Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab.
Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab.
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DOI：
10.1158/1078-0432.ccr-17-2386
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发表时间：
2018-10-15
期刊：
影响因子：
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通讯作者：
Gangadhar TC
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文献类型：
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作者：
Joseph RW;Elassaiss-Schaap J;Kefford R;Hwu WJ;Wolchok JD;Joshua AM;Ribas A;Hodi FS;Hamid O;Robert C;Daud A;Dronca R;Hersey P;Weber JS;Patnaik A;de Alwis DP;Perrone A;Zhang J;Kang SP;Ebbinghaus S;Anderson KM;Gangadhar TC
在Keynote-001中评估培溴利珠单抗治疗的晚期黑色素瘤患者的基线肿瘤大小(BTS)与其他基线临床因素和预后的相关性。通过将所有可测量的基线靶区的最长尺寸之和相加来量化BTS。采用Logistic回归分析客观反应率(ORR)和COX回归分析总体生存期(OS)，将BTS作为一个二分连续变量与其他基线因素一起进行评估。没有多重性调整的名义P值描述了观察到的关联的强度。根据RECIST v1.1的中央审查，655名患者中有583名患者有基线可测量的疾病，并包括在这项特别分析中。中位BTS为10.2 cm(范围1~89.5)。更大的中位数BTS与东部合作肿瘤组表现状态1、乳酸脱氢酶升高、M1c期疾病和肝转移(有或没有任何其他部位)相关(均P≤0.001)。在单变量分析中，BTS低于中位数与较高的ORR(44%比23%；P<；0.001)和改善的OS(风险比，0.38；P<；0.001)相关。在多变量分析中，中位数以下的BTS仍然是OS的独立预后标志(P<；0.001)，但不是ORR。在459例可用肿瘤程序性死亡配体1(PD-L1)表达的患者中，BTS低于中位数和PD-L1阳性肿瘤独立地与较高的ORR和较长的OS相关。BTS与许多其他基线临床因素有关，但也是晚期黑色素瘤患者接受培溴利珠单抗治疗后生存的独立预后因素。
To assess the association of baseline tumor size (BTS) with other baseline clinical factors and outcomes in pembrolizumab-treated patients with advanced melanoma in KEYNOTE-001 (). BTS was quantified by adding the sum of the longest dimensions of all measurable baseline target lesions. BTS as a dichotomous and continuous variable was evaluated with other baseline factors using logistic regression for objective response rate (ORR) and Cox regression for overall survival (OS). Nominal P values with no multiplicity adjustment describe the strength of observed associations. Per central review by RECIST v1.1, 583 of 655 patients had baseline measurable disease and were included in this post hoc analysis. Median BTS was 10.2 cm (range, 1–89.5). Larger median BTS was associated with Eastern Cooperative Oncology Group performance status 1, elevated lactate dehydrogenase (LDH), stage M1c disease, and liver metastases (with or without any other sites) (all P ≤ 0.001). In univariate analyses, BTS below the median was associated with higher ORR (44% vs 23%; P < 0.001) and improved OS (hazard ratio, 0.38; P < 0.001). In multivariate analyses, BTS below the median remained an independent prognostic marker of OS (P < 0.001) but not ORR. In 459 patients with available tumor programmed death ligand 1 (PD-L1) expression, BTS below the median and PD-L1–positive tumors were independently associated with higher ORR and longer OS. BTS is associated with many other baseline clinical factors but is also independently prognostic of survival in pembrolizumab-treated patients with advanced melanoma.