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M. Takeda



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    MINI 07 - ChemoRT and Translational Science (ID 110)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      MINI07.01 - A Randomized Phase II Study of S-1 and Cisplatin vs Vinorelbine and Cisplatin with Concurrent Radiotherapy for Locally Advanced NSCLC: WJOG5008L (ID 544)

      16:45 - 16:50  |  Author(s): M. Takeda

      • Abstract
      • Presentation
      • Slides

      Background:
      Cisplatin-based chemotherapy and concurrent radiotherapy is the standard treatments for locally advanced non-small cell lung cancer ( LA-NSCLC). This trial evaluated two experimental regimens of chemotherapy with concurrent radiotherapy.

      Methods:
      Eligible patients (pts) with unresectable stage III NSCLC, 20 to 74 years of age, and ECOG PS of 0­–1 were randomized to either Arm SP, S-1 (40 mg/m[2]/dose per oral, b.i.d, on days 1-14) and cisplatin (60 mg/m[2] on day 1) repeated every 4 weeks or Arm VP, vinorelbine ( 20mg/m[2] on day 1, 8) and cisplatin (80 mg/m[2] on day) repeated every 4 weeks with early concurrent thoracic radiotherapy of 60Gy at 2 Gy per daily fraction. The primary endpoint was overall survival rate at 2-year (2yr-OS). A pick-the-winner design was used to identify the treatment regimen most likely to be superior. The planned sample size was 55 patients per arm, assuming in each arm that the null hypothesis for 2yr- OS was 50% versus an alternative hypothesis for 65% with one-sided alpha of 0.10 and power of 80%. All the radiation treatment plans were reviewed at quality assurance committee meetings. (Study ID: UMIN000002420)

      Results:
      One hundred eleven patients were registered between Sep 2009 and Sep 2012. Of 108 patients for efficacy analysis, the 2yr-OS was 76% (95% CI, 62-85%) for SP and 69% (95% CI, 54-79%) for VP. The hazard ratio (HR) of death between the two arms was 0.85 (0.48-1.49). The median progression-free survival (PFS) was 14.8 months for SP and 12.3 months for VP with a HR of 0.92 (0.58-1.44). 80% and 48% of pts completed the protocol treatment in SP and VP, respectively. Common grade 3-4 toxicities of both SP and VP were neutropenia 33%, 75%, platelets 9%, 4%, hemoglobin 26%, 28%, febrile neutropenia 9%, 17%, diarrhea 6%, 0% respectively. There were 4 and 5 treatment-related deaths in Arms SP and VP, respectively. The quality assurance committee judged that 74% of radiation treatment plans had no deviation and 24% had a minor deviation.

      Conclusion:
      Both arms rejected the null hypothesis for 2yr-OS. In this study Arm SP was declared the winner in terms of 2yr-OS, PFS, treatment completion, and toxicity.

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    P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      P3.04-032 - Clinical Applications of Next Generation Sequencing on Therapeutic Decision-Making in Lung Cancer (ID 1007)

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

      • Abstract
      • Slides

      Background:
      The identification of driver mutations, such as epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), have already been successfully translated into clinical practice. The clinical implementation of genomic profiling for NSCLC with high-throughput and multiplex genotyping tests is thus warranted in order to prioritize appropriate therapies for individual patients.

      Methods:
      The present study has recruited lung cancer patients at Kinki University Hospital from June 2013. To screen patients with lung cancer for genetic alterations relevant to novel molecular-targeted therapeutics, we have applied a Ion AmpliSeq RNA Fusion Lung Cancer Research Panel to detect known fusion transcripts such as ALK, ROS1, RET, and NTRK1 rearrangements simultaneously in a RNA sample obtained from FFPE lung cancer tissues. Deep sequencing was also performed using the Ion AmpliSeq Colon and Lung Cancer Panel. There were two co-primary endpoints for this study. First, we assessed the percentage of patients with additional therapy options uncovered by detecting potentially actionable genetic alterations. Second, we evaluated the percentage of patients who actually received genotype-directed therapy.

      Results:
      From June 2013, one hundred ten patient tumor samples were sequenced with these assays, and 104 (95%) patients received the results of Ion AmpliSeq Colon and Lung Cancer Panel and 106 (96%) patients received the results of the Ion AmpliSeq RNA Fusion Lung Cancer Research Panel with a >90% success rate for genotyping. An actionable driver alteration was detected in 43 (39%) of tumors from patients, leading to use of a targeted therapy in 23 (21%).

      Conclusion:
      Multiplexed genomic testing can aid physicians in matching patients with targeted treatments and appropriate clinical trials.

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