A phase 3 trial of whole brain radiation therapy and stereotactic radiosurgery alone versus WBRT and SRS with temozolomide or erlotinib for non-small cell lung cancer and 1 to 3 brain metastases: Radiation Therapy Oncology Group 0320.
A phase 3 trial of whole brain radiation therapy and stereotactic radiosurgery alone versus WBRT and SRS with temozolomide or erlotinib for non-small cell lung cancer and 1 to 3 brain metastases: Radiation Therapy Oncology Group 0320.
复制标题
DOI：
10.1016/j.ijrobp.2012.11.042
复制
发表时间：
2013-04-01
影响因子：
7
通讯作者：
Mehta, Minesh P.
中科院分区：
文献类型：
--
作者：
Sperduto, Paul W.;Wang, Meihua;Robins, H. Ian;Schell, Michael C.;Werner-Wasik, Maria;Komaki, Ritsuko;Souhami, Luis;Buyyounouski, Mark K.;Khuntia, Deepak;Demas, William;Shah, Sunjay A.;Nedzi, Lucien A.;Perry, Gad;Suh, John H.;Mehta, Minesh P.
一项III期放射治疗肿瘤学组（RTOG）研究子集分析表明，在全脑放射治疗（WBRT）基础上增加立体定向放射外科（SRS）可改善伴有1 - 3处脑转移的非小细胞肺癌（NSCLC）患者的总生存期（OS）。由于替莫唑胺（TMZ）和厄洛替尼（ETN）可以穿过血脑屏障，并且在NSCLC中具有记录的活性，因此设计了一项III期研究，以测试这些药物是否会改善与WBRT + SRS相关的OS。有1 - 3处脑转移的NSCLC患者随机接受WBRT（2.5戈伊×15 - 37.5戈伊）和SRS单药治疗，与WBRT + SRS + TMZ（75 mg/m2/天× 21天）或ETN（150 mg/天）治疗。ETN（150 mg/d）或TMZ（150-200 mg/m2/d ×5 d/月）可在WBRT后持续6个月。主要终点是OS。在入组126例患者后，由于招募限制，研究关闭。WBRT + SRS、WBRT + SRS + TMZ和WBRT + SRS + ETN的中位生存时间（MST）存在质的差异（分别为13.4、6.3和6.1个月），尽管差异无统计学显著性。WBRT-SRS组的中枢神经系统进展时间和6个月时的体能状态更好。3 - 5级毒性在第1、2和3组分别为11%、41%和49%（P<0.001）。在WBRT + SRS中加入TMZ或ETN治疗有1 - 3个脑转移的NSCLC患者并没有改善生存率，可能有有害影响。由于分析的效力不足，这些数据表明但不能证明毒性增加是药物组生存率较低的原因。
A phase 3 Radiation Therapy Oncology Group (RTOG) study subset analysis demonstrated improved overall survival (OS) with the addition of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) in non-small cell lung cancer (NSCLC) patients with 1 to 3 brain metastases. Because temozolomide (TMZ) and erlotinib (ETN) cross the bloodbrain barrier and have documented activity in NSCLC, a phase 3 study was designed to test whether these drugs would improve the OS associated with WBRT + SRS. NSCLC patients with 1 to 3 brain metastases were randomized to receive WBRT (2.5 Gy×15 to 37.5 Gy) and SRS alone, versus WBRT + SRS + TMZ (75 mg/m2/day× 21 days) or ETN (150 mg/day). ETN (150 mg/day) or TMZ (150–200 mg/m2/day ×5 days/month) could be continued for as long as 6 months after WBRT þ SRS. The primary endpoint was OS. After 126 patients were enrolled, the study closed because of accrual limitations. The median survival times (MST) for WBRT + SRS, WBRT + SRS + TMZ, and WBRT + SRS + ETN were qualitatively different (13.4, 6.3, and 6.1 months, respectively), although the differences were not statistically significant. Time to central nervous system progression and performance status at 6 months were better in the WBRT þ SRS arm. Grade 3 to 5 toxicity was 11%, 41%, and 49% in arms 1, 2, and 3, respectively (P<.001). The addition of TMZ or ETN to WBRT + SRS in NSCLC patients with 1 to 3 brain metastases did not improve survival and possibly had a deleterious effect. Because the analysis is underpowered, these data suggest but do not prove that increased toxicity was the cause of inferior survival in the drug arms.
登录
查看更多内容
DOI：
10.1158/1078-0432.ccr-08-2921
发表时间：
2009-08-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Sun M;Behrens C;Feng L;Ozburn N;Tang X;Yin G;Komaki R;Varella-Garcia M;Hong WK;Aldape KD;Wistuba II
通讯作者：
Wistuba II
影响因子：
45.3
作者：
Sperduto, Paul W.;Kased, Norbert;Mehta, Minesh
通讯作者：
Mehta, Minesh
影响因子：
3.6
作者：
Chua, Daniel;Krzakowski, Maciej;Throuvalas, Nikolaos
通讯作者：
Throuvalas, Nikolaos
DOI：
10.1158/1078-0432.ccr-08-0565
发表时间：
2008-12-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
McDonald JM;Pelloski CE;Ledoux A;Sun M;Raso G;Komaki R;Wistuba II;Bekele BN;Aldape K
通讯作者：
Aldape K
DOI：
10.1016/0021-9681(74)90015-0
发表时间：
1974-01-01
期刊：
JOURNAL OF CHRONIC DISEASES
影响因子：
--
作者：
ZELEN, M
通讯作者：
ZELEN, M