Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis.
Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis.
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DOI：
10.1200/jco.2009.27.15_suppl.4542
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发表时间：
2009-05
期刊：
影响因子：
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通讯作者：
H. Ishigami;J. Kitayama;S. Kaisaki;A. Hidemura;M. Kato;K. Otani;T. Kamei;Daisuke Soma;H. Miyato;H. Yamashita;H. Nagawa
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文献类型：
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作者：
H. Ishigami;J. Kitayama;S. Kaisaki;A. Hidemura;M. Kato;K. Otani;T. Kamei;Daisuke Soma;H. Miyato;H. Yamashita;H. Nagawa
4542背景：在伴有腹膜转移的胃癌患者中进行了一项II期研究，以评价每周静脉和腹腔注射紫杉醇联合S-1的疗效和耐受性。方法收集经腹腔穿刺细胞学检查发现胃癌腹膜转移和/或癌细胞的胃癌患者。在第1天和第8天，以50 mg/m2静脉内和20 mg/m2腹腔内给予紫杉醇。S-1以80 mg/m2/天剂量连续给药14天，随后停药7天。主要终点是1年总生存率。次要终点是反应率、对恶性腹水的有效性和安全性。结果40例患者入组，其中21例原发肿瘤伴腹膜转移，13例腹膜复发，6例仅腹膜细胞学阳性。中位疗程数为7（范围1-23）。1年总生存率为78%（95% CI，65-90%）。18例靶病灶患者的总缓解率为56%（95%CI，32-79%）。21例患者中13例（62%）恶性腹水消失或减少。3/4级血液学和非血液学毒性的发生率分别为40%和15%。常见的3/4级毒性包括中性粒细胞减少症（38%）、白细胞减少症（18%）、贫血（10%）和恶心（8%）。在1例患者中观察到的导管阻塞是与腹膜通路装置或腹膜内输注相关的唯一并发症。未发生给药相关死亡。结论紫杉醇联合替吉奥腹腔化疗对胃癌腹膜转移患者有较好的疗效和耐受性。无重大财务关系需要披露。
4542 Background: A phase II study to evaluate the efficacy and tolerability of weekly intravenous and intraperitoneal paclitaxel combined with S-1 was performed in gastric cancer patients with peritoneal metastasis. METHODS Gastric cancer patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled. Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. The primary endpoint was the 1-year overall survival rate. Secondary endpoints were the response rate, efficacy against malignant ascites and safety. RESULTS Forty patients were enrolled, including 21 with primary tumors with peritoneal dissemination confirmed by staging laparoscopy, 13 with peritoneal recurrence, and 6 with positive peritoneal cytology only. The median number of courses administered was 7 (range 1-23). The 1-year overall survival rate was 78% (95% CI, 65-90%). The overall response rate was 56% (95% CI, 32-79%) in 18 patients with target lesions. Malignant ascites disappeared or decreased in 13 of 21 (62%) patients. The incidences of grade 3/4 hematological and non- hematological toxicities were 40% and 15%, respectively. The frequent grade 3/4 toxicities included neutropenia (38%), leukopenia (18%), anemia (10%), and nausea (8%). Catheter obstruction observed in one patient was the only complication related to the peritoneal access device or intraperitoneal infusion. There were no treatment-related deaths. CONCLUSIONS Combination chemotherapy of intravenous and intraperitoneal paclitaxel with S-1 is well tolerated and active in gastric cancer patients with peritoneal metastasis. No significant financial relationships to disclose.