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Motoko Tachihara



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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): Motoko Tachihara

      • 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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    P2.17 - Treatment of Early Stage/Localized Disease (ID 189)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.17-05 - Feasibility Study of Adjuvant Chemotherapy with Carboplatin and Nab-Paclitaxel for Completely Resected NSCLC (ID 421)

      10:15 - 18:15  |  Author(s): Motoko Tachihara

      • Abstract
      • Slides

      Background

      Cisplatin-based regimen is the standard adjuvant chemotherapy for patients with completely resected stage II or III non-small cell lung cancer (NSCLC). However, the patients unfit for cisplatin-based chemotherapy due to old age or renal impairment recently increased. This phase II study was conducted to evaluate the tolerability and efficacy of carboplatin and nab-paclitaxel as adjuvant chemotherapy.

      Method

      Patients with completely resected stage II to IIIA NSCLC enrolled. Eligible patients received postoperative adjuvant chemotherapy with 4 cycles carboplatin (area under the curve=5, on day1) and nab-paclitaxel (100 mg/m2, on days 1, 8 and 15) administered every 4 weeks. The primary endpoint was to evaluate the completion rate of 4 cycles of chemotherapy. We assumed completion rate of 50% would be the lower limit.

      Result

      From Jan 1, 2014 to Jan 31, 2019, 21 patients were enrolled, but two patients were excluded. Two patients of them are on protocol chemotherapy at data cutoff point. Median age of the 17 patients was 73 years (ranging from 53 to 80 years). Four of 17 patients (23.5%) were at stage IIA, 3 (17.6%) were at stage IIB, and 10 (58.8%) were at stage IIIA. Eleven (64.7%) had adenocarcinoma and 6 (35.3%) had squamous cell carcinoma. The most reasons of unfit for cisplatin regimen were old age (≥70 years old, n=14) and renal impairment (n=7). Ten of 17 patients (58.8 (32.9-81.6) %) completed four cycles of regimen. The reasons for discontinuation of the chemotherapy were febrile neutropenia (n=2), neutropenia (n=1), empyema (n=1), drug-induced pneumonitis (n=1), renal failure (n=1), and patient refusal due to fatigue (n=1). Three of 10 patients who completed four cycles needed dose reduction due to grade 4 neutropenia. Nab-paclitaxel on day 15 was omitted in 39 of 49 cycles (79.6%) because of grade 3 or 4 neutropenia. The most common grade 3 or 4 adverse event was neutropenia (n=14, 82.4%), followed by anemia (n=3, 17.6%). Febrile neutropenia, grade 3 pneumonitis, grade 1 peripheral sensory neuropathy were observed in 11.8%, 5.9%, 35.3% of the 17 patients respectively. The median time to disease recurrence was 24.4 (10.8-37.5) months.

      Conclusion

      Carboplatin and nab-paclitaxel as adjuvant chemotherapy for NSCLC unfit for cisplatin was not tolerable. Dose reduction should be considered in further study of adjuvant chemotherapy.

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