Author of

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  P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 26795

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    P2.01-01 - The Impact of Anlotinib on Brain Metastases of NSCLC: Post-Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303) (ID 12454)

    16:45 - 18:00  |  Author(s): Xinyun Yang
    • Abstract
    • Slides

    Background
    

    Few evidence has measured the intracranial impact of multitargeted VEGFR-TKIs. Anlotinib hydrochloride, which targets VEGFR, PDGFR, FGFR and c-Kit, has been shown to significantly prolong PFS and OS compared with placebo as second/third-line treatment for NSCLC in a randomized, double-blind, phase Ⅲ trial (NCT02388919). Herein we sought to analyze anlotinib’s effect in managing brain metastases (BM) and its brain-associated toxicities.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    The PFS/OS of anlotinib versus placebo in those with and without BM records at baseline were calculated and compared respectively. In addition, time to brain progression (TTBP), a direct indicator of intracranial control, was also compared between anlotinib and placebo. All calculations were adjusted for confounding factors, including stage, histology, driver mutation type, etc.

    4c3880bb027f159e801041b1021e88e8 Result
    

    A total of 437 patients (294 receiving anlotinib; 143 receiving placebo) were included. 97 cases (22.2%) were recorded to have BM at baseline. There were more BM cases among younger patients and those with adenocarcinoma. Both of the benefit magnitude from anlotinib over placebo were similar between BM and non-BM group in terms of PFS (BM: HR 0.19, 0.11-0.34; non-BM: HR 0.29, 0.22-0.37; interaction P=0.691) and OS (BM: HR 0.71, 0.44-1.16; non-BM: HR 0.67, 0.51-0.89: interaction P=0.789). More specifically, anlotinib was associated with significantly longer TTBP (HR 0.11, 95% CI 0.03-0.41, P=0.001; Figure1) despite all confounders, indicating a 90% reduction of brain progression risk from anlotinib. Interestingly, anlotinib was also associated with more neural toxicities (18.4% vs. 8.4%, P=0.007) and psychological symptoms (49.3% vs. 35.7%, P=0.008) compared with placebo, especially headache (P=0.01), brain edema (P=0.04) but not infarction or cerebral hemorrhage. The above results were all confirmed both in intention-to-treat and per-protocol population.

    

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Anlotinib can benefit NSCLC patients with brain metastases and is highly potent in managing intracranial lesions. Its special effect on brain metastases and cerebral tissues merits further investigation.

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