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Noriyuki Masuda



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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • 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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      P3.01-37 - Phase II Study of Amrubicin Plus Erlotinib in Previously Treated, Advanced Non-Small Cell Lung Cancer Patients with Wild-Type EGFR: TORG 1320 (ID 12559)

      12:00 - 13:30  |  Author(s): Noriyuki Masuda

      • Abstract
      • Slides

      Background

      The combination of amrubicin (AMR) and erlotinib (ERL) was reported to have synergistic effect on non-small cell lung cancer (NSCLC) cell line with wild-type EGFR in vitro. We accomplished a phase I study of AMR plus ERL in previously treated advanced NSCLC patients, and determined the maximum tolerated dose (MTD). Furthermore, we observed a high response rate of 33% (Am J Clin Oncol 2015).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC with wild-type EGFR. Patients were treated at 3weeks intervals with AMR (35mg/m2 on days 1-3) plus ERL (100mg/day on days 1-21). The patients without disease progression after 4 cycles continued ERL until disease progression or unacceptable toxicity. The primary endpoint is progression free survival (PFS). Secondary endpoints are response rate (RR), disease control rate (DCR), time to treatment failure (TTF), overall survival (OS), and toxicity. The concentration of trough ERL was measured after first cycle of treatment and in maintenance phase as an exploratory research to analyze relation between effectivity/safety and pharmacokinetics.

      4c3880bb027f159e801041b1021e88e8 Result

      From June 2013 to July 2016, 25 patients were enrolled. With a median follow-up of 14.3 months (95%CI: 10.9 – 17.6), median PFS was 3.6 months (95%CI: 2.1 - 5.1). The RR and the DCR were 24.0% and 64.0%, respectively. Median OS was 15.4 months (95%CI: 13.4 – 17.4). We observed grade 3 or 4 toxicities such as leukopenia (68%), neutropenia (72%), anemia (8%), febrile neutropenia (12%), anorexia (12%), oral mucositis (12%) and rash (8%). We had no treatment related death. In pharmacokinetic analysis, the mean (±SD) trough concentrations (C trough) of ERL in induction and maintenance phase were 1.070±0.463µg/mL and 0.879±0.427µg/mL, respectively. The C trough of ERL in induction phase was higher than that in maintenance phase (p=0.0371). There was no relation between C trough of ERL and any toxicity/response.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Although the primary endpoint was not met in this trial, the PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy which was previously reported. In this study, pharmacokinetic analysis showed that C trough of ERL were elevated in combination therapy. This combination therapy might be an optional treatment as cytotoxic chemotherapy for NSCLC patients after platinum-doublet failure. Clinical trial information: UMIN 000010582.

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