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Hiroshi Mukae



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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
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      P1.01-65 - PII of Pemetrexed or Pemetrexed Plus Bevacizumab for Previously Untreated Elderly (>=75) Non-Squamous NSCLC (LOGIK1201) (ID 11305)

      16:45 - 18:00  |  Author(s): Hiroshi Mukae

      • Abstract

      Background

      Pemetrexed (P) provided equivalent or more efficacy to docetaxel with fewer side effects against NSqNSCLC and subset analysis revealed elderly patients receiving P had a longer time to progression and OS than those treated with docetaxel (JCO 22:1589, 2004). Bevacizumab (B), antibody binding with VEGF, is expected additional effect to chemotherapy for patients with NSqNSCLC. To evaluate the efficacy and safety, we conducted randomized phase II study of P and P/B for elderly patients with NSqNSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligibility criterias were: NSqNSCLC, no prior therapy, stage IIIB, IV, postoperative recurrence, age ≥75 years, PS 0-1, adequate bone marrow function. Patients were randomly assigned in a 1:1 ratio to P or P/B. Primary endpoint was PFS. Secondary were RR, OS, toxicity and cost-effect. Stratified log-rank test was used. Assuming PFS of median 3.3 (P) and 7.4 (P/B) months, significance level bilateral 20%, power ≥80%, estimated required number was 32 and target sample size was set 40.

      4c3880bb027f159e801041b1021e88e8 Result

      Forty-one patients from 12 institutions were enrolled between 8/31/2012 and 6/30/2016 and 40 patients (P 20, P/B 20) were assessable. Patients’ characteristics were as follows: male/female = 23/17; median age (range) = 78 (75-83); stage IIIB/IV/postOp = 1/30/9; PS 0/1 = 11/29; all adenocarcinoma. The median PFSs (95%CI) were 5.4 (3.0-7.4) and 5.5 (3.6-9.9) months, respectively, and there is no significant difference (p=0.66). RR was significantly higher in P/B (15% vs. 55%, p=0.0146) and there was no significant difference in OS (median 16.0 vs. 16.4 months, p=0.58). G3/4 leukopenia, neutropenia, thrombocytopenia and fatigue (%) were 10, 20, 5, 25 and 30, 55, 5, 45, respectively. Costs were higher in P/B (median 1,522,008 vs. 3,368,428 JPY, p=0.01). No treatment-related deaths occurred.

      8eea62084ca7e541d918e823422bd82e Conclusion

      P showed similar PFS and OS with favorable toxicity and low cost compare with P/B in elderly (>=75) patients with NSqNSCLC.

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