A Phase II trial of dosage escalation of sorafenib in Asian patients with metastatic renal cell carcinoma

作者:Wang, Hong-kai; Zhang, Hai-liang; Zhu, Yao; Yao, Xu-dong; Zhang, Shi-lin; Dai, Bo; Shen, Yi-jun; Zhu, Yi-ping; Shi, Guo-hai; Qin, Xiao-jian; Ma, Chun-guang; Lin, Guo-wen; Xiao, Wen-jun; Ye, Ding-wei*
来源:Future Oncology, 2014, 10(12): 1941-1951.
DOI:10.2217/fon.14.131

摘要

Aim: To investigate the role of sorafenib dosage escalation in Asian patients with metastatic renal cell carcinoma that had progressed after routine dosages. Patients & methods: Sorafenib dosage escalation to 600 or 800 mg twice a day was offered to 41 patients with metastatic renal cell carcinoma who had progressed on normal dosages. Clinical outcome, toxicity and favorable clinical covariables for progression-free survival (PFS) were evaluated. Results: The median PFS with dosage-escalated therapy was 7 months. Drug-related adverse events were tolerable. The pre-escalation Karnofsky performance status, serum calcium concentration, neutrophil/lymphocyte ratio, PFS and the highest toxicity grade at the routine dosage were associated with a longer PFS in the dosage-escalation period. Conclusion: Sorafenib dosage escalation was efficacious and tolerable in Asian patients. Trial registration: Chinese Clinical Trial Registry (no. ChiCTR-ONRC-12002088).