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完全切除的IIIA-N2期非小细胞肺癌辅助化疗的前瞻性随机研究

[A prospective randomized study of adjuvant chemotherapy in completely resected stage IIIA-N2 non-small cell lung cancer].

作者信息

Wang Siyu, Rong Tiehua, Ou Wei, Lin Yongbin, Liang Ying, Ye Xiong

机构信息

Department of Thoracic Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong 510060, P.R.China.

出版信息

Zhongguo Fei Ai Za Zhi. 2006 Oct 20;9(5):434-8. doi: 10.3779/j.issn.1009-3419.2006.05.09.

DOI:10.3779/j.issn.1009-3419.2006.05.09
PMID:21176466
Abstract

BACKGROUND

Recently, results from IALT, JBR10 and CALGB9633 showed that postoperative adjuvant chemotherapy improved survival rate of patients with non-small cell lung cancer (NSCLC) after complete resection. The aim of this study is to evaluate the effect of postoperative adjuvant chemotherapy on survival after complete resection for stage IIIA-N2 NSCLC.

METHODS

From Jan 1999 to Dec 2003, one-hundred and fifty patients with stage IIIA-N2 NSCLC were randomly divided into two groups. The chemotherapy group received four cycles of chemotherapy with navelbine or paclitaxel plus carboplatin, while the observation group did not receive chemotherapy after operation.

RESULTS

In the chemotherapy group, 86.1% (68/79) of patients finished 4 cycles of chemotherapy, and no one died of toxic effects of chemotherapy; 25% of patients had grade III-IV leukopenia, 2% of patients had febrile leukopenia. The median survival time for the entire 150 patients was 879 days, and 1-, 2- and 3-year survival rate was 81%, 59% and 43%. There was no significant difference in median survival between the chemotherapy and observation groups (P= 0.0527), but there was significant difference in the 1- and 2-year survival rate (94.71% and 76.28% vs 88.24% and 60.13%, P < 0.05). The most common site of recurrence was the brain. Twenty-six percent (39/150) of patients recurred in the brain as their first site of failure, and 22.8% (18/79) for the chemotherapy group, 29.6% (21/71) for the observation group. The median survival time for patients who developed brain metastasis was not significantly different between the chemotherapy and observation groups (812 days vs 512 days, P=0.122), but there was significant difference in the 2-year survival rate (66.7% vs 37.6%, P < 0.01). The median survival was 190 days for the patients since brain metastasis appeared.

CONCLUSIONS

Postoperative adjuvant chemotherapy dose not significantly improve median survival among patients with completely resected stage IIIA-N2 NSCLC, but significantly improves the 1- and 2-year survival rate. It also dose not decrease the incidence of brain metastasis but puts off the time of brain metastasis.

摘要

背景

最近,国际肺癌辅助治疗试验(IALT)、JBR10和CALGB9633的结果表明,术后辅助化疗可提高非小细胞肺癌(NSCLC)患者完全切除后的生存率。本研究旨在评估术后辅助化疗对IIIA-N2期NSCLC患者完全切除后生存的影响。

方法

1999年1月至2003年12月,150例IIIA-N2期NSCLC患者被随机分为两组。化疗组接受四个周期的长春瑞滨或紫杉醇联合卡铂化疗,而观察组术后不接受化疗。

结果

化疗组中,86.1%(68/79)的患者完成了4个周期的化疗,且无患者死于化疗毒性作用;25%的患者出现III-IV级白细胞减少,2%的患者出现发热性白细胞减少。150例患者的中位生存时间为879天,1年、2年和3年生存率分别为81%、59%和43%。化疗组和观察组的中位生存时间无显著差异(P = 0.0527),但1年和2年生存率有显著差异(94.71%和76.28% vs 88.24%和60.13%,P < 0.05)。最常见的复发部位是脑。26%(39/150)的患者以脑作为首个失败部位复发,化疗组为22.8%(18/79),观察组为29.6%(21/71)。化疗组和观察组发生脑转移患者的中位生存时间无显著差异(812天 vs 512天,P = 0.122),但2年生存率有显著差异(66.7% vs 37.6%,P < 0.01)。自出现脑转移起,患者的中位生存时间为190天。

结论

术后辅助化疗并不能显著提高完全切除的IIIA-N2期NSCLC患者的中位生存时间,但能显著提高1年和2年生存率。它也不会降低脑转移的发生率,但会推迟脑转移的时间。

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