Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: Overall survival analysis and updated results from a randomised phase 3 trial

The Lancet Oncology

Volumn 14, Issue 6, 2013, Pages 552-562

  Motzer, Robert J ^a   Escudier, Bernard ^b   Tomczak, Piotr ^c   Hutson, Thomas E ^d   Michaelson, M Dror ^e   Negrier, Sylvie ^f   Oudard, Stephane ^g   Gore, Martin E ^h   Tarazi, Jamal ⁱ   Hariharan, Subramanian ⁱ   Chen, Connie ⁱ   Rosbrook, Brad ⁱ   Kim, Sinil ⁱ   Rini, Brian I ^j  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^d TEXAS ONCOLOGY   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^f CENTRE LÉON BÉRARD   (France)

^g HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^h ROYAL MARSDEN HOSPITAL   (United Kingdom)

ⁱ PFIZER INC   (United States)

^j TAUSSIG CANCER INSTITUTE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; AXITINIB; BEVACIZUMAB; CYTOKINE; SORAFENIB; SUNITINIB; TEMSIROLIMUS;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER PROGNOSIS; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPHONIA; ERYTHEMA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEALTH STATUS; HUMAN; HYPERTENSION; HYPOTHYROIDISM; INTENTION TO TREAT ANALYSIS; KIDNEY CARCINOMA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; METASTASIS POTENTIAL; MUCOSAL DISEASE; NAUSEA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PAIN IN EXTREMITY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; PRURITUS; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMIDAZOLES; INDAZOLES; INTENTION TO TREAT ANALYSIS; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROPORTIONAL HAZARDS MODELS; PROTEIN KINASE INHIBITORS; QUALITY OF LIFE; QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84876974877     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70093-7     Document Type: Article

References (22)

1. Hu-Lowe DD, Zou HY, Grazzini ML, et al. Nonclinical antiangiogenesis and antitumor activities of axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3. Clin Cancer Res 2008, 14:7272-7283.
2. Rixe O, Bukowski RM, Michaelson MD, et al. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol 2007, 8:975-984.
3. Rini BI, Wilding G, Hudes G, et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol 2009, 27:4462-4468.
4. Tomita Y, Uemura H, Fujimoto H, et al. Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell carcinoma. Eur J Cancer 2011, 47:2592-2602.
5. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011, 378:1931-1939.
6. INLYTA® (axitinib) prescribing information (accessed Feb 14, 2013). http://labeling.pfizer.com/ShowLabeling.aspx?id=759.
7. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
8. Trotti A, Colevas AD, Setser A, et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003, 13:176-181.
9. Cella D, Yount S, Du H, et al. Development and validation of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). J Support Oncol 2006, 4:191-199.
10. Cella D, Yount S, Brucker PS, et al. Development and validation of a scale to measure disease-related symptoms of kidney cancer. Value Health 2007, 10:285-293.
11. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007, 356:125-134.
12. Anderson JR, Cain KC, Gelber RD Analysis of survival by tumor response. J Clin Oncol 1983, 1:710-719.
13. Motzer RJ, Bacik J, Schwartz LH, et al. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol 2004, 22:454-463.
14. Butt Z, Peipert J, Webster K, Chen C, Cella D General population norms for the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). Cancer 2013, 119:429-437.
15. Broglio KR, Berry DA Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009, 101:1642-1649.
16. Negrier S, Tang Y, Chen C, Bycott P Interpreting overall survival (OS) results when progression free survival (PFS) benefits exists in today's oncology landscape - metastatic renal cell carcinoma (mRCC) case study. Ann Oncol 2012, 23:ix453. (abstr).
17. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007, 356:2271-2281.
18. Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008, 372:449-456.
19. Hutson T, Escudier B, Esteban E, et al. Temsirolimus vs sorafenib as second line therapy in metastatic renal cell carcinoma: results from the INTORSECT trial. Ann Oncol 2012, 23:ixe14. (abstr).
20. Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010, 116:4256-4265.
21. Rini BI, Schiller JH, Fruehauf JP, et al. Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors. Clin Cancer Res 2011, 17:3841-3849.
22. Rini BI, Cohen DP, Lu DR, et al. Hypertension as a biomarker of efficacy in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 2011, 103:763-773.