Phase II multicenter study of antroquinonol in patients with stage IV non-small cell lung cancer who have failed at least two lines of anti-cancer therapy

Document Type

Conference Proceeding

Publication Date


Publication Title

J Clin Oncol


Background: The aim of this study was to assess the efficacy of Antroquinonol in patients with stage IV NSCLC after failure in twolines of anti-cancer therapy. Methods: Patients with stage IV nonsquamous NSCLC who have failed at 2-4 lines of anti-cancer therapy were eligible, though early stage or naive patients may voluntarily participate. A maximum of 30 evaluable patients were to receive Antroquinonol 600mg per day, of which 15 patients were to be KRAS-positive and 15 patients KRAS negative. The primary endpoint of the study was progression-free survival from the start of treatment to week 12 with disease control rate and overall survival as key secondary endpoints. Results: There were 31 patients enrolled with évaluable population 30 patients, of which 15 patients were KRAS positive and 15 patients KRAS negative. 73% were with at least two prior chemotherapy. The median PFS of 7 patients with 2 prior chemotherapy was 22.9 weeks (95% confidence interval [CI]: 5.0, 31.1); and 11 patients with more than 2 prior chemotherapy was 11.9 weeks (95% confidence interval [CI]: 6.0, 14.1), with a 1 -year PFS of 11.4%. Of 11 patients who had had more than 2 prior chemotherapy, the median OS was 47.3 weeks (95% CI: 14.1,-), with a 1-year OS of 39.3%, and the overall disease control rate was 72.7%, with 100% in KRAS negative and 50% in KRAS positive. No systemic toxicities were observed. Conclusions: The monotherapy of Antroquinonol brought up higher disease control rates and longer progression-free survival and overall survival, compared with historical data. Although KRAS negative shows much better than KRAS positive group, Antroquinonol still work well with KRAS positive patients.





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