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可手术胃癌的新辅助化疗:荷兰随机FAMTX试验的长期结果

Neo-adjuvant chemotherapy for operable gastric cancer: long term results of the Dutch randomised FAMTX trial.

作者信息

Hartgrink H H, van de Velde C J H, Putter H, Songun I, Tesselaar M E T, Kranenbarg E Klein, de Vries J E, Wils J A, van der Bijl J, van Krieken J H J M

机构信息

Department of Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC Leiden, The Netherlands.

出版信息

Eur J Surg Oncol. 2004 Aug;30(6):643-9. doi: 10.1016/j.ejso.2004.04.013.

DOI:10.1016/j.ejso.2004.04.013
PMID:15256239
Abstract

AIMS

Gastric cancer in Western countries is often diagnosed in an advanced stage and prognosis is poor. We performed a randomised trial with pre-operative FAMTX vs. surgery alone in order to evaluate the effect of pre-operative chemotherapy on resectability and survival.

METHODS

Patients with proven adenocarcinoma of the stomach were randomised to receive four courses of chemotherapy using 5-Fluorouracil, doxorubicin and methotrexate (FAMTX) prior to surgery or to undergo surgery alone.

RESULTS

Fifty-nine patients were randomised; 29 patients were allocated to the FAMTX regimen prior to surgery and 30 patients had surgery alone. Resectability rates were equal for both groups. Complete or partial response was registered in 32% of the FAMTX group. With a median follow-up of 83 months the median survival since randomisation is 18 months in the FAMTX group vs. 30 months in the surgery alone group (p=0.17).

CONCLUSIONS

This trial could not show a beneficial effect of pre-operative FAMTX. Until large randomised studies prove otherwise, adequate surgery without delay is the best treatment for operable gastric cancer.

摘要

目的

西方国家的胃癌往往在晚期才被诊断出来,预后较差。我们进行了一项随机试验,比较术前FAMTX化疗与单纯手术,以评估术前化疗对可切除性和生存率的影响。

方法

确诊为胃腺癌的患者被随机分为两组,一组在手术前接受四个疗程的使用5-氟尿嘧啶、阿霉素和甲氨蝶呤(FAMTX)的化疗,另一组仅接受手术。

结果

59例患者被随机分组;29例患者在手术前被分配到FAMTX方案组,30例患者仅接受手术。两组的可切除率相同。FAMTX组中32%的患者出现完全或部分缓解。中位随访83个月,自随机分组后的中位生存期在FAMTX组为18个月,而单纯手术组为30个月(p = 0.17)。

结论

该试验未能显示术前FAMTX化疗的有益效果。在大型随机研究证明相反情况之前,对于可手术的胃癌,及时进行充分的手术是最佳治疗方法。

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