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Kenji Sugio



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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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      P1.01-65 - PII of Pemetrexed or Pemetrexed Plus Bevacizumab for Previously Untreated Elderly (>=75) Non-Squamous NSCLC (LOGIK1201) (ID 11305)

      16:45 - 18:00  |  Author(s): Kenji Sugio

      • Abstract

      Background

      Pemetrexed (P) provided equivalent or more efficacy to docetaxel with fewer side effects against NSqNSCLC and subset analysis revealed elderly patients receiving P had a longer time to progression and OS than those treated with docetaxel (JCO 22:1589, 2004). Bevacizumab (B), antibody binding with VEGF, is expected additional effect to chemotherapy for patients with NSqNSCLC. To evaluate the efficacy and safety, we conducted randomized phase II study of P and P/B for elderly patients with NSqNSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligibility criterias were: NSqNSCLC, no prior therapy, stage IIIB, IV, postoperative recurrence, age ≥75 years, PS 0-1, adequate bone marrow function. Patients were randomly assigned in a 1:1 ratio to P or P/B. Primary endpoint was PFS. Secondary were RR, OS, toxicity and cost-effect. Stratified log-rank test was used. Assuming PFS of median 3.3 (P) and 7.4 (P/B) months, significance level bilateral 20%, power ≥80%, estimated required number was 32 and target sample size was set 40.

      4c3880bb027f159e801041b1021e88e8 Result

      Forty-one patients from 12 institutions were enrolled between 8/31/2012 and 6/30/2016 and 40 patients (P 20, P/B 20) were assessable. Patients’ characteristics were as follows: male/female = 23/17; median age (range) = 78 (75-83); stage IIIB/IV/postOp = 1/30/9; PS 0/1 = 11/29; all adenocarcinoma. The median PFSs (95%CI) were 5.4 (3.0-7.4) and 5.5 (3.6-9.9) months, respectively, and there is no significant difference (p=0.66). RR was significantly higher in P/B (15% vs. 55%, p=0.0146) and there was no significant difference in OS (median 16.0 vs. 16.4 months, p=0.58). G3/4 leukopenia, neutropenia, thrombocytopenia and fatigue (%) were 10, 20, 5, 25 and 30, 55, 5, 45, respectively. Costs were higher in P/B (median 1,522,008 vs. 3,368,428 JPY, p=0.01). No treatment-related deaths occurred.

      8eea62084ca7e541d918e823422bd82e Conclusion

      P showed similar PFS and OS with favorable toxicity and low cost compare with P/B in elderly (>=75) patients with NSqNSCLC.

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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): Kenji Sugio

      • 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.

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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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      P1.16-59 - A Phase II Study of Adjuvant Chemotherapy with Tegafur-Uracil for Vessel Invasion Positive Stage IA Non-Small Cell Lung Cancer (LOGIK0602) (ID 12111)

      16:45 - 18:00  |  Author(s): Kenji Sugio

      • Abstract

      Background

      Vessel invasion, which includes vascular or lymphatic invasions, is a representative prognostic factor in lung cancer therapy. Even in the patients with resected stage IA non-small cell lung cancer (NSCLC), vessel invasion is a significant poor prognostic factor. The pathological analysis of 322 cases of resected stage IA NSCLC in Oita Prefectural Hospital revealed that the 5-yr overall survival rate was 71.8% in the vessel invasion-positive group and significantly worse than the 89.6% in the vessel invasion-negative group. Interestingly, the 5-yr overall survival rate of the oral tegafur-uracil adjuvant chemotherapy group was 93.3% and significantly better than the 66.6% of the untreated group. Tegafur-uracil is known to affect vascular endothelial growth factor overexpressing tumours. Therefore, to estimate the positive effect of adjuvant tegafur-uracil in patients with vessel invasion-positive stage IA NSCLC, we conducted a multi-center single-arm phase II study (LOGIK0602).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The patients with completely resected vessel invasion-positive stage IA NSCLC were registered at the Lung Oncology Group in Kyushu (LOGIK). Vessel invasion was diagnosed by two of the three pathologists. Adjuvant chemotherapy consisted of 2 years of oral tegafur-uracil at 250 mg/m2/day. Fifty-five patients from 7 institutions were enrolled from June 2007 to September 2012. The primary endpoint was the 5-yr overall survival rate. Secondary endpoints were the rate of accomplishment of scheduled adjuvant chemotherapy, incidence and grade of adverse reactions, 3-yr overall and relapse-free survival rates, and 5-yr relapse-free survival rate.

      4c3880bb027f159e801041b1021e88e8 Result

      Among the 52 eligible patients, 16 (30.8%) discontinued tegafur-uracil administration and 36 (69.2%) completed the treatment course. The observation period was calculated as 562 to 3107 days and median observation period as 1947 days using the reverse Kaplan-Meier method. There were 39 male and 13 female patients. The 3-yr and 5-yr overall survival rates were 96.2% and 94.2% respectively, which were obviously better than the historical data of 28% to 78.7% in 8 reports. The 3-yr and 5-yr relapse-free survival rates were 92.3% and 88.5%, respectively. Eighteen adverse reactions were observed including 4 cases of grade 3 hepatic function disorder (7.7%) and 5 cases of grade 2 anorexia (9.6%). No grade 4 adverse effect was encountered. Five recurrences were observed including 1 distant metastasis (adrenal) and 4 local recurrences (lung: 2, lymph node: 2).

      8eea62084ca7e541d918e823422bd82e Conclusion

      A 2-year course of oral tegafur-uracil administration is feasible and might have a significant benefit in the adjuvant treatment of vessel invasion-positive stage IA NSCLC.

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