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Katsuhiko Naoki



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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.12-02 - Phase II Study of Amrubicin Monotherapy in Elderly or Poor-Risk Patients with Extensive Disease of Small Cell Lung Cancer (ID 11133)

      16:45 - 18:00  |  Author(s): Katsuhiko Naoki

      • Abstract

      Background

      Previous study indicated that an optional anti-cancer drug for the treatment in pretreated patients with small-cell lung cancer (SCLC) is amrubicin. However, no prospective studies have evaluated amrubicin in chemo-naive elderly or poor-risk patients with SCLC. Therefore, this study aimed to evaluate the efficacy of amrubicin as first-line chemotherapy for elderly or poor-risk patients with extensive-disease SCLC (ES-SCLC).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with chemotherapy-naive ES-SCLC received multiple cycles of 40 mg/m2 amrubicin for 3 consecutive days every 21 days. The primary endpoint was the overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.

      4c3880bb027f159e801041b1021e88e8 Result

      Between March 2011 and August 2015, 36 patients were enrolled in this study. Each patient received a median of four treatment cycles (range, 1–6 cycles). ORR was 52.8% [95% confidence interval (CI), 37–69%]. The median PFS and OS periods were 5.0 months (95% CI, 3.4–6.6 months) and 9.4 months (95% CI, 5.2–13.6 months), respectively. Neutropenia was the most common grade 3 or 4 adverse event (69.4%), with febrile neutropenia developing in 13.9% of patients. No treatment-related death occurred. At the time of starting second-line chemotherapy, 19 of 22 patients (86%) had significantly improved or maintained their performance status (PS) relative to their PS at the time of starting amrubicin monotherapy as first-line chemotherapy (P = 0.027).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The results of the present study suggest that amrubicin could be considered as a viable treatment option for chemotherapy-naive elderly or poor-risk patients with ES-SCLC.

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    P3.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 978)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.12-16 - Prognostic Impact of M Descriptors of the 8<sup>th</sup> Edition of TNM Classification for Extensive Disease-Small Cell Lung Cancer (ID 12282)

      12:00 - 13:30  |  Author(s): Katsuhiko Naoki

      • Abstract

      Background

      The International Association for the Study of Lung Cancer proposed the eighth edition of TNM classification of lung cancer on the basis of a new database in 2015. One of the most significant change in new criteria was that M descriptors has changed from three (M0, M1a and M1b) to four (M0, M1a, M1b and M1c). Although the 8th TNM classification is strong in the related with non-small cell lung cancer (non-SCLC) management, association between the 8th TNM classification and prognosis of SCLC patients remains unclear. In this study, we evaluated the applicability of the 8th TNM staging system to SCLC patients, especially whether prognosis of extensive disease (ED)-SCLC was related to the M descriptors.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We performed a retrospective study of consecutive 277 SCLC patients who had treated at our hospital between January 2008 and December 2016. The SCLC patients classified based on the 8th TNM classification and evaluated clinical factors and survival.

      4c3880bb027f159e801041b1021e88e8 Result

      186 (65.7%) of 277 SCLC patients were classified ED-SCLC based on the two-stage system, classically. Among the ED-SCLC patients, 10 (5.3%), 38 (20.4%), 32 (17.2%) and 106 (57.0%) were categorized into stage M0, M1a, M1b and M1c based on the 8th TNM classification, respectively. All ED-SCLC patients received systemic chemotherapy and median overall survival (OS) was 13.7 months. There were significant differences in OS [7.3 months; 95% confidence interval (CI), 5.7–8.9 months vs. 16.0 months; 95% CI, 13.2–18.8 months; p<0.001] according to the M descriptors (M0, M1a, M1b vs. M1c) and the TNM stage groups (III and IVa vs. IVb). Multivariate survival analyses showed that the M descriptor was one of prognostic factors (hazard ratio 1.50; 95% CI, 1.26–1.78 months; p<0.001) in addition to known prognostic factors such as ECOG performance status and pretreatment serum level of LDH.

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this study, the 8th TNM classification had prognostic value in the SCLC patients treated with systemic chemotherapy. We suggested that ED-SCLC patients was divided into two subgroups based on the TNM classification. In ED-SCLC as well as non-SCLC, treatment development should be considered based on the TNM classification.

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