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N. Okumura



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    P1.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 209)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      P1.02-032 - Randomized Feasibility Study of S-1 for Adjuvant Chemotherapy in Completely-Resected Stage IA Non-Small-Cell Lung Cancer (SLCG 0701) (ID 754)

      09:30 - 17:00  |  Author(s): N. Okumura

      • Abstract

      Background:
      The aim of this multicenter study (the Setouchi Lung Cancer Group Study 0701) was to determine the feasible administration schedule of S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely-resected pathological stage IA (tumor diameter, 2 to 3 cm) non-small-cell lung cancer (NSCLC).

      Methods:
      Patients were randomly assigned to receive an adjuvant chemotherapy of either 4-week oral administration of S-1 (80 mg/m2/day) followed by 2-week rest (group A), or 2-week oral administration of S-1 (80 mg/m2/day) followed by one week rest (Group B). The duration of adjuvant chemotherapy was one year in both arms. The primary endpoint was feasibility.

      Results:
      Figure 1 Eighty patients were enrolled, of whom 76 were received S-1 treatment. The treatment completion rates were 49.4% [95% confidential interval (CI), 32.8 to 65.9%] in group A and 52.1 % (95%CI, 35.5 to 68.6%) in group B (P = 0.4). The relative dose intensities were 40.4% (95%CI, 20.3 to 60.5%) in group A and 53.5% (95%CI, 37.7 to 69.3%) in group B (P = 0.4). There were no treatment-related deaths. Patients with grade 3/4 toxicities were significantly more frequent in group A (40.5%) than group B (15.4%, P = 0.02). The 2-year relapse-free survival rates were 97.5% in group A and 92.5% in group B, and the 2-year overall survival rates were 100% in both groups.



      Conclusion:
      Two-week oral administration of S-1 followed by one week rest for one year may be more feasible for adjuvant chemotherapy in patients with completely-resected stage IA (T diameter, 2 to 3 cm) NSCLC.

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    P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P3.03-022 - Feasibility of Adjuvant Therapy with S-1 plus Carboplatin Followed by Maintenance Therapy with S-1 for Resected Non-Small-Cell Lung Cancer (ID 470)

      09:30 - 17:00  |  Author(s): N. Okumura

      • Abstract

      Background:
      The prognosis of patients with locally-advanced stages (II or IIIA) non-small-cell lung cancer (NSCLC) is unsatisfactory, even after complete resection, and the 5-year survival rate is <50%, indicating the need for further improvements in postoperative survival. This multicenter study (the Setouchi Lung Cancer Group Study 0701) aimed to evaluate the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely-resected stage II–IIIA NSCLC.

      Methods:
      Figure 1 Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks’ rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by 1 week’s rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment-completion rate was determined and treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%.



      Results:
      Figure 1 Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment-completion rate was 63.2% (90% CI: 54.4–71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (11.5%), thrombocytopenia (10.3%), and anorexia (2.3%). The 2-year relapse-free survival rate was 59.8%.



      Conclusion:
      We concluded that novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 was feasible and tolerable in patients with completely-resected NSCLC.