الفهرس | Only 14 pages are availabe for public view |
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. |