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局部胃或胃食管交界腺癌患者术前顺铂和多西他赛化疗联合手术及夹闭导向术后放化疗的 II 期可行性研究结果。

Preoperative chemotherapy with cisplatin and docetaxel followed by surgery and clip-oriented postoperative chemoradiation in patients with localized gastric or gastroesophageal junction adenocarcinoma: results from a phase II feasibility study.

机构信息

Division of Haematology and Oncology, Department of Internal Medicine V, Innsbruck Medical University, Innsbruck, Austria.

出版信息

Ann Surg Oncol. 2011 Mar;18(3):677-83. doi: 10.1245/s10434-010-1388-2. Epub 2010 Nov 10.

DOI:10.1245/s10434-010-1388-2
PMID:21063792
Abstract

BACKGROUND

We conducted a phase II feasibility study using preoperative chemotherapy with cisplatin and docetaxel followed by surgical resection and postoperative chemoradiation in patients with gastric or gastroesophageal cancer.

METHODS

Preoperative chemotherapy (two or three cycles) consisted of 50 mg/m(2) docetaxel and 50 mg/m(2) cisplatin. Surgical resection was planned 4 weeks after the last chemotherapy cycle. Patients underwent postsurgical chemoradiation, receiving a total dose of 39.6 Gy and 5-fluorouracil (5-FU) continuous infusion (350 mg/m(2)/day). The primary end-points were feasibility, overall response rate and R0 resectability rate after preoperative chemotherapy. The secondary end-points were tolerability, treatment-associated complications, disease-free survival and overall survival.

RESULTS

Between 2002 and 2004, 15 patients were enrolled in this study. After neoadjuvant treatment, two patients (13%) experienced progressive disease, four patients (27%) showed partial remission and nine patients (60%) showed stable disease. In 11 patients (73%) R0 resectability could be achieved. Six of these patients (54%) were able to undergo postoperative chemoradiation. Notably, five (83%) of these patients were disease free and alive at median follow-up of 72 months. Chemotherapy-associated neutropaenia and neutropaenic fever, anastomotic dehiscence, pulmonary embolism and acute pancreatitis were observed.

CONCLUSIONS

The combination of preoperative chemotherapy and postoperative chemoradiation is feasible in a significant subset of gastric cancer patients.

摘要

背景

我们进行了一项 II 期可行性研究,对胃癌或胃食管交界癌患者采用顺铂和多西紫杉醇术前化疗,随后进行手术切除和术后放化疗。

方法

术前化疗(两或三个周期)包括 50mg/m²多西紫杉醇和 50mg/m²顺铂。末次化疗周期后 4 周计划进行手术切除。患者接受术后放化疗,总剂量为 39.6Gy 和 5-氟尿嘧啶(5-FU)持续输注(350mg/m²/天)。主要终点为术前化疗的可行性、总缓解率和 R0 切除率。次要终点为耐受性、治疗相关并发症、无病生存率和总生存率。

结果

2002 年至 2004 年间,15 例患者入组该研究。新辅助治疗后,2 例患者(13%)出现疾病进展,4 例患者(27%)部分缓解,9 例患者(60%)病情稳定。在 11 例患者(73%)中可以实现 R0 切除。其中 6 例患者(54%)能够接受术后放化疗。值得注意的是,这些患者中有 5 例(83%)在中位随访 72 个月时无疾病且存活。观察到化疗相关中性粒细胞减少和中性粒细胞减少性发热、吻合口裂开、肺栓塞和急性胰腺炎。

结论

术前化疗和术后放化疗的联合在相当一部分胃癌患者中是可行的。

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