Abstract:
BACKGROUND:The role of cytoreductive nephrectomy in metastatic clear cell renal cell carcinoma (ccRCC) is controversial. OBJECTIVE:To determine the outcome of patients with metastatic ccRCC who receive sunitinib prior to planned nephrectomy. DESIGN, SETTING, AND PARTICIPANTS:The study combined the data from two prospective phase 2 studies that assessed upfront sunitinib (12-16 wk) prior to nephrectomy in previously untreated patients with metastatic renal cell carcinoma (RCC). Sunitinib was discontinued during the perioperative period (median: 29 d). INTERVENTION:Sunitinib 50mg in six weekly cycles (4 wk on, 2 wk off). MEASUREMENTS:Progression-free (PFS) and overall survival (OS) using the Kaplan-Meier method. RESULTS AND LIMITATIONS:Twenty-one patients (32%) had Memorial Sloan-Kettering Cancer Centre (MSKCC) poor-risk disease; 45 (68%) had intermediate-risk disease. Nephrectomy was not performed in 19 (29%), most commonly due to disease progression (n = 12). The PFS for the cohort was 6.3 mo (95% confidence interval [CI], 5.1-8.5). Seventeen (36%) patients progressed during the treatment break, 13 (76%) of whom stabilised upon reinitiating of sunitinib. The OS for the cohort was 15.2 mo (95% CI, 10.3-NA). The OS for the intermediate MSKCC risk group was significantly longer than that for the poor-risk group (26.0 mo [95% CI, 13.6-NA] and 9.0 mo [95% CI, 5.8-20.5], respectively; p < 0.01). In multivariate analysis, progression of disease prior to planned nephrectomy (hazard ratio [HR]: 5.34; 95% CI, 3.17-13.27), high Fuhrman grade (HR 3.27; 95% CI, 1.38-7.72), and MSKCC poor risk at diagnosis (HR 4.75; 95% CI, 2.05-11.02) were associated with short survival (p < 0.01). However, in the absence of randomised studies it is not possible to determine if this approach is beneficial. CONCLUSIONS:Upfront sunitinib prior to planned nephrectomy in intermediate-risk disease is associated with a median survival of >2 yr despite frequent progression during treatment break. Progression in metastatic sites prior to planned surgery and MSKCC poor-risk disease was associated with a poor outcome.
journal_name
Eur Uroljournal_title
European urologyauthors
Powles T,Blank C,Chowdhury S,Horenblas S,Peters J,Shamash J,Sarwar N,Boleti E,Sahdev A,O'Brien T,Berney D,Beltran L,Nathan P,Haanen J,Bex Adoi
10.1016/j.eururo.2011.05.028subject
Has Abstractpub_date
2011-09-01 00:00:00pages
448-54issue
3eissn
0302-2838issn
1873-7560pii
S0302-2838(11)00517-3journal_volume
60pub_type
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