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.
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.
Authors: Jose A Karam; Catherine E Devine; Diana L Urbauer; Marisa Lozano; Tapati Maity; Kamran Ahrar; Pheroze Tamboli; Nizar M Tannir; Christopher G Wood Journal: Eur Urol Date: 2014-02-07 Impact factor: 20.096
Authors: Ross J Mason; Lori Wood; Anil Kapoor; Naveen Basappa; George Bjarnason; Stephen A Boorjian; Rodney H Breau; Ilias Cagiannos; Michael A S Jewett; Pierre I Karakiewicz; Wassim Kassouf; Christian Kollmannsberger; Aly-Khan A Lalani; Jean-Baptiste Lattouf; Luke T Lavallée; Stephen Pautler; Nicholas Power; Patrick Richard; Alan So; Simon Tanguay; Ricardo A Rendon Journal: Can Urol Assoc J Date: 2019-06 Impact factor: 1.862
Authors: Ariel Schulman; Mathew Fakhoury; Jean P Wuilleumier; Kevin Becker; Bernadine Donahue; Ruoqing Huang; James Butler; Howard Goodman; Ervin Teper; David Silver Journal: Curr Urol Date: 2016-12-26
Authors: Jose A Karam; Catherine E Devine; Bryan M Fellman; Diana L Urbauer; E Jason Abel; Mohamad E Allaf; Axel Bex; Brian R Lane; R Houston Thompson; Christopher G Wood Journal: BJU Int Date: 2015-06-29 Impact factor: 5.588
Authors: Javier Puente Vázquez; T Alonso Gordoa; J Moreno; L Poma; E Diaz Rubio; A Gomez; J Blazquez; J L Gonzalez Larriba Journal: Curr Treat Options Oncol Date: 2015-03