Futatsuki K, Wakui A, Nakao I, Sakata Y, Kambe M, Shimada Y, Yoshino M, Taguchi T, Ogawa N
Dept. of Gastroenterology, Saitama Cancer Center.
Gan To Kagaku Ryoho. 1994 Jun;21(7):1033-8.
A multi-institutional collaborative late phase II study of irinotecan hydrochloride (CPT-11) was performed on patients with advanced gastric cancer. CPT-11 was administered as a 100 mg/m2 weekly intravenous infusion or as 150 mg/m2 fortnightly. Of 81 registered patients, 77 cases were eligible and 60 cases were evaluable for response. The overall response rate for evaluable cases was 23.3% (14/60), and the response rate was 16.1% (9/45) for the patients who had received prior chemotherapy. The primary tumor showed a 4.5% response, while metastatic lesions in the lymph-nodes, lungs, and liver showed response rates of 36.4%, 33.3%, and 17.4%, respectively. The major toxicities (> or = Grade 3) were leukopenia (41.2%), anemia (28.9%), diarrhea (22.4%) and anorexia (19.7%). These toxicities were generally reversible. CPT-11 showed activity against advanced gastric cancer, suggesting that further clinical studies of CPT-11 combined with other active chemotherapy agents are warranted.
对晚期胃癌患者进行了一项关于盐酸伊立替康(CPT - 11)的多机构协作II期后期研究。CPT - 11以100mg/m²的剂量每周静脉输注,或150mg/m²的剂量每两周输注一次。在81名登记患者中,77例符合条件,60例可评估疗效。可评估病例的总缓解率为23.3%(14/60),接受过先前化疗的患者缓解率为16.1%(9/45)。原发肿瘤的缓解率为4.5%,而淋巴结、肺和肝转移灶的缓解率分别为36.4%、33.3%和17.4%。主要毒性(≥3级)为白细胞减少(41.2%)、贫血(28.9%)、腹泻(22.4%)和厌食(19.7%)。这些毒性一般是可逆的。CPT - 11对晚期胃癌显示出活性,这表明有必要对CPT - 11与其他活性化疗药物联合进行进一步的临床研究。