医学
腹水
中性粒细胞减少症
耐受性
白细胞减少症
胃肠病学
内科学
转移
癌症
实体瘤疗效评价标准
化疗
存活率
临床终点
临床研究阶段
外科
不利影响
临床试验
作者
Hironori Ishigami,Joji Kitayama,Shoichi Kaisaki,Akio Hidemura,Masaki Kato,Koichi Otani,Takashi Kamei,Daisuke Soma,Hideyo Miyato,Hidetoshi Yamashita,Hirokazu Nagawa
标识
DOI:10.1093/annonc/mdp260
摘要
A phase II study to evaluate the efficacy and tolerability of weekly i.v. and i.p. paclitaxel (PTX) combined with S-1 was carried out in gastric cancer patients with peritoneal metastasis.Gastric cancer patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled. PTX was administered i.v. at 50 mg/m(2) and i.p. at 20 mg/m(2) on days 1 and 8. S-1 was administered at 80 mg/m(2)/day for 14 consecutive days, followed by 7 days rest. The primary end point was the 1-year overall survival (OS) rate. Secondary end points were the response rate, efficacy against malignant ascites and safety.Forty patients were enrolled, including 21 with primary tumors with peritoneal dissemination, 13 with peritoneal recurrence and six with positive peritoneal cytology only. The median number of courses was 7 (range 1-23). The 1-year OS rate was 78% (95% confidence interval 65% to 90%). The overall response rate was 56% in 18 patients with target lesions. Malignant ascites disappeared or decreased in 13 of 21 (62%) patients. The frequent grade 3/4 toxic effects included neutropenia (38%), leukopenia (18%) and anemia (10%).Combination chemotherapy of i.v. and i.p. PTX with S-1 is well tolerated and active in gastric cancer patients with peritoneal metastasis.
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