非小细胞肺癌根治性手术后的辅助化疗：一项针对70例患者的随机研究。

Adjuvant chemotherapy following radical surgery for non-small-cell lung cancer: a randomized study on 70 patients.

作者信息

Xu G, Rong T, Lin P

机构信息

Tumor Hospital, Sun Yat-Sen University of Medical Sciences, Guangzhou 510060, China.

出版信息

Chin Med J (Engl). 2000 Jul;113(7):617-20.

PMID:11776031

Abstract

OBJECTIVE

To evaluate the efficacy of adjuvant chemotherapy after radical surgery for non-small-cell lung cancer (NSCLC).

METHODS

Seventy patients with NSCLC (stages I-III) undergoing radical surgery were randomized into two groups. Group 1 (n = 35): combination group, which received adjuvant chemotherapy with cyclophosphamide 300 mg/m2, vincristine 1.4 mg/m2, adriamycin 50 mg/m2, and lomustine 50 mg/m2 on day 1, and cisplatin 20 mg/m2 on days 1-5. The treatment was repeated every 4-6 weeks for 4 cycles, followed by oral administration of ftorafur (FT-207) 600-900 mg/d for 1 year. Group 2 (n = 35): surgery group, which received surgical treatment only.

RESULTS

The overall 5-year survival rate was 48.6% in the combination group versus 31.4% in the surgery group, and difference between the two groups was not statistically significant (chi 2 = 3.09, P > 0.05). The 5-year survival rate for patients with stage III disease was 44% and 20.8% in the combination and surgery groups, respectively, showing a statistically significant difference (chi 2 = 5.28, P < 0.025). The 5-year survival rates of patients in stages I-II in the two groups were 60.0% and 54.5%, respectively, and were not significantly different (chi 2 = 0.03, P > 0.75).

CONCLUSION

Postoperative adjuvant chemotherapy provides statistically significant improvement in the 5-year survival rate only in patients with stage III NSCLC.

摘要

目的

评估非小细胞肺癌（NSCLC）根治性手术后辅助化疗的疗效。

方法

70例接受根治性手术的NSCLC（Ⅰ-Ⅲ期）患者被随机分为两组。第1组（n = 35）：联合组，于第1天接受环磷酰胺300 mg/m²、长春新碱1.4 mg/m²、阿霉素50 mg/m²和洛莫司汀50 mg/m²的辅助化疗，第1-5天接受顺铂20 mg/m²。每4-6周重复治疗1次，共4个周期，随后口服替加氟（FT-207）600-900 mg/d，持续1年。第2组（n = 35）：手术组，仅接受手术治疗。

结果

联合组的总5年生存率为48.6%，手术组为31.4%，两组间差异无统计学意义（χ² = 3.09，P > 0.05）。Ⅲ期疾病患者在联合组和手术组的5年生存率分别为44%和20.8%，差异有统计学意义（χ² = 5.28，P < 0.025）。两组中Ⅰ-Ⅱ期患者的5年生存率分别为60.0%和54.5%，差异无统计学意义（χ² = 0.03，P > 0.75）。