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Elia Sais



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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-29 - Overall Response Rate of Nintedanib and Docetaxel in Combination with the Nutraceutical Use of Silibinin in Advanced NSCLC (ID 13239)

      16:45 - 18:00  |  Author(s): Elia Sais

      • Abstract
      • Slides

      Background

      The bioactive flavonolignan silibinin, the main component of standardized extracts from the seeds of the milk thistle herb Silybum marianum, has been shown to exhibit significant anticancer activity in preclinical models. Silibinin is a direct inhibitor of pSTAT3, a signal transducer and key transcription factor that is associated with chemoresistance in cancer cells. Our group has shown that oral administration of the silibinin-containing nutraceutical Legasil® could represent the first silibinin formulation with proven clinical benefit as an adjunct cancer treatment in patients with brain metastases. Nintedanib is an orally administered, small-molecule triple angiokinase inhibitor of VEGF1–3, PDGFa and b, and FGFR1–3. The LUME-Lung 1 trial showed that nintedanib significantly extended progression-free survival (PFS) and overall survival (OS) in patients with NSCLC adenocarcinoma when added to docetaxel chemotherapy, with no differences in response rate.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with stage IV NSCLC who failed ≥1 prior treatment were eligible for nintedanib/docetaxel combination. We present retrospective data analysis regarding patients that received nintedanib/docetaxel with or without combination with up to 5 capsules (630 mg)/day of Legasil®.

      4c3880bb027f159e801041b1021e88e8 Result

      Fifty-nine patients were enrolled in the study: median age, 60y (range: 43–79); male, 46 (78%). All the cases had adenocarcinoma histology. All patients had received first line therapy and 13 (22%) patients had >2 prior lines of treatment. A higher overall response rate (ORR) was observed in the group receiving Legasil® supplementation: ORR 55.5% versus 22%, p=0.02. No statistically significant differences in the median PFS were observed in the two arms: 2.34 months (95% confidence interval [CI] 1.83–2.91) for nintedanib/docetaxel combination (n=41) versus 4.99 (95%CI 0.94–9.05) for nintedanib, docetaxel and Legasil® triple combination (n=18) (p=0.241) at the data cut-off of January 2018. In the control group (n=41), ORR was greater in patients with known KRAS (n=8) or EGFR (n=3) mutations: 45% versus 13%, p=0.028.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The inhibition of pSTAT3 with silibinin may increase tumor responses to nintedanib/docetaxel combination. In addition, patients with known KRAS or EGFR mutations may show higher tumor responses to nintedanib/docetaxel combination.

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