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K. Watanabe



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    P2.02 - Poster Session with Presenters Present (ID 462)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P2.02-027 - A Randomized Phase II Trial of S-1 plus Cisplatin or Docetaxel plus Cisplatin with Concurrent Thoracic Radiotherapy for Stage III NSCLC: TORG1018 (ID 4164)

      14:30 - 14:30  |  Author(s): K. Watanabe

      • Abstract

      Background:
      Concurrent chemoradiotherapy (CCRT) is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC), and a clearly superior regimen has not yet been identified. This study was conducted to evaluate cisplatin with S-1 (SP) or docetaxel (DP) with concurrent thoracic radiotherapy in patients with inoperable stage III NSCLC.

      Methods:
      In this open-label, non-comparative phase II trial, patients with inoperable stage IIIA/B NSCLC were randomized (1:1) to SP (S-1 40 mg/m[2] twice a day on days 1-14 and 29-42, and cisplatin 60 mg/m[2] on days 1 and 29) or DP (docetaxel 50 mg/m[2] and cisplatin 60 mg/m[2 ]on days 1 and 29), stratified by institution, gender, histology, and stage. In both arms, concurrent radiotherapy was started on day 1 (total 60 Gy in 30 fractions). After CCRT, patients in each group received two additional cycles of consolidation chemotherapy with the same regimen as that for the CCRT part. The primary endpoint was the 2-year overall survival (OS) rate, and secondary endpoints were OS, progression-free survival (PFS), toxicity profile, dose intensity and objective response rate (ORR).

      Results:
      Between May 2011 and August 2014, 110 patients from 19 institutions were enrolled. Finally, 106 patients (56 in each arm) were evaluable for efficacy and safety. The patient characteristics were: male/female, 83/23; median age, 65 (range 42-74) yr; performance status 0/1, 59/47; IIIA/IIIB, 59/47. After a median follow-up of 23.1 months, ORR and median PFS were 71.7% (95%CI: 57.7-83.2) and 11.5 months (95%: 9.00-14.1) in the SP arm, and 67.9% (95%CI: 53.7-80.1) and 17.2 months (95%: 9.62-24.0) in the DP arm, respectively. Grade 3-4 leukopenia (34.0%/62.3%) and neutropenia (28.3%/56.6%) were significantly higher in the DP arm than in the SP arm. Incidences of non-hematological toxicity including febrile neutropenia, anorexia, nausea, diarrhea, radiation pneumonitis and esophagitis tended to be high in the DP arm. No treatment-related death occurred.

      Conclusion:
      At this preliminary stage, it appears that although the DP arm may have more toxic effects than the SP arm, it has a favorable PFS. The OS data will be available soon.

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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): K. Watanabe

      • 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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