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

Author:

Wang Hong-kai12,Zhang Hai-liang12,Zhu Yao12,Yao Xu-dong12,Zhang Shi-lin12,Dai Bo12,Shen Yi-jun12,Zhu Yi-ping12,Shi Guo-hai2,Qin Xiao-jian12,Ma Chun-guang12,Lin Guo-wen12,Xiao Wen-jun12,Ye Ding-wei12

Affiliation:

1. Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China

2. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China

Abstract

ABSTRACT  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).

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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