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Nobuyuki Yamamoto



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • 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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      P1.01-34 - Docetaxel Plus Ramucirumab with Prophylactic PEG-G-CSF Support for Chemo-NaïVe Elderly NSCLC Patients: A Phase II Study (WJOG9416L) (ID 12400)

      16:45 - 18:00  |  Author(s): Nobuyuki Yamamoto

      • Abstract

      Background

      Docetaxel monotherapy is the standard of care for chemo-naïve Japanese elderly patients with advanced non-small cell lung cancer (NSCLC), according to our results of phase III trial comparing docetaxel and vinorelbine monotherapies (WJTOG9904). In a pivotal phase III study (REVEL), docetaxel plus ramucirumab demonstrated superior response rate (RR) and progression-free survival (PFS) over docetaxel monotherapy in second-line setting for advanced NSCLC. These differences in RR and PFS were translated into overall survival (OS) benefit. This evidence prompted us to investigate docetaxel plus ramucirumab for chemo-naïve elderly patients. However, in a similarly designed Japanese randomized phase II trial (JVCG trial), febrile neutropenia (FN) was observed in 34.2% of docetaxel plus ramucirumab arm. This high incidence of FN is a clinical concern when using docetaxel plus ramucirumab for elderly patients. The ASCO practice guideline recommends primary prophylactic granulocyte-colony stimulating factor (G-CSF) when the risk of FN is 20% or higher. PEGylated-G-CSF (pegfilgrastim) administered once a cycle demonstrated reduction of FN incidence in many types of cancers. Based on the above background, we considered that primary prophylactic PEG-G-CSF would be beneficial for elderly NSCLC patients who received docetaxel plus ramucirumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a prospective multicenter, single-arm, phase II study conducted by West Japan Oncology Group (WJOG). Main inclusion criteria includes: chemo-naïve; aged ≥75; histologically or cytologically confirmed NSCLC; ECOG PS 0/1; adequate organ functions; with measurable disease; without contraindication of ramucirumab; written informed consent; and estimated life expectancy of at least 3 months. Intravenous docetaxel (60 mg/m2, day 1) plus ramucirumab (10 mg/kg, day 1) with subcutaneous PEG-G-CSF (3.6 mg, day 2) every 3 weeks is administered until progression. Continuous docetaxel or ramucirumab monotherapy is permitted when intolerable toxicities occur but clinical benefit is obtained by each drug. The primary endpoint is objective response rate (ORR). Secondary endpoints are PFS, OS, disease control rate, and safety. We assumed that the threshold and expected ORR were 20% and 35%, respectively. Based on this, the number of patients was calculated to be 59 to provide a power of 80% with probability of one-sided type I error being 0.05. Taking ineligible patients into account, the sample size was set at 65. When the study results are promising, we plan to conduct a phase III trial to compare docetaxel plus ramucirumab with PEG-G-CSF support vs. docetaxel monotherapy for chemo-naïve elderly NSCLC patients. Clinical trial information: UMIN000030598.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion


      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.14 - Thymoma/Other Thoracic Malignancies (Not CME Accredited Session) (ID 946)

    • 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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      P1.14-03 - Phase II Trial of Amrubicin and Cisplatin Chemotherapy for Invasive Thymoma: WJOG5509L (ID 11706)

      16:45 - 18:00  |  Author(s): Nobuyuki Yamamoto

      • Abstract

      Background

      Background: Platinum and anthracycline combination chemotherapy has been considered as the standard treatment for invasive thymoma for a long time. The clinical activity of amrubicin (AMR)—an anthracycline agent—has been previously reported in the treatment of small cell lung cancer (SCLC). The aim of this study was to evaluate the efficacy and safety of the combination of AMR and cisplatin (CDDP) in patients with advanced or recurrent invasive thymoma.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Methods: Patients were eligible for inclusion in the study if they met the following criteria: were chemo-naive; not amenable to curative surgery or radiotherapy; and presented with histologically confirmed invasive thymoma in each site. The patients received AMR (35 mg/m2, on days 1–3) and CDDP (60 mg/m2, on day 1) every 3 weeks, for up to 4 cycles. The primary endpoint was the objective response rate (ORR) assessed by an independent review, and the secondary endpoints were overall survival (OS) and toxicity profile of the patients. Based on the SWOG 2-stage design, the planned sample size of 40 patients was determined to reject the ORR of 60% under the expectation of 80% with a power of 0.85 and a type I error of 0.05. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000003933.

      4c3880bb027f159e801041b1021e88e8 Result

      Results: From August 2010 to November 2014, a total of 26 patients were enrolled at 14 institutions in Japan. During the planned interim analysis in April 2014, the ORR of the 20 patients who had been enrolled so far, was assessed via independent review and found to be 55.6% (11/20), resulting in the early termination of this study because of its futility. In the final assessment, the ORR was 54.2% (95% confidence interval, 32.8–74.4) and the disease control rate was 95.8%. The OS did not reach the median value. The major grade 3 or 4 toxicities noted were neutropenia (96.2%), anemia (26.9%), anorexia (11.5%) and febrile neutropenia (26.9%), albeit these were transient and manageable. There was one treatment-related death.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusions: The combination of AMR with CDDP had minimal activity on invasive thymoma. Thus, we do not recommend further study of this regimen.

      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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      P3.01-30 - Treatment Sequencing in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) in Japan (ID 12786)

      12:00 - 13:30  |  Author(s): Nobuyuki Yamamoto

      • Abstract
      • Slides

      Background

      Limited data are available on real-world treatment patterns and outcomes of ALK inhibitors used sequentially. Access to a large medical records database and availability of multiple ALK inhibitors in Japan, the first country to approve alectinib in 2014, presents a unique opportunity to evaluate real-world treatment sequencing and outcomes in ALK-positive NSCLC patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This descriptive, retrospective observational study used inpatient/outpatient medical and prescription records, claims and diagnoses from the Japan Medical Data Vision (MDV) Database. Included patients had confirmed diagnosis of lung cancer, an ALK test and first prescription order for an ALK inhibitor (prescription date = index date) on or before March 31, 2017. Descriptive analyses included demographics, baseline characteristics, treatment patterns including ALK inhibitor sequences, non-ALK inhibitor treatments received, and treatment duration.

      4c3880bb027f159e801041b1021e88e8 Result

      Overall, 378 patients (mean age 61 years; 53% female; 48% no history of smoking) met inclusion criteria. Baseline characteristics were similar among mutually exclusive groups of patients receiving 1, 2, or 3 ALK inhibitors. Similar proportions of patients received crizotinib (52%) and alectinib (48%) as index ALK inhibitor. Prior to the index date, 40% of patients received chemotherapy. ALK inhibitor sequences are shown (Table). In patients who had discontinued all ALK inhibitors, the next treatments were chemotherapy (46%) and immunotherapy (6%). The most common sequence was a crizotinib-led sequence of 2 ALK inhibitors; median duration of treatment was 53 months. Changes in treatment patterns over time and further duration of treatment data will be presented.

      Sequence

      Overall Population

      N = 378

      n (%)
      1 ALK inhibitor (n=261)
      Crizotinib 91 (24.07)
      Alectinib 170 (44.97)
      2 ALK inhibitors (n=98)
      Crizotinib -> Alectinib 89 (23.54)
      Crizotinib -> Ceritinib 1 (0.26)
      Alectinib -> Crizotinib 7 (1.85)
      Alectinib -> Ceritinib 1 (0.26)
      3 ALK inhibitors (n=19)
      Crizotinib -> Alectinib -> Ceritinib 16 (4.23)
      Alectinib -> Crizotinib -> Ceritinib 3 (0.79)
      8eea62084ca7e541d918e823422bd82e Conclusion

      Treatment patterns in ALK-positive NSCLC patients have evolved over time. The most common sequence for patients receiving > 1 ALK inhibitor was crizotinib-led. Median duration of treatment with crizotinib-led sequences is consistent with what has been reported previously. Additional research is warranted to evaluate non-crizotinib-led sequences as data mature.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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