Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10744

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    P1.10-001 - Phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small lung cancer that is refractory or relapsed after 1-2 previous Treatment (BEST study) (ID 124)

    09:30 - 09:30  |  Author(s): H. Nagai
    • Abstract

    Background
    We report the interim-analysis result of the BEST trial, which examines efficacy and safety of second- or third-line chemotherapy with erlotinib (E) and bevacizumab (B) for the Japanese patients (pts) with non-squamous, non-small cell lung cancer.

    Methods
    E was administered initially at 150 mg/day orally and B was administered at a dose of 15 mg/kg on the first day of each 3-week cycle. The primary endpoint was objective response rate (RR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and incidence of adverse events. This trial was planned to accrue 80 pts based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status was planned (Trials. 2011; 12: 120).

    Results
    Total of 28 pts enrolled in 2 years from November, 2010. One patient was excluded due to thrombosis in lower limb and 27 pts (15 men and 12 women) with a median age of 67 (43-82) were analyzed; 18 pts had a PS of 0; all had adenocarcinoma; 11 pts had EGFR mutation; 1 patient had stage IIIB, 23 pts had stage IV and 3 pts had recurrences after surgery; 21 pts received as second-line and 6 pts received as third-line chemotherapy. RR was 18.5% (p=1.00; one-sided); DCR was 77.8%. Median PFS was 5.6 months (m); OS data were not yet mature (median follow-up time was 11.9 m). Grade 3/4 non-hematologic toxicities were mainly acne (11.1%) and hypertension (11.1%). The subset analysis according to EGFR showed significantly higher RR (p=0.02) and better PFS (p=0.03) in mutant group than in wild group. RR in mutant group was compared with 20% null hypothesis using the same binomial test (p=0.056).

    Conclusion
    Combination therapy of B and E had mild adverse effects but did not increase anti-cancer effect.