[非小细胞肺癌术后辅助治疗的随机对照研究]

[A randomized controlled study of post-operative adjuvant therapy in non-small cell lung cancer].

作者信息

Fukushima M, Tsushima T, Ito H, Fukuda Y, Maruyama A, Fujita H, Yagihashi N, Tsuge T, Ishioka T, Kudo T, Kishibe S, Sato T, Machida S, Kogawa R, Takashima K, Koie H, Fujita K

机构信息

The Lung Cancer Study Group of First Department of Surgery, Hirosaki University School of Medicine, Japan.

出版信息

Gan To Kagaku Ryoho. 1996 Feb;23(3):303-9.

PMID:8712823

Abstract

The efficacy of postoperative adjuvant chemo- and chemoimmunotherapy in non-small cell lung cancer was evaluated in a multicentric prospective randomized study. From September 1987 to June 1990, resected lung cancer patients were randomly stratified into three groups. Group A received 2 courses of chemotherapy with CDDP and VDS following operation. Group B was administered UFT daily for 1 year after 2 courses of CDDP. Group C received intrapleural administration of OK-432 after lung resection, then UFT and OK-432 once every 2 weeks for 1 year. Out of 94 cases, analyses were carried out on 87 of eligible cases. The five-year survival rate was 56.8% in stage I (43 cases), 73.3% in stage II (12 cases), 18.8% in stage IIIA (24 cases), 50% in stage IIIB (2 cases) and 33.3% in stage IV (6 cases). The five-year survival rate in group A was 32.2%, 55.2% in group B and 53.9% in group C, and no statistical difference was recognized between 3 groups. But in the cases of noncurative resection, the 5-year survival rate was significantly low in group A compared with Group B or C. Similarly, the cases with low-grade TP (<6.0 g/dl) or low response of PPD skin reaction (< 12mm) showed a significantly low 5-year survival rate only in group A. From these results, it was suspected that aggressive chemotherapy provides no benefit for postoperative lung cancer patients with advanced disease.

摘要

在一项多中心前瞻性随机研究中评估了术后辅助化疗和化疗免疫疗法对非小细胞肺癌的疗效。1987年9月至1990年6月，将接受肺癌切除术的患者随机分层分为三组。A组术后接受2个疗程的顺铂（CDDP）和长春地辛（VDS）化疗。B组在接受2个疗程的顺铂治疗后，每天服用优福定（UFT），持续1年。C组在肺切除术后行胸腔内注射溶链菌制剂（OK-432），然后每2周服用一次优福定和溶链菌制剂，持续1年。94例患者中，对87例符合条件的病例进行了分析。I期（43例）的五年生存率为56.8%，II期（12例）为73.3%，IIIA期（24例）为18.8%，IIIB期（2例）为50%，IV期（6例）为33.3%。A组的五年生存率为32.2%，B组为55.2%，C组为53.9%，三组之间无统计学差异。但在非根治性切除的病例中，A组的5年生存率与B组或C组相比显著较低。同样，血清总蛋白（TP）水平低（<6.0 g/dl）或结核菌素皮肤试验（PPD）反应低（<12mm）的病例仅在A组显示出显著较低的5年生存率。从这些结果推测，积极的化疗对晚期术后肺癌患者无益处。