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多西他赛联合卡培他滨二线治疗晚期食管鳞状细胞癌的Ⅱ期研究 被引量:2

Phase Ⅱ trial of second-line chemotherapy with docetaxel and capecitabine in advanced esophageal squamous cell carcinoma
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摘要 目的 研究多西他赛联合卡培他滨二线治疗晚期食管鳞状细胞癌的疗效、患者不良反应、至疾病进展时间(TTP)和总生存(OS).方法 30例一线治疗失败的晚期食管鳞状细胞癌患者接受多西他赛60 mg/m2,第1天,静脉滴注1h;卡培他滨每天825 mg/m2,分2次口服,第1天至第14天;21d为1个周期,最多不超过6个周期.结果 30例患者接受中位2个周期(2~6个周期)化疗.中位随访时间15.4个月(3.0 ~ 31.5个月).疗效评价为部分缓解7例(23.3%),稳定13例(43.3%).中位TTP为3.0个月(95%CI 1.929 ~ 4.071),中位OS为8.3个月(95%CI 6.848 ~ 9.752).严重(3/4级)不良反应为中性粒细胞减少10例,贫血5例,血小板减少3例,手足综合征4例和疲乏3例.结论 多西他赛联合卡培他滨对一线治疗失败的晚期食管鳞状细胞癌患者有效,不良反应可接受,可考虑作为治疗晚期食管鳞状细胞癌的二线化疗方案. Objective To evaluate the effects of antitumor,toxicity and survival of second-line chemotherapy with docetaxel and capecitabine in patients with advanced esophageal squamous cell carcinoma.Methods Thirty eligible patients with measurable lesions received 1-hour intravenous treatment of docetaxel (60 mg/m2 on day 1) plus oral capecitabine (825 mg/m2 twice daily on days 1-14) every 3 weeks for up to 6 cycles.Results Patients received a median of two cycles of treatment (range 2-6).The median follow-up interview was 15.4 months (3.0-31.5 months).Intent-to-treat efficacy analysis demonstrated an overall response rate of 23.3 % (0 complete and 7 partial) and stability of 43.3 % (13 cases).The median time to progression was 3.0 months (95 % CI 1.929-4.071).The median survival was 8.3 months (95 % CI6.848-9.752).Severe adverse events (grade 3/4) reported were neutropenia (10 cases),anaemia (5 cases),thrombocytopenia (3 cases),hand-foot syndrome (4 cases),and fatigue (3 cases).Conclusion Docetaxel plus capecitabine have a manageable adverse event profile and promising activity in advance esophageal squamous cell carcinoma as a second-line treatment.
出处 《肿瘤研究与临床》 CAS 2014年第11期767-769,778,共4页 Cancer Research and Clinic
关键词 食管肿瘤 多西他赛 卡培他滨 治疗 Esophageal neoplasms Docetaxel Capecitabine Therapy
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