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X. Li



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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-052 - Randomized Phase II Individualized Chemotherapy Study Based on BRCA1 and RRM1 Message RNA Level for Advanced NSCLC (BRAVO Study) (ID 2306)

      09:30 - 09:30  |  Author(s): X. Li

      • Abstract
      • Slides

      Background:
      We assessed whether BRCA1 and RRM1 message RNA(mRNA) levels could help to select chemotherapy regimen to improve objective response rate in patients with advanced NSCLC.

      Methods:
      Eligible patients were randomly assigned 2:1 according to stratification factors of smoking, gender and histological type. In experimental arm, gemcitabine/cisplatin(GP) were selected if both RRM1 and ERCC1 mRNA levels were low, irinotecan/cisplatin(IP) if RRM1 high and BRCA1 low, gemcitabine/vinorelbine(GN) if RRM1 low and BRCA1 high, and docetaxel(T) if both high. GP was chose in the control arm. The primary end point was objective response rate (ORR). (Registered No. NCT01424709).

      Results:
      121 patients were enrolled and 120 received at least one dose of therapy. The median number of cycles given was four in both arms. In experimental arm, 36 patients treated with GP, 14 with IP, 13 with GN and 17 with T. The ORR and DCR were 33.3% and 79.5% in the experimental arm, which were not significant different from 32.5% (p=0.12) and 87.5%(p=0.18) in the control arm. When patients with both low mRNA levels of RRM1 and ERCC1 were removed, the sub-analysis showed the ORR in the experimental arm was marginally significantly higher than in the control arm (42% vs. 36.3%, p=0.06)). Survival analysis showed similar PFS in the two arms (5.1 vs. 5.3m, p=0.11), while sub-analysis revealed that PFS was marginally significantly longer in the experimental arm (5.7 vs. 5.3m p=0.09). No unexpected side effect happened in both arms.

      Conclusion:
      BRCA1 and RRM1 mRNA levels were potentially used for therapeutic decision making in newly diagnosed patients with advanced NSCLC.

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