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Ying Jin

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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • 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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      P1.12-01 - A Single-Arm Multi-Center Phase II Study of Apatinib in Patients with ES-SCLC After Second/Third-Line Chemotherapy (ID 12960)

      16:45 - 18:00  |  Author(s): Ying Jin

      • Abstract
      • Slides


      The survival of patients (pts) with extensive-stage small-cell lung cancer (ES-SCLC) was poor. And the standard treatment strategies have not yet been established for those who failed from second/third-line chemotherapy. Apatinib, a vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, has been shown anti-cancer activity and manageable toxicities in several solid cancers.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A single-arm multi-center phase II study was designed to determine the efficacy and safety of apatinib in pts with ES-SCLC after second/third-line chemotherapy (clinical trial information: NCT02945852). The inclusion criteria mainly included aged 18-75 years; pathologically confirmed SCLC; received chemotherapy with two or three regimens previously, including first-line platinum-based regimen. Pts were treated with afatinib 500 mg/day p.o. until tumor progression or lack of tolerability. One treatment cycle was 28 days long. The full analysis set included patients who received at least one cycle of treatment. Treatment interruptions or dose reductions were allowed when grade 3 hematologic or grade 2 nonhematologic toxicities occurred. The primary endpoint is progression-free survival(PFS); secondary endpoint includes the safety of afatinib, overall survival (OS), objective response rate (ORR) and disease control rate (DCR).

      4c3880bb027f159e801041b1021e88e8 Result

      As of Mar 2018, 40 pts from 3 institutions were recruited into the trial. Median age was 60 years, and 37 pts were male (92.5%). 17/40 (42.5%) pts experienced dose reduction or treatment interruptions. Followed up to Apr 26, 2018, the median during time of afatinib treatment was 80 days and 36 pts were eligible for assessing tumor responses. In the 36 pts, 8 (22.2%) pts achieved partial responses [PR], 20 (55.5%) pts achieved stable disease [SD] and 8 (22.2%) pts were assessed as progressive disease [PD]. The ORR was 22.2% (8 pts PR) and the DCR was 77.8% (8 pts PR, 20 pts SD). During the follow-up, a total of 25 pts died. The median PFS and OS was 86 days and 105 days, respectively. The most common adverse events were anemia (69.4%, 25/36), hand-foot syndrome (61.1%, 22/36), urine protein (55.6%, 20/36), hypertension (52.8%, 19/36) and fatigue (44.4%, 16/36). The related grade 3-4 toxicities included hypertension (47.2%, 17/36), hand-foot syndrome (5.6%, 2/36), Oral ulcer (5.6%, 2/36) and elevated aminotransferase (5.6%, 2/36).

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this prospective phase II trial, apatinib showed encouraging durable response rates and survival in patients with ES-SCLC after second/third-line chemotherapy, with an acceptable safety profile.


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