Yang Lin, Shi Lei, Fu Qiang, Xiong Huihua, Zhang Mengxian, Yu Shiying
Oncology Center, Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University, Wuhan 430030, P.R. China.
Oncol Lett. 2012 Apr 1;3(4):935-939. doi: 10.3892/ol.2012.585. Epub 2012 Jan 31.
Sorafenib has been confirmed as an effective drug in advanced renal cell carcinoma (RCC). This study aimed to evaluate the long-term efficacy and safety of sorafenib in ethnic Chinese patients with advanced RCC, and to develop optimal treatment strategies for Asian patients. Between May 2006 and August 2011, 30 patients with advanced RCC were treated with sorafenib in the Oncology Center, Tongji Hospital. All 30 patients received continuous treatment with 400 mg of sorafenib orally twice daily until disease progression or intolerable toxicities or mortality occurred. Dose reduction to 600 mg daily or even less was required if toxicities of grade 3 or 4 occurred. Patients were assessed for tumor response, progression-free survival (PFS), overall survival (OS) and drug-related toxicities. The median follow-up time was 58 weeks (range, 12-270). Among the 30 patients, 1 patient had complete remission (CR 3.3%), 4 patients had partial remission (PR 13.3%), 19 patients had stable disease (SD 63.3%) and 6 patients had disease progression (PD 20%). The disease control rate (DCR, CR+PR+SD) was 80%, the median PFS time was 14 months, and the median OS time was 16 months. Only 1 patient discontinued sorafenib treatment permanently due to severe toxicities. Dose reduction or interruption was required in 12 patients (40%) who developed adverse events of grade 3 or 4. Seven of these patients tolerated the dose of 600 mg per day well, and experienced clinical benefit. The Kaplan-Meier method and log-rank test revealed that the Memorial Sloan-Kettering Cancer Center (MSKCC) status was a prognostic factor for PFS and OS in advanced RCC. The long-term efficacy and safety of sorafenib were confirmed in Chinese advanced RCC patients who showed an even greater benefit in PFS. The findings of this study indicate that a dose of 600 mg instead of 400 mg per day may be an optimal choice for Asian patients when a reduction of the initial dose is required.
索拉非尼已被确认为晚期肾细胞癌（RCC）的有效药物。本研究旨在评估索拉非尼在华裔晚期RCC患者中的长期疗效和安全性，并为亚洲患者制定最佳治疗策略。2006年5月至2011年8月期间，30例晚期RCC患者在同济医院肿瘤科接受索拉非尼治疗。所有30例患者均接受400mg索拉非尼口服，每日两次的持续治疗，直至疾病进展、出现无法耐受的毒性反应或死亡。如果出现3级或4级毒性反应，则需要将剂量减至每日600mg甚至更低。对患者进行肿瘤反应、无进展生存期（PFS）、总生存期（OS）和药物相关毒性评估。中位随访时间为58周（范围12 - 270周）。30例患者中，1例完全缓解（CR 3.3%），4例部分缓解（PR 13.3%），19例病情稳定（SD 63.3%），6例病情进展（PD 20%）。疾病控制率（DCR，CR + PR + SD）为80%，中位PFS时间为14个月，中位OS时间为16个月。仅1例患者因严重毒性反应永久停用索拉非尼治疗。12例（40%）发生3级或4级不良事件的患者需要减少剂量或中断治疗。其中7例患者对每日600mg剂量耐受良好，并获得了临床益处。Kaplan-Meier法和对数秩检验显示，纪念斯隆凯特琳癌症中心（MSKCC）状态是晚期RCC患者PFS和OS的预后因素。索拉非尼在华裔晚期RCC患者中的长期疗效和安全性得到了证实，这些患者在PFS方面显示出更大的获益。本研究结果表明，当需要降低初始剂量时，每日600mg而非400mg的剂量可能是亚洲患者的最佳选择。
