Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma: Final report of NABTT 97-11
Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma: Final report of NABTT 97-11
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DOI：
10.1215/s1152851703000218
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发表时间：
2004-01-01
期刊：
影响因子：
15.9
通讯作者：
Phuphanich, S
中科院分区：
文献类型：
--
作者：
Batchelor, TT;Gilbert, MR;Phuphanich, S
本研究的主要目的是确定在接受伊立替康治疗的复发性恶性胶质瘤患者队列中放射学反应的患者比例。次要目标是确定无进展生存期、总生存期和毒性。在首批18名患者入组这项多中心、2期、2期研究后，试验终止。12例患者同时服用酶诱导抗癫痫药物，6例未服用。每个周期包括每周静脉输注伊立替康90分钟，连续4周，然后休息2周。1例完全缓解，5例病情稳定，5例影像学进展，6例因毒性退出研究，1例拒绝进一步治疗，退出研究。本研究的有效率为6%(1/18),28%（5/18）的患者在接受伊立替康治疗后出现进展。剂量限制性毒性包括5例腹泻、1例中性粒细胞减少、1例感染和1例呼吸衰竭。伊立替康对18例复发性恶性胶质瘤患者疗效甚微。毒性显著，但与其他患者群体报告的毒性相似。
The primary objective of this study was to determine the proportion of patients exhibiting a radiographic response in a cohort of patients with recurrent malignant glioma who were treated with irinotecan. Secondary objectives were to determine progression-free survival, overall survival, and toxicity. The trial was terminated after the first 18 patients were enrolled in this multicenter, 2-stage, phase 2 study. Twelve patients received concurrent enzyme-inducing antiepileptic drugs, and 6 did not. Each cycle consisted of a 90-min i.v. infusion of irinotecan every week for 4 consecutive weeks, followed by 2 weeks off. One patient had a complete response, 5 patients had stable disease, 5 patients had radiographic progression, 6 patients were removed from the study because of toxicity, and 1 patient refused further therapy and was removed from the study. The response rate in this study was 6% (1/18), and 28% (5/18) of these patients progressed while receiving irinotecan. Dose-limiting toxicities consisted of diarrhea in 5 patients, neutropenia in 1 patient, infection in 1 patient, and respiratory failure in 1 patient. Irinotecan had minimal efficacy in this cohort of 18 patients with recurrent malignant glioma. Toxicity was significant but similar to that reported in other patient populations.