索拉非尼增量治疗转移性肾癌的初步报告
Preliminary report of dosage-escalated sorafenib in patients with metastatic renal cell carcinoma
摘要目的 评价索拉非尼增量治疗转移性肾癌的疗效及安全性. 方法 16例复治的转移性肾透明细胞癌患者,中位年龄53(37~71)岁.男女比例3:1.既往均接受过肾癌根治术和至少1个方案的全身治疗,存在至少1个单径可测病灶,均服用索拉非尼,从800 mg/d逐渐增量至1200或1600 mg/d,直至不能耐受或病情进展,评价近期疗效、不良反应和无进展生存期. 结果 16例患者中位随访时间11(9~16)个月.客观有效(完全缓解加部分缓解)7例,临床受益(完全缓解加部分缓解加病灶稳定)13例.严重不良反应(≥3级)主要表现为手足皮肤反应25%(4/16)、黏膜炎19%(3/16)、腹泻19%(3/16)、高血压12%(2/16)和骨髓抑制12%(2/16),经剂量调整和一般对症治疗后短期内症状可消失或减轻到1~2级. 结论 索拉非尼增量治疗晚期肾癌可获较高的客观反应率,不良反应可控制,能延长高危患者的无进展生存期.
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abstractsObjective To evaluate the safety and efficacy of dosage-escalated sorafenib in pa-tients with metastatic renal cell carcinoma. Methods Twelve male patients and 4 female patients with median age of 53 (37-71 years) were included in this study. They were with refractory meta-static renal-clear-cell carcinoma and received sorafenib from 800 mg/d to 1200mg/d or 1800 mg/d gradually until intolerable or disease progression occurred. Overall response rate, toxicity and progres-sion free survival (PFS) were recorded and analyzed. Results The median follow-up was 11 months (9-16 months). The overall rate of objective response and disease control rate were 44%(7/16)and 81%(13/16), respectively. Serious adverse effects (≥Grade Ⅲ) included hand-foot skin reaction (25%, 4/16), mucositis (19%, 3/16), diarrhea (19%, 3/16), hypertension (12%, 2/16) and my-elosuppression (12%, 2/16). PFS for high risk patient was 9.2 months at the end of this study. Conclusions The dosage-escalated sorafenib could obtain a high response rate and prolong PFS of high-risk patients. The toxicities are tolerable for metastatic renal cell carcinoma patients treated with sorafenib.
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