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H. Ishikura



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    P2.12 - Poster Session 2 - NSCLC Early Stage (ID 205)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.12-022 - A feasibility study of postoperative adjuvant chemotherapy with fluoropyrimidine S-1 in patients with stage II-IIIA non-small cell lung cance (ID 3352)

      09:30 - 09:30  |  Author(s): H. Ishikura

      • Abstract

      Background
      S-1 is an orally active combination of tegafur, gimeracil and oteracil in a molar ratio of 1:0.4:1. We conducted a feasibility study of S-1 as postoperative adjuvant chemotherapy in patients with curatively resected pathologically stage II-IIIA non-small cell lung cancer (NSCLC).

      Methods
      Patient eligibility required compliance with the following criteria: histologically proved NSCLC; pathologic stage II-IIIA (according to the Union for International Cancer Control 6th edition) after complete resection; no previous treatment except for surgery; age >=20 and <80 years; performance status (PS) 0 or 1; no organ dysfunction; no concurrent malignancy; and written informed consent. Chemotherapy comprised 9 courses (4-week administration, 2-week withdrawal) of S-1 at 80-120 mg per day according to body surface area and renal function. The primary end point was the completion rate of scheduled adjuvant chemotherapy. Secondary end points were safety, overall survival and relapse-free survival. From November 2007 through December 2010, 24 patients were enrolled in this trial.

      Results
      Patient characteristics were as follows: median age of 68 (range: 49-79); male/female: 16/8; surgical procedure lobectomy/pneumonectomy: 21/3; pathologic stage IIA/IIB/IIIA: 8/6/10; and histologic type adenocarcinoma/squamous cell carcinoma/other: 19/4/1. Three patients were censored due to the disease recurrence, and the completion rate of 9 courses was calculated to be 42.9% (9/21). Completion rate of more than 70% of scheduled 9 courses was 61.9% (13/21). Most common adverse events were grade 1 or 2 anorexia (54.2%) or fatigue (20.8%), which were reasons of discontinuation of S-1 administration. Although grade 3 elevated total bilirubin (4.2%) and pneumonitis (4.2%) were observed, no grade 4 or 5 adverse events occurred. Overall and relapse-free survival rates at 3 years were 69.5% and 51.1%, respectively. Patients who completed more than 70% of scheduled 9 courses showed better relapse-free survival than 70% uncompleted patients (p=0.01).

      Conclusion
      Postoperative administration of S-1 seems feasible with few severe adverse events as adjuvant chemotherapy for patients with curatively resected pathologically stage II-IIIA NSCLC.