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X. Chen



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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-031 - Chinese randomized phase II trial of customized chemotherapy based on BRCA1-RAP80 mRNA expression in advanced non-small-cell lung cancer (NSCLC) patients (p) (ChiCTR-TRC-12001860/BREC-CHINA) (ID 1883)

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

      • Abstract

      Background
      BRCA1 serves as a differential modulator of chemosensitivity to docetaxel (doc) and cisplatin (cis). RAP80 targets the BRCA1-BARD1 E3 ligase at double-strand breaks. A Spanish Lung Cancer Group (SLCG) phase II customized chemotherapy trial (NCT00883480) indicated that RAP80 and BRCA1 jointly influenced outcome in NSCLC p treated with cis- or doc-based chemotherapy. Based on these findings, the SLCG initiated a randomized phase III trial (NCT00617656/GECP-BREC), and we have performed a parallel phase II trial comparing non-customized cis/doc with customized therapy in metastatic NSCLC p in China.

      Methods
      Since October 2010, 104 p have been randomized 1:3 to control and three experimental arms. p in the control arm receive cis/doc; p in the experimental arm receive treatment according to their BRCA1 and RAP80 levels: p with low RAP80, regardless of BRCA1 levels, cis/gemcitabine (gem); p with intermediate/high RAP80 and low/intermediate BRCA1, cis/doc; p with intermediate/high RAP80 and high BRCA1, doc alone. The primary endpoint is progression-free survival (PFS).

      Results
      PFS was 4.15 months (m) in the control and 3.59 m in the experimental arm (P=0.68). Overall survival (OS) was 10.82 m in the control and 11.74 m in the experimental arm (P=0.68). Response rate (RR) was 23.3% in the control and 32.4% in the experimental arm (P=0.48). In ancillary analyses of p with low, intermediate and high BRCA1 levels, PFS in the control arm was 2.66, 4.15 m and 7.5 m, respectively, while PFS in the experimental arm was 10.66 m, 3.45 m and 3.06 m, respectively. In the multivariate analysis including PS, treatment arm, BRCA1, RAP80, histology and smoking status, only ex-smokers were associated with an increased risk of progression (HR, 1.906; P=0.029).

      Conclusion
      Customized chemotherapy based on BRCA1/RAP80 expression does not improve PFS. The predictive value of BRCA1 alone seems to be stronger than that of BRCA1/RAP80 combined.