Analyzing the pivotal trial that compared sunitinib and IFN-α in renal cell carcinoma, using a method that assesses tumor regression and growth

Clinical Cancer Research

Volumn 18, Issue 8, 2012, Pages 2374-2381

  Stein, Wilfred D ^a,b   Wilkerson, Julia ^a   Kim, Sindy T ^c   Huang, Xin ^c   Motzer, Robert J ^d   Fojo, Antonio Tito ^a   Bates, Susan E ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^c PFIZER INC   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; SUNITINIB;

ANALYTIC METHOD; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; COMPARATIVE EFFECTIVENESS; DRUG RESPONSE; HUMAN; KIDNEY CARCINOMA; MATHEMATICAL ANALYSIS; METASTASIS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURVIVAL RATE; SURVIVAL TIME; TUMOR GROWTH; TUMOR REGRESSION;

ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; CELL PROLIFERATION; DISEASE-FREE SURVIVAL; HUMANS; INDOLES; INTERFERON-ALPHA; KIDNEY NEOPLASMS; PYRROLES; REMISSION INDUCTION; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 84859871183     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-2275     Document Type: Article

References (21)

1. American Cancer Society: Cancer facts & figures. Tables & figures; 2010. Available from: http://www.cancer.org/Research/CancerFacts- Figures/CancerFactsFigures/most-requested-tables-figures-2010
2. Escudier B, Eisen T, StadlerWM,Szczylik C, Oudard S, Siebels M, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125-34. (Pubitemid 46089673)
3. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24. (Pubitemid 46089672)
4. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81. (Pubitemid 46849157)
5. Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007;370:2103-11. (Pubitemid 350296300)
6. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449-56.
7. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28:1061-8.
8. Larkin J, Gore M. Is advanced renal cell carcinoma becoming a chronic disease? Lancet 2010;376:574-5.
9. Stein WD, Yang J, Bates SE, Fojo T. Bevacizumab reduces the growth rate constants of renal carcinomas: a novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. Oncologist 2008;13:1055-62.
10. Stein WD, Figg WD, Dahut W, Stein AD, Hoshen MB, Price D, et al. Tumor growth rates derived from data for patients in a clinical trial correlate strongly with patient survival: a novel strategy for evaluation of clinical trial data. Oncologist 2008;13:1046-54.
11. Stein WD, Huang H, Menefee M, Edgerly M, Kotz H, Dwyer A, et al. Other paradigms: growth rate constants and tumor burden determined using computed tomography data correlate strongly with the overall survival of patients with renal cell carcinoma. Cancer J 2009;15:441-7.
12. Stein WD, Gulley J, Schlom J, Madan RA, Dahut W, Figg WD, et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate as an indicator of therapeutic efficacy. Clin Cancer Res 2011;17:907-14.
13. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, et al. Overall survival and updated results for sunitinib compared with IFN-alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584-90.
14. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, 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;92:205-16.
15. Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003;349:427-34. (Pubitemid 36910021)
16. Huang H, Menefee M, Edgerly M, Zhuang S, Kotz H, Poruchynsky M, et al.Aphase II clinical trial of ixabepilone (Ixempra; BMS-247550;NSC 710428), an epothilone B analog, in patients with metastatic renal cell carcinoma. Clin Cancer Res 2010;16:1634-41.
17. Dodd LE, EKorn EL, Freidlin B, Jaffe CC, Rubinstein LV, Dancey J, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-6.
18. Gray R, Bhattacharya S, Bowden C, Miller K, Comis RL. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol 2009;27:4966-72.
19. Ebos JM, Lee CR, Cruz-Munoz W, Bjarnason GA, Christensen JG, Kerbel RS. Accelerated metastasis after short-term treatment with a potent inhibitor of tumor angiogenesis. Cancer Cell 2009;15: 232-9.
20. McDermott DF. Update on the application of interleukin-2 in the treatment of renal cell carcinoma. Clin Cancer Res 2007;13:716s-720s.
21. Canil C, Hotte S, Mayhew LA, Waldron TS, Winquist E. IFN-alfa in the treatment of patients with inoperable locally advanced or metastatic renal cell carcinoma: a systematic review. Can Urol Assoc J 2010;4: 201-8.