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A. Bessho



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    MA08 - Treatment Monitoring in Advanced NSCLC (ID 386)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA08.10 - Detection of the T790M Mutation of EGFR in Plasma of Advanced NSCLC Patients with Acquired Resistance to EGFR-TKI (WJOG8014LTR) (ID 5377)

      12:06 - 12:12  |  Author(s): A. Bessho

      • Abstract
      • Presentation
      • Slides

      Background:
      NSCLC patients with activating mutations of the EGFR initially respond well to TKIs, but about half such patients develop TKI resistance through acquisition of a secondary T790M mutation. Whereas next-generation EGFR-TKIs have been developed to overcome T790M-mediated resistance, performance of a second tumor biopsy to assess T790M mutation status can be problematic.

      Methods:
      We developed and evaluated liquid biopsy assays for detection of TKI-sensitizing and T790M mutations of EGFR by droplet digital PCR (ddPCR) in EGFR mutation–positive patients with acquired EGFR-TKI resistance.

      Results:
      A total of 260 patients was enrolled between November 2014 and March 2015 at 29 centers for this West Japan Oncology Group (WJOG 8014LTR) study. Plasma specimens from all subjects as well as tumor tissue or malignant pleural effusion or ascites from 41 patients were collected after the development of EGFR-TKI resistance. All plasma samples were genotyped successfully and the results were reported to physicians within 14 days. TKI-sensitizing and T790M mutations were detected in plasma of 120 (46.2%) and 75 (28.8%) patients, respectively. T790M was detected in 56.7% of patients with plasma positive for TKI-sensitizing mutations. For the 41 patients with paired samples obtained after acquisition of EGFR-TKI resistance, the concordance for mutation detection by ddPCR in plasma compared with tumor tissue or malignant fluid specimens was 78.0% for TKI-sensitizing mutations and 65.9% for T790M.

      Conclusion:
      Noninvasive genotyping by ddPCR with cell-free DNA extracted from plasma is a promising approach to the detection of gene mutations during targeted treatment.

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    P2.06 - Poster Session with Presenters Present (ID 467)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
    • Presentations: 1
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      P2.06-018 - Multicenter, Single-Arm Phase II Study of Nab-Paclitaxel/Carboplatin in Untreated PS2 Patients with Advanced NSCLC: TORG1426 (ID 4805)

      14:30 - 14:30  |  Author(s): A. Bessho

      • Abstract
      • Slides

      Background:
      No standard of care exists for ECOG Performance Status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC) and therefore clinical practice ranges from supportive care to combination chemotherapy. It was first reported that the combination therapy with carboplatin (CBDCA)/pemetrexed significantly improved survival for PS2 patients with advanced non-squamous NSCLC (J Clin Oncol 31:2849-2853.2013). However, due to the limited utilities of this regimen, establishment of other combination therapy is warranted in PS2 patients with especially squamous NSCLC or unfavorable renal function. On the other hand, in CA031 trial, CBDCA/nab-paclitaxel (PTX) demonstrated a significantly higher response rate (RR) compared with CBDCA/PTX in PS0-1 patients with advanced NSCLC, especially squamous histology (J Clin Oncol 30:2055-2062.2012). Furthermore, in elderly patients over 70 years old, CBDCA/nab-PTX tended to show superior PFS and OS on the basis of better tolerability compared with CBDCA/PTX. Thus, CBDCA/nab-PTX could be a valid treatment option for PS2 patients whose PS is exacerbated due to mass effect of NSCLC despite appropriate organ function.

      Methods:
      This phase 2 trial is enrolling untreated PS2 patients with NSCLC and appropriate organ function under 75 years old. Patients are included if they had histologically/cytologically confirmed stage IIIB/IV NSCLC unfit for surgery or radiotherapy, whereas they are excluded if they had uncontrolled symptomatic brain metastasis or uncontrolled pleural effusion. The primary endpoint is PFS rate at 6months. Achievement of more than 50% is considered worthy of further development of this combination therapy, whereas that of less than 30% is considered insufficient for further investigation. The estimated power of this design is 80% with a type I error of 0.05, resulting in 35 patients needed. Considering that about 20% of patients are likely to be excluded from the trial, we planned to enroll 45 patients. Patients are treated with nab-PTX (70 mg/m[2] on day1, 8, and15, q4w) and CBDCA (AUC 5 on day1, q4w), up to 6 cycles. Concurrently, Quality of life and Charlson Comorbidity Index are planned to be checked about the patients treated with this regimen. This study is open for enrollment and recruitment is ongoing. Clinical trial information: UMIN000019458.

      Results:
      Section not applicable

      Conclusion:
      Section not applicable

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