Sakata Y, Yoshida Y
Gan To Kagaku Ryoho. 1985 May;12(5):1068-72.
Twenty-eight patients with inoperable or recurrent gastric cancer were entered for a phase II study of SF-SP. Of these, 24 were evaluable for response. The SF-SP was given orally at a dose of 800 to 1,200 mg/body b.i.d. daily. Six at the evaluable 24 patients showed PR, 16 NC and 2 PD. Three of the 6 PR patients were administered 1000 mg/body/day of SF-SP and the other 3, 1200 mg/body/day. The hematological toxicities were anemia (5 cases), leukopenia (3 cases) and thrombocytopenia (3 cases). The other side effects were gastrointestinal complaints, such as anorexia (5 cases), nausea (5 cases) and stomatitis (5 cases), and a further toxic effect of pigmentation (4 cases). These side effects tended to develop dose-dependently and disappeared after the SF-SP was discontinued. It was concluded that SF-SP was beneficial for the treatment of advanced gastric cancer, and that its optimal dose was 1000 mg/body/day.
28例无法手术或复发的胃癌患者进入了SF-SP的II期研究。其中，24例可评估疗效。SF-SP口服给药，剂量为800至1200毫克/体，每日两次。可评估的24例患者中，6例显示部分缓解（PR），16例疾病稳定（NC），2例疾病进展（PD）。6例PR患者中，3例接受1000毫克/体/天的SF-SP治疗，另外3例接受1200毫克/体/天的治疗。血液学毒性包括贫血（5例）、白细胞减少（3例）和血小板减少（3例）。其他副作用为胃肠道不适，如厌食（5例）、恶心（5例）和口腔炎（5例），以及进一步的色素沉着毒性作用（4例）。这些副作用倾向于剂量依赖性发生，在停用SF-SP后消失。得出的结论是，SF-SP对晚期胃癌的治疗有益，其最佳剂量为1000毫克/体/天。
