Safety and efficacy of sorafenib in elderly patients treated in the North American advanced renal cell carcinoma sorafenib expanded access program.
OBJECTIVE
In this retrospective analysis of the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program in North America, we compared the safety and efficacy of sorafenib in patients aged ≥70 with those aged <70 years.


METHODS
Patients were treated with oral sorafenib twice daily until the occurrence of disease progression or treatment intolerance. The primary objective of the ARCCS program was making sorafenib available to patients with advanced renal cell carcinoma (RCC) in the USA and Canada before marketing approval was obtained; the secondary objective was the evaluation of its safety and efficacy.


RESULTS
Of the 2,504 patients enrolled in the ARCCS program who received at least 1 dose of sorafenib, 736 (29%) were aged ≥70 years. The most common grade ≥3 adverse events included rash/desquamation (5% in both groups), hand-foot skin reaction (8% in those aged ≥70 years vs. 10% in those <70 years of age), hypertension (5 vs. 4%) and fatigue (7 vs. 4%). Partial response was seen in 4% of the patients in both age groups. The median overall survival for the ≥70-year versus <70-year groups was also similar (46 vs. 50 weeks).


CONCLUSIONS
There were no substantial differences in safety and efficacy between patients aged ≥70 and <70 years with advanced RCC treated with sorafenib.
Bukowski
Ronald M
RM
Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, OH 441214, USA. bukow464@sbcglobal.net
Stadler
Walter M
WM
McDermott
David F
DF
Dutcher
Janice P
JP
Knox
Jennifer J
JJ
Miller
Wilson H
WH
Hainsworth
John D
JD
Henderson
Charles A
CA
Hajdenberg
Julio
J
Kindwall-Keller
Tamila L
TL
Ernstoff
Marc S
MS
Drabkin
Harry A
HA
Curti
Brendan D
BD
Chu
Luis
L
Ryan
Christopher W
CW
Hotte
Sebastien J
SJ
Xia
Chenghua
C
Cupit
Lisa
L
Figlin
Robert A
RA
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005006:Ethnicity; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012449:Safety; D000077157:Sorafenib; D016019:Survival Analysis
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib