Kakeji Yoshihiro, Oki Eiji, Egashira Akinori, Sadanaga Noriaki, Takahashi Ikuo, Morita Masaru, Emi Yasunori, Maehara Yoshihiko
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Oncology. 2009;77(1):49-52. doi: 10.1159/000226111. Epub 2009 Jun 25.
This phase II study evaluated the toxicity and efficacy of a novel dosing schedule of docetaxel and S-1 as treatment for advanced gastric cancer.
Patients with measurable advanced or recurrent gastric cancer and no prior exposure to the investigational drugs were treated with intravenous docetaxel 35 mg/m(2) on days 1 and 15, and oral S-1 80 mg/m(2)/day on days 1-14 every 4 weeks. The primary endpoint was objective response.
Thirty-five eligible patients were enrolled and received a total of 151 cycles of treatment (median 3, range 1-19). One complete response and 13 partial responses were observed, with an overall response rate of 40% (95% CI: 24-56%). Median progression-free survival and median overall survival times were 4.5 and 14.2 months, respectively. The most common grade 3-4 toxicities were neutropenia (23%) and leukocytopenia (15%).
Biweekly docetaxel combined with S-1 is active in advanced or recurrent gastric cancer, and can be administered with proper management of adverse events in an outpatient clinic.
本II期研究评估了多西他赛和S-1的一种新型给药方案治疗晚期胃癌的毒性和疗效。
可测量的晚期或复发性胃癌患者且未接受过研究药物治疗，每4周在第1天和第15天静脉注射多西他赛35mg/m²，在第1 - 14天口服S-1 80mg/m²/天。主要终点为客观缓解。
35例符合条件的患者入组，共接受151个周期的治疗（中位数3，范围1 - 19）。观察到1例完全缓解和13例部分缓解，总缓解率为40%（95%CI：24 - 56%）。无进展生存期和总生存期的中位数分别为4.5个月和14.2个月。最常见的3 - 4级毒性为中性粒细胞减少（23%）和白细胞减少（15%）。
每两周一次的多西他赛联合S-1对晚期或复发性胃癌有效，且在门诊对不良事件进行适当管理的情况下即可给药。
