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首页> 外文期刊>British Journal of Cancer >Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents
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Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents

机译：细胞毒性药物与新的非细胞毒性药物I期试验中患者的预后因素比较

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The aims of this study were to identify prognostic variables for toxicity and survival in patients with cancer participating in phase I clinical trials and compare characteristics of those treated with cytotoxic chemotherapy (CT) and non-cytotoxic drugs (non-CT). Data were collected from 420 (114 CT, 306 non-CT) patients enrolled in 16 phase I trials (five CT and 11 non-CT trials) in one cancer centre. Analyses of all patients were used to compare treatment groups, identify predictive variables for toxicity and to estimate prognostic factors in overall survival (OS). These were used to develop a prognostic index (PI). Multivariate analysis found those patients with better performance status, fewer sites of metastases, baseline Hb>12?g?dl?1 and WBC or LDH in the normal range had significantly better OS. Male gender, platelet count 9?l?1, high WBC or treatment with a non-CT phase I agent significantly reduced the chance of grade 3/4 toxicity. Overall survival was not significantly different between the CT and non-CT groups (260 vs 192 days, P=0.47) except for those with liver metastases (228 vs 137 days, P=0.02). Overall tumour response was 4.9% (95% CI: 2.7–7.0%). The PI identified three distinct patient groups with median survival of 321, 257 and 117 days. In conclusion, entry into a phase I trial of a non-CT drug is a safe option for heavily pretreated patients with cancer. The PI generated from these data can estimate the survival probability for patients entering phase I studies.
机译：这项研究的目的是确定参与I期临床试验的癌症患者的毒性和生存的预后变量，并比较接受细胞毒性化学疗法（CT）和非细胞毒性药物（non-CT）治疗的患者的特征。从一个癌症中心的16项I期试验（5项CT和11项​​非CT试验）中招募的420名患者（114例CT，306例非CT）收集了数据。所有患者的分析均用于比较治疗组，确定毒性的预测变量以及估计总体生存率（OS）的预后因素。这些被用于制定预后指数（PI）。多变量分析发现，那些患者的病情状态较好，转移部位较少，基线Hb> 12？g？dl？1，且WBC或LDH在正常范围内，其OS明显改善。男性，血小板计数9？l？1，高白细胞或使用非CT I期药物治疗可显着降低3/4级毒性的机会。除了有肝转移的患者（228 vs 137天，P = 0.02）以外，CT组和非CT组的总生存期无显着差异（260 vs 192天，P = 0.47）。总体肿瘤反应为4.9％（95％CI：2.7-7.0％）。 PI确定了三个不同的患者组，中位生存期分别为321、257和117天。总之，对于经过大量预处理的癌症患者，进入非CT药物的I期试验是一种安全的选择。从这些数据生成的PI可以估计进入I期研究的患者的生存概率。

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