替莫唑胺联合聚乙二醇化脂质体阿霉素治疗实体瘤脑转移的II期研究

Phase II study of temozolomide plus pegylated liposomal doxorubicin in the treatment of brain metastases from solid tumours.

作者信息

Caraglia Michele, Addeo Raffaele, Costanzo Raffaele, Montella Liliana, Faiola Vincenzo, Marra Monica, Abbruzzese Alberto, Palmieri Giovannella, Budillon Alfredo, Grillone Francesco, Venuta Salvatore, Tagliaferri Pierosandro, Del Prete Salvatore

机构信息

Oncology Department, S.Giovanni di Dio Hospital, ASL Napoli 3 Via Giovanni XXIII, 80028 Frattaminore, Naples, Italy.

出版信息

Cancer Chemother Pharmacol. 2006 Jan;57(1):34-9. doi: 10.1007/s00280-005-0001-z. Epub 2005 Nov 5.

DOI:10.1007/s00280-005-0001-z

PMID:16010592

Abstract

OBJECTIVE

A combination regimen of temozolomide (TMZ) and pegylated liposomal doxorubicin has been evaluated in the treatment of brain metastases from solid tumours.

STUDY DESIGN

Nineteen consecutive patients (pts) have been enrolled in a prospective phase II trial and treated with TMZ 200 mg/m2 (days 1-5) and pegylated liposomal doxorubicin 35 mg/m2 (day 1) every 28 days. The study was prospectively projected according to the Simon's two-stage optimal design.

RESULTS

Major toxicities have been grade III neutropenia and thrombocytopenia in one patient (pt) and grade III erythrodisesthesia in two pts. Three pts achieved a complete response (CR) and four a partial response (PR), for an overall response rate of 36.8% (95% CI: 19.1-59.2), which exceeded the target activity in the study design. A significant improvement in quality of life was demonstrated by FACT-G analysis. The median Progression Free Survival (PFS) was 5.5 (95% CI: 2.7-8.2) months while the median Overall Survival (OS) was 10.0 months (95% CI: 6.3-13.7).

CONCLUSIONS

The TMZ/pegylated liposomal doxorubicin regimen was well tolerated with an encouraging activity in brain metastases from solid tumours.

摘要

目的

已对替莫唑胺（TMZ）与聚乙二醇化脂质体阿霉素联合方案治疗实体瘤脑转移瘤进行了评估。

研究设计

19例连续患者入组一项前瞻性II期试验，每28天接受TMZ 200mg/m²（第1 - 5天）和聚乙二醇化脂质体阿霉素35mg/m²（第1天）治疗。该研究根据西蒙两阶段最优设计进行前瞻性规划。

结果

主要毒性为1例患者出现III级中性粒细胞减少和血小板减少，2例患者出现III级红斑感觉异常。3例患者达到完全缓解（CR），4例部分缓解（PR），总缓解率为36.8%（95%CI：19.1 - 59.2），超过了研究设计中的目标活性。FACT - G分析显示生活质量有显著改善。无进展生存期（PFS）中位数为5.5（95%CI：2.7 - 8.2）个月，总生存期（OS）中位数为10.0个月（95%CI：6.3 - 13.7）。