Prognostic and predictive role of the VeriStrat plasma test in patients with advanced non-small-cell lung cancer treated with erlotinib or placebo in the NCIC Clinical Trials Group BR.21 trial.
Prognostic and predictive role of the VeriStrat plasma test in patients with advanced non-small-cell lung cancer treated with erlotinib or placebo in the NCIC Clinical Trials Group BR.21 trial.
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DOI：
10.1097/jto.0b013e31826c1155
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发表时间：
2012-11
期刊：
影响因子：
--
通讯作者：
Shepherd FA
中科院分区：
文献类型：
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作者：
Carbone DP;Ding K;Roder H;Grigorieva J;Roder J;Tsao MS;Seymour L;Shepherd FA
We investigated the predictive and prognostic effects of VeriStrat®, a serum or plasma based assay, on response and survival in a subset of patients enrolled on the NCIC Clinical Trials Group (CTG) BR.21 phase III trial of erlotinib versus placebo in previously treated advanced non-small cell lung cancer (NSCLC) patients. 731 名登记患者中的 441 名可获得治疗前血浆样本，并以匿名等份形式提供给 Biodesix。 VeriStrat 测试在 Biodesix, Inc. 的 CLIA 认可实验室中进行。结果（好、差）返回给 NCIC CTG，由其进行所有统计分析。 VeriStrat 测试在 436 个样本 (98.9%) 中取得成功，其中 61% 被评为良好。 VeriStrat 对接受厄洛替尼治疗的患者和接受安慰剂的患者的总生存期具有预测作用，与临床协变量无关。对于 VeriStrat Good 患者，厄洛替尼组的中位生存期为 10.5 个月，而安慰剂组为 6.6 个月（HR 0.63，95% C.I. 0.47–0.85，P=0.002）。对于 VeriStrat Poor 患者，接受厄洛替尼的患者的中位生存期为 4 个月，安慰剂组的中位生存期为 3.1 个月（HR：0.77，95% C.I. 0.55–1.06，P=0.11）。 VeriStrat 可预测客观缓解 (P = 0.002)，但无法预测厄洛替尼带来的不同生存获益（交互作用 p 值 0.48）。无进展生存期（PFS）也有类似的结果。我们能够确认 VeriStrat 可以预测厄洛替尼的客观反应。 VeriStrat 可预测 OS 和 PFS，与临床特征无关，但不能预测与安慰剂相比的不同生存获益。
We investigated the predictive and prognostic effects of VeriStrat®, a serum or plasma based assay, on response and survival in a subset of patients enrolled on the NCIC Clinical Trials Group (CTG) BR.21 phase III trial of erlotinib versus placebo in previously treated advanced non-small cell lung cancer (NSCLC) patients. Pretreatment plasma samples were available for 441 of 731 enrolled patients and were provided as anonymized aliquots to Biodesix. The VeriStrat test was performed in a CLIA-accredited laboratory at Biodesix, Inc. Results (Good, Poor) were returned to NCIC CTG, who performed all statistical analyses. VeriStrat testing was successful in 436 samples (98.9%), with 61% classified as Good. VeriStrat was prognostic for overall survival in both erlotinib-treated patients and those on placebo, independent of clinical covariates. For VeriStrat Good patients, the median survival was 10.5 months on erlotinib vs. 6.6 months for placebo (HR 0.63, 95% C.I. 0.47–0.85, P=0.002). For VeriStrat Poor patients, the median survival was 4 months for patients receiving erlotinib, and 3.1 months for placebo (HR: 0.77, 95% C.I. 0.55–1.06, P=0.11). VeriStrat was predictive for objective response (P =0.002), but was not able to predict for differential survival benefit from erlotinib (interaction p-value 0.48). Similar results were found for progression-free survival (PFS). We were able to confirm that VeriStrat is predictive of objective response to erlotinib. VeriStrat is prognostic for both OS and PFS, independent of clinical features, but is not predictive of differential survival benefit vs. placebo.