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Ryo Toyozawa



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    P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)

    • 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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      P1.16-21 - Phase I / II Study of Carboplatin, Nab-Paclitaxel, and Concurrent Radiotherapy for Patients with Locally Advanced NSCLC (ID 12112)

      16:45 - 18:00  |  Author(s): Ryo Toyozawa

      • Abstract

      Background

      We performed an open-label, multicenter phase I/II study (UMIN ID 000012719) to prospectively evaluate the efficacy and safety of the combination of nab-paclitaxel plus carboplatin (nab-P/C) with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In the phase I study (standard 3+3 design), escalating doses of weekly nab-paclitaxel were given along with weekly carboplatin area under the plasma concentration time curve (AUC) 2 and concurrent radiotherapy 60 Gy in 30 fractions, followed by 2 cycles of nab-paclitaxel (100 mg/m2 on Days 1, 8 and 15) plus carboplatin (AUC 6 on Day 1). In the phase II study, nab-P/C at recommend dose (RD) was administered.

      4c3880bb027f159e801041b1021e88e8 Result

      In the Phase I study, 11 patients were enrolled with 9 evaluable for dose limiting toxicity (DLT). At level 1 (nab-paclitaxel 40mg/m2), none of 3 patients experienced DLT. At level 2 (nab-paclitaxel 50mg/ m2), 1 of 6 patients experienced DLT: grade 3 leukopenia requiring a second consecutive skip in the administration of weekly nab-P/C. Level 2 was defined as the RD. A total of 56 patients including 6 patients who received at dose of RD, were evaluable for the efficacy and safety. Of the 56 patients for safety analysis, common toxicities in the concurrent phase included grade 3/4 leukopenia (60.7 %), neutropenia (26.8 %), anemia (7.1 %), anorexia (7.1 %), esophagitis (5.4 %) and febrile neutropenia (1.8 %). In one patient, grade 3 pneumonitis was observed. There were no treatment-related deaths. The objective response rate was 76.8 % (95% confidence interval (CI), 64.2 to 85.9 %). The median progression-free survival was 11.8 months (60% CI, 10.6 to 16.2 months, 95% CI, 8.2 to 20.8 months), and the median overall survival was not reached.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first study to demonstrate encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel 50 mg/m2 and CBDCA AUC 2 in patients with locally advanced NSCLC.

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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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      P3.01-76 - Clinical Background and Response to Chemotherapy in NSCLC Patients with MET Exon14 Skipping Mutation or High MET Gene Copy Number (ID 12850)

      12:00 - 13:30  |  Author(s): Ryo Toyozawa

      • Abstract
      • Slides

      Background

      MET exon14 skipping mutation (SM) and high gene copy number (HGCN) are present in 3-4% and <1% of NSCLCs. The response to MET inhibitor treatment has been reported in ongoing clinical trials; however, the response to chemotherapy, including immunotherapy, is currently unknown. We conducted a retrospective analysis of patients with MET gene alteration.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We collected the clinicopathological data of NSCLC patients with MET gene alteration. The response to chemotherapy was evaluated according to RECIST v1.1.

      4c3880bb027f159e801041b1021e88e8 Result

      Systemic chemotherapy was given to 10 patients: SM (n=5) and HGCN (n=5). The median age was 67.5 (range 41- 77) years. Thirty percent of the patients were female and 40% were never smokers. The most common histology was adenocarcinoma (40%), followed by pulmonary sarcomatoid carcinoma (20 %). The tumor PD-L1 expression was >50% in 57% (4/7) of the cases and 1-49% in 43% (3/7) of the cases. Platinum doublet, MET inhibitor, immunotherapy (I-O), and I-O+chemotherapy were given to 6, 8, 2 and 1 patients. The overall response rate was 50%, 83%, 0% and 100%, respectively. Hyper-progressive disease after immunotherapy was observed in one patient with SM.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The responses to platinum doublet and MET inhibitor treatment were good, while the response to immunotherapy was poor in NSCLC patients with MET gene alteration. MET gene alterations should be identified before the administration of immunotherapy.

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