索拉非尼治疗老年晚期肾癌患者有效性与安全性的初步评价

Preliminary evaluation about efficacy and safety of sorafenib therapy in elderly patients with advanced renal cell carcinoma

目的探讨索拉非尼治疗老年晚期肾癌患者的有效性与安全性。方法晚期肾癌患者40例，男26例，女14例，平均年龄70（65-81）岁。32例行患肾切除术后发现复发或转移，其中22例复发及转移前曾行细胞因子治疗；术后距出现复发或转移〈1年者5例，≥1年者27例；肾原发病灶不能切除者8例，均行穿刺活检确诊。病理类型均为透明细胞癌。用药前患者体能状态按Karnofsky标准评分均≥70分。均以索拉非尼作为一线药物，采用单一用药，口服索拉非尼400mg 2次／d，持续使用至疾病进展或出现不可耐受的不良反应。结果平均服用索拉非尼7．5（3～18）个月。完全缓解0例、部分缓解6例、疾病稳定29例、疾病进展5例，客观反应率15．0％（6／40），疾病控制率87．5％（35／40）。中位随访时间11（2．5～18．0）个月。不良反应有手足皮肤反应28例（70．0％）、脱发25例（62．5％）、皮疹21例（52．5％）、腹泻15例（37．5％）、食欲减退13例（32．5％）、疲劳乏力11例（27．5％）。3级以上不良反应有手足皮肤反应5例（12．5％）、脱发6例（15．0％）、疲劳乏力2例（5．0％）。多数不良反应于服药2周左右出现，持续时间不等，经对症治疗后缓解，未影响服药。结论索拉非尼治疗老年晚期肾癌患者有效，不良反应程度较轻，具有良好的耐受性与安全性。

Objective To evaluate the tolerance and safety of sorafenib for elderly patients with advanced renal cell carcinoma. Methods Forty cases with advanced renal cell carcinoma were enrolled, 26 were males and 14 were females, the average age was 70 years. Recurrence or metastasis was found in 32 patients who had received nephrectomy, 22 of the 32 cases had received cytokine therapy before recurrence or metastasis. Primary renal lesions of 8 cases could not be reseeted, so patients get renal tumor biopsy. PathOlogical type of all patients was clear cell carcinoma. KPS of all the patients were ≥70 points. Sorafenib was used as first-line treatment, with 400 mg twice per day, until intolerance or disease progression occurred. Results The average treatment time was 7. 5 months （3-18 months）,CR 0 case,PR 6 cases,SD 29 eases,PD 5 cases. The overall objective response rate and disease control rate were 15.0% （6/40）and 87.5% （35/40）, respectively. The median follow-up period was 11 months. The adverse reaction included hand-foot skin reaction（70. 0K）, alopecia （62.5%）, rash（52.5%）, diarrhea（37.5%）, loss of appetite（32.5%）, fatigue（27.5%）. Most adverse reactions occurred around the second week after drug therapy initiation, their duration did not equal. And most of these adverse reactions could be released by symptomatic treatment, they did not affect the treatment. Concluions The types of adverse reactions of sorafenib for elderly patients with advanced renal cell carcinoma are similar to those reported in the literature. Generally the degree of adverse reactions is minor, with good tolerance and safety.