Author of

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  P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall

  • 26271

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    P1.01-40 - Randomized Phase II Study of Docetaxel Plus Bevacizumab or Pemetrexed Plus Bevacizumab for Elderly pts with Untreated Advanced NSCLC: TORG1323 (ID 12868)

    16:45 - 18:00  |  Author(s): Natsumi Yamashita
    • Abstract
    • Slides

    Background
    

    The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous NSCLC. The role of monotherapy with B is unclear for elderly non-squamous NSCLC pts.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Pts were pathologically diagnosed untreated elderly (≥75 years old) non-squamous NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALK rearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m², or P was 500 mg/m² every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Enrollment was terminated in early at the end of March 2017 because of slow accrual. Total 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) were full analysis set. Patient characteristics were well balanced between two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. Total 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months and 4.6 months (HR 1.03, 95%C.I. 0.66-1.61: p=0.901). The response rates were 43% and 40% (p=0.840), respectively. The incident of ≥Grade 3 leukopenia (69% vs. 27%, p<0.001), neutropenia (86% vs. 44%, p<0.001) and fatigue (10% vs. 0%, p=0.027) were higher in DB. However, the frequency of febrile neutropenia was not different (16% vs.12%, p=0.578). One patient in PB was died of rupture of abdominal aortic aneurysm.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    PB is less toxic and the efficacy is comparable between two arms for elderly (≥75 years old) advanced non-squamous NSCLC. PB is a candidate for the further evaluation. Clinical Trial information: UMIN000012786.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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