A phase II study of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brainstem gliomas: a Pediatric Brain Tumor Consortium study.
A phase II study of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brainstem gliomas: a Pediatric Brain Tumor Consortium study.
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DOI：
10.1007/s11060-011-0709-z
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发表时间：
2012-02
影响因子：
3.9
通讯作者：
Kun, Larry E.
中科院分区：
文献类型：
--
作者：
Warren, Katherine E.;Gururangan, Sri;Geyer, J. Russell;McLendon, Roger E.;Poussaint, Tina Young;Wallace, Dana;Balis, Frank M.;Berg, Stacey L.;Packer, Roger J.;Goldman, Stewart;Minturn, Jane E.;Pollack, Ian F.;Boyett, James M.;Kun, Larry E.
评估O 6-苄基鸟嘌呤（O 6 BG）和替莫唑胺®（TMZ）联合治疗复发性或进展性高级别胶质瘤（HGG，A层）或脑干胶质瘤（BSG，B层）儿科患者的持续（≥8周）客观缓解率。患者接受O 6 BG 120 mg/m2/d IV，随后接受TMZ 75 mg/m2/d口服，每日一次，连续5天，每个28天疗程。认为联合治疗有效的目标客观缓解率为17%。采用两阶段设计。入组了43例患者; 41例可评价缓解，包括25例HGG患者和16例BSG患者。O 6 BG与TMZ联合治疗可耐受，主要毒副反应为骨髓抑制和胃肠道症状。在HGG队列中观察到1例持续（≥8周）部分缓解;在BSG队列中未观察到持续客观缓解。在A层4例患者和B层1例患者中观察到长期（≥6个疗程）疾病稳定（SD）。在5例客观缓解或长期SD的患者中，3例接受了中心审查，2例重新分类为低级别胶质瘤。O 6 BG和TMZ联合治疗复发性或进行性HGG和BSG儿童患者的活动未达到目标缓解率。
To estimate the sustained (≥8 weeks) objective response rate in pediatric patients with recurrent or progressive high-grade gliomas (HGG, Stratum A) or brainstem gliomas (BSG, Stratum B) treated with the combination of O6-benzylguanine (O6BG) and temozolomide® (TMZ). Patients received O6BG 120 mg/m2/d IV followed by TMZ 75 mg/m2/d orally daily for 5 consecutive days of each 28-day course. The target objective response rate to consider the combination active was 17%. A two-stage design was employed. Forty-three patients were enrolled; 41 were evaluable for response, including 25 patients with HGG and 16 patients with BSG. The combination of O6BG and TMZ was tolerable, and the primary toxicities were myelosuppression and gastrointestinal symptoms. One sustained (≥8 weeks) partial response was observed in the HGG cohort; no sustained objective responses were observed in the BSG cohort. Long-term (≥6 courses) stable disease (SD) was observed in 4 patients in Stratum A and 1 patient in Stratum B. Of the 5 patients with objective response or long-term SD, 3 underwent central review with 2 reclassified as low-grade gliomas. The combination of O6BG and TMZ did not achieve the target response rate for activity in pediatric patients with recurrent or progressive HGG and BSG.
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影响因子：
45.3
作者：
Hegi, Monika E.;Liu, Lili;Gilbert, Mark R.
通讯作者：
Gilbert, Mark R.
影响因子：
45.3
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Brandes, Alba A.;Tosoni, Alicia;Ermani, Mario
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影响因子：
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影响因子：
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作者：
Bobola, MS;Silber, JR;Goff, RD
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Goff, RD