Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice

Journal of Oncology Practice

Volumn 11, Issue 6, 2015, Pages 491-497

  Mitchell, Aaron P ^b   Harrison, Michael R ^b   Walker, Mark S ^b   George, Daniel J ^b   Abernethy, Amy P ^b   Hirsch, Bradford R ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; PAZOPANIB; SORAFENIB; SUNITINIB; TEMSIROLIMUS; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; INDOLE DERIVATIVE; NICOTINAMIDE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE; RAPAMYCIN; SULFONAMIDE;

AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER REGISTRY; CLINICAL EVALUATION; CLINICAL PRACTICE; CLINICAL RESEARCH; COHORT ANALYSIS; CONTROLLED STUDY; FEMALE; HUMAN; KARNOFSKY PERFORMANCE STATUS; KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); RISK ASSESSMENT; ANALOGS AND DERIVATIVES; CARCINOMA, RENAL CELL; CLINICAL TRIAL (TOPIC); KAPLAN MEIER METHOD; KIDNEY NEOPLASMS; MIDDLE AGED; PATIENT; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; INDOLES; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NIACINAMIDE; PATIENTS; PHENYLUREA COMPOUNDS; PROTEIN KINASE INHIBITORS; PYRIMIDINES; PYRROLES; SEVERITY OF ILLNESS INDEX; SIROLIMUS; SULFONAMIDES;

EID: 84947203459     PISSN: 15547477     EISSN: 1935469X     Source Type: Journal    
DOI: 10.1200/JOP.2015.004929     Document Type: Article

References (31)

1. Sateren WB, Trimble EL, Abrams J, et al: How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 20:2109-2117, 2002
2. Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291:2720-2726, 2004
3. Falit BP: Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results. Seton Hall Law Rev 37:969-1049, 2007
4. Clisant S, Clermont A, Adenis A., et al: Inflation in the number of eligibility criteria for industry-sponsored phase II cancer clinical trial: Illustration over a 20-year period. Contemp Clin Trials 33:459, 2012
5. Unger JM, Barlow WE, Martin D.P., et al: Comparison of survival outcomes among cancer patients treated in and out of clinical trials. J Natl Cancer Inst 106:dju002, 2014
6. Elting LS, Cooksley C, Bekele B.N., et al: Generalizability of cancer clinical trial results: Prognostic differences between participants and nonparticipants. Cancer 106:2452-2458, 2006
7. Sorbye H, Pfeiffer P, Cavalli-Björkman N, et al: Clinical trial enrollment, patient characteristics, and survival differences in prospectively registered metastatic colorectal cancer patients. Cancer 115:4679-4687, 2009
8. Mengis C, Aebi S, Tobler A., et al: Assessment of differences in patient populations selected for excluded from participation in clinical phase III acute myelogenous leukemia trials. J Clin Oncol 21:3933-3939, 2003
9. Zulman DM, Sussman JB, Chen X, et al: Examining the evidence: A systematic review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med 26:783-790, 2011
10. Stokes T: Is enrolling in a clinical trial tied to survival? www.reuters.com/article/2013/02/28/us-clinical-trial-idUSBRE91R1GU20130228
11. Scher KS, Hurria A: Under-representation of older adults in cancer registration trials: Known problem, little progress. J Clin Oncol 30:2036-2038, 2012
12. Mayers C, Panzarella T, Tannock IF: Analysis of the prognostic effects of inclusion in a clinical trial and of myelosuppression on survival after adjuvant chemotherapy for breast carcinoma. Cancer 91:2246-2257, 2001
13. Costa LJ, Drabkin HA: Renal cell carcinoma: New developments in molecular biology and potential for targeted therapies. Oncologist 12:1404-1415, 2007
14. CenterWatch: FDA approved drugs for oncology. www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?AreaID=12
15. Harrison MR, George DJ, Walker M.S., et al: "Real world" treatment of metastatic renal cell carcinoma in a joint community-academic cohort: Progressionfree survival over three lines of therapy. Clin Genitourin Cancer 11:441-450, 2013
16. Harrison MR, Hirsch BR, George D.J., et al: Real-world outcomes in metastatic renal cell carcinoma: Insights from a joint community-academic registry. J Oncol Pract 10:e63-e72, 2014
17. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115-124, 2007
18. Escudier B, Eisen T, Stadler W.M., et al: Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356:125-134, 2007
19. HudesG, CarducciM, Tomczak P, et al: Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281, 2007
20. Sternberg CN, Davis ID, Mardiak J, et al: Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial. J Clin Oncol 28:1061-1068, 2010
21. 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 372:449-456, 2008
22. Rini BI, Halabi S, Rosenberg J.E., et al: Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: Final results of CALGB 90206. J Clin Oncol 28:2137-2143, 2010
23. 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 378:1931-1939, 2011
24. Motzer RJ, Hutson TE, Tomczak P, et al: Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27:3584-3590, 2009
25. Sternberg CN, Hawkins RE, Wagstaff J, et al: A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: Final overall survival results and safety update. Eur J Cancer 49:1287-1296,2013
26. MaC, BandukwalaS, Burman D, et al: Interconversion of three measures of performance status: An empirical analysis. Eur J Cancer 46:3175-3183, 2010
27. Heng DY, Choueiri TK, Rini B.I., et al: Outcomes of patients with metastatic renal cell carcinoma that do not meet eligibility criteria for clinical trials. Ann Oncol 25:149-154, 2014
28. Procopio G, Verzoni E, Bracarda S., et al: Overall survival for sorafenib plus interleukin-2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): Final results of the ROSORC trial. Ann Oncol 24:2967-2971, 2013
29. Motzer RJ, Barrios CH, Kim T.M., et al: Record-3: Phase II randomized trial comparing sequential first-line everolimus (EVE) and second-line sunitinib (SUN) versus first-line SUN and second-line EVE in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol 31:285s, 2013 (suppl; abstract 4504)
30. Gore ME, Szczylik C, Porta C., et al: Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: An expanded-access trial. Lancet Oncol 10:757-763, 2009
31. SledgeGW Jr, Miller RS, Hauser R: Cancer Lin Q and the futureof cancer care. Am Soc Clin Oncol Educ Book 2013:430-434, 2013