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Naoyuki Sone

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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-45 - Cisplatin Plus Gemcitabine Therapy Followed by Maintenance Gemcitabine for Advanced Squamous Cell Lung Cancer (KTORG1302) (Now Available) (ID 514)

      08:00 - 18:00  |  Author(s): Naoyuki Sone

      • Abstract
      • Slides


      One of the standard treatments in chemo-naïve patients with advanced non-small cell lung cancer (NSCLC) is platinum-containing doublet chemotherapy. Moreover non-squamous NSCLC, patients benefit from pemetrexed maintenance therapy following induction therapy with cisplatin (CDDP) plus pemetrexed. However, no large-scale trial showing the efficacy of maintenance therapy has been reported in squamous cell lung cancer. We evaluated the efficacy and the safety of continuation maintenance therapy with gemcitabine (GEM) after induction chemotherapy with CDDP plus GEM in advanced squamous cell lung cancer.


      This study was a single-arm, multicenter and phase II trial. Main eligibility criteria included Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1, and the aged of 20 to 74 years old. Patients received an induction phase which consisted of 4 cycles of CDDP (80mg/m2, day 1, q3w) plus GEM (1000mg/m2, day 1, 8, q3w). Patients who did not progress after completion of 4 cycles of induction received continuation maintenance therapy with GEM (1000mg/m2, day 1, 8, q3w) until disease progression. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population.


      Between June 2013 and October 2018, 26 patients were enrolled in this study. Although the scheduled numbers were 60, this study was ended early for poor accrual.

      The mean age was 65.7 years (range, 47 – 74 years). 18 patients (69.2%) completed 4 cycles of CDDP plus GEM, and 16 patients (61.5%) received continuation maintenance therapy with GEM. At the cutoff date of December 31, 2018, overall response rate was 46.2%, median PFS from induction therapy was 5.3 months (95% confidence interval [CI]: 2.9-7.3), and median PFS from continuation maintenance therapy was 3.8 months (95% CI: 2.3-5.2). Median overall survival from induction therapy was 11.9 months (95% CI: 7.5-26.5). The most common grade 4 adverse events were neutropenia (16%) and thrombocytopenia (12%). Pneumonitis ware seen in 3 cases (grade 1: 1, grade 2: 1, grade 3: 1 case). Adverse events except for hematotoxicity were generally well tolerated. There were no treatment-related deaths.


      This study terminated early because of poor accrual and did not meet its primary endpoint. However, this study indicated continuation maintenance therapy with GEM can be well-tolerated treatment option for patients with advanced squamous NSCLC.

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