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氟尿嘧啶S-1用于II-IIIA期非小细胞肺癌患者术后辅助化疗的可行性研究。

A feasibility study of postoperative adjuvant chemotherapy with fluoropyrimidine S-1 in patients with stage II-IIIA non-small cell lung cancer.

作者信息

Tsuboi Mitsuhiro, Kondo Kazuya, Takizawa Hiromitsu, Kawakita Naoya, Sawada Toru, Toba Hiroaki, Kawakami Yukikiyo, Yoshida Mitsuteru, Ishikura Hisashi, Kimura Suguru, Tangoku Akira

机构信息

Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School.

Department of Oncological Medical Services, Institute of Biomedical Sciences, Tokushima University Graduate School.

出版信息

J Med Invest. 2018;65(1.2):90-95. doi: 10.2152/jmi.65.90.

Abstract

BACKGROUND

Adjuvant chemotherapy with uracil tegafur (UFT) improved survival among patients with completely resected stage I lung adenocarcinoma. S-1, an oral dihydropyrimidine dehydrogenase (DPD)-inhibitory 5-fluorouracil, is a more potent DPD inhibitor than UFT;therefore, we hypothesized that postoperative adjuvant chemotherapy with S-1 would be effective for advanced non-small cell lung cancer (NSCLC). We conducted a feasibility study of S-1 as postoperative adjuvant chemotherapy in patients with curatively resected pathological stage bold I back 10 bold I and bold I back 10 bold I back 20 bold I A NSCLC.

METHODS

Adjuvant chemotherapy consisted of 9 courses (4-week administration, 2-week withdrawal) of S-1 at 80-120 mg/body per day. Twenty-four patients with completely resected NSCLC were enrolled in this study from November 2007 through December 2010. The primary endpoint was the rate of completion of the scheduled adjuvant chemotherapy. The secondary endpoints were safety, overall survival, and relapse-free survival.

RESULTS

Five patients were censored because of disease recurrence. The planned 9 courses of S-1 were administered to completion in 8 patients. Twelve patients completed more than 70% of the planned courses. Grade 3 adverse reactions, such as elevated total bilirubin (4.2%) and pneumonitis (4.2%), were observed, but there were no Grade 4 adverse reactions. Patients who completed more than 70% of the 9 courses demonstrated better overall survival than those who completed less than 70%.

CONCLUSION

Postoperative administration of S-1 may be possible with few severe adverse events as adjuvant chemotherapy for patients with curatively resected pathological stage bold I back 10 bold I -bold I back 10 bold I back 20 bold I A NSCLC. J. Med. Invest. 65:90-95, February, 2018.

摘要

背景

尿嘧啶替加氟(UFT)辅助化疗可提高完全切除的I期肺腺癌患者的生存率。S-1是一种口服的二氢嘧啶脱氢酶(DPD)抑制性5-氟尿嘧啶,是比UFT更强效的DPD抑制剂;因此,我们推测S-1术后辅助化疗对晚期非小细胞肺癌(NSCLC)有效。我们开展了一项关于S-1作为病理分期为I A期(I期,10≤I≤20)的根治性切除NSCLC患者术后辅助化疗的可行性研究。

方法

辅助化疗包括9个疗程(给药4周,停药2周),每天服用S-1 80 - 120mg/体。2007年11月至2010年12月,24例完全切除NSCLC的患者纳入本研究。主要终点是计划辅助化疗的完成率。次要终点是安全性、总生存期和无复发生存期。

结果

5例患者因疾病复发被 censored。8例患者完成了计划的9个疗程的S-1治疗。12例患者完成了超过70%的计划疗程。观察到3级不良反应,如总胆红素升高(4.2%)和肺炎(4.2%),但无4级不良反应。完成9个疗程超过70%的患者的总生存期优于完成不足70%的患者。

结论

对于病理分期为I A期(I期,10≤I≤20)的根治性切除NSCLC患者,S-1术后给药作为辅助化疗可能严重不良事件较少。《医学调查杂志》2018年2月第65卷:90 - 95页 。

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