蛋白的细胞百分比与PFS之间的趋势(危险比=1.76，95%可信区间=0.96-3.21)。西妥昔单抗与顺铂的联合用药耐受性良好，但并不表明西妥昔单抗对顺铂治疗有额外的益处。
The purpose of this study was to evaluate the safety and efficacy of cetuximab (C225), an antibody that inhibits epidermal growth factor receptor (EGFR) activity, with cisplatin and to explore associations between EGFR protein expression with patient demographics or clinical outcome. Women with advanced, persistent, or recurrent carcinoma of the cervix were eligible. The women received cisplatin at 30 mg/m2 days 1 and 8 with a loading dose of cetuximab at 400 mg/m2 followed by 250 mg/m2 days 1, 8, and 15 in a 21 day cycle. Adverse events were assessed with CTCAE v 3.0. Primary measure of efficacy was tumor response by RECIST. The study was stratified by prior chemotherapy (CT). EGFR protein expression in pre-treatment tumor was analyzed by immunohistochemistry. Between September 2004 and March 2008, 76 patients were enrolled. Of these, 69 were eligible and evaluable; 44 (64%) received prior chemotherapy. There were 4 responses in each group, prior chemotherapy and no chemotherapy, 9% and 16%, respectively. Grade 4 toxicities included anemia (1), allergy (1), metabolic (1), and vascular (1). The most common grade 3 toxicities were metabolic (15), dermatologic (8), fatigue (6), and gastrointestinal (6). EGFR protein was expressed in 47/48 (98%) of tumors analyzed with a median cellular expression of 81%. Exploratory analyses revealed a trend between the percentage of cells expressing EGFR protein and PFS (hazard ratio =1.76, 95% confidence interval=0.96–3.21). The combination of cetuximab with cisplatin was adequately tolerated but did not indicate additional benefit beyond cisplatin therapy.
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影响因子：
8
作者：
Kim, SH;Juhnn, YS;Song, YS
通讯作者：
Song, YS
影响因子：
4.7
作者：
Kim, YT;Park, SW;Kim, JW
通讯作者：
Kim, JW
影响因子：
3.4
作者：
HALE, RJ;BUCKLEY, CH;WILCOX, FL
通讯作者：
WILCOX, FL
DOI：
10.1158/1078-0432.ccr-08-0539
发表时间：
2008-10-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Hirsch FR;Varella-Garcia M;Dziadziuszko R;Xiao Y;Gajapathy S;Skokan M;Lin M;O'Neill V;Bunn PA Jr
通讯作者：
Bunn PA Jr
影响因子：
158.5
作者：
Cunningham, D;Humblet, Y;Van Cutsem, E
通讯作者：
Van Cutsem, E