Survival of 1,181 patients in a phase I clinic: the MD Anderson Clinical Center for targeted therapy experience.
Survival of 1,181 patients in a phase I clinic: the MD Anderson Clinical Center for targeted therapy experience.
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DOI：
10.1158/1078-0432.ccr-11-2217
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发表时间：
2012-05-15
期刊：
影响因子：
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通讯作者：
Kurzrock R
中科院分区：
文献类型：
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作者：
Wheler J;Tsimberidou AM;Hong D;Naing A;Falchook G;Piha-Paul S;Fu S;Moulder S;Stephen B;Wen S;Kurzrock R
为了确定皇家马斯登医院（RMH）一期患者的预后评分是否可以在不同中心的大量个体中得到验证，以及其他预后变量是否也相关，我们对在MD安德森癌症中心（MDACC）一期临床治疗的1181名患者进行了分析。我们回顾了在I期临床至少接受一项试验治疗的1181名连续患者的医疗记录。中位年龄为58岁，其中50%为女性。先前治疗的中位数为4次；中位生存期为10个月（95% CI-9.1 - 10.9个月）。在多变量Cox模型中预测较短生存期并可内部验证的独立因素包括：RMH评分> (p<0.0001)（白蛋白<3.5 mg/dL, LDH >上限为正常，>为转移部位）；胃肠道肿瘤类型（p<0.0001）；ECOG性能状态≥1 （p=0.0004）。具有上述0、1、2、3、4或5个危险因素的患者的中位生存期分别为24.0、15.2、8.4、6.2和4.1个月。RMH评分在MDACC的一大组患者中得到了验证。独立生存预后因素的内部验证导致MDACC预后评分的发展，RMH评分的修改加强了它。
In order to determine if the Royal Marsden Hospital (RMH) prognostic score for phase I patients can be validated in a large group of individuals seen in a different center, and if other prognostic variables are also relevant, we present an analysis of 1,181 patients treated in the MD Anderson Cancer Center (MDACC) Phase I clinic. Medical records of 1,181 consecutive patients who were treated on at least one trial in the Phase I clinic were reviewed. The median age was 58 years and 50% were women. The median number of prior therapies was four; median survival, 10 months (95% CI-9.1 to 10.9 months). Independent factors that predicted shorter survival in a multivariate Cox model and could be internally validated included: RMH score >1 (p<0.0001) (albumin <3.5 mg/dL, LDH >upper limit of normal, and >2 sites of metastases); gastrointestinal tumor type (p<0.0001); and, ECOG performance status ≥1 (p=0.0004). The median survival was 24.0, 15.2, 8.4, 6.2 and 4.1 months for patients with 0, 1, 2, 3, and 4 or 5 of the above risk factors respectively. The RMH score was validated in a large group of patients at MDACC. Internal validation of the independent prognostic factors for survival led to the development of the MDACC prognostic score, a modification of the RMH score that strengthens it.