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首页> 外文期刊>The clinical respiratory journal. >Impact of baseline characteristics on extensive‐stage SCLC patients treated with etoposide/carboplatin: A secondary analysis of a phase III study
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Impact of baseline characteristics on extensive‐stage SCLC patients treated with etoposide/carboplatin: A secondary analysis of a phase III study

机译:基线特征对依托磷脂/卡铂治疗的广泛阶段SCLC患者的影响:III期研究的二级分析

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Abstract Background The purpose of the current study is to investigate the impact of baseline characteristics on the outcomes of extensive‐stage small cell lung cancer (SCLC) patients recruited into a clinical trial. Methods This is a secondary analysis of the control arm (etoposide/carboplatin arm) of the ‘NCT00363415’ study which is a phase III study conducted between 2006 and 2007. Univariate analysis of factors affecting overall and progression‐free survival (PFS) was conducted through Cox regression analysis [including age, race, gender, Eastern Cooperative Oncology Group performance score, body mass index, Lactate dehydrogenase, number of metastatic sites and brain metastases]. Factors with P ??.05 in the univariate analysis were then included in the multivariate analysis. Results All patients within the control arm (etoposide/carboplatin) were included in the analysis (N?=?455 patients). The following factors were predictive of worse overall survival (OS) in univariate analysis ( P ??.05): performance score?=?2, LDH??upper limit of normal and ≥3 metastatic sites. Multivariate Cox regression analysis incorporating these three factors showed that only number of metastatic sites predicts worse OS ( P ??.0001) . Likewise, the following factors were associated with worse PFS in univariate analysis ( P ??.05): performance score?=?2 and ≥ 3 metastatic sites predict worse PFS ( P ??.05). Multivariate analysis incorporating these two factors showed that only number of metastatic sites predicts worse PFS ( P ??.0001). Conclusion Number of metastatic sites is the most important predictive factor for overall and PFS among patients with extensive‐stage SCLC treated with systemic chemotherapy within a clinical trial.
机译:摘要背景目前的研究目的是探讨基线特征对招募临床试验的广泛阶段小细胞肺癌(SCLC)患者的影响。方法是对“NCT00363415”研究的控制臂(Etoposide / Carboplatin Arm)的二次分析,该研究是2006年至2007年之间进行的III期研究。对影响总体和无进展生存(PFS)的单一进行分析通过Cox回归分析[包括年龄,种族,性别,东方合作肿瘤学绩效评分,体重指数,乳酸脱氢酶,转移性位点数和脑转移]。具有p≤α的因素。然后将单变量分析中的05分析中包括在多变量分析中。结果控制臂内所有患者(依托普苷/卡铂)均包含在分析中(n?= 455名患者)。下列因素是在单变量分析中更差的整体存活率(OS)(P?& 05):性能得分?=?2,LDH?&?α上限正常和≥3转移性位点。包含这三个因素的多变量Cox回归分析表明,只有数量的转移位点预测更差的OS(P?& 0001)。同样,以下因素与单变量分析中的更差的PFS相关(P?& 05):性能评分?=Δ2和≥3转移位点预测更差的PFS(p?& 05)。包含这两个因素的多变量分析表明,只有转移位点的数量预测到更差的PFS(P?& 0001)。结论转移性位点的数量是临床试验中全身化疗的广泛阶段SCLC患者中总体和PFS最重要的预测因素。

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