الفهرس 
Epidemiology and Risk FactorsOnly 14 pages are availabe for public view
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Abstract
Background: Itraconazole is an oral antifungal that has a been reported to have anticancer effect in non-small cell
lung cancer (NSCLC) through inhibition of angiogenesis. Aim: to evaluate the effect of using itraconazole on the
clinical outcome of metastatic NSCLC. Methods: this was a prospective randomized controlled open label study
conducted on 60 chemotherapy naïve metastatic NSCLC. Patients were simply randomized to either Control group
who received platinum-based chemotherapy for a maximum of six cycles or Itraconazole group who received the same
chemotherapy regimen in addition to itraconazole 200 mg daily for 21 days starting from day 1 in each cycle. Primary
outcome was 1-year progression free survival (PFS) while secondary outcomes included overall response rate (ORR),
1-year overall survival (OS) and tolerability. Results: The two groups were comparable at baseline with no significant
difference between groups regarding demographics and clinical characteristics. The ORR in Control group was 66.7%
versus 90% in Itraconazole group (p-value 0.028). There was a significant difference between groups regarding PFS
where the mean 1-year PFS was 5.415 months in Control group versus 6.556 months in Itraconazole group (p-value=
0.002). However, there was no significant difference between groups with respect to 1-year OS. All adverse effect
reported were tolerable EXCEPT for one patient who developed grade 2 cardiotoxicity in Itraconazole group requiring
itraconazole discontinuation. Conclusion: Itraconazole use was beneficial in NSCLC in terms of 1-year PFS and ORR
which was not reflected by improvement in 1-year OS.