Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: A phase II randomized trial

Oral temozolomide in heavily pre-treated brain metastases from non-small cell lung cancer: Phase II study

“…Antonodau et al in a randomized phase II study and in a confirmatory phase III study comparing TMZ plus WBRT to WBRT alone in population largely consisting of lung cancer patients, reported a significantly greater overall response in the patients receiving TMZ [25,26]. Instead, in a preliminary report of Verger et al, a response of only 16% was noted with WBRT plus TMZ in 85 patients, half of whom had lung cancer [27]. Furthermore, in two phase II studies TMZ was reported to be inactive or marginally active in NSCLC [28,29].…”

Whole Brain Radiotherapy Plus Chemotherapy in the Treatment of Brain Metastases from Lung Cancer: A Meta-analysis of 19 Randomized Controlled Trails

“…There were 1471 citations yielded, of which 1440 were removed during abstract review stage as being duplications or irrelevant to the specific question. The remaining 31 studies were to full text screening, and 19 RCTs were included (He et al, 2003;Guerrieri et al, 2004;Ge et al, 2005;Gao et al, 2009;Neuhaus et al, 2009;Dong et al, 2010;Gao, 2011;Pan et al, 2004;Peng et al, 2008;Postmus et al, 2000;Sun et al, 2009;Verger et al, 2005;Xiao et al, 2001;Xie et al, 2007;Zeng et al, 2009;Zhao et al, 2007;Zhu et al, 2009).…”

“…Figure 2 showed the results of authors' judgement of risk of biases. According to the bias risk assessment tool in the Cochrane systematic reviews handbook (Higgins et al, 2011), 6 RCTs (Postmus et al, 2000;Guerrieri et al, 2004;Verger et al, 2005;Zhao et al, 2007;Gao et al, 2009;Neuhaus et al, 2009) were randomized correctly using the method of random sequence Generation, one study (Xiao et al, 2001) was randomized incorrectly by grouping the patients in the order of admission, and the remain 12 RCTs were just mentioned "randomized" but unclear how to performed. Five RCTs used correct allocation concealment strategies (He et al, 2003;Ge et al, 2005;Sun et al, 2009;Xie et al, 2007;, but the other 14 failed to describe the methods of allocation concealment.…”

“…Five RCTs used correct allocation concealment strategies (He et al, 2003;Ge et al, 2005;Sun et al, 2009;Xie et al, 2007;, but the other 14 failed to describe the methods of allocation concealment. Blind rater was used in one RCT (Verger et al, 2005), while the blinding methods were not mentioned in the remaining 18 RCTs. Four RCTs (Postmus et al, 2000;He et al, 2003; reported the withdrawal or decease of patients but only 1 RCT (Postmus et al, 2000) used intent-to-treat analysis, the other 15 RCTs did not report any loss of patients and provided complete outcome data.…”

“…2003; Guerrieri et al, 2004;Li et al, 2004;Pan et al, 2004;Ge et al, 2005;Verger et al, 2005;Xie et al, 2007;Zhao et al, 2007;Fan et al, 2008;Peng et al, 2008;Wang et al, 2008;Gao et al, 2009;Neuhaus et al, 2009;Sun et al, 2009;Zeng et al, 2009;Zhu et al, 2009;Dong et al, 2010;Gao, 2011;Guo, 2011). However, not all the results show the differences have statistical significance, and the sample sizes of some studies are small.…”