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He Zhi Yong

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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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      P1.13-27 - A Randomized Study of Concurrent vs Sequential Alternating EGFR-TKIs and Chemotherapy for Advanced NSCLC with EGFR Mutations (ID 13170)

      16:45 - 18:00  |  Presenting Author(s): He Zhi Yong

      • Abstract
      • Slides


      EGFR-TKIs have been accepted as the standard first-line treatment for EGFR-mutated NSCLC, and EGFR-TKIs in combination with chemotherapy are found to achieve PFS benefits. However, the optimal sequence of EGFR-TKIs and chemotherapy remains controversial until now. This study aimed to compare the efficacy and safety of concurrent versus sequential alternating EGFR-TKIs and chemotherapy for treatment-naive advanced nonsquamous EGFR-mutated NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A multicentre, open-label, parallel, randomized controlled trial was performed. Eligible participants were randomly assigned into Group A (n = 36) and Group B (n = 59). Subjects in Group A were concurrently given EGFR-TKI and platinum-based doublet chemotherapy on day 1, every 3 weeks for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs, while patients in Group B received EGFR-TKI alone, and platinum-based doublet chemotherapy was given upon disease progression. Chemotherapy regimens included selected cisplatinum (75 mg/m2) or carboplatin (AUC 5.0) plus pemetrexed (500 mg/m2) or paclitaxel (175 mg/m2) on day 1 of a 21-day cycle. All subjects were administered orally with erlotinib 150 mg QD (n = 40), gefitinib 250 mg QD (n = 30) or icotinib 125 mg TID (n =19), until disease progression or intolerance to adverse events. The primary endpoint was PFS, and the secondary endpoints were OS and safety.

      4c3880bb027f159e801041b1021e88e8 Result

      At a median follow-up of 18 months, 53.4% of patients had progressive disease and 23.2% died. Median PFS was 15.0 months (95% CI, 9.9 to 20.1 months) for the concurrent regimen and 17.5 months (95% CI, 14.4 to 20.5 months) for the sequential alternating regimen (P = 0.614). In addition, administration of EGFR-TKIs alone achieved 12.0 months PFS (95% CI, 9.3 to 14.8 months), which was comparative to the concurrent regimen (P = 0.508). Drug-related grade 3 or 4 adverse events didn’t occur.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This interim analysis demonstrates that concurrent EGFR-TKIs and chemotherapy achieves comparative PFS to sequential alternating EGFR-TKIs and chemotherapy and EGFR-TKIs monotherapy for treatment-naive advanced nonsquamous non-small-cell lung cancer with sensitive EGFR mutations.


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