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Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.

Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial.

Author information

1
Institut Gustave Roussy/Medical Oncology Department, Villejuif 94805, France.
2
Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA.
3
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
4
Baylor-Sammons/Texas Oncology Physician's Association, Sammons Cancer Center, Dallas, TX 75246, USA.
5
Department of Medicine, Loyola University Chicago Cardinal Bernardin Cancer Center, Maywood, IL 60153, USA.
6
Department of Internal Medicine, Samsung Medical Center/Sungkyunkwan University, Seoul 135-710, Korea.
7
Queen Elizabeth Hospital Birmingham, Birmingham B15 2WB, UK.
8
Durham Regional Cancer Centre, Oshawa, Ontario L1G 2B9, Canada.
9
Fiona Elsey Cancer Research Institute and Ballarat Oncology and Haematology Services, Ballarat, Victoria 3355, Australia.
10
Ludwig-Maximilians University of Munich, Munich 80539, Germany.
11
Pfizer Oncology, San Diego, CA 92121, USA.
12
Pfizer Oncology, New York, NY 10017, USA.
13
Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH 44195, USA.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00678392.

PMID:
24823696
PMCID:
PMC4056058
DOI:
10.1038/bjc.2014.244
[Indexed for MEDLINE]
Free PMC Article

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