Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET

Medical Oncology

Volumn 27, Issue 3, 2010, Pages 899-906

  Negrier, S ⁱ   Jager E ^a   Porta, C ^b   McDermott, D ^c   Moore, M ^d   Bellmunt, J ^e   Anderson, S ^f   Cihon, F ^f   Lewis, J ^f   Escudier, B ^g   Bukowski, R ^h  

^a KRANKENHAUS NORDWEST   (Germany)

^b FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^c BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e HOSPITAL DEL MAR   (Spain)

^f BAYER CORPORATION   (United States)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h TAUSSIG CANCER INSTITUTE   (United States)

ⁱ NONE

Author keywords

Cytokine; Interferon; Interleukin; Multikinase inhibitor; Renal cell cancer; Sorafenib; Subanalysis

Indexed keywords

ALPHA INTERFERON; CYTOKINE; INTERLEUKIN 2; SORAFENIB;

ADULT; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER CONTROL; CANCER PATIENT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOPENIA; DESQUAMATION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRY SKIN; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART INFARCTION; HEART LEFT VENTRICLE CONTRACTION; HEART MUSCLE ISCHEMIA; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEMOGLOBIN BLOOD LEVEL; HOT FLUSH; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SENSORY NEUROPATHY; SIDE EFFECT; SYSTEMIC THERAPY; SYSTOLIC DYSFUNCTION; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARCINOMA, RENAL CELL; CARDIOVASCULAR DISEASES; CLINICAL TRIALS, PHASE III AS TOPIC; DIARRHEA; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HEMATOLOGIC DISEASES; HUMANS; INTERFERON-ALPHA; INTERLEUKIN-2; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; PROGESTINS; PROTEIN KINASE INHIBITORS; PYRIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; VINCA ALKALOIDS;

EID: 77956903115     PISSN: 13570560     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12032-009-9303-z     Document Type: Article

References (31)

1. VE Reuter JC Presti Jr 2000 Contemporary approach to the classification of renal epithelial tumors Semin Oncol 27 2 124 137 10768592 1:STN:280:DC%2BD3c3ivFSkuw%3D%3D
2. National Cancer Institute. Cancer topics: kidney cancer. http://www.cancer.gov/cancertopics/types/kidney. 13 April 2009.
3. JK McLaughlin L Lipworth RE Tarone 2006 Epidemiologic aspects of renal cell carcinoma Semin Oncol 33 5 527 533 10.1053/j.seminoncol.2006.06.010 17045081 (Pubitemid 44511980)
4. G Scelo P Brennan 2007 The epidemiology of bladder and kidney cancer Nat Clin Pract Urol 4 4 205 217 10.1038/ncpuro0760 17415353 (Pubitemid 46567153)
5. NJ Vogelzang WM Stadler 1998 Kidney cancer Lancet 352 9141 1691 1696 10.1016/S0140-6736(98)01041-1 9853456 1:STN:280:DyaK1M%2FmvVentw%3D%3D
6. MI Milowsky DM Nanus 2001 Advanced renal cell carcinoma Curr Treat Options Oncol 2 5 437 445 10.1007/s11864-001-0049-x 12057107 1:STN:280:DC%2BD38zhsFSnsg%3D%3D
7. P Schoffski H Dumez P Clement, et al. 2006 Emerging role of tyrosine kinase inhibitors in the treatment of advanced renal cell cancer: a review Ann Oncol 17 8 1185 1196 10.1093/annonc/mdj133 16418310 1:STN:280: DC%2BD28vkvVOltQ%3D%3D (Pubitemid 44288208)
8. GA Fyfe RI Fisher SA Rosenberg, et al. 1996 Long-term response data for 255 patients with metastatic renal cell carcinoma treated with high-dose recombinant interleukin-2 therapy J Clin Oncol 14 8 2410 2411 8708739 1:STN:280:DyaK28zis1Cnug%3D%3D
9. S Negrier B Escudier C Lasset, et al. 1998 Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie N Engl J Med 338 18 1272 1278 10.1056/NEJM199804303381805 9562581 1:CAS:528:DyaK1cXivF2qt74%3D (Pubitemid 28216581)
10. JR Gnarra K Tory Y Weng, et al. 1994 Mutations of the VHL tumour suppressor gene in renal carcinoma Nat Genet 7 1 85 90 10.1038/ng0594-85 7915601 1:CAS:528:DyaK2cXktlaitbg%3D (Pubitemid 24232386)
11. PH Maxwell MS Wiesener GW Chang, et al. 1999 The tumour suppressor protein VHL targets hypoxia-inducible factors for oxygen-dependent proteolysis Nature 399 6733 271 275 10.1038/20459 10353251 1:CAS:528:DyaK1MXjsFyqt74%3D (Pubitemid 29246458)
12. HM Sowter RR Raval JW Moore PJ Ratcliffe AL Harris 2003 Predominant role of hypoxia-inducible transcription factor (Hif)-1alpha versus Hif-2alpha in regulation of the transcriptional response to hypoxia Cancer Res 63 19 6130 6134 14559790 1:CAS:528:DC%2BD3sXotV2jtLg%3D
13. T Ahmad T Eisen 2004 Kinase inhibition with BAY 43-9006 in renal cell carcinoma Clin Cancer Res 10 18 Pt 2 6388S 6392S 10.1158/1078-0432.CCR-040028 15448036 1:CAS:528:DC%2BD2cXnvVOjtrw%3D (Pubitemid 39302607)
14. SM Wilhelm L Adnane P Newell, et al. 2008 Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling Mol Cancer Ther 7 10 3129 3140 10.1158/1535-7163.MCT-08-0013 18852116 1:CAS:528:DC%2BD1cXht1ensLfE
15. E Lierman C Folens EH Stover, et al. 2006 Sorafenib is a potent inhibitor of FIP1L1-PDGFRalpha and the imatinib-resistant FIP1L1-PDGFRalpha T674I mutant Blood 108 4 1374 1376 10.1182/blood-2006-02-004457 16645167 1:CAS:528: DC%2BD28Xot1ymu7w%3D (Pubitemid 44232039)
16. SM Wilhelm C Carter L Tang, et al. 2004 BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis Cancer Res 64 19 7099 7109 10.1158/0008-5472.CAN-04-1443 15466206 1:CAS:528: DC%2BD2cXotFalsbk%3D (Pubitemid 39331023)
17. B Escudier T Eisen WM Stadler, et al. 2007 Sorafenib in advanced clear-cell renal-cell carcinoma N Engl J Med 356 2 125 134 10.1056/NEJMoa060655 17215530 1:CAS:528:DC%2BD2sXksVKitg%3D%3D (Pubitemid 46089673)
18. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol 2009 (Epub ahead of print).
19. RJ Motzer M Mazumdar J Bacik, et al. 1999 Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma J Clin Oncol 17 8 2530 2540 10561319 1:STN:280:DC%2BD3c%2FjtVSnug%3D%3D
20. Nexavar (sorafenib) prescribing information. Bayer Pharmaceuticals; 2008.
21. C Coppin F Porzsolt A Awa, et al. 2005 Immunotherapy for advanced renal cell cancer Cochrane Database Syst Rev 1 CD001425 15674877
22. S Ramsey M Aitchison 2006 Treatment for renal cancer: are we beyond the cytokine era? Nat Clin Pract Urol 3 9 478 484 10.1038/ncpuro0581 16964189 1:CAS:528:DC%2BD28XhtVKru7jM (Pubitemid 44377538)
23. G Fyfe RI Fisher SA Rosenberg, et al. 1995 Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy J Clin Oncol 13 3 688 696 7884429 1:STN:280: DyaK2M7ptVGiuw%3D%3D
24. S Negrier B Escudier F Gomez, et al. 2002 Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Francais d'Immunotherapie Ann Oncol 13 9 1460 1468 10.1093/annonc/mdf257 12196373 1:STN:280:DC%2BD38vjvVGitA%3D%3D
25. JM Tourani C Pfister N Tubiana, et al. 2003 Subcutaneous interleukin-2 and interferon alfa administration in patients with metastatic renal cell carcinoma: final results of SCAPP III, a large, multicenter, phase II, nonrandomized study with sequential analysis design-the Subcutaneous Administration Propeukin Program Cooperative Group J Clin Oncol 21 21 3987 3994 10.1200/JCO.2003.02.073 14581421 1:CAS:528:DC%2BD2cXpsVajsbs%3D (Pubitemid 46606213)
26. B Escudier C Chevreau C Lasset, et al. 1999 Cytokines in metastatic renal cell carcinoma: is it useful to switch to interleukin-2 or interferon after failure of a first treatment? Groupe Francais d'Immunotherape J Clin Oncol 17 7 2039 2043 10561255 1:CAS:528:DyaK1MXkvVSmtb0%3D
27. RJ Motzer M Mazumdar J Bacik, et al. 2000 Effect of cytokine therapy on survival for patients with advanced renal cell carcinoma J Clin Oncol 18 9 1928 1935 10784634 1:CAS:528:DC%2BD3cXjvVentro%3D
28. ME Gleave M Elhilali Y Fradet, et al. 1998 Interferon gamma-1b compared with placebo in metastátic renal-cell carcinoma N Engl J Med 338 18 1265 1271 10.1056/NEJM199804303381804 9562580 1:CAS:528:DyaK1cXivF2qtrc%3D (Pubitemid 28216580)
29. JA Gollob WK Rathmell TM Richmond, et al. 2007 Phase II trial of sorafenib plus interferon alfa-2b as first- or second-line therapy in patients with metastatic renal cell carcinoma J Clin Oncol 25 22 3288 3295 10.1200/JCO.2007.10.8613 17664476 1:CAS:528:DC%2BD2sXhtVWqs7jM (Pubitemid 47325614)
30. CW Ryan BH Goldman PN Lara, et al. 2007 Sorafenib with interferon alfa-2b as first-line treatment of advanced renal carcinoma: a phase II study of the Southwest Oncology Group J Clin Oncol 25 22 3296 3301 10.1200/JCO.2007.11.1047 17664477 1:CAS:528:DC%2BD2sXhtVWqs7jO (Pubitemid 47325615)
31. RJ Motzer NH Bander DM Nanus 1996 Renal-cell carcinoma N Engl J Med 335 12 865 875 10.1056/NEJM199609193351207 8778606 1:STN:280:DyaK28zlslajtA%3D%3D (Pubitemid 26304070)