Sun Haibo, Wang Siyu, Ou Wei, Zhang Binbin, Yang Hua, Fang Qin, Li Pan
Department of Thoracic Surgery, Cancer Center of Sun Yat-sen University, Guangzhou 510060, China.
Zhongguo Fei Ai Za Zhi. 2009 Sep 20;12(9):975-82. doi: 10.3779/j.issn.1009-3419.2009.09.007.
Lung cancer is one of the leading cause of cancer-related death around the world. Surgery is the primary treatment for patients with stage I, II, or IIIA non-small cell lung cancer (NSCLC). However, longterm survival of NSCLC patients after surgery alone is largely unsatisfactory. We undertook to determine whether adjuvant vinorelbine/paclitaxel plus carboplatin prolong overall survival among patients with completely resected stage IIIA-N2 nonsmall cell lung cancer.
We randomly assigned patients with completely resected stage IIIA-N2 non-small cell lung cancer to vinorelbine/paclitaxel plus carboplatin or to observation
A total of 150 patients (1999-2003) underwent randomization to vinorelbine/paclitaxel plus carboplatin (79 patients) or observation. In both groups, the median age was 57 years, 73 percent were male, and 28 percents had squamous carcinoma. Chemotherapy caused neutropenia in 82 percents of patients (including grade 3 and 4 neutropenia in 42 percent) and there was no treatment-related death observed in this trial. After median follow-up of 39 months (range 1-110), overall survival was significantly prolonged in the chemotherapy group as compared with the observation group (33 months versus 24 months, Chi-square=4.363, P=0.037), as was disease-free survival (32 months versus 20 months, Chi-square=5.413, P=0.020). Five-year overall survival rates were 31.1 percent and 19.1 percent, respectively.
Adjuvant vinorelbine/paclitaxel plus carboplatin have an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected stage IIIA-N2 non-small cell lung cancer.
肺癌是全球癌症相关死亡的主要原因之一。手术是I期、II期或IIIA期非小细胞肺癌（NSCLC）患者的主要治疗方法。然而，仅接受手术治疗的NSCLC患者的长期生存率在很大程度上并不令人满意。我们旨在确定辅助长春瑞滨/紫杉醇联合卡铂是否能延长完全切除的IIIA-N2期非小细胞肺癌患者的总生存期。
我们将完全切除的IIIA-N2期非小细胞肺癌患者随机分为长春瑞滨/紫杉醇联合卡铂组或观察组。
共有150例患者（1999 - 2003年）被随机分为长春瑞滨/紫杉醇联合卡铂组（79例患者）或观察组。两组患者的中位年龄均为57岁，73%为男性，28%患有鳞状细胞癌。化疗导致82%的患者出现中性粒细胞减少（包括42%的3级和4级中性粒细胞减少），且该试验中未观察到与治疗相关的死亡。在中位随访39个月（范围1 - 110个月）后，化疗组的总生存期与观察组相比显著延长（33个月对24个月，卡方 = 4.363，P = 0.037），无病生存期也是如此（32个月对20个月，卡方 = 5.413，P = 0.020）。五年总生存率分别为31.1%和19.1%。
辅助长春瑞滨/紫杉醇联合卡铂具有可接受的毒性水平，并能延长完全切除的IIIA-N2期非小细胞肺癌患者的无病生存期和总生存期。
