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Sotaro Enatsu



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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-74 - Docetaxel-Related Febrile Neutropenia (FN) And Patient Reported Symptoms/ QOL (PROs) in East Asian (EA) and Non-EA Patients (ID 11871)

      16:45 - 18:00  |  Presenting Author(s): Sotaro Enatsu

      • Abstract
      • Slides

      Background

      A post hoc analysis of JVCG, a Japanese phase 2 trial suggested that the QOL (quality of life) deteriorated more rapidly in patients with docetaxel-related FN than in patients without FN. A post hoc analysis of REVEL, a global phase 3 trial, was performed to explore the association between FN and PROs in East Asian (EA) (Korea, Taiwan) and Non-EA patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Lung Cancer Symptom Scale (LCSS) and EQ-5D-3L were assessed at baseline, every cycle, at discontinuation and 30-day follow up. The summary statistics of LCSS total score and EQ-5D Visual Analog Scale (VAS) score were calculated. Time to deterioration (TtD) was defined as the time from randomization to the first 15-mm increase from baseline for the LCSS and first 15% decrease for the EQ-5D VAS and analysed with the Kaplan-Meier method and Cox proportional hazard model by treatment-emergent FN status regardless of assigned treatment. Also the changes in LCSS total score and EQ-5D VAS score from baseline to the treatment completion were summarized.

      4c3880bb027f159e801041b1021e88e8 Result

      1253 patients randomized to receive RAM+DOC (EA: n=43 and Non-EA: 585) or PLA+DOC (n=46 and 579). FN occurred in 21.3% of EA and 12.3% of Non-EA patients. Patient compliance with the LCSS and EQ-5D were 84.2% and 84.4%, respectively in EA and 82.7% and 83.2% in Non-EA patients. For EA patients, HRs (95% CI) for TtD were 0.572 (0.250, 1.313) in LCSS total and 0.792 (0.350, 1.790) in EQ-5D VAS, indicating longer TtD in PROs for patients without FN. For Non-EA patients, HRs (95% CI) for TtD were 0.994 (0.728, 1.357) in LCSS total and 1.023 (0.787, 1.330) in EQ-5D VAS and there seemed to be no difference in TtD between patients with and without FN. At treatment completion, the unadjusted mean change from baseline of LCSS total was numerically lower in EA patients without FN: 12.97 (with FN) vs 5.94 (without FN) (p=0.1748) and significantly lower in Non-EA patients without FN: 10.50 (with FN) vs 5.55 (without FN) (p=0.0147), demonstrating a greater PROs deterioration in patients with FN.

      8eea62084ca7e541d918e823422bd82e Conclusion

      PROs of EA patients with FN deteriorated more rapidly than in those without FN in contrast with non-EA patients. This finding was consistent with a result in the Japanese phase 2 JVCG trial. Also Non-EA patients without FN maintained their PROs significantly better than patients with FN upon treatment completion. This trend was also shown in EA patients. Prevention of docetaxel-related FN may contribute to maintaining QOL.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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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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      P3.01-75 - RELAY+, an Exploratory Study of Gefitinib with Ramucirumab in Untreated Patients with EGFR Mutation-Positive Metastatic NSCLC (ID 12637)

      12:00 - 13:30  |  Author(s): Sotaro Enatsu

      • Abstract
      • Slides

      Background

      RELAY is a randomized, double-blind phase 1b/3 study investigating the efficacy and safety of the addition of ramucirumab (a human IgG1 monoclonal antibody that binds to Vascular Endothelial Growth Factor (VEGF) Receptor 2) to erlotinib (an EGFR TKI) in treatment-naïve EGFR-mutant metastatic NSCLC. Results from the Phase 1b cohort showed that combining ramucirumab with erlotinib was safe with encouraging clinical activity and a median PFS of 17.1mo (Reck et al., Clinical Lung Cancer 2017). While enrolment for the RELAY Phase 3 cohort has been completed, the RELAY+ cohort was recently added to explore the safety and efficacy of the combination of ramucirumab with gefitinib, a frequently used EGFR TKI in East Asia.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      RELAY+ is an open-label, 2-period, single-arm exploration of the efficacy and safety of the addition of ramucirumab to gefitinib in previously untreated East-Asian patients with EGFR mutation-positive metastatic NSCLC (Period 1) and of ramucirumab to osimertinib in patients whose disease progressed in Period 1 and harbors the T790M mutation (Period 2). The trial is planned to be conducted in Japan, Taiwan and South-Korea and is currently open for enrollment. Approximately 80 patients will be enrolled.

      In Period 1 patients will receive ramucirumab (10mg/kg) every two weeks and gefitinib (250mg/day) until disease progression, unacceptable toxicity or other withdrawal criteria are met. The study objectives are to determine the 1-yr PFS rate, safety and patient reported outcomes (Lung Cancer Symptom Scale and EQ-5D-5L]). In Period 2 the efficacy and safety of ramucirumab (10mg/kg) every two weeks with osimertinib (80mg/day) will be explored.

      Both RELAY+ and RELAY participants will be enrolled in a liquid biopsy exploratory substudy. ctDNA (circulating tumor DNA) from plasma samples will be used for ddPCR (droplet digital PCR) and NGS (Next Generation Sequencing) to characterize mechanisms of acquired resistance and to test the hypothesis if the addition of ramucirumab to an EGFR TKI delays or modifies the emergence of EGFR TKI resistance.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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