替莫唑胺用于一线亚硝基脲-丙卡巴肼治疗失败后第二次复发的胶质母细胞瘤患者：一项II期研究。

Temozolomide in patients with glioblastoma at second relapse after first line nitrosourea-procarbazine failure: a phase II study.

作者信息

Brandes Alba A, Ermani Mario, Basso Umberto, Paris Myriam K, Lumachi Franco, Berti Franco, Amistà Pietro, Gardiman Marina, Iuzzolino Paolo, Turazzi Sergio, Monfardini Silvio

机构信息

Department of Medical Oncology, Azienda Ospedale-Università, Padova, Italy.

出版信息

Oncology. 2002;63(1):38-41. doi: 10.1159/000065718.

DOI:10.1159/000065718

PMID:12187069

Abstract

OBJECTIVES

To investigate the efficacy of temozolomide (TMZ) in relationship to progression free survival at 6 months (PFS-6), median time to progression (TTP), response rate and toxicity, a phase II study was conducted in patients with recurrent glioblastoma multiforme (GBM) following surgery plus radiotherapy and a first-line regimen based on nitrosourea, procarbazine and vincristine.

METHODS

Forty-two patients with GBM were administered TMZ at the dose of 150 mg/m(2)/daily for 5 days every 4 weeks.

RESULTS

The PFS-6 and at 12 months (PFS-12) was 24% (95% Confidence Interval [CI] = 14-42%) and 8% (CI = 2-27%), respectively, with a median TTP of 11.7 weeks (CI = 9-22 weeks). The response was assessed in all 42 patients; we observed 2 complete responses (CR) (4.7%), 6 partial responses (PR) (14.3%), and 9 stable disease (SD) (21.4%), with CR+PR = 19% (CI = 7-31%).

CONCLUSION

TMZ as a second line regimen is a valid option in patients with heavily pretreated GBM.

摘要

目的

为了研究替莫唑胺（TMZ）与6个月无进展生存期（PFS-6）、中位疾病进展时间（TTP）、缓解率及毒性之间的疗效关系，对多形性胶质母细胞瘤（GBM）复发患者开展了一项II期研究，这些患者接受过手术加放疗以及基于亚硝基脲、丙卡巴肼和长春新碱的一线治疗方案。

方法

42例GBM患者接受替莫唑胺治疗，剂量为150mg/m²/日，每4周给药5天。

结果

PFS-6和12个月无进展生存期（PFS-12）分别为24%（95%置信区间[CI]=14-42%）和8%（CI=2-27%），中位TTP为11.7周（CI=9-22周）。对所有42例患者进行了疗效评估；我们观察到2例完全缓解（CR）（4.7%）、6例部分缓解（PR）（14.3%）和9例疾病稳定（SD）（21.4%），CR+PR=19%（CI=7-31%）。