Prognostic nomogram for sunitinib in patients with metastatic renal cell carcinoma Journal Article


Authors: Motzer, R. J.; Bukowski, R. M.; Figlin, R. A.; Hutson, T. E.; Michaelson, M. D.; Kim, S. T.; Baum, C. M.; Kattan, M. W.
Article Title: Prognostic nomogram for sunitinib in patients with metastatic renal cell carcinoma
Abstract: BACKGROUND: In a randomized, phase 3 trial, sunitinib demonstrated superior efficacy over interferon-alfa as first-line therapy in patients with metastatic clear-cell renal cell carcinoma (RCC). On the basis of outcome data from that trial, the authors developed a nomogram for predicting the probability of 12-month progression-free survival for patients who received sunitinib therapy. METHODS: Three-hundred seventy-five patients who received sunitinib in the phase 3 trial were the subject of the current analysis. Nomogram pretreatment predictor variables included corrected serum calcium levels, the number of metastatic sites, hemoglobin levels, prior nephrectomy, the presence of lung and liver metastases, thrombocytosis, Eastern Cooperative Oncology Group performance status, time from diagnosis to treatment, and serum levels of alkaline phosphatase and lactate dehydrogenase. Investigator-assessed progression-free survival was the predicted outcome endpoint. Internal validation of the nomogram consisted of quantification of the discrimination with the concordance index and assessment of calibration. RESULTS: One-hundred seventy-four of 375 patients (46%) who received sunitinib achieved an objective response, and the median progression-free survival was 10.8 months (95% confidence interval, 10.6-12.6 months). A nomogram for predicting the probability of 12-month progression-free survival for patients who received sunitinib therapy was constructed on the basis of a Cox regression model from 11 parameters that were determined before treatment. The concordance index was 0.633. CONCLUSIONS: A nomogram was developed from pretreatment clinical features to predict the probability of achieving 12-month progression-free survival with sunitinib therapy for metastatic clear-cell RCC. The authors concluded that independent validation of the nomogram and additional studies to identify tumor-specific prognostic factors are warranted.
Keywords: disease-free survival; sunitinib; disease free survival; randomized controlled trial; randomized controlled trials as topic; pathology; kidney carcinoma; kidney neoplasms; kidney tumor; carcinoma, renal cell; evaluation; clinical trials, phase iii as topic; nomograms; phase 3 clinical trial; indoles; pyrroles; indole derivative; nomogram; pyrrole derivative
Journal Title: Cancer
Volume: 113
Issue: 7
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2008-10-01
Start Page: 1552
End Page: 1558
Language: English
DOI: 10.1002/cncr.23776
PUBMED: 18720362
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 46" - "Export Date: 17 November 2011" - "Source: Scopus"
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  1. Robert Motzer
    1243 Motzer