Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial.
BACKGROUND
In the AXIS trial, axitinib prolonged progression-free survival (PFS) vs sorafenib in patients with advanced renal cell carcinoma (RCC) previously treated with sunitinib or cytokines.


METHODS
In post hoc analyses, patients were grouped by objective response to prior therapy (yes vs no), prior therapy duration (< vs ⩾median), and tumour burden (baseline sum of the longest diameter < vs ⩾median). PFS and overall survival (OS), and safety by type and duration of prior therapy were evaluated.


RESULTS
Response to prior therapy did not influence outcome with second-line axitinib or sorafenib. PFS was significantly longer in axitinib-treated patients who received longer prior cytokine treatment and sorafenib-treated patients with smaller tumour burden following sunitinib. Overall survival with the second-line therapy was longer in patients who received longer duration of prior therapy, although not significant in the sunitinib-to-axitinib sequence subgroup; OS was also longer in patients with smaller tumour burden, but not significant in the cytokine-to-axitinib sequence subgroup. Safety profiles differed modestly by type and duration of prior therapy.


CONCLUSIONS
AXIS data suggest that longer duration of the first-line therapy generally yields better outcome with the second-line therapy and that lack of response to first-line therapy does not preclude positive clinical outcomes with a second-line vascular endothelial growth factor-targeted agent in patients with advanced RCC.
Institut Gustave Roussy/Medical Oncology Department, Villejuif 94805, France.
B
B
Escudier
Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA.
M D
MD
Michaelson
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
R J
RJ
Motzer
Baylor-Sammons/Texas Oncology Physician's Association, Sammons Cancer Center, Dallas, TX 75246, USA.
T E
TE
Hutson
Department of Medicine, Loyola University Chicago Cardinal Bernardin Cancer Center, Maywood, IL 60153, USA.
J I
JI
Clark
Department of Internal Medicine, Samsung Medical Center/Sungkyunkwan University, Seoul 135-710, Korea.
H Y
HY
Lim
Queen Elizabeth Hospital Birmingham, Birmingham B15 2WB, UK.
E
E
Porfiri
Durham Regional Cancer Centre, Oshawa, Ontario L1G 2B9, Canada.
P
P
Zalewski
Fiona Elsey Cancer Research Institute and Ballarat Oncology and Haematology Services, Ballarat, Victoria 3355, Australia.
G
G
Kannourakis
Ludwig-Maximilians University of Munich, Munich 80539, Germany.
M
M
Staehler
Pfizer Oncology, San Diego, CA 92121, USA.
J
J
Tarazi
Pfizer Oncology, San Diego, CA 92121, USA.
B
B
Rosbrook
Pfizer Oncology, New York, NY 10017, USA.
L
L
Cisar
Pfizer Oncology, New York, NY 10017, USA.
S
S
Hariharan
Pfizer Oncology, San Diego, CA 92121, USA.
S
S
Kim
Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH 44195, USA.
B I
BI
Rini
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016207:Cytokines / Q000627:therapeutic use; D018572:Disease-Free Survival; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007191:Indazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007211:Indoles / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use; D000077157:Sorafenib; D000077210:Sunitinib; D016896:Treatment Outcome; D047368:Tumor Burden
D000970:Antineoplastic Agents; D016207:Cytokines; D007093:Imidazoles; D007191:Indazoles; D007211:Indoles; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011758:Pyrroles; D009536:Niacinamide; D000077157:Sorafenib; D000077784:Axitinib; D000077210:Sunitinib