Validation of prognostic scoring systems for patients with metastatic renal cell carcinoma enrolled in phase I clinical trials.
Validation of prognostic scoring systems for patients with metastatic renal cell carcinoma enrolled in phase I clinical trials.
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DOI：
10.1136/esmoopen-2020-001073
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发表时间：
2020-11
期刊：
影响因子：
7.3
通讯作者：
Subbiah V
中科院分区：
文献类型：
--
作者：
Hahn AW;Alhalabi O;Msaouel P;Meric-Bernstam F;Naing A;Jonasch E;Piha-Paul S;Hong D;Pant S;Yap T;Campbell E;Le H;Tannir NM;Roszik J;Subbiah V
对于在标准治疗方面取得进展的转移性肾细胞癌(MRCC)患者来说，对新的治疗方法的需求尚未得到满足。第一阶段临床试验旨在测试新药的安全性、毒性和最佳剂量。在这里，我们分析了参加I期试验的肾细胞癌患者的结局，并评估了预后评分的实用性。如果在MD Anderson癌症中心(MDACC)接受了I期临床试验，则包括所有组织学类型的肾细胞癌患者。生存结局采用COX比例风险模型计算。采用似然比(LR)χ2检验和c指数评价国际转移性肾癌数据库联盟、皇家马斯登医院和MDAC值对预后的预测价值。在接受治疗的82名mRCC患者中，21名患者参与了一项以上试验，导致106名试验参与者(TP)。之前接受治疗的中位数为两次。所有TPS的中位总生存期(OS)为31.2个月，无进展生存期(PFS)为5.9个月，客观有效率为22%。随着IMDC、RMH和MDACC评分的增加，中位OS和PFS显著缩短。在预测OS(RMH LRχ2=8.6 4；MDACC LRχ2=7.74；IMDC LRχ2=2.36)和PFS(RMH LRχ2=17.5；MDACC LRχ2=2 0.3；IMDC LRχ2=4.2 8)方面，RMH和MDACC值优于IMDC。在I期试验中，RMH和MDACC预后评分可以用来预测mRCC患者的OS，并可以指导患者的选择。MRCC患者应考虑进行I期试验。
For patients with metastatic renal cell carcinoma (mRCC) who progress on standard-of-care therapies, there is an unmet need for novel treatments. Phase I clinical trials are designed to test the safety, toxicity and optimal dosing of novel agents. Herein, we analysed the outcomes of patients with mRCC enrolled in phase I trials and assess the utility of prognostic scores. Patients with all histologies of mRCC were included if they received treatment on a phase I clinical trial at MD Anderson Cancer Center (MDACC). Survival outcomes were calculated using Cox proportional hazard model. Prognostic value of the International Metastatic RCC Database Consortium (IMDC), Royal Marsden Hospital (RMH) and MDACC scores was assessed using the likelihood ratio (LR) χ2 test and the c-index. Among 82 patients with mRCC who received treatment, 21 patients participated in more than one trial, resulting in 106 trial participants (TP). Median prior therapies was two. For all TPs, median overall survival (OS) was 31.2 months, progression-free survival (PFS) was 5.9 months and objective response rate was 22%. Median OS and PFS were significantly shorter with increasing IMDC, RMH and MDACC scores. The RMH and MDACC scores outperformed the IMDC score for predicting OS (RMH LR χ2=8.64; MDACC LR χ2=7.74; IMDC LR χ2=2.36) and PFS (RMH LR χ2=17.5; MDACC LR χ2=20.3; IMDC LR χ2=4.28). The RMH and MDACC prognostic scores can be used to predict OS for patients with mRCC in phase I trials and may guide patient selection. Patients with mRCC should be considered for phase I trials.
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影响因子：
10.9
作者：
Groisberg R;Hong DS;Behrang A;Hess K;Janku F;Piha-Paul S;Naing A;Fu S;Benjamin R;Patel S;Somaiah N;Conley A;Meric-Bernstam F;Subbiah V
通讯作者：
Subbiah V
影响因子：
51.1
作者：
Ko, Jenny J.;Xie, Wanling;Heng, Daniel Y. C.
通讯作者：
Heng, Daniel Y. C.
影响因子：
18.4
作者：
Subbiah V;Kurzrock R
通讯作者：
Kurzrock R
影响因子：
6.6
作者：
Cook N;Hansen AR;Siu LL;Abdul Razak AR
通讯作者：
Abdul Razak AR
DOI：
10.1158/1078-0432.ccr-11-2217
发表时间：
2012-05-15
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
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
通讯作者：
Kurzrock R