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Kazuo Inada

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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): Kazuo Inada

      • Abstract


      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.