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Masahiko Ando



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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.06 - Ph3 Study of Maintenance Therapy with S-1 vs BSC After Induction Therapy with Carboplatin + S-1 for Advanced Squamous Cell Lung Cancer (WJOG7512L) (Now Available) (ID 563)

      14:00 - 15:30  |  Author(s): Masahiko Ando

      • Abstract
      • Presentation
      • Slides

      Background

      Our previous phase 3 study established carboplatin plus the oral fluorinated pyrimidine formulation S-1 as a standard option for first-line treatment of advanced non–small cell lung cancer (NSCLC) (J Clin Oncol 2010; 28:5240). The importance of maintenance therapy for patients with advanced squamous NSCLC has been unknown, however.

      Method

      WJOG7512L was designed as a randomized phase 3 study to evaluate whether maintenance therapy with S-1 improves clinical outcome after induction therapy with carboplatin plus S-1 in such patients. Before randomization, patients received carboplatin (AUC of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m2 twice per day on days 1 to 14 every 3 weeks) as induction therapy. Those who did not progress after four cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective was to confirm the superiority of S-1 plus BSC with regard to progression-free survival.

      Result

      Of the 365 patients enrolled, 347 participated in the induction phase and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). Baseline demographics and clinical characteristics of the subjects, including the response to induction therapy, were well balanced. Patients receiving S-1 plus BSC showed a significantly reduced risk of disease progression compared with those receiving BSC alone (hazard ratio [HR], 0.548; 95% confidence interval [CI], 0.374–0.802; P = 0.0019). Median overall survival from randomization did not differ significantly between the two arms: 17.8 months for BSC alone and 16.7 months for S-1 plus BSC (HR, 0.890; 95% CI, 0.583–1.357). Time to deterioration in quality of life also showed no significant difference (P = 0.8754 for FACT-TOI, P = 0.9016 for FACT-LCS). The incidence of adverse events during maintenance therapy was low, with neutropenia, anemia, and thrombocytopenia of grade 3 or 4 each occurring in ~1% to 4% of patients.

      Conclusion

      Maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-04 - A Phase II Trial of Weekly Nab-Paclitaxel in the Salvage Setting for Advanced Non-Small Cell Lung Cancer: Results of NICE Salvage Study   (ID 1534)

      09:45 - 18:00  |  Author(s): Masahiko Ando

      • Abstract

      Background

      The optimal treatment in patients with advanced non-small cell lung cancer (NSCLC) after failing second- or third-line chemotherapy, i.e. NSCLC in salvage setting, has yet to be established. A small study reported that solvent-based paclitaxel (sb-P) monotherapy was safe and efficacious and could be a treatment option for NSCLC in salvage setting (Anticancer Res 2005).  Nanoparticle albumin-bound paclitaxel (nab-P) showed a higher overall response rate (ORR) and better tolerability than sb-P when combined with carboplatin (CBDCA) as a first-line chemotherapy (J Clin Oncol 2012). These results suggest that nab-P monotherapy could be better therapeutic option than sb-P monotherapy for NSCLC in salvage setting. We therefore planned NICE Salvage study aiming to assess the efficacy and safety of nab-P monotherapy for NSCLC patients in salvage setting. 

      Method

      NICE Salvage study was a multicenter single arm phase II study. Eligibility criteria included patients aged >= 20 years, with PS 0-2 and adequate organ function, and who have failed two or three prior lines of chemotherapy including at least a platinum-containing regimen for pathologically-proven advanced NSCLC. Patients who had treatment history with sb-P or nab-P, or had tumors harboring EGFR mutation or ALK fusion gene were excluded. Nab-P was administered at a dose of 80 mg/m2 on days 1,8 and 15 of a 28-days cycle and repeated until progressive disease, unacceptable toxicity, or patient’s refusal. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), ORR, disease control rate (DCR), efficacy according to prior use of docetaxel, quality of life, and safety. The study is powered to detect a 1.5-month improvement in median PFS in the investigational arm beyond the 2.0-month median PFS estimated from historical data. Assuming a one-sided 0.10 level of Type I error and 80% power, target sample size is calculated at 35.  (UMIN000016173).

      Result

      Thirty-eight patients were enrolled and a patient was excluded from efficacy and safety analysis. Patient’s characteristics (n = 38) were as follows: median age = 68 years, male/female = 31/7, adenocarcinoma/squamous cell carcinoma /others = 20/15/3. Median PFS and OS was 3.5 month (95% confidence interval (CI), 1.7-3.8), and 13.4 month (95%CI, 9.1-25.1), respectively. ORR and DCR were 10.8% (95%CI, 2.9-24.8 ) and 56.8% (95%CI, 38.3-71.3 ), respectively. Grade 3 or 4 treatment-related adverse events were neutropenia (10.8%), anemia (2.7%), hepatotoxicity (2.7%) and diarrhea (2.7%). One treatment-related death (pulmonary infection) was observed.

      Conclusion

      This study failed to meet predefined primary endpoint. However the results showed that nab-P monotherapy was moderately efficacious and well-tolerated, suggesting the need for further investigation for NSCLC in salvage setting.