Creatinine Clearance Is Associated with Toxicity from Molecularly Targeted Agents in Phase I Trials

被引：0

作者：

Basu, B. ^{[2
]}

Vitfell-Pedersen, J. ^{[2
]}

Garcia, V. Moreno ^{[2
]}

Puglisi, M. ^{[2
]}

Tjokrowidjaja, A. ^{[2
]}

Shah, K. ^{[2
]}

Malvankar, S. ^{[2
]}

Anghan, B. ^{[2
]}

de Bono, J. S. ^{[1
,2
]}

Kaye, S. B. ^{[1
,2
]}

Molife, L. R. ^{[2
]}

Banerji, U. ^{[1
,2
]}

机构：

[1] Royal Marsden NHS Fdn Trust, Inst Canc Res, Div Canc Therapeut, Drug Dev Unit, Sutton SM2 5PT, Surrey, England

[2] Royal Marsden NHS Fdn Trust, Inst Canc Res, Div Clin Studies, Drug Dev Unit, Sutton SM2 5PT, Surrey, England

来源：

ONCOLOGY | 2012年 / 83卷 / 04期

关键词：

Cockcroft-Gault; Creatinine clearance; Molecularly targeted agent; Phase I trial; Toxicity; BODY-SURFACE AREA; CLINICAL-TRIALS; RENAL DYSFUNCTION; CANCER; BENEFITS; RISKS;

D O I：

10.1159/000341152

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objectives: This study aimed to evaluate any correlations between baseline creatinine clearance and the development of grade 3/4 toxicities during treatment within oncology phase I trials of molecularly targeted agents where entry criteria mandate a serum creatinine of <= 1.5 x the upper limit of normal. Methods: Documented toxicity and creatinine clearance (calculated by the Cockcroft-Gault formula) from all patients treated with molecularly targeted agents in the context of phase I trials within our centre over a 5-year period were analyzed. Results: Data from 722 patients were analyzed; 116 (16%) developed at least one episode of grade 3/4 toxicity. Patients who developed a late-onset (>1 cycle) grade 3/4 toxicity had a lower creatinine clearance than those who did not (82.69 ml/min vs. 98.97 ml/min; p = < 0.001). Conclusion: Creatinine clearance (even when within normal limits) should be studied as a potential factor influencing late toxicities in the clinical trials of molecularly targeted anti-cancer drugs. Copyright (C) 2012 S. Karger AG, Basel

引用

页码：177 / 182

页数：6

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