A Phase II trial of dosage escalation of sorafenib in Asian patients with metastatic renal cell carcinoma.
OBJECTIVE
To investigate the role of sorafenib dosage escalation in Asian patients with metastatic renal cell carcinoma that had progressed after routine dosages.


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.


CONCLUSIONS
Sorafenib dosage escalation was efficacious and tolerable in Asian patients.


BACKGROUND
Chinese Clinical Trial Registry (no. ChiCTR-ONRC-12002088).
Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Hong-kai
HK
Wang
Hai-liang
HL
Zhang
Yao
Y
Zhu
Xu-dong
XD
Yao
Shi-lin
SL
Zhang
Bo
B
Dai
Yi-jun
YJ
Shen
Yi-ping
YP
Zhu
Guo-hai
GH
Shi
Xiao-jian
XJ
Qin
Chun-guang
CG
Ma
Guo-wen
GW
Lin
Wen-jun
WJ
Xiao
Ding-wei
DW
Ye
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077157:Sorafenib; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
dosage-escalation therapy; prognostic factors; progression-free survival; sorafenib