A phase II trial of perioperative chemotherapy involving a single intraperitoneal administration of paclitaxel followed by sequential S-1 plus intravenous paclitaxel for serosa-positive gastric cancer
A phase II trial of perioperative chemotherapy involving a single intraperitoneal administration of paclitaxel followed by sequential S-1 plus intravenous paclitaxel for serosa-positive gastric cancer
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DOI：
10.1002/jso.23928
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发表时间：
2015-06-15
影响因子：
2.5
通讯作者：
Furukawa, Hiroshi
中科院分区：
文献类型：
--
作者：
Peng, Ying-Feng;Imano, Motohiro;Furukawa, Hiroshi
背景和目的我们进行了一项II期试验，以评估围手术期化疗的可行性，疗效和耐受性，包括单次腹腔内（IP）给药紫杉醇（PTX），然后静脉内（IV）给药紫杉醇与S-1在血清阳性胃癌的新辅助治疗设置。在纳入研究前进行腹腔镜检查，以确认浆膜浸润、灌洗液细胞学检查阴性和腹膜转移阴性。腹腔注射紫杉醇80 mg/m2，全身化疗。化疗结束后进行手术。主要终点为治疗完成率。治疗完成率为67.6%（25/37; 90% CI，52.8-80.1%），显著高于50%;我们将其设定为阈值（P=2.4% [单侧]）。14例患者有靶病灶;其中10例显示部分缓解（71.4%），3例疾病稳定（21.4%），1例疾病进展（7.2%）。有效率为71.4%（10/14）。所有患者均行胃切除术和D2淋巴结清扫术。3年和5年OS率分别为78.0和74.9%，respectives.ConclusionsPerioperative化疗，包括新辅助IP PTX其次是序贯IV PTX与S-1血清阳性胃癌是可行的，安全的，有效的。外科肿瘤学杂志2015 111：1041-1046. (c)2015 Wiley Periodicals，Inc.
Background and ObjectivesWe carried out a phase II trial to evaluate the feasibility, efficacy, and tolerability of perioperative chemotherapy including single intraperitoneal(IP) administration of paclitaxel(PTX) followed by intravenous(IV) administrations of PTX with S-1 in a neoadjuvant setting for serosa-positive gastric cancer.MethodsPatients with cT4a gastric cancer were enrolled. A laparoscopic survey was performed before study inclusion for the confirmation of serosal invasion, negative lavage cytology, and negative peritoneal metastasis. IP PTX (80mg/m(2)) was administered, followed by systemic chemotherapy. Surgery was performed after the completion of chemotherapy. The primary endpoint was the treatment completion rate.Results37 patients were recruited. The treatment completion rate was 67.6% (25/37; 90% CI, 52.8-80.1%), which was significantly higher than 50%; we set this as a threshold value (P=2.4% [one-sided]). 14 patients had target lesions; of these, 10 showed a partial response (71.4%), three had stable disease (21.4%), and one had progressive disease(7.2%). The response rate was 71.4% (10/14). All patients underwent gastrectomy with D2 lymph node dissection. The 3- and 5-year OS rates were 78.0 and 74.9%, respectively.ConclusionsPerioperative chemotherapy including neoadjuvant IP PTX followed by sequential IV PTX with S-1 for serosa-positive gastric cancer is feasible, safe, and efficient. J. Surg. Oncol. 2015 111:1041-1046. (c) 2015 Wiley Periodicals, Inc.