RTOG 0211: a phase 1/2 study of radiation therapy with concurrent gefitinib for newly diagnosed glioblastoma patients.
RTOG 0211: a phase 1/2 study of radiation therapy with concurrent gefitinib for newly diagnosed glioblastoma patients.
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DOI：
10.1016/j.ijrobp.2012.10.008
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发表时间：
2013-04-01
影响因子：
7
通讯作者：
Mehta, Minesh
中科院分区：
文献类型：
--
作者：
Chakravarti, Arnab;Wang, Meihua;Robins, H. Ian;Lautenschlaeger, Tim;Curran, Walter J.;Brachman, David G.;Schultz, Christopher J.;Choucair, Ali;Dolled-Filhart, Marisa;Christiansen, Jason;Gustavson, Mark;Molinaro, Annette;Mischel, Paul;Dicker, Adam P.;Bredel, Markus;Mehta, Minesh
确定吉非替尼（一种EGFR酪氨酸激酶抑制剂）联合放疗治疗新诊断胶质母细胞瘤（GBM）患者的安全性和疗效。在2002年3月21日至2004年5月3日期间，RTOG 0211在I期和II期组中分别入组了31例和147例GBM患者。治疗包括在常规颅放疗（RT）时开始每日口服吉非尼，并在RT后持续18个月或直至进展。对68例病例的组织微阵列进行了EGFR表达分析。吉非替尼的最大耐受剂量（MTD）在非酶诱导抗惊厥药物（非EIAED）患者中确定为500 mg。II期部分的所有患者均接受吉非替尼500 mg剂量治疗;接受EIADS的患者可递增至750 mg。吉非替尼联合放疗最常见的副作用是皮肤和胃肠道。按照方案治疗的患者的中位生存期为11.5个月。与RTOG RPA分类分布匹配的单用RT治疗的患者历史队列相比，吉非替尼+ RT治疗的患者没有总生存期获益。年龄越小，预后越好。根据方案分层，未发现EGFR表达对吉非替尼+ RT治疗的患者具有预后价值。RT中添加吉非替尼耐受性良好。RTOG 0211患者接受放射治疗同时和辅助吉非替尼治疗的中位生存期与仅接受放射治疗的历史对照队列相似。
To determine the safety and efficacy of gefitinib, an EGFR tyrosine kinase inhibitor, in combination with radiation for newly diagnosed glioblastoma (GBM) patients. Between 3/21/2002 and 5/03/2004 RTOG 0211 enrolled 31 and 147 GBM patients in the phase I and II arms respectively. Treatment consisted of daily oral gefinitnib started at the time of conventional cranial radiotherapy (RT) and continued post RT for 18 months or until progression. Tissue microarrays from 68 cases were analyzed for EGFR expression. The maximum tolerated dose (MTD) of gefitinib was determined to be 500 mg in patients on non enzyme-inducing anticonvulsant drugs (non-EIAEDs). All patients in the phase II component were treated at a gefitinib dose of 500mg; patients receiving EIADSs could be escalated to 750mg. The most common side-effects of gefitinib in combination with radiation were dermatologic and gastrointestinal. Median survival was 11.5 months for patients treated per protocol. There was no overall survival benefit for patients treated with gefitinib + RT when compared to a historical cohort of patients treated with RT alone, matched by RTOG RPA class distribution. Younger age was significantly associated with better outcome. Per protocol stratification, EGFR expression was not found to be of prognostic value for gefitinib + RT treated patients. The addition of gefitinib to RT is well tolerated. Median survival of RTOG 0211 patients treated with radiation therapy with concurrent and adjuvant gefitinib was similar to a historical control cohort treated with radiation alone.
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影响因子：
120.7
作者：
Yadav, Ajay K.;Renfrow, Jaclyn J.;Scholtens, Denise M.;Xie, Hehuang;Duran, George E.;Bredel, Claudia;Vogel, Hannes;Chandler, James P.;Chakravarti, Arnab;Robe, Pierre A.;Das, Sunit;Scheck, Adrienne C.;Kessler, John A.;Soares, Marcelo B.;Sikic, Branimir I.;Harsh, Griffith R.;Bredel, Markus
通讯作者：
Bredel, Markus
影响因子：
4.8
作者：
Antonyak, MA;Moscatello, DK;Wong, AJ
通讯作者：
Wong, AJ
影响因子：
9.7
作者：
Stea, B;Falsey, R;Martinez, JD
通讯作者：
Martinez, JD
影响因子：
4.8
作者：
Eller, JL;Longo, SL;Canute, GW
通讯作者：
Canute, GW
影响因子：
15.9
作者：
Pichlmeier, Uwe;Bink, Andrea;Stummer, Walter
通讯作者：
Stummer, Walter