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M. Takeda



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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-010 - Survival outcome assessed by response and tumor shrinkage pattern in non-small cell lung cancer patients with activating mutations of the epidermal growth factor receptor (ID 752)

      09:30 - 09:30  |  Author(s): M. Takeda

      • Abstract

      Background
      Somatic mutations in the epidermal growth factor receptor (EGFR) gene are associated with the dramatic therapeutic response to EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non–small cell lung cancer (NSCLC); however, there are no studies investigating clinical indicators that affect the likelihood of survival benefit from EGFR-TKI in selected patients with EGFR mutations. We evaluated the progression-free survival (PFS) and overall survival (OS) according to response and tumor shrinkage pattern among EGFR-mutated NSCLC.

      Methods
      Among 145 EGFR-mutation positive patients treated with EGFR-TKI, 68 patients were selected for the present analysis.

      Results
      Of those 68 patients, six patients achieved complete response (CR), 42 patients partial response (PR), and 14 patients stable disease (SD). The PFS and OS of CR/PR group was significantly longer than that of the SD group. A multivariate analysis demonstrated that response (CR/PR) to EGFR-TKI significantly correlated with both PFS and OS. Among CR/PR group, the median maximum tumor change from baseline was -56%, and the median time to response (TTR) was 4.2 weeks. No trend toward more favorable PFS and OS benefit was seen in the subset of patients who had experienced rapid tumor regression (TTR < 4.2 weeks) as well as high degree of tumor shrinkage (< -56%) compared with those who showed slow tumor regression (TTR > 4.2 weeks), or low degree of tumor shrinkage (> -56%) among CR/PR patients.

      Conclusion
      Response (CR/PR) may represent the optimal surrogate for efficacy among EGFR mutation-positive patients treated with EGFR-TKI patients.

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    P3.09 - Poster Session 3 - Combined Modality (ID 214)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P3.09-007 - Update data of biomarker analysis of WJOG4107 (A randomized phase II trial of adjuvant chemotherapy with S-1 versus CDDP+S-1 for resected stage II-IIIA non-small cell lung cancer (NSCLC)) (ID 1504)

      09:30 - 09:30  |  Author(s): M. Takeda

      • Abstract

      Background
      We conducted a randomized phase II trial for patients with resected stage II-IIIA NSCLC comparing postoperative oral S-1 (80 mg/m2/day for consecutive 2 weeks q3w for 1 year) (S) (N=100) or cisplatin (CDDP) (60 mg/m2 day1) plus oral S-1, (80 mg/m2/day for 2 weeks) q3w for 4 cycles (PS)(N=100). We reported that disease free survival rate at 2 years (DFS@2) (95% confidence interval: CI), a primary endpoint, was 66 (55-74) % for S and 58 (48-67)% for PS. Here, we report the preliminary results of preplanned biomarker analysis, a co-primary endpoint, to identify molecules whose expression is significantly associated with patient outcome.

      Methods
      　cDNA extracted from macro-dissected formalin-fixed paraffin-embedded specimens were available for 197/200 patients. Thirty-one genes including those whose expressions have been potentially associated with　CDDP (e.g. ERCC1, XRCC1, BRCA1, GSTpi, HMG1, TBP) or fluorouracil (FU) sensitivity (TS, DHFR, DPD, UMPS, UPP1) were measured by QGE analysis (MassArray, Sequenom, CA). Additional analysis are being performed to assess ERCC1 isoform expression with an isoform-specific TaqMan probe (Applied Biosystems, CA). The expression of each gene was dichotomized according to its median value.

      Results
      Molecules such as ERCC1 and GSTpi whose expression have been previously associated with CDDP sensitivity did not emerge as predictive markers (P=0.7908, 0.6406, respectively). We quantitated ERCC1 by isotype (202 and 204 cannot be distinguished). There was a trend in patients with high 201 or 202/204, CDDP/S-1 was worse than S-1.

      Conclusion
      Quantitation of ERCC1 by isotype may define a patient subset that would benefit from postoperative platinum therapy.