Clear cell renal cell carcinoma

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There are several related dedicated pages:

• General RCC page: Renal cell carcinoma
• Histology-specific:
  • Clear cell renal cell carcinoma (this page)
  • Non-clear cell renal cell carcinoma
    • Papillary renal cell carcinoma
    • Sarcomatoid renal cell carcinoma
• Biomarker-specific:
  • RCC, VHL-associated

34 regimens on this page 48 variants on this page

Guidelines

EAU

• 2016: Powles et al. Updated EAU guidelines for clear cell renal cancer patients who fail VEGF targeted therapy PubMed

ESMO

• 2021: Powles Recent eUpdate to the ESMO Clinical Practice Guidelines on renal cell carcinoma on cabozantinib and nivolumab for first-line clear cell renal cancer: Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Metastatic disease, second-line

Nivolumab monotherapy

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Regimen

Study	Years of enrollment	Evidence
McFarlane et al. 2020 (CheckMate 374)	2015-2016	Phase 3b/4

Immunotherapy

• Nivolumab (Opdivo) 240 mg IV once on day 1

14-day cycles

References

1. CheckMate 374: McFarlane JJ, Kochenderfer MD, Olsen MR, Bauer TM, Molina A, Hauke RJ, Reeves JA, Babu S, Van Veldhuizen P, Somer B, Gunuganti V, Schnadig I, George S, Page RD, Arrowsmith E, Jain RK, Zhang J, McHenry MB, Johansen JL, Vogelzang NJ. Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study. Clin Genitourin Cancer. 2020 Dec;18(6):469-476.e4. Epub 2020 Jun 14. link to original article contains protocol PubMed NCT02596035

Sorafenib monotherapy

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Escudier et al. 2007 (TARGETRCC)	2003-2005	Phase 3 (E-RT-esc)	Placebo	Did not meet primary endpoint of OS1

¹Reported efficacy for TARGET is based on the 2009 update.
Note that TARGET should not be confused with the study by the same name in breast cancer.

Targeted therapy

• Sorafenib (Nexavar) 400 mg PO twice per day
  • Can be decreased to 400 mg PO once per day or 400 mg PO every other day if needed due to toxicity

Continued indefinitely

References

1. TARGET: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. link to original article contains verified protocol PubMed NCT00073307
   1. Update: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. Epub 2009 May 18. link to original article PubMed
   2. Subgroup analysis: Hutson TE, Bellmunt J, Porta C, Szczylik C, Staehler M, Nadel A, Anderson S, Bukowski R, Eisen T, Escudier B; Sorafenib TARGET Clinical Trial Group. Long-term safety of sorafenib in advanced renal cell carcinoma: follow-up of patients from phase III TARGET. Eur J Cancer. 2010 Sep;46(13):2432-40. Epub 2010 Jul 23. link to original article contains verified protocol PubMed