A phase III study of conventional radiation therapy plus thalidomide versus conventional radiation therapy for multiple brain metastases (RTOG 0118)

被引：78

作者：

Knisely, Jonathan P. S. ^{[1
,2
]}

Berkey, Brian ^{[3
]}

Chakravarti, Arnab ^{[4
,5
]}

Yung, Al W. K. ^{[6
,7
]}

Curran, Walter J., Jr. ^{[8
]}

Robins, H. Ian ^{[9
,10
]}

Movsas, Benjamin ^{[11
]}

Brachman, David G. ^{[12
,13
]}

Henderson, Randall H. ^{[14
]}

Mehta, Minesh P. ^{[10
]}

机构：

[1] Yale Univ, Sch Med, Dept Therapeut Radiol, New Haven, CT 06520 USA

[2] Yale Canc Ctr, New Haven, CT 06520 USA

[3] Radiat Therapy Oncol Grp, Philadelphia, PA USA

[4] Massachusetts Gen Hosp, Dept Radiat Oncol, Boston, MA 02114 USA

[5] Harvard Univ, Sch Med, Boston, MA USA

[6] Univ Texas MD Anderson Canc Ctr, Dept Neurooncol, Houston, TX 77030 USA

[7] Univ Texas MD Anderson Canc Ctr, Brain Tumor Ctr, Houston, TX 77030 USA

[8] Emory Univ, Dept Radiat Oncol, Atlanta, GA 30322 USA

[9] Univ Wisconsin, Dept Human Oncol, Madison, WI USA

[10] Univ Wisconsin, Dept Med, Madison, WI USA

[11] Henry Ford Hlth Syst, Dept Radiat Oncol, Detroit, MI USA

[12] AZ Oncol Serv, Dept Radiat Oncol, Phoenix, AZ USA

[13] St Josephs Hosp, Phoenix, AZ USA

[14] Univ Florida, Proton Therapy Inst, Jacksonville, FL USA

来源：

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2008年 / 71卷 / 01期

关键词：

brain metastases; whole-brain radiotherapy; thalidomide; phase III trial; antiangiogenesis;

D O I：

10.1016/j.ijrobp.2007.09.016

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: To compare whole-brain radiation therapy (WBRT) with WBRT combined with thalidomide for patients with brain metastases not amenable to resection or radiosurgery. Patients and Methods: Patients with Zubrod performance status 0-1, MRI-documented multiple (>3), large (>4 cm), or midbrain brain metastases arising from a histopathologically confirmed extracranial primary tumor, and an anticipated survival of >8 weeks were randomized to receive WBRT to a dose of 37.5 Gy in 15 fractions with or without thalidomide during and after WBRT. Prerandomization stratification used Radiation Therapy Oncology Group (RTOG) Recursive Partitioning Analysis (RPA) Class and whether post-WBRT chemotherapy was planned. Endpoints included overall survival, p rogressio n -free survival, time to neurocognitive progression, the cause of death, toxicities, and quality of life. A protocol -planned interim analysis documented that the trial had an extremely low probability of ever showing a significant difference favoring the thalidomide arm given the results at the time of the analysis, and it was therefore closed on the basis of predefined statistical guidelines. Results: Enrolled in the study were 332 patients. Of 183 accrued patients, 93 were randomized to receive WBRT alone and 90 to WBRT and thalidomide. Median survival was 3.9 months for both arms. No novel toxicities were seen, but thalidomide was not well tolerated in this population. Forty-eight percent of patients discontinued thalidomide because of side effects. Conclusion: Thalidomide provided no survival benefit for patients with multiple, large, or midbrain metastases when combined with WBRT; nearly half the patients discontinued thalidomide due to side effects. (c) 2008 Elsevier Inc.

引用

页码：79 / 86

页数：8