Cytoreductive Nephrectomy in Patients with Synchronous Metastases from Renal Cell Carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium

Heng, Daniel Y.C.; Wells, J.C.; Rini, Brian I.; Beuselinck, Benoît; Lee, Jae‐Lyun; Knox, Jennifer J.; Bjarnason, Georg A.; Pal, Sumanta K.; Kollmannsberger, Christian; Yuasa, Takeshi; Srinivas, Sandy; Donskov, Frede; Bamias, Aristotelis; Wood, Lori; Ernst, D. Scott; Agarwal, Neeraj; Vaishampayan, Ulka N.; Rha, Sun Young; Kim, Jaeyeon; Choueiri, Toni K.

doi:10.1016/j.eururo.2014.05.034

Cited by 420 publications

(322 citation statements)

References 17 publications

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“…These patients have a poor outcome, which is supported by retrospective series and prognostic scoring systems 4,5 . There is also uncertainty about the role and timing of nephrectomy.…”

Section: Discussionmentioning

confidence: 89%

“…These patients had a poor outcome irrespective of whether they had surgery (median overall survival <6 months, eFigure 2). Previous retrospective analysis of other smaller prospective series with sunitinib suggested that nephrectomy was not recommended in this setting 4,15 . Our data supports this recommendation with the most robust data to date.…”

Section: Discussionmentioning

confidence: 99%

“…4 were not assessable as they came off drug for toxicity prior to radiological assessment for clinical benefit. The primary objective of the trial was achieved with 84/100 [84% (95% CI: 75% -91%)] patients achieving clinical benefit.…”

Section: Efficacy Of Upfront Pazopanibmentioning

confidence: 99%

“…The use of nephrectomy in metastatic disease was established prior to the development of VEGF TKIs 2,3 . This sequence has not been prospectively evaluated in the era of VEGF targeted therapy, although large recent retrospective series suggest nephrectomy is still associated with a survival benefit in unselected patients 4 . A potential problem with this sequence is that there is a significant delay in starting VEGF targeted therapy while patients are recovering from the nephrectomy.…”

Section: Introductionmentioning

confidence: 99%

“…A potential problem with this sequence is that there is a significant delay in starting VEGF targeted therapy while patients are recovering from the nephrectomy. This is of particular concern for patients with aggressive disease or poor prognostic features where any delay in disease control may be detrimental [4][5][6] .…”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of Pazopanib Therapy Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer

et al. 2016

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“…These patients have a poor outcome, which is supported by retrospective series and prognostic scoring systems 4,5 . There is also uncertainty about the role and timing of nephrectomy.…”

Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Efficacy Of Upfront Pazopanibmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of Pazopanib Therapy Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer

et al. 2016

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Survival Outcomes Associated With Cytoreductive Nephrectomy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

et al. 2022

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IMPORTANCELevel I evidence has failed to demonstrate an overall survival (OS) advantage for cytoreductive nephrectomy in patients with metastatic clear cell renal cell carcinoma (ccRCC) in the modern era, which is at odds with observational studies reporting a marked OS benefit associated with these operations. These observational studies were not designed to adjust for unmeasured confounding.OBJECTIVE To assess whether cytoreductive nephrectomy is associated with improved OS in patients with metastatic ccRCC.

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Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib

et al. 2019

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patients with primary metastatic renal cell carcinoma (mRCC) have been offered cytoreductive nephrectomy (CN) followed by targeted therapy, but the optimal sequence of surgery and systemic therapy is unknown. OBJECTIVE To examine whether a period of sunitinib therapy before CN improves outcome compared with immediate CN followed by sunitinib. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial began as a phase 3 trial on July 14, 2010, and continued until March 24, 2016, with a median follow-up of 3.3 years and a clinical cutoff date for this report of May 5, 2017. Patients with mRCC of clear cell subtype, resectable primary tumor, and 3 or fewer surgical risk factors were studied. INTERVENTIONS Immediate CN followed by sunitinib therapy vs treatment with 3 cycles of sunitinib followed by CN in the absence of progression followed by sunitinib therapy. MAIN OUTCOMES AND MEASURES Progression-free survival was the primary end point, which needed a sample size of 458 patients. Because of poor accrual, the independent data monitoring committee endorsed reporting the intention-to-treat 28-week progression-free rate (PFR) instead. Overall survival (OS), adverse events, and postoperative progression were secondary end points. RESULTS The study closed after 5.7 years with 99 patients (80 men and 19 women; mean [SD] age, 60 [8.5] years). The 28-week PFR was 42% in the immediate CN arm (n = 50) and 43% in the deferred CN arm (n = 49) (P = .61). The intention-to-treat OS hazard ratio of deferred vs immediate CN was 0.57 (95% CI, 0.34-0.95; P = .03), with a median OS of 32.4 months (95% CI, 14.5-65.3 months) in the deferred CN arm and 15.0 months (95% CI, 9.3-29.5 months) in the immediate CN arm. In the deferred CN arm, 48 of 49 patients (98%; 95% CI, 89%-100%) received sunitinib vs 40 of 50 (80%; 95% CI, 67%-89%) in the immediate arm. Systemic progression before planned CN in the deferred CN arm resulted in a per-protocol recommendation against nephrectomy in 14 patients (29%; 95% CI, 18%-43%). CONCLUSIONS AND RELEVANCE Deferred CN did not improve the 28-week PFR. With the deferred approach, more patients received sunitinib and OS results were higher. Pretreatment with sunitinib may identify patients with inherent resistance to systemic therapy before planned CN. This evidence complements recent data from randomized clinical trials to inform treatment decisions in patients with primary clear cell mRCC requiring sunitinib.

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Cytoreductive Nephrectomy in Patients with Synchronous Metastases from Renal Cell Carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium

Abstract: We looked at the survival outcomes of metastatic renal cell carcinoma patients who did or did not have the primary tumor removed. We found that most patients benefited from tumor removal, except for those with four or more IMDC risk factors.

Cited by 420 publications

References 17 publications

Safety and Efficacy of Pazopanib Therapy Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer

Safety and Efficacy of Pazopanib Therapy Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer

Survival Outcomes Associated With Cytoreductive Nephrectomy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib

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