Renal Cell Carcinoma Treatment Protocols 

Renal Cell Carcinoma Treatment Protocols 

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Treatment protocols for renal cell carcinoma are provided below, including treatment of localized and advanced disease and recommendations for patients with predominantly clear cell carcinoma and those with predominantly non–clear cell carcinoma. [1]

The therapeutic approach for renal cell carcinoma is guided by the probability of cure, which is related directly to the stage or degree of tumor dissemination. More than 50% of patients with early stage renal cell carcinoma are cured, but the outcome for stage IV disease is poor; thus, the approach is curative for early stage disease. [2]

Adjuvant treatment currently does not have a role in patients who have undergone a complete tumor resection; observation remains the standard of care after nephrectomy or clinical-trial enrollment. [3, 4, 5, 6]

See Renal Cell Carcinoma: Recognition and Follow-up, a Critical Images slideshow, to help evaluate renal masses and determine when and what type of follow-up is necessary.

Surgical resection is the preferred treatment for localized disease, [7] including radical or partial nephrectomy or nephron-sparing surgery. Radical nephrectomy is commonly preferred for treatment of tumors that extend into the inferior vena cava. [7]

Stage IA:

Surgical resection with partial nephrectomy is preferred (open/robotic/laparoscopic) [8, 9, 10, 11, 12]

If partial nephrectomy is not feasible or the tumor is centrally located, radical nephrectomy may be recommended

Active surveillance is preferred in selected patients

Thermal ablation may be considered for nonsurgical candidates [13]

Stage IB:

Partial nephrectomy (open/robotic/laparoscopic) or radical nephrectomy is the standard treatment

Stages II and III:

Radical nephrectomy is the preferred treatment for most patients

See the list below:

Primary treatment includes consideration for cytoreductive nephrectomy for primary tumor before systemic therapy in patients with a resectable primary tumor [14]

Cytoreductive nephrectomy is recommended in selected patients with favorable performance status [15]

First-line therapy for previously untreated patients low or intermediate risk:

Clinical trial or

Sunitinib 50 mg/day PO for 28 d; every 6 wk (compared with interferon, it provides increased progression-free survival [PFS] and overall survival [OS]: PFS is 11 mo with sunitinib vs 5 mo with interferon alone; median overall survival is 26.4 mo vs 21.8 mo with interferon alone, and response is 47% with sunitinib vs 12% with interferon alone) or

Sorafenib 400 mg (two 200 mg tablets) PO BID either 1 h before or 2 h after meals [16, 17] (this can be considered first-line therapy if the patient is not able to receive any of the other first-line therapies) or

Pazopanib 800 mg/day PO either 1 h before or 2 h after meals [18] (it is superior to best supportive care with or without cytokines: PFS is 9.2 mo with pazopanib vs 4.2 mo without pazopanib, and OS is nonsignificantly superior with pazopanib, at 22.9 mo vs 20.5 mo) or

High-dose interleukin (IL)-2 in selected patients (ie, excellent performance status and normal organ function): recombinant IL-2 600,000-720,000 IU/kg IV over 15 min every 8 h for 14 consecutive doses on days 1-5 and days 15-19; re-treat in responding patients and those with stable disease every 12 wk for up to three cycles [19] (this should be considered first-line therapy in carefully selected younger patients with good performance status) or

Interferon alfa-2a 9 million units SC three times weekly for 1y plus bevacizumab 10 mg/kg every 2 wk [20, 21] (bevacizumab and interferon are superior to single-agent interferon: OS is nonsignificantly superior [18.3 mo vs 17.4 mo], and PFS [8.5 mo vs 5.2 mo] and objective response [25.5% vs 13.1%] are significantly superior) and

Supportive care: palliative radiation therapy, metastasectomy, and bisphosphonates for bony metastasis

First-line for previously untreated clear-cell renal cell cancer in patients with poor prognostic (high-risk) characteristics and patients with non–clear cell history:

Temsirolimus 25 mg IV weekly until disease progression [22, 23] (compared with single-agent interferon, it significantly prolongs OS [10.9 mo vs 7.3 mo] and PFS [5.5 mo vs 3.1 mo]) when compared with single-agent interferon; consider as first option for patients with poor prognosis

Nivolumab 3 mg/kg IV infused over 30 min, followed by ipilimumab 1 mg/kg IV infused over 30 min on the same day; repeat every 3 weeks for 4 doses; then  nivolumab as a single agent, 240 mg IV q2wk or 480 mg IV q4wk infused over 30 min; significantly prolongs OS at 18 mo compared with sunitinib (75% vs 60%, respectively) [24]

Sunitinib, pazopanib, or sorafenib if the patient is not a candidate to receive temsirolimus

Patients with predominantly sarcomatoid renal cancers may respond to combination chemotherapy

Subsequent targeted therapy after tyrosine kinase inhibitors (ie, axitinib, pazopanib, sorafenib, sunitinib):

Sorafenib is superior to placebo in patients in whom interferon therapy failed: PFS improves (5.5 mo vs 2.8 mo), and OS trends better (17.8 mo vs 15.2 mo) or

Everolimus 10 mg PO once daily, improves survival compared with placebo in patients in whom sunitinib or sorafenib therapy previously failed: PFS is statistically superior (4.9 mo vs 1.9 mo), and OS is better but not significantly so [25] or

Axitinib 5 mg PO BID; comparable to sorafenib: Longer PFS (8.3mo vs 5-7mo) and similar OS (20.2 mo vs 19.2 mo) or

Sunitinib 50 mg PO once daily; 6-week cycle (4 weeks on followed by 2 weeks off treatment, then repeat) or

Pazopanib 800 mg PO once daily or

Temsirolimus 25 mg IV once weekly or

Bevacizumab 10 mg/kg IV q2 wk until disease progression or unacceptable toxicity

Subsequent targeted therapy after cytokine therapy:

Axitinib 5 mg PO BID or

Sorafenib 400 mg PO BID or

Sunitinib 50 mg PO once daily; 6-week cycle (4 weeks on followed by 2 weeks off treatment, then repeat) or

Pazopanib 800 mg PO once daily or

Temsirolimus 25 mg IV once weekly or

Bevacizumab 10 mg/kg IV q2 wk until disease progression or unacceptable toxicity or

Subsequent cytokine therapy with IL-2

Subsequent targeted therapy after antiangiogenic therapy:

Clinical trial (preferred) or:

Temsirolimus 25 mg IV weekly; continue until disease progression [29, 30] or

Sorafenib 400 mg PO (two 200 mg tablets) twice daily either 1 h before or 2 h after meals or

Sunitinib 50 mg PO daily; 6-week cycle (4 weeks on followed by 2 weeks off treatment, then repeat) or

Pazopanib 800 mg PO once daily either 1 h before or 2 h after meals or

Axitinib 5 mg PO q12 h or

Everolimus 10 mg PO once daily or

Bevacizumab 10 mg/kg IV q2wk or

Erlotinib 150 mg once daily (off-label use; not approved by the US Food and Drug Administration [FDA] for renal cell carcinoma) or

Gemcitabine and doxorubicin for disease with sarcomatoid-only features: doxorubicin 50 mg/m2 IV push on day 1 plus gemcitabine 1500 or 2000 mg/m2 IV on day 1 every 2-3 wk with granulocyte colony-stimulating factor (G-CSF) support [31] or

Supportive care

Supportive care is essential for patients diagnosed with metastatic renal cell carcinoma and may include any of the following:

Tyrosine kinase inhibitors have the potential to cause hand-foot syndrome, which usually consists of blisters, hyperkeratosis in areas of friction, acral erythema with or without paresthesias, and pain in the palms and soles. For mild (grade I) changes, topical corticosteroids and moisturizers are helpful; dose reduction may be needed for grade II changes, and temporary discontinuance of the drug may be needed for grade III. This condition is more common with sorafenib (30-60%).

Other common adverse events seen with sorafenib are rash, upper and lower gastrointestinal distress (eg, diarrhea), fatigue, and hypertension. These typically range from grade I to III in severity. [33]

Mammalian target of rapamycin (mTOR) inhibitors have common toxicities, including skin rash, asthenia, loss of appetite, and nausea; anemia is common.

See the list below for overall 5-year survival according to stage: [34]

Stage I: 81%

Stage II: 74%

Stage III: 53%

Stage IV: 8%

The size of the primary tumor remains a prognostic factor in patients with non-metastatic RCC. The 10-year kidney cancer–specific survival rates for tumors of varying sizes are as follows [35] :

<4 cm: 95%

4-7 cm: 89%

>7 cm: 79%

Median survival for patients with stage IV disease is 19 months [36]

Clinical trials of newest therapies have reported median survival >2 years [26]

Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A, et al. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer-Verlag; 2010.

Mekhail TM, Abou-Jawde RM, Boumerhi G, Malhi S, Wood L, Elson P. Validation and extension of the Memorial Sloan-Kettering prognostic factors model for survival in patients with previously untreated metastatic renal cell carcinoma. J Clin Oncol. 2005 Feb 1. 23(4):832-41. [Medline].

Clark JI, Atkins MB, Urba WJ, et al. Adjuvant high-dose bolus interleukin-2 for patients with high-risk renal cell carcinoma: a cytokine working group randomized trial. J Clin Oncol. 2003 Aug 15. 21(16):3133-40. [Medline].

Lam JS, Leppert JT, Belldegrun AS, Figlin RA. Adjuvant therapy of renal cell carcinoma: patient selection and therapeutic options. BJU Int. 2005 Sep. 96(4):483-8. [Medline].

Messing EM, Manola J, Wilding G, et al. Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial. J Clin Oncol. 2003 Apr 1. 21(7):1214-22. [Medline].

NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. V 3.2018 (February 6, 2018). Available at Accessed: April 16, 2018.

Motzer RJ, Agarwal N, Beard C, et al. NCCN clinical practice guidelines in oncology: kidney cancer. J Natl Compr Canc Netw. 2009 Jun. 7(6):618-30. [Medline].

Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH. Guideline for management of the clinical T1 renal mass. J Urol. 2009 Oct. 182(4):1271-9. [Medline].

Lee CT, Katz J, Shi W, Thaler HT, Reuter VE, Russo P. Surgical management of renal tumors 4 cm. or less in a contemporary cohort. J Urol. 2000 Mar. 163(3):730-6. [Medline].

Leibovich BC, Blute ML, Cheville JC, Lohse CM, Weaver AL, Zincke H. Nephron sparing surgery for appropriately selected renal cell carcinoma between 4 and 7 cm results in outcome similar to radical nephrectomy. J Urol. 2004 Mar. 171(3):1066-70. [Medline].

Shuch B, Lam JS, Belldegrun AS. Open partial nephrectomy for the treatment of renal cell carcinoma. Curr Urol Rep. 2006 Jan. 7(1):31-8. [Medline].

Weight CJ, Larson BT, Gao T, Campbell SC, Lane BR, Kaouk JH, et al. Elective partial nephrectomy in patients with clinical T1b renal tumors is associated with improved overall survival. Urology. 2010 Sep. 76(3):631-7. [Medline].

Kunkle DA, Uzzo RG. Cryoablation or radiofrequency ablation of the small renal mass : a meta-analysis. Cancer. 2008 Nov 15. 113(10):2671-80. [Medline]. [Full Text].

Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22. 358 (9286):966-70. [Medline].

Alt AL, Boorjian SA, Lohse CM, Costello BA, Leibovich BC, Blute ML. Survival after complete surgical resection of multiple metastases from renal cell carcinoma. Cancer. 2011 Jan 10. [Medline].

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Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11. 356(2):125-34. [Medline].

Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20. 28(6):1061-8. [Medline].

Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar. 13(3):688-96. [Medline].

Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22. 370(9605):2103-11. [Medline].

Rini BI, Halabi S, Rosenberg JE, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010 May 1. 28(13):2137-43. [Medline]. [Full Text].

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Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1. 27(22):3584-90. [Medline].

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Motzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov. 16 (15):1473-82. [Medline].

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31. 356(22):2271-81. [Medline].

Dutcher JP, de SP, McDermott D, et al. Effect of temsirolimus versus interferon-alpha on outcome of patients with advanced renal cell carcinoma of different tumor histologies. Med Oncol. 2009. 26:202-9.

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Lipton A, Zheng M, Seaman J. Zoledronic acid delays the onset of skeletal-related events and progression of skeletal disease in patients with advanced renal cell carcinoma. Cancer. 2003 Sep 1. 98(5):962-9. [Medline].

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Kutikov A, Egleston BL, Wong YN, Uzzo RG. Evaluating overall survival and competing risks of death in patients with localized renal cell carcinoma using a comprehensive nomogram. J Clin Oncol. 2010 Jan 10. 28 (2):311-7. [Medline].

Heng DY, Xie W, Regan MM, Harshman LC, Bjarnason GA, Vaishampayan UN, et al. External validation and comparison with other models of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study. Lancet Oncol. 2013 Feb. 14 (2):141-8. [Medline].

Kush Sachdeva, MD Southern Oncology and Hematology Associates, Inspira Health Network

Disclosure: Nothing to disclose.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee

Christopher D Braden, DO is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology

Disclosure: Nothing to disclose.

E Jason Abel, MD Associate Professor of Urologic Oncology, Department of Urology, Associate Professor of Radiology (Affiliate Appointment), Department of Radiology, University of Wisconsin School of Medicine and Public Health; Attending Urologist, William S Middleton Memorial Veterans Hospital

E Jason Abel, MD is a member of the following medical societies: American Medical Association, American Society of Clinical Oncology, American Urological Association, Harris County Medical Society, Kidney Cancer Association, Society for Basic Urologic Research, Society of Urologic Oncology, Texas Medical Association

Disclosure: Nothing to disclose.

Renal Cell Carcinoma Treatment Protocols 

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