Creatinine clearance is associated with toxicity from molecularly targeted agents in phase I trials.

Abstract:

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 × 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.

journal_name

Oncology

journal_title

Oncology

authors

Basu B,Vitfell-Pedersen J,Moreno Garcia V,Puglisi M,Tjokrowidjaja A,Shah K,Malvankar S,Anghan B,de Bono JS,Kaye SB,Molife LR,Banerji U

doi

10.1159/000341152

subject

Has Abstract

pub_date

2012-01-01 00:00:00

pages

177-82

issue

4

eissn

0030-2414

issn

1423-0232

pii

000341152

journal_volume

83

pub_type

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