Tanaka F, Miyahara R, Ohtake Y, Yanagihara K, Fukuse T, Hitomi S, Wada H
Department of Thoracic Surgery, Chest Disease Research Institute, Kyoto University, Japan.
Eur J Cardiothorac Surg. 1998 Sep;14(3):256-62; discussion 263-4. doi: 10.1016/s1010-7940(98)00186-9.
Although adjuvant therapy after surgery for non-small cell lung cancer (NSCLC) has been reported to be ineffective, it has been recently reported in prospective randomised studies conducted by two different groups in Japan that oral administration of a 5-fluorouracil (5-FU) derivative drug, UFT (a combination drug of tegafur and uracil) can improve the post-operative survival [The Study Group of Adjuvant Chemotherapy for Lung Cancer (Chubu, Japan). A randomized trial of postoperative adjuvant chemotherapy in non-small cell lung cancer (the second cooperative study). Eu J Surg Oncol 1995;21:69-77; Wada, H., Hitomi, S., Teramatsu, T, West Japan Study Group for Lung Cancer Surgery. Adjuvant chemotherapy after complete resection in non-small-cell lung cancer. J Clin Oncol 1996;14:1048-1054]. To examine the efficacy of UFT as post-operative adjuvant therapy, a retrospective study was performed.
A total of 655 consecutive patients who underwent complete tumor resection for pathologic stage I-IIIa, NSCLC at the Department of Thoracic Surgery, Chest Disease Research Institute, Kyoto University between 1976 and 1992 were retrospectively reviewed. As post-operative adjuvant therapy, UFT was administrated to 98 patients (UFT group), and was not administered to the other 557 patients (Control group).
The 5-year survival rate of the UFT group was 76.5%, which was significantly better than that of the Control group (5-year survival rate: 58.6%, P = 0.005). Stratified with pathologic stage, the efficacy of UFT was seen in the p-stage I disease (5-year survival rate: 88.6% for the UFT group, 72.0% for the Control group, P = 0.013) and in the p-stage IIIa, pN2 disease (5-year survival rate: 54.3% for the UFT group, 37.5% for the Control group, P = 0.037). Multivariate analysis of the prognostic factors also revealed the efficacy of UFT (P = 0.004, 95% confidence interval of relative risk: 0.325-0.840). Post-operative intravenous chemotherapy or radiation therapy did not prove to be significant factors affecting the prognosis.
Efficacy of oral administration of UFT as post-operative adjuvant therapy for completely resected NSCLC was proposed. To confirm the efficacy, a prospective randomized study for a more homogenous patient group is needed.
尽管有报道称非小细胞肺癌（NSCLC）手术后的辅助治疗无效，但最近日本两个不同研究小组进行的前瞻性随机研究报告称，口服5-氟尿嘧啶（5-FU）衍生物药物优福定（替加氟与尿嘧啶的复方制剂）可提高术后生存率[日本中部肺癌辅助化疗研究组。非小细胞肺癌术后辅助化疗的随机试验（第二项合作研究）。《欧洲外科肿瘤学杂志》1995年；21：69 - 77；和田浩、人见史、寺松彻，日本西部肺癌手术研究组。非小细胞肺癌完全切除术后的辅助化疗。《临床肿瘤学杂志》1996年；14：1048 - 1054]。为了检验优福定作为术后辅助治疗的疗效，进行了一项回顾性研究。
对1976年至1992年间在京都大学胸部疾病研究所胸外科接受I - IIIa期NSCLC肿瘤完全切除的655例连续患者进行回顾性分析。作为术后辅助治疗，98例患者接受了优福定治疗（优福定组），另外557例患者未接受治疗（对照组）。
优福定组的5年生存率为76.5%，显著高于对照组（5年生存率：58.6%，P = 0.005）。按病理分期分层，优福定在p - I期疾病（优福定组5年生存率：88.6%，对照组72.0%，P = 0.013）和p - IIIa、pN2期疾病（优福定组5年生存率：54.3%，对照组37.5%，P = 0.037）中显示出疗效。对预后因素的多因素分析也显示了优福定的疗效（P = 0.004，相对风险的95%置信区间：0.325 - 0.840）。术后静脉化疗或放疗并未被证明是影响预后的重要因素。
提出口服优福定作为完全切除的NSCLC术后辅助治疗具有疗效。为了证实疗效，需要针对更同质的患者群体进行前瞻性随机研究。
