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单药希罗达治疗复发转移性乳腺癌的疗效观察 被引量:57

Single-agent Xeloda in the treatment of recurrent and metastatic breast cancer
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摘要 目的 观察单药希罗达治疗复发转移性乳腺癌的疗效和不良反应。方法 希罗达单药治疗 6 9例复发转移性乳腺癌。希罗达用药每天 2 5 0 0mg/m2 ,早晚两次 ,餐后服用。连续服用 2周 ,休息 1周 ,为 1个周期。结果  6 9例均治疗 1周期以上。总有效率 (CR +PR)为 16 .0 % ,临床获益率 (CR +PR +SD >6个月 )为 2 7.5 % ,疾病控制率 (CR +PR +SD)为 75 .4 %。中位治疗失败时间为 3(0 .7~ 11)个月 ,中位疾病进展时间为 2 (0 .7~ 11)个月。CR和PR患者的中位缓解时间为 6 (4~ 11)个月。最常见的不良反应是手足综合征 (HFS) ,发生率为 6 0 .9% (42 /6 9) ,程度主要为Ⅰ~Ⅱ度。应用大剂量维生素B6进行预防的患者 ,HFS发生率为 5 5 .0 % (2 2 /40 ) ,无Ⅲ度HFS ;而未应用者 ,HFS发生率为 6 9.0 %(2 0 /2 9) ,有 2例为Ⅲ度HFS ;但用与未用维生素B6者 ,HFS发生率差异未见有显著性 (P =0 .2 4 1)。结论 单药希罗达对复发转移性乳腺癌疗效确切 ,患者不良反应可耐受。应用大剂量维生素B6进行预防 ,可能减轻HFS的症状 。 Objective To evaluate the efficacy and adverse reactions of Xeloda in the treatment of recurrent and metastatic breast cancer. Methods This clinical study was designed to treat 69 patients with recurrent and metastatic breast cancer with Xeloda, 2500 mg/m 2/d, twice daily for 2 weeks followed by a 1 week rest period, repeated every 3 weeks. Results Sixty nine patients received Xeloda for more than 1 cycle. The overall response rate (CR + PR) was 16.0%, clinical benefit rate (CR + PR + SD≥ 24 months) was 27.5%, disease control rate (CR+PR+SD) was 75.4%. The median time to failure (TTF) was 3 months (range: 0.7 11months). The median time to progression (TTP) was 2 months (range: 0.7 11months). The median duration of response (CR + PR) was 6 months (range: 4 11months). The most common treatment related adverse events were hand foot syndrome (HFS) that occurred in 60.8% (42/69) patients mostly as grade Ⅰ Ⅱ. Fifty five percent (22/40) of patients who had received high dose preventive Vit B6 developed HFS without grade Ⅲ; while 69% (20/29) of patients who had not received such treatment did develop HFS including 2 patients with grade Ⅲ. However, there was not significant difference between the two groups. Conclusion Xeloda is an effective and well tolerated treatment in patients with recurrent and metastatic breast cancer. The symptoms of HFS may be relieved by high dose Vit B6 as prevention.
出处 《中华肿瘤杂志》 CAS CSCD 北大核心 2004年第6期379-381,共3页 Chinese Journal of Oncology
关键词 希罗达 复发转移性乳腺癌 肿瘤 手足综合征 不良反应 Xeloda Breast neoplasms/drug therapy Hand-foot syndrome
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