Renal Cell Carcinoma Treatment Regimens

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RENAL CELL CARCINOMA TREATMENT REGIMENS

Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced health care team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The renal cell carcinoma cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These renal cell carcinoma cancer treatment regimens are provided only to supplement the latest treatment strategies.

These Cancer Treatment Guidelines are a work in progress that may be refined as often as new significant data become available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

General treatment notes:1

• Targeted therapy using tyrosine kinase inhibitors and anti-vascular endothelial growth factor antibodies is now widely used as first- and second-line treatments in renal cell carcinoma (RCC). To date, seven such agents have been approved by the FDA for the treatment of advanced RCC: sunitinib, sorafenib, pazopanib, axitinib, temsirolimus, everolimus, and bevacizumab in combination with interferon.

• Prior to targeted therapies, systemic treatment options were limited to cytokine therapy, notably IL-2 and interferon-α-2A (IFN-α-2a).

First-line Therapy for Patients with Predominantly Clear Cell Histology1

Note: All recommendations are Category 2A unless otherwise indicated.

(Revised 1/2017)

© 2017 Haymarket Media, Inc.

REGIMEN

DOSING

Pazopanib (Category 1; preferred)2,3

Pazopanib 800mg orally once daily without food.

Sunitinib (Category 1; preferred)4,5

Sunitinib 50mg orally daily with or without food for 4 weeks, followed by 2 weeks off.

Bevacizumab + IFN-α (Category 1)6-8

Bevacizumab 10mg/kg IV every 2 weeks + IFN-α.

Temsirolimus (Category 1: poor-prognosis patients; Category 2B: selected patients of other risk groups)9,10

Temsirolimus 25mg IV over 30–60 minutes once weekly until disease progression or unacceptable toxicity.

Axitinib11,12a

Axitinib 5mg orally every 12 hours.

High-dose IL-2 (for selected patients with excellent performance status and normal organ function)13,14b

Days 1–5 and 15–19: IL-2 600,000 IU/kg IV every 8 hours (max 14 doses).

Repeat cycle every 4 weeks for max 3 cycles.

Sorafenib (for selected patients)15c

Sorafenib 400mg orally twice daily without food.

Subsequent Therapy for Patients with Predominantly Clear Cell Carcinoma1

Cabozantinib (Category 1; preferred)16d

Cabozantinib 60mg orally once daily without food until disease progression or unacceptable toxicity.

Nivolumab (Category 1; preferred)17,18d

Nivolumab 240mg IV every 2 weeks until disease progression or unacceptable toxicity.

Axitinib (Category 1)11,12a

Axitinib 5mg orally every 12 hours.

Lenvatinib + everolimus (Category 1)19

Lenvatinib 18 mg orally once daily + everolimus 5 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Everolimus20,21

Everolimus 10mg orally once daily with or without food.

Pazopanib2,3

Pazopanib 800mg orally once daily without food.

Sorafenib22-25

Sorafenib 400mg orally twice daily without food.

Sunitinib4,26,27

Sunitinib 50mg orally daily with or without food for 4 weeks, followed by 2 weeks off.

Bevacizumab (Category 2B)28

Bevacizumab 10mg/kg IV every 2 weeks.

High-dose IL-2 (for selected patients) (Category 2B)13,14b

Days 1–5 and 15–19: IL-2 600,000 IU/kg IV every 8 hours (max 14 doses).

Repeat cycle every 4 weeks for max 3 cycles.

Temsirolimus (Category 2B)29,30

Temsirolimus 25mg IV over 30-60 minutes weekly until disease progression or unacceptable toxicity.

Systemic Therapy for Patients with Non-Clear Cell Histology1

Sunitinib (preferred)4,26,27

Sunitinib 50mg orally daily with or without food for 4 weeks, followed by 2 weeks off.

Axitinib11,12a

Axitinib 5mg orally every 12 hours.

Bevacizumab28

Bevacizumab 10mg/kg IV every 2 weeks.

Cabozantinib16d

Cabozantinib 60mg orally once daily without food until disease progression or unacceptable toxicity.

Erlotinib31e

Erlotinib 150mg orally once daily without food.

Everolimus20,21

Everolimus 10mg orally once daily with or without food.

Lenvatinib + everolimus19

Lenvatinib 18 mg orally once daily + everolimus 5 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Nivolumab17,18d

Nivolumab 240mg IV every 2 weeks until disease progression or unacceptable toxicity.

Pazopanib2,3

Pazopanib 800mg orally once daily without food.

Sorafenib22-25

Sorafenib 400mg orally twice daily without food.

Temsirolimus (Category 1: poor-prognosis patients; Category 2A: selected patients of other risk groups)27,28

Temsirolimus 25mg IV over 30–60 minutes weekly until disease progression or unacceptable toxicity.

a May increase to 7mg every 12 hours after 2 weeks based on criteria; may increase to 10mg every 12 hours after 2 weeks based on criteria.

b Treatments divided into 60-day courses, with each IV treatment course consisting of 2 cycles of therapy, separated by approximately 7–10 days of rest with no other therapy during the remainder of the 60 days.

c Patients who progressed were dose-escalated to 600 mg twice daily.

d Based on the results of phase III trials, eligible patients should preferentially receive this agent over everolimus.

e Erlotinib is used off-label for RCC. The NCCN guidelines include it as an optional first-line therapy for patients with relapsed or medically unresectable stage IV non-clear cell carcinoma.

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology™. Kidney. v 2.2017. Available at: http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed December 16, 2016.

2. Votrient [package insert]. Research Triangle Park, NC: GSK; 2016.

3. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28:1061–1068.

4. Sutent [package insert]. New York, NY: Pfizer Labs; 2016.

5. Gore ME, Szczylik C, Porta C, et al. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009;10:757–763.

6. Avastin [package insert]. San Francisco, CA: Genentech; 2016.

7. Escudier B, Pluzanska A, Koralewski P, et al; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370:2103–2111.

8. 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;28:2137–2143.

9. Torisel [package insert]. Philadelphia, PA: Wyeth; 2016.

10. Hudes G, Carducci M, Tomczak P, et al; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356:2271–2281.

11. Inlyta [package insert]. New York, NY: Pfizer Inc; 2016.

12. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomized phase 3 trial. Lancet. 2011;378:1931–1939.

13. Proleukin [package insert]. San Diego, CA: Prometheus Laboratories; 2016.

14. McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005;23:133–141.

15. Escudier B, Szczylik C, Hutson TE, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009;27(8):1280–1289.

16. Choueiri TK, Escudier B, Powles T, et al; METEOR Investigators. Cabozantinib versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1814–1823.

17. Motzer RJ, Escudier B, McDermott DF, et al; CheckMate 025 Investigators. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1803–1813.

18. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2016.

19. Lenvima [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2016.

20. Afinitor [package insert]. East Hanover, NJ: Novartis; 2016.

21. Motzer RJ, Escudier B, Oudard S, et al; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372:449–456.

22. Nexavar [package insert]. Wayne, NJ: Bayer HealthCare; 2016.

23. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear cell renal-cell carcinoma. N Engl J Med. 2007;356:125–134.

24. Di Lorenzo G, Carteni G, Autorino R, et al. Phase II study of sorafenib in patients with sunitinib-refractory metastatic renal cell cancer. J Clin Oncol. 2009;27:4469–4474.

25. Garcia JA, Hutson TE, Elson P, et al. Sorafenib in patients with metastatic renal cell carcinoma refractory to either sunitinib or bevacizumab. Cancer. 2010;116:5383–5390.

26. Motzer RJ, Michaelson MD, Redman BG, et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24:16–24.

27. Motzer RJ, Rini BI, Bukowski RM, et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006;295:2516–2524.

28. Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody,for metastatic renal cancer. N Engl J Med. 2003;349:427–434.

29. Atkins MB, Hidalgo M, Stadler WM, et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol. 2004;22:909–918.

30. Hutson TE, Escudier B, Esteban E, et al. Temsirolimus vs Sorafenib as Second Line Therapy in Metastatic Renal Cell Carcinoma: Results from the INTORSECT Trial [abstract]. Ann Oncol. 2012;23:Abstract: LBA22.

31. Gordon MS, Hussey M, Nagle RB, et al. Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol. 2009;27:5788–5793.


Genitourinary Cancer Drug Monographs

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Bladder, Kidney, And Other Urologic Cancers

AFINITOR AVASTIN CABOMETYX
Cisplatin COSMEGEN DEPO-PROVERA
Doxorubicin HCl Doxorubicin HCl Solution INLYTA
LENVIMA NEXAVAR OPDIVO
PROLEUKIN SUTENT TECENTRIQ
Thiotepa TICE BCG TORISEL
VALSTAR VINCASAR PFS VOTRIENT

Prostate And Other Male Cancers

Bleomycin CASODEX Cisplatin
COSMEGEN DELESTROGEN ELIGARD
EMCYT ESTRACE ETOPOPHOS
FIRMAGON Flutamide IFEX
JEVTANA Leuprolide acetate LUPRON DEPOT 7.5mg
LUPRON DEPOT-3 MONTH 22.5mg LUPRON DEPOT-4 MONTH 30mg LUPRON DEPOT-6 MONTH 45mg
MENEST Mitoxantrone HCl NILANDRON
PREMARIN PROVENGE TAXOTERE
TOPOSAR TRELSTAR VANTAS
Vinblastine for injection Vinblastine injection XOFIGO
XTANDI ZOLADEX ZOLADEX 3-MONTH 10.8mg
ZYTIGA

Data provided by the Monthly Prescribing Reference (MPR) Hematology/Oncology Edition.

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