Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma.
OBJECTIVE
To describe survival in previously treated patients with metastatic renal cell carcinoma (RCC) who are candidates for clinical trials of new agents as second-line therapy.


METHODS
The relationship between pretreatment clinical features and survival was studied in 251 patients with advanced RCC treated during 29 consecutive clinical trials between 1975 and 2002. Clinical features were first examined in univariate analyses, and then a stepwise modeling approach based on Cox regression was used to form a multivariate model.


RESULTS
Median survival for the 251 patients was 10.2 months and differed according to year of treatment, with patients treated after 1990 showing longer survival. In this group, the median overall survival time was 12.7 months. Because the purpose of this analysis was to establish prognostic factors for present-day clinical trial design, prognostic factor analysis was performed on these patients. Pretreatment features associated with a shorter survival in the multivariate analysis were low Karnofsky performance status, low hemoglobin level, and high corrected serum calcium. These were used as risk factors to categorize patients into three different groups. The median time to death in patients with zero risk factors was 22 months. The median survival in patients with one of these prognostic factors was 11.9 months. Patients with two or three risk factors had a median survival of 5.4 months.


CONCLUSIONS
Treatment with novel agents during a clinical trial is indicated for patients with metastatic RCC after progression to cytokine treatment. Three prognostic factors for predicting survival were used to categorize patients into risk groups. These risk categories can be used in clinical trial design and interpretation.
Motzer
Robert J
RJ
Geritourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. motzerr@mskcc.org
Bacik
Jennifer
J
Schwartz
Lawrence H
LH
Reuter
Victor
V
Russo
Paul
P
Marion
Stephanie
S
Mazumdar
Madhu
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism*; D002118:Calcium / Q000097:blood; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000401:mortality* / Q000556:secondary*; D002986:Clinical Trials as Topic / Q000401:mortality*; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D017567:Karnofsky Performance Status; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012189:Retrospective Studies; D015996:Survival Rate
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D006454:Hemoglobins; D007770:L-Lactate Dehydrogenase; D002118:Calcium