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2015 ; 4
(6
): 887-96
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Complex renal cysts associated with crizotinib treatment
#MMPMID25756473
Schnell P
; Bartlett CH
; Solomon BJ
; Tassell V
; Shaw AT
; de Pas T
; Lee SH
; Lee GK
; Tanaka K
; Tan W
; Tang Y
; Wilner KD
; Safferman A
; Han JY
Cancer Med
2015[Jun]; 4
(6
): 887-96
PMID25756473
show ga
An apparent causal association between crizotinib treatment and renal cyst
development emerged during clinical trials in anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC). Serious adverse event (SAE)
reports of renal cysts from a safety database of 1375 patients from four clinical
trials were reviewed. A blinded, retrospective, independent radiologic review
(IRR) was performed using scans from patients on study for ? 6 months in three
clinical trials; risk factors for renal cyst development were assessed. Among 17
patients with renal cysts reported as SAEs, evidence of invasion into adjacent
structures was noted in seven patients, with no evidence of malignancy found.
These patients generally did not require dose reductions, none required permanent
crizotinib discontinuation due to this AE, and most continued treatment with
clinical benefit. In the blinded IRR, among 255 crizotinib-treated patients, 22%,
3%, and 2% had preexisting simple cysts, complex cysts, or both, respectively. At
the 6-month tumor assessment, 9% of all patients had acquired new cysts, and 2%
of patients with preexisting cysts had developed new cysts and enlargements
(>50%) of preexisting simple cysts. Asians appeared to have an increased risk of
developing new cysts on treatment; Koreans in particular had 5.18 times higher
odds of developing cysts than non-Asians (95% confidence interval, 1.51-17.78; P
= 0.05). Crizotinib treatment appears to be associated with an increased risk of
development and progression of renal cysts in patients with ALK-positive NSCLC.
While close monitoring is recommended, dosing modification was not generally
necessary, allowing patients to remain on crizotinib treatment.
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