Stage migration and increasing proportion of favorable-prognosis metastatic renal cell carcinoma patients: Implications for clinical trial design and interpretation Journal Article

Authors: Patil, S.; Ishill, N.; Deluca, J.; Motzer, R. J.
Article Title: Stage migration and increasing proportion of favorable-prognosis metastatic renal cell carcinoma patients: Implications for clinical trial design and interpretation
Abstract: BACKGROUND: The Memorial Sloan-Kettering Cancer Center risk model classifies patients with metastatic renal cell carcinoma (RCC) by 5 pretreatment features as favorable, intermediate, and poor risk. The number of Memorial Sloan-Kettering Cancer Center patients in each risk group was examined by year of treatment to analyze stage migration. METHODS: The distribution of risk groups was examined retrospectively in 789 Memorial Sloan-Kettering Cancer Center patients with metastatic RCC treated in a first-line therapy clinical trial from 1975 to 2007. Date of treatment onset was divided into 6 cohorts between 1975 and 2007 (1975-1980, 1981-1985, 1986-1990, 1991-1995, 1996-2001, and 2001-2007). RESULTS: The median age of the first-line metastatic RCC clinical trial patients was 59 years (range, 20-82 years). Most patients received cytokine therapy (55%), 37% received chemotherapy/other, and 8% received vascular endothelial growth factor-targeted therapies. Overall survival increased with each consecutive cohort year group (P < .001). Median survival was 0.43 years (95% confidence interval [CI], 0.27-0.68) in the 1973-1980 cohort and 1.5 years in the 2001-2007 cohort (95% CI, 1.15-2.11). Memorial Sloan-Kettering Cancer Center risk-group distribution shifted between 1975 and 2007 (P < .0001). The poor-risk group proportion became smaller (from 44% in 1975-1980 to 13% in 2001-2007), whereas the favorable-risk group increased (from 0% in 1975-1980 to 49% in 2001-2007). The intermediate-risk group remained stable at 50%. After adjusting for type of therapy, the shifts continue to be significant (P < .0001). CONCLUSIONS: The risk-group distribution for metastatic RCC patients in clinical trials shifted from 1975 to 2007. These shifts have direct implications for data analysis, interpretation of metastatic RCC trends, and drug development. © 2010 American Cancer Society.
Keywords: adult; controlled study; aged; aged, 80 and over; middle aged; survival analysis; major clinical study; overall survival; thalidomide; mortality; cancer localization; doxorubicin; clinical trials as topic; alpha interferon; cancer patient; topotecan; neoplasm staging; interleukin 2; unindexed drug; metastasis; bortezomib; calcium; hemoglobin; calcium blood level; hemoglobin blood level; retrospective study; cetuximab; risk factor; kidney carcinoma; kidney neoplasms; vinblastine; time factors; risk assessment; temsirolimus; arsenic trioxide; cancer center; karnofsky performance status; carcinoma, renal cell; agatolimod; prognostic factors; neoplasm metastasis; epirubicin; vindesine; lactate dehydrogenase; idarubicin; high risk population; flutamide; isotretinoin; stage migration; interleukin 12; suramin; mitoguazone; trends; memorial sloan-kettering cancer center risk groups; metastatic renal cell carcinoma; trimetrexate; 10 deazaaminopterin; 2,2' anhydro 5 fluorocytosine arabinoside; bisantrene; elliptinium; n methylformamide; peginterferon alpha
Journal Title: Cancer
Volume: 116
Issue: 2
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2010-01-15
Start Page: 347
End Page: 354
Language: English
DOI: 10.1002/cncr.24713
PUBMED: 19921736
PROVIDER: scopus
Notes: --- - "Cited By (since 1996): 3" - "Export Date: 20 April 2011" - "CODEN: CANCA" - "Source: Scopus"
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MSK Authors
  1. Sujata Patil
    386 Patil
  2. Robert Motzer
    769 Motzer
  3. Nicole Marie Leoce
    86 Leoce
  4. John Vito K Deluca
    8 Deluca