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T. Yokoi



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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-019 - Oral S-1 and carboplatin followed by maintenance S-1 for chemo-naive patients with advanced squamous cell lung cancer (OSAKA-LCSG 1102) (ID 1384)

      09:30 - 09:30  |  Author(s): T. Yokoi

      • Abstract

      Background
      The subset analysis of LETS study suggested that S-1 plus carboplatin was more beneficial than paclitaxel plus carboplatin in overall survival (OS) in squamous cell lung cancer. We previously showed the validity of tailored dose S-1 adjusted by BSA and Ccr. No maintenance study focusing on squamous cell lung cancer has been reported yet. Here, we conducted a phase II study to evaluate the efficacy and safety of tailored dose S-1 plus carboplatin followed by S-1 maintenance in chemonaïve patients with advanced and recurrent squamous cell lung cancer.

      Methods
      Patients receive carboplatin (AUC = 5, day1) plus S-1 (tailored dose b.i.d., days 1-14) every 21 days. Non-progressive patients after 4 cycles of induction continued to receive S-1 until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) with a threshold value of 15%. The secondary endpoints were progression-free survival (PFS) and OS from enrollment, PFS in maintenance phase, and safety.

      Results
      Between April 2011 and October 2012, 35 patients were enrolled. Thirty-three patients excluding 2 patients with protocol violations were analyzed. The median age was 72 years (range, 44-82), The ORR was 30.3% (95% CI: 15.6-48.7%) that met the primary endpoint. Disease control rate was 75.8%, and 10 patients (30.3%) received maintenance therapy. The median PFS was 3.7 months. The median OS and maintenance PFS are under follow-up. 10 patients received maintenance S-1 (median: 3 cycles, range: 1-9 cycles); median PFS from the beginning of induction treatment was 5.6 months. Grade 3/4 toxicities with the frequency more than 5% included 4 neutropenia (12.1%), 7 thrombocytopenia (21.2%), 2 anemia (6.1%), 4 appetite loss (12.1%), 2 nausea (6.1%) and 2 fatigue (6.1%). All of them were controllable and febrile neutropenia was not experienced.

      Conclusion
      This is the first trial of S-1 plus carboplatin followed by maintenance S-1 for chemo-naïve advanced and recurrent squamous cell lung cancer. This treatment strategy was effective and feasible.

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    P3.21 - Poster Session 3 - Diagnosis and Staging (ID 171)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P3.21-010 - A retrospective compability assessment of ALK translocation diagnosis in NSCLC (ID 2212)

      09:30 - 09:30  |  Author(s): T. Yokoi

      • Abstract

      Background
      A fusion gene between the anaplastic lymphoma kinase (ALK) gene and echinoderm microtubule-associated protein-like 4 (EML4) occurs in nearly 5% of cases of non-small cell lung cancer (NSCLC). This fusion gene leads to the production of the EML4-ALK tyrosine kinase, which is considered as one of the oncogene driver mutations in NSCLC. The ALK inhibitor, crizotinib, showed remarkable antitumor activity in patients with advanced ALK-positive NSCLC, and was approved in Japan in 2011. Although the break apart FISH is considered as the gold standard to identify ALK rearrangement, pre-screening by immunohistochemistry (IHC) have been proposed in Japan because diagnosable number of cases is limited. However, disagreement of IHC and FISH are indicated. Therefore, the ALK rearrangements of NSCLC in our institute were screened by the IHC, FISH and RT-PCR, and that compatibility was examined.

      Methods
      EML4-ALK rearrangements of 176 examples were screened by IHC(5A4), FISH, and RT-PCR among 179 patients diagnosed as NSCLC in Kansai Medical University Hirakata Hospital from June 2012 to December 2012.

      Results
      Ten patients (5.7%) were diagnosed as ALK positive NSCLC. Five were male, and median age was 63 (46-81). The results by each technique of ten cases are shown in Table.

      patient IHC FISH RT-PCR
      1 positive positive positive
      2 positive positive negative
      3 positive positive negative
      4 positive positive negative
      5 positive positive negative
      6 negative positive negative
      7 negative positive negative
      8 negative positive negative
      9 negative negative positive
      10 negative negative positive

      Conclusion
      Although IHC is useful as a large-scale screening test, many false negative do exist. According to our results, there are few cases in agreement between IHC, FISH and RT-PCR. Various laboratory tests for ALK rearrangement detection are required for effective medication.